CONCLUSION ON PESTICIDES PEER REVIEW
APPROVED: 19 February 2016
PUBLISHED: 07 March 2016
doi:10.2903/j.efsa.2016.4419
Peer review of the pesticide risk assessment of the active
substance mesotrione
European Food Safety Authority (EFSA)
Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial
risk assessments carried out by the competent authorities of the rapporteur Member State the United
Kingdom and co-rapporteur Member State Belgium for the pesticide active substance mesotrione are
reported. The context of the peer review was that required by Commission Implementing Regulation
(EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative
use of mesotrione as a herbicide on maize. The reliable end points, appropriate for use in regulatory
risk assessment are presented. Missing information identified as being required by the regulatory
framework is listed. Concerns are identified.
© European Food Safety Authority, 2016
Key words: mesotrione, peer review, risk assessment, pesticide, herbicide
Requestor: European Commission
Question number: EFSA-Q-2014-00743
Correspondence: [email protected]
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EFSA Journal 2016;14(3):4419
Peer review of the pesticide risk assessment of the active substance mesotrione
Suggested citation: EFSA (European Food Safety Authority), 2016. Conclusion on the peer review
of the pesticide risk assessment of the active substance mesotrione. EFSA Journal 2016;14(3):4419,
103 pp. doi:10.2903/j.efsa.2016.4419
ISSN: 1831-4732
© European Food Safety Authority, 2016
Reproduction is authorised provided the source is acknowledged.
The EFSA Journal is a publication of the European Food
Safety Authority, an agency of the European Union.
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Summary
Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’)
lays down the procedure for the renewal of the approval of active substances submitted under Article
14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission
Implementing Regulation (EU) No 686/2012. Mesotrione is one of the active substances listed in
Regulation (EU) No 686/2012.
In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the United
Kingdom, and co-rapporteur Member State (co-RMS), Belgium, received an application from Syngenta
Crop Protection AG for the renewal of approval of the active substance mesotrione. Complying with
Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the
applicant, the co-RMS (Belgium), the European Commission and the European Food Safety Authority
(EFSA) about the admissibility.
The RMS provided its initial evaluation of the dossier on mesotrione in the renewal assessment report
(RAR), which was received by EFSA on 23 February 2015. In accordance with Article 12 of the
Regulation, EFSA distributed the RAR to the Member States and the applicant, Syngenta Crop
Protection AG, for comments on 17 April 2015. EFSA also provided comments. In addition, EFSA
conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to
the European Commission on 18 June 2015.
Following consideration of the comments received on the RAR, it was concluded that additional
information should be requested from the applicant, and that EFSA should conduct an expert
consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and
ecotoxicology.
In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether
mesotrione can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC)
No 1107/2009 of the European Parliament and of the Council.
The conclusions laid down in this report were reached on the basis of the evaluation of the
representative use of mesotrione as a herbicide on maize, as proposed by the applicant. Full details of
the representative uses can be found in Appendix A of this report.
The use of mesotrione according to the representative use proposed at EU level results in a sufficient
herbicidal efficacy against the target weeds.
In the area of identity, physical/chemical/technical properties and methods of analysis, a data gap was
identified for specifying two of the significant impurities on dry weight basis. Data gaps were identified
for validation data of methods used in data generation.
Regarding the mammalian toxicology area, a number of data gaps were identified. The toxicological
relevance of individual impurities present in the technical specification in comparison with the toxicity
profile of mesotrione needs to be addressed. Interspecies comparative in vitro metabolism should be
conducted to identify at least potentially unique human metabolites to mesotrione. As the genotoxic
potential of metabolite AMBA could not be ruled out due to positive results obtained in an in vitro
cytogenetic assay, and no in vivo genotoxicity testing was performed, a critical area of concern has
been identified regarding consumer risk assessment; repeated dose toxicity would also have to be
addressed for this metabolite. Mesotrione is proposed to be classified as Repr. 2 for development by
the peer review (in contrast with the harmonised classification according to CLP Regulation) and
adverse effects were observed on endocrine organs. Therefore, according to the interim provisions of
Annex II, point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health, mesotrione may be
considered to have endocrine disrupting properties. As no study is available to investigate a potential
ED mode of action, a general data gap has been identified such as level 2 and 3 indicated in the OECD
Conceptual Framework to address this issue; this was identified as another critical area of concern.
The consumer dietary risk assessment could not be finalised with regard to products of animal origin
considering the requested clarification of the genotoxic potential and the toxicological profile of AMBA.
Furthermore, the consumer risk assessment from consumption of drinking water could not be finalised
whilst the nature of residues in drinking water following water treatment had not been addressed.
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A data gap was also identified for the determination of the residues in pollen and bee products for
human consumption.
Enough information was available to finalise the exposure assessment in the environment.
Nevertheless, a data gap has been identified for the applicant to address the substances of potential
toxicological concern that could be derived from mesotrione and its metabolites under drinking water
treatment procedure conditions to assess if the approval criteria in Article 4 of Regulation (EC) No
1107/2009 are satisfied.
In the area of ecotoxicology, a data gap and a critical area of concern were identified to further
address the long-term risk for wild mammals. A data gap was identified to further refine the risk to
aquatic organisms in the scenarios R2, R3, and R4. Data gaps were also identified for bees to provide
information to further assess the risk to adult honeybees and honeybee larvae from exposure via
guttation and via consumption of contaminated water. Effects on HPG development should be
considered. Furthermore additional data would be needed to assess the risk to honeybees for relevant
metabolites in pollen and nectar. The risk to non-target terrestrial plants was low with mitigation
measures. A data gap was also identified to further address the sensitivity to mesotrione of
dicotyledonous and monocotyledonous plant species.
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Table of contents
Abstract .........................................................................................................................................1
Summary .......................................................................................................................................3
Background....................................................................................................................................6
The active substance and the formulated product ............................................................................8
Conclusions of the evaluation ..........................................................................................................8
1.
Identity, physical/chemical/technical properties and methods of analysis ................................8
2.
Mammalian toxicity .............................................................................................................9
3.
Residues........................................................................................................................... 10
4.
Environmental fate and behaviour ...................................................................................... 12
5.
Ecotoxicology .................................................................................................................... 13
6.
Overview of the risk assessment of compounds listed in residue definitions triggering
assessment of effects data for the environmental compartments ......................................... 16
7.
Data gaps ......................................................................................................................... 18
8.
Particular conditions proposed to be taken into account to manage the risk(s) identified ....... 19
9.
Concerns .......................................................................................................................... 19
9.1.
Issues that could not be finalised ....................................................................................... 19
9.2.
Critical areas of concern .................................................................................................... 19
9.3.
Overview of the concerns identified for each representative use considered ......................... 20
References ................................................................................................................................... 22
Abbreviations ............................................................................................................................... 25
Appendix A – List of end points for the active substance and the representative formulation ............ 30
Appendix B – Used compound code(s) ........................................................................................ 102
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Background
Commission Implementing Regulation (EU) No 844/20121 (hereinafter referred to as ‘the Regulation’)
lays down the provisions for the procedure of the renewal of the approval of active substances,
submitted under Article 14 of Regulation (EC) No 1107/2009.2 This regulates for the European Food
Safety Authority (EFSA) the procedure for organising the consultation of Member States, the
applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS)
and/or co-rapporteur Member State (co-RMS) in the renewal assessment report (RAR), and the
organisation of an expert consultation where appropriate.
In accordance with Article 13 of the Regulation, unless formally informed by the European
Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the
active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation
(EC) No 1107/2009 within five months of the end of the period provided for the submission of written
comments, subject to an extension of up to eight months where additional information is required to
be submitted by the applicant(s) in accordance with Article 13(3).
In accordance with Article 1 of the Regulation, the RMS the United Kingdom and co-RMS Belgium
received an application from Syngenta Crop Protection AG for the renewal of approval of the active
substance mesotrione. Complying with Article 8 of the Regulation, the RMS checked the completeness
of the dossier and informed the applicant, the co-RMS (Belgium), the European Commission and EFSA
about the admissibility.
The RMS provided its initial evaluation of the dossier on mesotrione in the RAR, which was received by
EFSA on 23 February 2015 (United Kingdom, 2015a).
In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and
the applicant, Syngenta Crop Protection AG, for consultation and comments on 17 April 2015. EFSA
also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated
and forwarded all comments received to the European Commission on 18 June 2015. At the same
time, the collated comments were forwarded to the RMS for compilation and evaluation in the format
of a reporting table. The applicant was invited to respond to the comments in column 3 of the
reporting table. The comments and the applicant’s response were evaluated by the RMS in column 3.
The need for expert consultation and the necessity for additional information to be submitted by the
applicant in accordance with Article 13(3) of the Regulation were considered in a telephone
conference between EFSA, the RMS and co-RMS on 5 August 2015. On the basis of the comments
received, the applicant’s response to the comments and the RMS’s evaluation thereof, it was
concluded that additional information should be requested from the applicant, and that EFSA should
conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate
and behaviour and ecotoxicology.
The outcome of the telephone conference, together with EFSA’s further consideration of the
comments, is reflected in the conclusions set out in column 4 of the reporting table. All points that
were identified as unresolved at the end of the comment evaluation phase and which required further
consideration, including those issues to be considered in an expert consultation, were compiled by
EFSA in the format of an evaluation table.
The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points
identified in the evaluation table, together with the outcome of the expert consultation and the written
consultation on the assessment of additional information, where these took place, were reported in
the final column of the evaluation table.
A final consultation on the conclusions arising from the peer review of the risk assessment took place
with Member States via a written procedure in January-February 2016.
1
2
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the
implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the
European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 252,
19.9.2012, p. 26–32.
Regulation (EC) No 1107/2009 of 21 October 2009 of the European Parliament and of the Council concerning the placing of
plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009,
p. 1–50.
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This conclusion report summarises the outcome of the peer review of the risk assessment of the
active substance and the representative formulation, evaluated on the basis of the representative use
of mesotrione as a herbicide on maize, as proposed by the applicant. A list of the relevant end points
for the active substance and the formulation is provided in Appendix A.
In addition, a key supporting document to this conclusion is the peer review report (EFSA, 2016),
which is a compilation of the documentation developed to evaluate and address all issues raised in the
peer review, from the initial commenting phase to the conclusion. The peer review report comprises
the following documents, in which all views expressed during the course of the peer review, including
minority views, where applicable, can be found:

the comments received on the RAR;

the reporting table (10 August 2015);

the evaluation table (16 February 2016);

the reports of the scientific consultation with Member State experts (where relevant);

the comments received on the assessment of the additional information (where relevant);

the comments received on the draft EFSA conclusion.
Given the importance of the RAR, including its revisions (United Kingdom, 2015b), and the peer
review report, both documents are considered as background documents to this conclusion and, thus,
are made publicly available.
It is recommended that this conclusion report and its background documents would not be accepted
to support any registration outside the EU for which the applicant has not demonstrated that it has
regulatory access to the information on which this conclusion report is based.
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The active substance and the formulated product
Mesotrione is the ISO common name for 2-(4-mesyl-2-nitrobenzoyl)cyclohexane-1,3-dione (IUPAC).
The representative formulated product for the evaluation was ‘Callisto 100 SC’ (A12739A), a
suspension concentrate (SC) containing 100 g/L mesotrione.
The representative use evaluated was application by spraying against annual broadleaved weeds and
annual grass weeds in maize. Full details of the GAP can be found in the list of end points in Appendix
A.
Data were submitted to conclude that the use of mesotrione according to the representative use
proposed at EU level results in a sufficient herbicidal efficacy against the target weeds following the
guidance document SANCO/10054/2013 - rev. 3 (European Commission, 2013).
Conclusions of the evaluation
1.
Identity, physical/chemical/technical properties and methods of
analysis
The following guidance documents were followed in the production of this conclusion:
SANCO/3029/99-rev. 4 (European Commission, 2000a), SANCO/3030/99-rev. 4 (European
Commission, 2000b), SANCO/825/00-rev. 8.1 (European Commission, 2010), SANCO/10597/2003-rev.
10.1 (European Commission, 2012) and SANCO/10054/2013-rev. 3 (European Commission, 2013).
The reference specification for first approval was updated. The active substance is manufactured as a
technical concentrate with a minimum purity of 740 g/kg. The minimum purity of the technical
material on dry weight basis is 930 g/kg. No FAO specification exists.
Impurities R287431, R287432 and 1,2-dichloroethane are considered relevant impurities with
maximum content of 2 mg/kg, 2 g/kg and 1 g/kg respectively (on dry weight basis) (see Section 2).
The proposed specifications are based on batch data from industrial scale production and quality
control data. For two of the significant impurities a data gap was set for specifying them on dry
weight basis.
The assessment of the data package revealed no issues that need to be included as critical areas of
concern with respect to the identity, physical, chemical and technical properties of mesotrione or the
representative formulation. It should however be noted that the formulation is heat sensitive.
Furthermore a data gap was identified for validation data for a method used in data generation. The
analytical methods used for non-radiolabelled test material used in toxicity studies have not been
identified and therefore their respective validation could not be checked (data gap identified by EFSA
when drafting the conclusion, see Section 2).
The main data regarding the identity of mesotrione and its physical and chemical properties are given
in Appendix A.
Methods of analysis are available for the determination of the active substance in the technical
materials and formulation and also for the determination of the relevant impurities.
Mesotrione residues can be monitored in food and feed of plant origin by the QuEChERS method (LCMS/MS) with LOQs of 0.01 mg/kg in each commodity group. Residue monitoring method for food of
animal origin is not required as no MRLs were set, however mesotrione can be determined in food and
feed of animal origin by the QuEChERS method (LC-MS/MS) with LOQs of 0.01 mg/kg in all animal
matrices.
Residues of mesotrione and its metabolites AMBA and MNBA in soil can be monitored by LC-MS/MS
with LOQs of 0.002 mg/kg for all three compounds. Appropriate LC-MS/MS method exists for
monitoring residues of mesotrione and its metabolites AMBA and MNBA in ground water and surface
water with a LOQ of 0.05 µg/L for all compounds. It should be mentioned however, that pending on
the final residue definition for monitoring for the environmental compartment, additional data might
be required. Residues of mesotrione in air can be monitored by LC-MS/MS with a LOQ of 0.45 µg/m3.
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The QuEChERS method (LC-MS/MS) can be used for monitoring mesotrione residues in blood with a
LOQ of 0.01 mg/kg.
2.
Mammalian toxicity
The following guidance documents were followed in the production of this conclusion:
SANCO/221/2000-rev. 10 (final) (European Commission, 2003a), SANCO/10597/2003-rev. 10.1
(European Commission, 2012), Guidance on the Application of the CLP Criteria (ECHA, 2015) and
Guidance on dermal absorption (EFSA PPR Panel, 2012).
Mesotrione was discussed at the Pesticides Peer Review Experts’ meeting 134 in November 2015.
The technical specification is supported by the batches used in the toxicity studies. Three impurities
were found to be relevant: 1,2-dichloroethane that is classified inter alia as Carc 1B (harmonised
classification according to CLP Regulation3), R287431 that presented positive results in an Ames test
(in the absence and presence of metabolic activation) and R287432 that was positive in an Ames test
in the absence of metabolic activation, but did not present mutagenic activity when present at 0.54%
in the tested item. The toxicological relevance of the other individual impurities present in the
technical specification (except the two solvents whose toxicological profile is well defined) needs to be
addressed (data gap). The RMS disagreed with the setting of a data gap and in considering impurity
R287432 a relevant impurity.
Bioavailability of mesotrione was found to be limited after oral administration (70% of the
administered dose in rats and 50% in mice). Metabolism of the substance is limited and mesotrione is
rapidly excreted (>80% within 72 hours), mostly unchanged. No potential for accumulation was
observed. Low acute toxicity was observed when mesotrione was administered by the oral, dermal or
inhalation routes; no skin or eye irritation and no potential for skin sensitisation were attributed to the
active substance. No data have been provided to clarify the interspecies differences in metabolism; a
data gap was identified for an interspecies comparative in vitro study that should include human
material; the RMS disagreed with the setting of this data gap.
Mesotrione is a 4-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor, a key enzyme of the tyrosine
catabolic pathway, resulting in increased 4-hydroxyphenyl pyruvate, the proximal tyrosine metabolite
and increased blood tyrosine concentration. This mode of action is common to herbicides of the
triketone family, such as sulcotrione and tembotrione, and to the pharmaceutical drug NTBC, used in
human medicine. It has been shown that the mode of action (MoA) may be relevant to all species
tested but with different degree of sensitivity. Rats were recognised as being more sensitive to
mesotrione and primary effects in short term and long term studies, characterized by corneal lesions,
linked to tyrosinaemia, have been shown to be of lower relevance for human risk assessment. A
complete toxicological dossier has been submitted on mice and this species was considered a better
model in comparison to rats to extrapolate the risk to humans. However from a hazard point of view,
the peer review suggested a classification of mesotrione as STOT RE 2, H373 ‘May cause damage to
organs (eyes) through prolonged or repeated exposure’ 4; the RMS disagreed with the proposed
classification. Increased incidence of thyroid follicular adenomas was also considered a secondary
effect of increased levels of tyrosinaemia in rats upon long term exposure and no classification
proposal was retained regarding the carcinogenic potential of mesotrione. The active substance is
unlikely to be genotoxic.
Reproductive toxicity was investigated in rats and mice. In mice, the offspring’s NOAEL was 2 mg/kg
bw per day based on testes and kidney weight changes, while parental and reproductive NOAELs were
10 mg/kg bw per day based on increased tyrosinaemia and reduced successful mating respectively.
Developmental toxicity was investigated in rats, mice and rabbits; in both mice and rabbit’s studies,
pups were found to be more sensitive than the parents (reduced/delayed ossification in the absence
of maternal toxicity) and on this basis, classification as Repr. 2, H361d ‘suspected of damaging the
3
4
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, p. 1–1355.
It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with
Regulation (EC) No 1272/2008. Proposals for classification made in the context of the evaluation procedure under Regulation
(EC) No 1107/2009 are not formal proposals.
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unborn child’ was proposed by the peer review, in contrast with the harmonised classification
according to the CLP Regulation; the RMS disagreed with the proposed classification. With regards to
the assessment of endocrine disruptive properties of mesotrione, the substance is proposed to be
classified as Repr. 2 for development and adverse effects were observed on endocrine organs:
increased testes and epididymides weights, and thyroid adenomas in female rats. Therefore,
according to the interim provisions of Annex II, point 3.6.5 of Regulation (EC) No 1107/2009
concerning human health, mesotrione may be considered to have endocrine disrupting properties; the
RMS disagreed with this statement. As no study is available to investigate a potential endocrine
disrupting mode of action, a general data gap has been identified for the level 2 and 3 tests currently
indicated in the OECD Conceptual Framework (OECD, 2012) and analysed in the EFSA Scientific
Opinion on the hazard assessment of endocrine disruptors (EFSA Scientific Committee, 2013) to
address this issue; this was identified as a critical area of concern. The RMS disagreed with the setting
of a data gap and in considering the issue a critical area of concern.
No neurotoxic or immunotoxic potential has been observed.
Toxicological studies have been submitted on metabolites MNBA and AMBA. MNBA is of low acute
toxicity by the oral and dermal routes; it is unlikely to be genotoxic and presented a lower toxicity
profile compared with mesotrione. AMBA is of low acute oral toxicity and did not present mutagenic
potential in an Ames test; however its genotoxic potential in vivo could not be ruled out due to
positive results obtained in an in vitro cytogenetic assay, and no in vivo genotoxicity follow up testing;
repeated dose toxicity would also have to be addressed as this metabolite is relevant to consumer risk
assessment (see Section 3). As a groundwater metabolite, AMBA is relevant according to stage 3 of
step 3 of the guidance document on the assessment of the relevance of metabolites in groundwater
(European Commission, 2003a) due to its genotoxic potential and based on the classification of the
parent mesotrione as Repr. 2 by the peer review. The RMS disagreed in considering the genotoxic
potential of AMBA a critical area of concern.
The acceptable daily intake (ADI) of mesotrione is 0.01 mg/kg body weight (bw) per day, based on
decreased organ weights in pups in the mouse multigeneration study with a NOAEL of 2 mg/kg bw
per day, applying an increased uncertainty factor (UF) of 200 to account for the increased
tyrosinaemia at the NOAEL; this confirms the ADI set during the first evaluation of mesotrione
(European Commission, 2003b). The acute reference dose (ARfD) is 0.02 mg/kg bw, based on the
same NOAEL of 2 mg/kg bw per day as developmental effects may be relevant to acute exposure,
standard UF of 100 applied; this confirms the ARfD set during the first evaluation of mesotrione
(European Commission, 2003b). The acceptable operator exposure level (AOEL) is 0.005 mg/kg bw
per day based on the same NOAEL of 2 mg/kg bw per day from the mouse multigeneration study,
applying a correction factor to account for the limited oral absorption in mice of 50% and an increased
UF of 200 to account for the increased tyrosinaemia at the NOAEL. An AOEL of 0.015 mg/kg bw per
day was set during the first review of mesotrione based on the same NOAEL, an UF of 100 and
corrected for limited oral absorption by 70% (European Commission, 2003b).
Personal protective equipment (PPE) such as gloves during mixing, loading and application, has to be
worn to ensure that the AOEL is not exceeded for operator applying the representative formulation
‘Callisto 100SC’ according to the UK POEM; according to the German model, estimated operator
exposure remains below the AOEL even when no PPE is considered. Estimated worker, bystander and
resident’s exposure does not exceed the AOEL, even when no specific PPE is considered for re-entry
workers.
3.
Residues
The assessment in the residue section is based on the test guidelines of the Organisation for
Economic Co-operation and Development Nos. 501 to 509 (OECD, 2007a-g, 2008, 2009a,b), the Joint
Meeting on Pesticide Residues (JMPR) recommendations on livestock burden calculations (JMPR,
2004, 2007), the OECD publication on MRL calculations (OECD, 2011) and the European Commission
guideline document on data requirements for setting MRLs (European Commission, 2015).
Mesotrione was discussed at the Pesticides Peer Review Meeting 135 in December 2015.
Plant metabolism was studied in maize (pre- and post-emergence), peanuts (pre-emergence) and
genetically modified soya bean (pre-, post-emergence and combined pre-/post-emergence) with
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mesotrione labelled on cyclohexane-2-14C and phenyl-U-14C. The metabolic pattern of mesotrione was
found to be quantitatively different in conventional crops (maize, peanut) compared to genetically
modified soya bean. In maize and peanuts, parent mesotrione was hardly recovered (3% TRR in
maize forage only) whilst the most pertinent metabolites identified in the feed items were MNBA (up
to 20% TRR in maize forage leaves) and AMBA, free and conjugated (13% and 28% TRR respectively
in maize forage leaves and fodder; 15% TRR in peanut meat). Further metabolites’ identification was
not conducted in maize grain due to the very low recovered total residues (0.014 mg/kg). In
genetically modified herbicide tolerant soya bean, parent mesotrione was less extensively metabolised
compared to conventional crops and occurred in forage at up to 18% TRR and in soya bean seed
(10% TRR). The predominant compounds were identified as 4/5-hydroxy mesotrione (forage 19%
TRR; hay 25% TRR; seed 8% TRR) and MNBA (forage 25% TRR; hay 20% TRR; seed 5% TRR).
AMBA compound was never detected. The unextracted radioactivity was further characterized as polar
compounds (soya bean), lipids (peanut meat) and carbohydrates (maize) incorporated into the natural
constituents of the plant. The metabolism of mesotrione in maize, peanuts and soya bean proceeds by
oxidation of the parent molecule to 4/5-hydroxy mesotrione and to MNBA with subsequent reduction
to AMBA and its conjugates observed in conventional maize and peanuts only. The metabolism of
mesotrione in rotational crops was found to be similar to the primary crops.
Since the absolute concentration of all metabolites was below 0.01 mg/kg in the seeds, the residue
definition for enforcement and risk assessment was set as mesotrione only for food commodities. For
feed commodities, the potential inclusion of the predominant metabolites MNBA and AMBA (free and
conjugated) besides mesotrione in the residue definition for risk assessment was envisaged. MNBA
was characterized as non genotoxic and of lower toxicity compared to the parent compound and was
never detected in the GAP-compliant residue trials on maize (<0.01 mg/kg). In contrast, a genotoxic
potential in vivo could not be excluded for AMBA and repeated dose toxicity profile needs to be
addressed (see data gap in section 2). For risk assessment in feed commodities and pending on the
toxicological profile of AMBA conjugates, the residue definition is provisionally proposed as mesotrione
and AMBA (including its conjugates). If it can be demonstrated that the conjugates of AMBA are not
genotoxic and of no toxicological relevance, additional residue trials on maize where AMBA is analysed
for are not needed and only mesotrione has to be included in the residue definition. These residue
definitions are valid for conventional crops (cereals, pulses and oilseeds) only. For future uses on
genetically modified crops and considering the significant proportions of 4/5-hydroxy mesotrione
recovered in soya bean forage and hay, this compound may have to be included in the residue
definition for risk assessment pending on its toxicological relevance.
Sufficient GAP-compliant residue trials supported by acceptable storage stability data are available to
derive a MRL for mesotrione on maize grain. Hydrolysis studies addressing the nature of the residues
in processed commodities are not triggered.
The livestock dietary burden was tentatively estimated using the highest magnitude of AMBA
conjugates residues in maize forage, fodder from the metabolism study and the total residues in
maize grain. In this case, livestock metabolism studies are not triggered. A ruminant metabolism study
was however conducted with phenyl-U-14C AMBA. The total residues were below 0.01 mg/kg in all
matrices except in kidney (0.053 mg/kg) and fat (0.018 mg/kg) with AMBA being the predominant
compound that accounted for 79% TRR and 62% TRR, respectively. At the estimated dietary burden,
the transfer of AMBA residues in all matrices was shown to be negligible and residue definitions for
animal commodities are provisionally not required for the representative use. This assessment has
however to be reconsidered pending the outcome of AMBA toxicity (see Section 2). Furthermore, the
setting of residue definitions for products of animal origin will also have to be assessed with regard to
the authorized European uses for mesotrione (maize forage, grass) (EFSA, 2015), and in the case
animals are fed with genetically modified soya bean seed (meal) where mesotrione can be find at
significant proportions.
The consumer risk assessment was performed with the EFSA PRIMo rev.2A. No chronic and acute
intake concerns were identified (TMDI: 0.2% of ADI (WHO Cluster diet B); IESTI: 0.3% of ARfD)
considering the MRL on maize grain only. The consumer dietary risk assessment could however not be
finalised with regard to products of animal origin as the genotoxic potential of AMBA in vivo could not
be ruled out due to positive results obtained in an in vitro cytogenetic assay.
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A data gap was also identified for the determination of the residues in pollen and bee products for
human consumption. It is noted that RMS disagreed with the setting of this data gap.
4.
Environmental fate and behaviour
Mesotrione was discussed at the Pesticides Peer Review Meeting TC 124 in November 2015.
The route and rate of degradation of mesotrione (14C labelled at the cyclohexane and or phenyl rings)
in soil under dark aerobic conditions at 20ºC was investigated in 18 soils. The rates of dissipation and
degradation in the environmental matrices investigated were estimated using FOCUS (2006) kinetics
guidance. Mesotrione exhibited low to moderate persistence in these experiments. A pH dependence
of the rate of degradation could be assumed from the available data. Peer review agreed to use a
fitting of data to a lineal relationship to represent this dependence in environmental modelling.
Mesotrione degraded to form metabolites MNBA (max. 57.2% AR after 28 d) and AMBA (max. 9.3%
AR after 13 days). MNBA exhibited very low to moderate persistence and AMBA low to moderate
persistence. Unextractable radioactivity increased up to 37. 6% AR (after 28 d) and volatiles trapped
in the alkaline trap (assumed to be CO2) increased up to 37.6% AR (after 121 d) in the phenyl
radiolabeled mesotrione experiments. Unextractable radioactivity increased up to 15.2% AR (after 21
d) and volatiles trapped in the alkaline trap (assumed to be CO 2) increased up to 75.2% AR (after 58
d) in the cyclohexane radiolabeled mesotrione experiments.
Mesotrione degradation in soil under anaerobic conditions was investigated in one study. Mesotrione
was low persistent under these conditions. Metabolite AMBA reached 40.7% AR after 30 d.
Photolysis of mesotrione in soil was investigated in a study submitted for the renewal application in a
microbially active soil under dry and wet conditions irradiated by simulated sunlight. Photolysis can
enhance degradation of mesotrione (especially when dry conditions prevail and lower microbial
competition occurs).
Field dissipation studies carried out at four sites in Germany, two in Italy and one in France are
available. However, results from these studies have not been relied on for the assessment performed
in the context of the renewal of the authorisation.
PEC soils were calculated for parent mesotrione and the metabolites MNBA and AMBA for the
representative use in maize based on standard calculation and worst case assumptions.
Batch soil adsorption/desorption studies were performed with mesotrione in 10 soils and with
metabolites MNBA and AMBA with two and three soils respectively. In addition, a batch soil
adsorption/desorption study has been performed with metabolite SYN546974 identified in the watersediment study. According to these studies mesotrione may be considered to exhibit very high to
medium mobility in soil. A pH dependence could be assumed from the available data. Peer review
agreed to use a fitting of data to an exponential curve to represent this dependence in environmental
modelling. Metabolite MNBA may be considered to exhibit very high mobility and metabolite AMBA
high to very high mobility. Water / sediment metabolite SYN546974 may be considered to be low
mobile to immobile in soil (KFoc = 1702-27031 mL / g).
Neither column leaching nor lysimeter studies were provided in the dossier presented for the renewal
authorisation of mesotrione.
Hydrolysis of mesotrione in water was investigated in buffered solutions (pH 4, 5, 7 and 9) at
temperatures in the range of 25 – 50ºC. Mesotrione was stable in the whole range of pH investigated.
Direct and indirect aqueous photolysis of mesotrione was investigated in two separated studies
simulating sunlight radiation. In the lack of a study investigating biodegradability of mesotrione, it is
assumed to be not readily biodegradable.
Fate and behaviour of mesotrione in dark water sediment systems under aerobic conditions was
investigated in four systems (two of them were investigated using mesotrione labelled in cyclohexane
and phenyl rings). Mesotrione partitioned to the sediment in a very low extend (max 4.3% AR after 1
d) and most of the product remained in the water phase. Degradation was relatively fast in all
systems tested (DT50 whole system = 2.6–11.1 days). Even after normalising to 12ºC persistence
triggers were not exceeded for fresh water compartment (ECHA, 2014). Three metabolites were found
in the in water phase: MNBA (max. 7.4% AR after 3 days), AMBA (max. 15.8% AR after 46 days) and
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SYN546974 (max. 9.4% AR after 29 d). Metabolites AMBA and SYN546974 were found in the
sediment at significant amounts (AMBA max. 8.8% AR after 46 d; SYN546974 max. 25.6% AR after
102 d). Mineralization was generally low (lower for the phenyl ring labelled substance than the
cyclohexane labelled one) and the un-extractable residue in the sediment increased up to 73.7% AR
at end of the study.
PECsw were calculated for parent mesotrione and metabolites MNBA, AMBA and SYN546974 with
FOCUS SW tools up to step 2. FOCUSsw Step 3 and Step 4 concentrations assuming mitigation up to
20 m by spray drift buffers and vegetative run off strips were also calculated for parent mesotrione in
order to characterize feasibility of mitigation considered in the assessment of potential unacceptable
effects to the aquatic environment. The pH dependence observed on the degradation and soil
adsorption of mesotrione was taken into account in these calculations (FOCUS, 2001; FOCUS, 2007).
However, risk managers and others may wish to note that whilst run-off mitigation is included in the
step 4 calculations available, the FOCUS (FOCUS, 2007) report acknowledges that for substances with
KFoc < 2000 mL/g (i.e. mesotrione), the general applicability and effectiveness of run-off mitigation
measures had been less clearly demonstrated in the available scientific literature, than for more
strongly adsorbed compounds.
Potential for ground water contamination by mesotrione and soil metabolites MNBA and AMBA was
assessed by calculation of 80th percentile of 20 years annual average concentrations at 1m depth with
FOCUSsw PEARL v4.4.4. and PELMO v.5.5.3 models for the representative use in maize, selecting input
values based on ad hoc estimation of most relevant soil pHs for maize in EU (using GIS assessment).
Limit of 0.1 μg/L was only exceeded by metabolite MNBA in one of the eight relevant FOCUS gw
scenarios (Hamburg) when a soil pH of 5.1 was assumed (FOCUS, 2009; European Commission,
2003a). At national and zonal level, or for crops other than maize, MSs may need to reassess the
choice of pH for which groundwater and surface water exposure is calculated to ensure
representativeness based on GIS assessments.
The applicant provided a statement to address the effect of water treatments processes on the nature
of the residues that might be present in surface water and groundwater, when surface water or
groundwater are abstracted for drinking water. According to this statement the formation of potential
harmful transformation products cannot be ruled out. Therefore a data gap has been identified to
address the substances of potential toxicological concern that could be derived from mesotrione and
its metabolites under water treatment procedure conditions. Those substances indicated in the
applicants statement (concerning any potential formation of nitrosobenzene, nitrobenzene (MNBA) or
azobenzene analogues) and those identified by Member States experts during the peer review
(nitrosamine production from AMBA metabolite) would need to be addressed. A study to investigate if
these compounds are actually formed and in which proportion needs to be provided to assess if the
approval criteria in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
5.
Ecotoxicology
The risk assessment was based on the following documents: European Commission (2002a, b), SETAC
(2001) and EFSA (2009), EFSA PPR Panel (2013) and EFSA (2013). According to Regulation (EU) No
283/2013 data should be provided regarding the acute and chronic toxicity to honeybees and data to
address the development of honeybee brood and larvae. As the European Commission (2002a) does
not provide a risk assessment scheme which is able to use the chronic toxicity data for adult
honeybees and the honeybee brood, when performing the risk assessment according to European
Commission (2002a), the risk to adult honeybees from chronic toxicity and the risk to bee brood,
could not be finalised due to the lack of a risk assessment scheme. Therefore, the EFSA (2013) was
used for risk assessment in order to reach a conclusion for the representative uses.
Mesotrione was discussed at the Pesticides Peer Review experts Meeting 136 in December 2015.
Specifically two issues were examined: 1) the relevant endpoint to be used in the reproductive risk
assessment for mammals; 2) the approaches proposed for the probabilistic risk assessment for nontarget terrestrial plants.
For birds a low acute risk via dietary exposure was concluded at the screening step for the
representative uses on maize. A low long-term risk was concluded at tier 1 for all the generic focal
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species via dietary exposure for the representative use. The risk from consumption of contaminated
water was assessed as low.
For wild mammals a low acute risk via dietary exposure was concluded at the screening level for the
representative use on maize.
The long-term endpoint for mammals was discussed at the Pesticides Peer Review experts Meeting
136 in December 2015. The experts agreed on a NOAEL of 0.3 mg/kg bw per day based on the
effects on litter size of the F2 generation. The long-term risk to mammals was assessed as high for all
scenarios at the tier 1.
For risk refinement, a range of studies were available for identification of specific focal species and PT
values. The omnivorous wood mouse (Apodemus sylvaticus) and the herbivorous European brown
hare (Lepus europaeus) were considered appropriate focal species for maize at the early stages after
germination (BBCH 10-16). Based on the provided dataset, the PT refinement was possible only for
the wood mouse. It was not possible to further refine the risk assessment based on residue decline
data, as no reliable DT50 on maize could be derived. Overall, the long-term risk to mammals was
concluded as high. Therefore, a data gap was identified.
No secondary poisoning assessment was triggered for mesotrione and its metabolites (LogKow<3).
The long-term risk to mammals via consumption of contaminated water was assessed as high at tier 1
level. Therefore a data gap was identified.
A high long-term risk to aquatic macrophytes from the exposure to mesotrione was identified for 6 out
of 8 FOCUS scenarios at Step 3, while a low risk for all the other aquatic organisms was concluded at
the FOCUSsw step 1. A high risk for aquatic macrophytes was still identified in three scenarios (R2, R3,
and R4) considering PECsw calculated at FOCUS Step 4 where a 20 m vegetated buffer strip as
mitigation measure was considered. Therefore a data gap was identified to further refine the risk to
aquatic organisms in these scenarios. A low risk was concluded for all other scenarios provided that in
three of them (D3, D6, and R1) mitigation measures equivalent to 5 m no-spray buffer zone (D3 and
D6) or a 20 m no-spray buffer zone and 20 m vegetated buffer strip (R1) are put in place.
The risk to aquatic organisms for the metabolites MNBA, AMBA and SYN546974 was assessed as low
at FOCUSsw Step 1 for the representative use on maize. Additionally, the risk to aquatic organisms to
the metabolites MNBA and AMBA via groundwater contamination was assessed as low according to
the representative use on maize.
Acute contact and acute oral toxicity studies for honeybees, performed with the active substance and
the representative formulation were available. A honeybee chronic oral toxicity study with the
formulation was available. A semi-chronic laboratory study on larvae with the formulation was also
available. An assessment of the hypopharyngeal glands (HPG) was not performed; therefore a data
gap was identified.
A low acute contact and oral risk was concluded on the basis of a screening level assessment.
The first tier chronic assessment via oral exposure indicated a low risk to honeybees for all the
scenarios for the representative use on maize.
A risk could not be excluded at the screening level for adult honeybees and for larvae from the
exposure via residues in guttation fluid for the representative use on maize. Therefore, further risk
assessment refinements would be needed for this route of exposure (data gap). A low risk for adult
honeybee and larvae was concluded from the exposure via residues in the surface water on the basis
of PECsw FOCUS step 1. No specific assessment was performed for puddle scenario. Therefore, a data
gap was identified.
Insufficient information was available to perform a risk assessment to honeybees for relevant
metabolites in pollen and nectar. Therefore, a further data gap was identified. Addressing this data
requirement, it is suggested that EFSA (2013) is used for identification of those metabolites requiring
assessment.
No assessment for accumulative effects was available.
No data were available to perform a risk assessment for bumble bees or solitary bees.
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For non-target arthropod species other than bees a low off-field risk was concluded for both
Typhlodromus pyri and Aphidius rhopalosiphi at tier 1, whereas the in-field risk was only assessed as
low for Typhlodromus pyri for the representative field use on maize. The in-field risk for Aphidius
rhopalosiphi was assessed as low based on extended laboratory tests.
A low acute and long-term risk was identified for earthworms, other non-target soil macro fauna and
for nitrogen transformation for the representative use on maize.
For terrestrial non-target plants, studies were available to investigate the effects on vegetative vigour
and seedling emergence. Moreover, three semi-field studies were submitted, investigating four
different plant species (i.e., Brassica rapa, Cucumis sativa, Lactuca sativa and Lycopersicon
esculentum) at early, middle and late growth stages. The probabilistic approach to be used was
discussed at the Pesticides Peer Review Experts’ Meeting 136 in December 2015. The experts agreed
on a probabilistic risk assessment for non-target terrestrial plants, where the most sensitive endpoint
for each species (i.e. monocotyledons and dicotyledons) from the vegetative vigour study, including a
single unbounded value, was used. As a consequence a low risk was concluded with mitigation
measures equivalent to in-field no-spray buffer zones of 20 m and 50% drift reducing nozzles.
A data gap was identified to further address the sensitivity to mesotrione of dicotyledonous plant
species and monocotyledonous plant species.
A low risk was also concluded for the representative uses of mesotrione for organisms involved in
biological methods for sewage water treatment.
A non-identified metabolite (metabolite A) (max 9.7% AR) exceeded levels above 5% AR from day 5
to day 30 (end of the study). A data gap has been identified in Section 4 for further consideration of
this metabolite in case anaerobic conditions cannot be excluded.
No assessment on the endocrine disrupting potential was carried out for birds and fish species.
However, reference is made to the mammalian toxicology section, where the active substance is
proposed to be classified as Repr. Cat. 2 and adverse effects were observed on endocrine organs.
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6.
Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects
data for the environmental compartments
Table 1:
Soil
Compound
(name and/or code)
mesotrione
MNBA
AMBA
Table 2:
Mobility in soil
mesotrione
very high to medium
(KFoc = 14–354 mL/g).
A pH dependence was
identified.
very high
(KFoc = 3.2–6.1 mL/g)
AMBA
5
Ecotoxicology
low to moderate (DT50 = 4.3 d – 28.7 d)
very low to moderate (DT50 = 0.5 d – 15.7 d)
low to moderate (DT50 = 7.8 d – 58.7 d)
Low risk to soil-dwelling organisms
Low risk to soil-dwelling organisms
Low risk to soil-dwelling organisms
Groundwater
Compound
(name and/or code)
MNBA
Persistence
high to very high mobility
(KFoc = 18.1–122 mL/g)
> 0.1 μg/L at 1 m
depth for the
representative uses
(at least one FOCUS
scenario or relevant
lysimeter)
FOCUS GW: No
Pesticidal
activity
Toxicological relevance
Ecotoxicology
Yes
Yes
FOCUS GW: No
No
Yes, based on the proposed
classification by the peer review
as Repr. 25.
MNBA is unlikely to be genotoxic
and present a lower toxicity
profile than the parent mesotrione
Yes, based on the proposed
classification by the peer review
as Repr. 25.
Genotoxic potential cannot be
ruled out due to positive effects
observed in an in vitro
clastogenicity assay
A high risk for aquatic
organisms was indicated in
the surface water risk
assessment.
A low risk was indicated
for aquatic organism from
exposure via groundwater
contamination
FOCUS GW: No
No
A low risk was indicated
for aquatic organism from
exposure via groundwater
contamination
Not in agreement with harmonised classification – Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)
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Table 3:
Surface water and sediment
Compound
(name and/or code)
mesotrione
MNBA
AMBA
SYN546974
Table 4:
Ecotoxicology
A high risk for aquatic organisms was indicated in situations which are represented by the R2, R3 and R4 FOCUSsw
scenario.
A low risk was indicated for aquatic organism
A low risk was indicated for aquatic organism
A low risk was indicated for aquatic organism
Air
Compound
(name and/or code)
mesotrione
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Toxicology
Rat LC50 inhalation > 4.75 mg/L air/4 h (nose-only); no classification required
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7.
Data gaps
This is a list of data gaps identified during the peer review process, including those areas in which a
study may have been made available during the peer review process but not considered for
procedural reasons (without prejudice to the provisions of Article 56 of Regulation (EC) No 1107/2009
concerning information on potentially harmful effects).

Validation data for method SF-424/1 used in data generation (relevant for all representative
uses evaluated; submission date proposed by the applicant: unknown; see Section 1).

A data gap for specifying two significant impurities on dry weight basis (relevant for all
representative uses evaluated; submission date proposed by the applicant: unknown; see
Section 1).

Identification and validation of the pre-registration analytical methods supporting the studies
used in the area of mammalian toxicology (relevant for all representative uses evaluated;
submission date proposed by the applicant: unknown; see Section 1, 2).

Assessment of the toxicological relevance of individual impurities present in the technical
specification in comparison with the toxicological profile of the parent mesotrione (except for
the impurities already identified as relevant and solvents of known toxicological profile)
(relevant for all representative uses evaluated; submission date proposed by the applicant:
unknown; see Section 2).

Interspecies comparative in vitro metabolism including human material (relevant for all
representative uses evaluated; submission date proposed by the applicant: unknown; see
Sections 2).

Clarification of the endocrine disrupting potential of mesotrione considering in particular level
2 and 3 tests currently indicated in the OECD Conceptual Framework (relevant for all
representative uses evaluated; submission date proposed by the applicant: unknown; see
Section 2, 5).

Clarification of the genotoxic potential of AMBA and of its toxicological profile (relevant for all
representative uses evaluated; submission date proposed by the applicant: unknown; see
Section 2, 3).

Determination of the residues in pollen and bee products for human consumption resulting
from residues taken up by honeybees from crops at blossom (relevant for all representative
uses evaluated; submission date proposed by the applicant: not known; see Section 3).

Applicant to address the substances of potential toxicological concern that could be derived
from mesotrione and its metabolites under water treatment procedure conditions. Those
substances indicated in the applicants statement (concerning any potential formation of
nitrosobenzene, nitrobenzene (MNBA) or azobenzene analogues) and those identified by
Member States experts (nitrosamine production from AMBA metabolite) would need to be
addressed. A study to investigate if these compounds are actually formed and in which
proportion needs to be provided to assess if the approval criteria in Article 4 of Regulation
(EC) No 1107/2009 is satisfied (relevant for all representative uses evaluated; submission date
proposed by the applicant: not known; see Section 4).

The long-term risk to small omnivorous mammals and herbivorous lagomorphs for the
representative uses in maize needs to be further addressed (relevant for all representative
uses evaluated; submission date proposed by the applicant: unknown; see Section 5).

The long term risk to mammals from consumption of contaminated water should be further
addressed (relevant for all representative uses evaluated; submission date proposed by the
applicant: unknown; see Section 5).

A data gap has been identified to further address the sensitivity to mesotrione of
dicotyledonous plant species in comparison to monocotyledonous plant species (relevant for
all representative uses evaluated; submission date proposed by the applicant: unknown; see
Section 5).
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
A data gap has been identified to further refine the risk to mesotrione for aquatic organisms
(R2, R3 and R4 scenarios) (relevant for all representative uses evaluated; submission date
proposed by the applicant: unknown; see Section 5).

The acute and chronic risk for adult honeybees and the risk for larvae from the exposure via
residues in guttation fluid should be further addressed (relevant for all representative uses
evaluated; submission date proposed by the applicant: unknown; see Section 5).

A data gap was identified to further address the assessment of the effects on the
hypopharyngeal glands (HPGs) (relevant for all representative uses evaluated; submission
date proposed by the applicant: unknown; see Section 5).

Further consideration of the risk to honeybees from consumption of contaminated water is
required (relevant for all representative uses evaluated; submission date proposed by the
applicant: unknown; see Section 5).

A data gap was identified to perform a risk assessment to honeybees for relevant metabolites
in pollen and nectar (relevant for all representative uses evaluated; submission date proposed
by the applicant: unknown; see Section 5).
8.
Particular conditions proposed to be taken into account to manage
the risk(s) identified

Mitigation measures equivalent to in-field no-spray buffer zones of 20 m and 50% drift
reducing nozzles were needed to conclude a low risk to terrestrial non-target plants for the
representative uses on maize.

A 20 m vegetated buffer strip and 20 m no-spray buffer zone as mitigation measure were
needed to conclude a low risk to mesotrione for aquatic organisms for the FOCUS sw Step 4
scenario R1 for the representative use on maize. A 5 m no-spray buffer zone was required for
the FOCUSsw Step 4 scenario D3 and D6.
9.
Concerns
9.1.
Issues that could not be finalised
An issue is listed as ‘could not be finalised’ if there is not enough information available to perform an
assessment, even at the lowest tier level, for the representative uses in line with the uniform
principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in
Commission Regulation (EU) No 546/20116 and if the issue is of such importance that it could, when
finalised, become a concern (which would also be listed as a critical area of concern if it is of
relevance to all representative uses).
An issue is also listed as ‘could not be finalised’ if the available information is considered insufficient to
conclude on whether the active substance can be expected to meet the approval criteria provided for
in Article 4 of Regulation (EC) No 1107/2009.
1. The consumer dietary risk assessment could not be finalised with regard to products of animal
origin as the genotoxic potential of AMBA in vivo could not be ruled out due to positive results
obtained in an in vitro cytogenetic assay (see Section 3).
2. The consumer risk assessment from consumption of drinking water could not be finalised
whilst the nature of residues in drinking water following water treatment had not been
addressed (see Section 4).
9.2.
Critical areas of concern
An issue is listed as a critical area of concern if there is enough information available to perform an
assessment for the representative uses in line with the uniform principles in accordance with Article
6
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L
155, 11.6.2011, p. 127–175.
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29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011,
and if this assessment does not permit the conclusion that, for at least one of the representative uses,
it may be expected that a plant protection product containing the active substance will not have any
harmful effect on human or animal health or on groundwater, or any unacceptable influence on the
environment.
An issue is also listed as a critical area of concern if the assessment at a higher tier level could not be
finalised due to a lack of information, and if the assessment performed at the lower tier level does not
permit the conclusion that, for at least one of the representative uses, it may be expected that a plant
protection product containing the active substance will not have any harmful effect on human or
animal health or on groundwater, or any unacceptable influence on the environment.
An issue is also listed as a critical area of concern if, in the light of current scientific and technical
knowledge using guidance documents available at the time of application, the active substance is not
expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
3. Mesotrione is proposed to be classified as Repr. 2 for development by the peer review (in
contrast with the harmonised classification in the CLP Regulation) and adverse effects were
observed on endocrine organs: increased testes and epididymides weights, and thyroid
adenomas in female rats. Therefore, according to the interim provisions of Annex II, point
3.6.5 of Regulation (EC) No 1107/2009 concerning human health, mesotrione may be
considered to have endocrine disrupting properties. As no study is available to investigate a
potential endocrine disrupting mode of action, a general data gap has been identified (see
Section 2 and 5).
4. A genotoxic potential of AMBA could not be ruled out due to positive results obtained in an in
vitro cytogenetic assay, and no in vivo genotoxicity follow up testing; repeated dose toxicity
would also have to be addressed as this metabolite is relevant to consumer risk assessment
(see Section 2 and 3).
5. The long-term risk to mammals for the representative uses in maize was identified as high
(see Section 5).
9.3.
Overview of the concerns identified for each representative use
considered
(If a particular condition proposed to be taken into account to manage an identified risk, as listed in
Section 8, has been evaluated as being effective, then ‘risk identified’ is not indicated in Table 5
below.)
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Table 5:
Overview of concerns
Representative use
Operator risk
Worker risk
Resident/Bystander risk
Consumer risk
Risk to wild non-target
terrestrial vertebrates
Risk to wild non-target
terrestrial organisms other than
vertebrates
Risk to aquatic organisms
Groundwater exposure to active
substance
Groundwater exposure to
metabolites
Maize
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Risk identified
Assessment not finalised
Legal parametric value breached
Assessment not finalised
Legal parametric value breached(a)
Parametric value of 10µg/L(b) breached
Assessment not finalised
X1,2
X5
X
X (for R2, R3, R4)
Columns are grey if no safe use can be identified. The superscript numbers in this table relate to the numbered points indicated
in Sections 9.1 and 9.2. Where there is no superscript number, see Sections 2 to 6 for further information.
(a): When the consideration for classification made in the context of this evaluation under Regulation (EC) No 1107/2009 is
confirmed under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.
(b): Value for non-relevant metabolites prescribed in SANCO/221/2000 rev 10—final, European Commission, 2003.
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References
ACD/Labs 2015 Release,
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Advanced
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safety assessment. Chapter R11: PBT/vPvB assessment. Version 2.0. November 2014. Available
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ECHA (European Chemicals Agency), 2015. Guidance on the Application of the CLP Criteria; Guidance
to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and
mixtures. Version 4.1, June 2015. Reference: ECHA-15-G-05-EN; ISBN: 978-92-9247-413-3;
available online: http://echa.europa.eu/documents/10162/13562/clp_en.pdf
EFSA (European Food Safety Authority), 2009. Guidance on Risk Assessment for Birds and Mammals
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EFSA (European Food Safety Authority), 2011. Submission of scientific peer-reviewed open literature
for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal
2011;9(2):2092, 49 pp. doi:10.2903/j.efsa.2011.2092
EFSA (European Food Safety Authority), 2013. EFSA Guidance Document on the risk assessment of
plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal
2013;11(7):3295, 268 pp., doi:10.2903/j.efsa.2013.3295
EFSA (European Food Safety Authority), 2015. Reasoned opinion on the review of the existing
maximum residue levels (MRLs) for mesotrione according to Article 12 of Regulation (EC) No
396/2005. EFSA Journal 2015;13(1):3976, 36 pp. doi:10.2903/j.efsa.2015.3976
EFSA (European Food Safety Authority), 2016. Peer review report to the conclusion regarding the peer
review of the pesticide risk assessment of the active substance mesotrione. Available online:
www.efsa.europa.eu
EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2012. Guidance on
dermal absorption. EFSA Journal 2012;10(4):2665, 30 pp. doi:10.2903/j.efsa.2012.2665
EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2013. Guidance on
tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface
waters. EFSA Journal 2013;11(7):3290, 186 pp. doi:10.2903/j.efsa.2013.3290.
EFSA Scientific Committee, 2013. Scientific Opinion on the hazard assessment of endocrine disruptors:
scientific criteria for identification of endocrine disruptors and appropriateness of existing test
methods for assessing effects mediated by these substances on human health and the
environment. EFSA Journal 2013;11(3):3132, 84 pp. doi:10.2903/j.efsa.2013.3132
European Commission, 2000a. Residues: guidance for generating and reporting methods of analysis in
support of pre-registration data requirements for Annex II (Part A, Section 4) and Annex III (Part
A, Section 5) of Directive 91/414. SANCO/3029/99-rev. 4, 11 July 2000.
European Commission, 2000b. Technical material and preparations: guidance for generating and
reporting methods of analysis in support of pre- and post-registration data requirements for Annex
II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414. SANCO/3030/99-rev. 4,
11 July 2000.
European Commission, 2002a. Guidance document on terrestrial ecotoxicology under Council Directive
91/414/EEC. SANCO/10329/2002-rev. 2 (final), 17 October 2002.
European Commission, 2002b. Guidance document on aquatic ecotoxicology under Council Directive
91/414/EEC. SANCO/3268/2001-rev. 4 (final), 17 October 2002.
European Commission, 2003a. Guidance document on assessment of the relevance of metabolites in
groundwater of substances regulated under Council Directive 91/414/EEC. SANCO/221/2000-rev.
10 (final), 25 February 2003.
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European Commission, 2003b. Review report for the active substance mesotrione. Finalised in the
Standing Committee on the Food Chain and Animal Health at its meeting on 11 April 2003 in view
of the inclusion of mesotrione in Annex I of Directive 91/414/EEC. Mesotrione SANCO/1416/2001 Final, 14 April 2003.
European Commission, 2010. Guidance document on residue analytical methods. SANCO/825/00-rev.
8.1, 16 November 2010.
European Commission, 2012. Guidance document on the assessment of the equivalence of technical
materials of substances regulated under Regulation (EC) No 1107/2009. SANCO/10597/2003-rev.
10.1, 13 July 2012.
European Commission, 2013. Guidance document on data requirements on efficacy for the dossier to
be submitted for the approval of new active substances contained in plant protection products.
SANCO/10054/2013-rev. 3, 11 July 2013.
European Commission, 2015. Guidelines on comparability, extrapolation, group tolerances and data
requirements for setting MRLs. SANCO 7525/VI/95-rev. 10.1, December 2015.
FOCUS (Forum for the Co-ordination of Pesticide Fate Models and their Use), 2001. FOCUS surface
water scenarios in the EU evaluation process under 91/414/EEC. Report of the FOCUS Working
Group on Surface Water Scenarios. EC Document Reference SANCO/4802/2001-rev. 2, 245 pp., as
updated by Generic guidance for FOCUS surface water scenarios, v. 1.1, March 2012.
FOCUS (Forum for the Co-ordination of Pesticide Fate Models and their Use), 2006. Guidance
document on estimating persistence and degradation kinetics from environmental fate studies on
pesticides in EU Registration Report of the FOCUS Work Group on Degradation Kinetics. EC
Document Reference SANCO/10058/2005-v. 2.0, 434 pp.
FOCUS (Forum for the Co-ordination of Pesticide Fate Models and their Use), 2007. Landscape and
mitigation factors in aquatic risk assessment. Volume 1. Extended summary and recommendations.
Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk
Assessment. EC Document Reference SANCO/10422/2005 v. 2.0, 169 pp.
FOCUS (Forum for the Co-ordination of Pesticide Fate Models and their Use), 2009. Assessing
potential for movement of active substances and their metabolites to ground water in the EU.
Report of the FOCUS Workgroup. EC Document Reference SANCO/13144/2010-v. 1, 604 pp., as
outlined in Generic guidance for tier 1 FOCUS groundwater assessment, v. 2.0, January 2011
JMPR (Joint Meeting on Pesticide Residues), 2004. Report of the Joint Meeting of the FAO Panel of
Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group
on Pesticide Residues, Rome, Italy, 20–29 September 2004, 383 pp.
JMPR (Joint Meeting on Pesticide Residues), 2007. Report of the Joint Meeting of the FAO Panel of
Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group
on Pesticide Residues, Geneva, Switzerland, 18–27 September 2007, 164 pp.
OECD (Organisation for Economic Co-operation and Development) 2007a. Test No. 501: Metabolism
in Crops, OECD Guidelines for the Testing of Chemicals, Section 5, OECD Publishing, Paris. doi:
http://dx.doi.org/10.1787/9789264061835-en
OECD (Organisation for Economic Co-operation and Development), 2007b. Test No. 502: Metabolism
in Rotational Crops, OECD Guidelines for the Testing of Chemicals, Section 5, OECD Publishing,
Paris. doi: http://dx.doi.org/10.1787/9789264061859-en
OECD (Organisation for Economic Co-operation and Development) 2007c. Test No. 503: Metabolism in
Livestock, OECD Guidelines for the Testing of Chemicals, Section 5, OECD Publishing, Paris. doi:
http://dx.doi.org/10.1787/9789264061873-en
OECD (Organisation for Economic Co-operation and Development) 2007d. Test No. 504: Residues in
Rotational Crops (Limited Field Studies), OECD Guidelines for the Testing of Chemicals, Section 5,
OECD Publishing, Paris. doi: http://dx.doi.org/10.1787/9789264013384-en
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OECD (Organisation for Economic Co-operation and Development), 2007e. Test No. 505: Residues in
Livestock, OECD Guidelines for the Testing of Chemicals, Section 5, OECD Publishing, Paris. doi:
http://dx.doi.org/10.1787/9789264061903-en
OECD (Organisation for Economic Co-operation and Development) 2007f. Test No 506: Stability of
Pesticide Residues in Stored Commodities, OECD Guidelines for the Testing of Chemicals, Section
5, OECD Publishing, Paris. doi: http://dx.doi.org/10.1787/9789264061927-en
OECD (Organisation for Economic Co-operation and Development), 2007g. Test No. 507: Nature of
the Pesticide Residues in Processed Commodities - High Temperature Hydrolysis, OECD Guidelines
for the Testing of Chemicals, Section 5, OECD Publishing, Paris. doi: http://dx.doi.org/
10.1787/9789264067431-en
OECD (Organisation for Economic Co-operation and Development), 2008. Test No. 508: Magnitude of
the Pesticide Residues in Processed Commodities, OECD Guidelines for the Testing of Chemicals,
Section 5, OECD Publishing, Paris. doi: http://dx.doi.org/10.1787/9789264067622-en
OECD (Organisation for Economic Co-operation and Development) 2009a. Test No. 509: Crop Field
Trial, OECD Guidelines for the Testing of Chemicals, Section 5, OECD Publishing, Paris. doi:
http://dx.doi.org/10.1787/9789264076457-en
OECD (Organisation for Economic Co-operation and Development), 2009b. Guidance Document of the
definition of residue (as revised I 2009), OECD Publishing, Paris. ENV/JM/MONO(2009)30;
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2009)30&d
oclanguage=en
OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL calculator:
spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide
Publications/Publications on Pesticide Residues. Available online: http://www.oecd.org
OECD (Organisation for Economic Co-operation and Development), 2012. Series on Testing and
Assessment: No 150: Guidance document on standardised test guidelines for evaluating chemicals
for endocrine disruption. ENV/JM/MONO(2012)22, 524 pp.
SETAC (Society of Environmental Toxicology and Chemistry), 2001. Guidance document on regulatory
testing and risk assessment procedures for plant protection products with non-target arthropods.
ESCORT 2.
United Kingdom, 2015a. Renewal assessment report (RAR) on the active substance mesotrione
prepared by the rapporteur Member State, the United Kingdom, in the framework of Commission
Implementing Regulation (EU) No 844/2012, February 2015. Available online: www.efsa.europa.eu
United Kingdom, 2015b. Revised renewal assessment report (RAR) on mesotrione, compiled by EFSA,
December 2015. Available online: www.efsa.europa.eu
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Abbreviations
1/n
slope of Freundlich isotherm
λ
wavelength

decadic molar extinction coefficient
°C
degree Celsius (centigrade)
µg
microgram
a.s.
active substance
AChE
acetylcholinesterase
ADE
actual dermal exposure
ADI
acceptable daily intake
AF
assessment factor
AOEL
acceptable operator exposure level
AP
alkaline phosphatase
AR
applied radioactivity
ARfD
acute reference dose
AST
aspartate aminotransferase (SGOT)
AV
avoidance factor
BCF
bioconcentration factor
BUN
blood urea nitrogen
bw
body weight
CAS
Chemical Abstracts Service
ChE
cholinesterase
CI
confidence interval
CIPAC
Collaborative International Pesticides Analytical Council Limited
CL
confidence limits
CLP
classification, labelling and packaging
Cmax
concentration achieved at peak blood level
cm
centimetre
d
day
DAA
days after application
DAR
draft assessment report
DAT
days after treatment
DDD
daily dietary dose
DM
dry matter
DT50
period required for 50% dissipation (define method of estimation)
DT90
period required for 90% dissipation (define method of estimation)
dw
dry weight
DWR
Drinking water rate
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EbC50
effective concentration (biomass)
EC50
effective concentration
ECHA
European Chemicals Agency
ED
endocrine disruptor
EEC
European Economic Community
EINECS
European Inventory of Existing Commercial Chemical Substances
ELINCS
European List of New Chemical Substances
EMDI
estimated maximum daily intake
ER50
emergence rate/effective rate, median
ErC50
effective concentration (growth rate)
ETR
exposure toxicity ratio
ETRacute
exposure toxicity ratio for acute exposure
ETRlarvae
exposure toxicity ratio for chronic exposure
ETRlarvae
exposure toxicity ratio for larvae
ETRHPG
exposure toxicity ratio for effects on honeybee hypopharygeal glands
EU
European Union
EUROPOEM
European Predictive Operator Exposure Model
f(twa)
Time-weighted average factor
FAO
Food and Agriculture Organization of the United Nations
FID
flame ionisation detector
FIR
food intake rate
FOB
functional observation battery
FOCUS
Forum for the Co-ordination of Pesticide Fate Models and their Use
g
gram
GAP
good agricultural practice
GC
gas chromatography
GCPF
Global Crop Protection Federation (formerly known as International Group of National
Associations of Manufacturers of Agrochemical Products (GIFAP))
GGT
gamma glutamyl transferase
GM
geometric mean
GS
growth stage
GSH
glutathione
ha
hectare
Hb
haemoglobin
Hct
haematocrit
HPLC
high-pressure liquid chromatography or high-performance liquid chromatography
HPLC-DAD
high performance liquid chromatography with diode array detector
HPLC-MS
high-pressure liquid chromatography–mass spectrometry
HPLC-MS/MS
high performance liquid chromatography with tandem mass spectrometry
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HPLC-UV
high performance liquid chromatography with ultra violet detector
HPG
hypopharygeal glands
HPPD
4-hydroxyphenylpyruvate dioxygenase
HQ
hazard quotient
HQcontact
hazard quotient for contact exposure
HR
hazard rate
IEDI
international estimated daily intake
IESTI
international estimated short-term intake
ILV
independent laboratory validation
ISO
International Organization for Standardization
IUPAC
International Union of Pure and Applied Chemistry
JMPR
Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the
Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on
Pesticide Residues)
Kdoc
organic carbon linear adsorption coefficient
KFoc
Freundlich organic carbon adsorption coefficient
LC
liquid chromatography
LC50
lethal concentration, median
LC-MS
liquid chromatography–mass spectrometry
LC-MS/MS
liquid chromatography with tandem mass spectrometry
LD50
lethal dose, median; dosis letalis media
LDD50
lethal dietary dose; median
LDH
lactate dehydrogenase
LLNA
local lymph node assay
LOAEL
lowest observable adverse effect level
LOD
limit of detection
LOQ
limit of quantification (determination)
m
metre
M
mol
M/L
mixing and loading
MAF
multiple application factor
MCH
mean corpuscular haemoglobin
MCHC
mean corpuscular haemoglobin concentration
MCV
mean corpuscular volume
mg
milligram
M&K
Maximisation test of Magnusson & Kligman
mL
millilitre
mm
millimetre (also used for mean measured concentrations)
mN
milli-newton
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MOA
mode of action
MRL
maximum residue level
MS
mass spectrometry
MSDS
material safety data sheet
MTD
maximum tolerated dose
MWHC
maximum water-holding capacity
NESTI
national estimated short-term intake
NOAEC
no observed adverse effect concentration
NOAEL
no observed adverse effect level
NOEC
no observed effect concentration
NOEL
no observed effect level
NPD
nitrogen–phosphorus detector
OECD
Organisation for Economic Co-operation and Development
OM
organic matter content
Pa
pascal
PD
proportion of different food types
PEC
predicted environmental concentration
PECair
predicted environmental concentration in air
PECgw
predicted environmental concentration in groundwater
PECsed
predicted environmental concentration in sediment
PECsoil
predicted environmental concentration in soil
PECsw
predicted environmental concentration in surface water
PHED
pesticide handler’s exposure data
pH
pH-value
PHI
pre-harvest interval
PIE
potential inhalation exposure
pKa
negative logarithm (to the base 10) of the dissociation constant
Pow
partition coefficient between n-octanol and water
POEM
Predictive Operator Exposure Model
PPE
personal protective equipment
ppm
parts per million (10–6)
PT
proportion of diet obtained in the treated area
PTT
partial thromboplastin time
QSAR
quantitative structure–activity relationship
QuEChERS
quick, easy, cheap, effective and safe method
r2
coefficient of determination
RBC
red blood cells
REACH
Registration, Evaluation, Authorisation of Chemicals Regulation
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RMS
rapporteur Member State
RPE
respiratory protective equipment
RUD
residue per unit dose
SANCO
Directorate-General for Health and Consumers
SC
suspension concentrate
SD
standard deviation
SFO
single first-order
SMILES
simplified molecular-input line-entry system
SPG
specific protection goal
sRBC
sheep red blood cells
SSD
species sensitivity distribution
STMR
supervised trials median residue
STOT-RE
specific target organ toxicity – repeated exposure
t1/2
half-life (define method of estimation)
TC
Technical material
TER
toxicity exposure ratio
TERA
toxicity exposure ratio for acute exposure
TERLT
toxicity exposure ratio following chronic exposure
TERST
toxicity exposure ratio following repeated exposure
TK
technical concentrate
TLV
threshold limit value
Tmax
time until peak blood levels achieved
TMDI
theoretical maximum daily intake
TRR
total radioactive residue
TSH
thyroid-stimulating hormone (thyrotropin)
TWA
time-weighted average
UDS
unscheduled DNA synthesis
UF
uncertainty factor
UV
ultraviolet
W/S
water/sediment
w/v
weight per unit volume
w/w
weight per unit weight
WBC
white blood cell
WHO
World Health Organization
wk
week
yr
year
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Appendix A –
List of end points for the active substance and the
representative formulation
Identity, Physical and Chemical Properties, Details of Uses, Further Information
(Regulation (EU) N° 283/2013, Annex Part A, points 1.3 and 3.2)
Active substance (ISO Common Name)
Mesotrione
Function (e.g. fungicide)
Herbicide
Rapporteur Member State
UK
Co-rapporteur Member State
BE
Identity (Regulation (EU) N° 283/2013, Annex Part A, point 1)
Chemical name (IUPAC)
2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione
Chemical name (CA)
2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1-3cyclohexanedione
CIPAC No
625
CAS No
104206-82-8
EC No (EINECS or ELINCS)
609-064-00
FAO
Specification
publication)
(including
year
of
N.A.
Minimum purity of the active substance as
manufactured
930 g/kg on a dry weight basis
Identity of relevant impurities (of toxicological,
ecotoxicological
and/or
environmental
concern) in the active substance as
manufactured
R287431
max 2 mg/kg
R287432
max 2 g/kg
1,2-dichloroethane max 1 g/kg
Other impurities: open (except solvents)
Molecular formula
C14H13NO7S
Molar mass
339.3 g/mol
Structural formula
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Physical and chemical properties (Regulation (EU) N° 283/2013, Annex Part A, point 2)
Melting point (state purity)
Boiling point (state purity)
165.3°C with decomposition (99.3% pure)
The test substance decomposes without boiling (99.6%
pure)
Temperature of decomposition (state purity)
Some decomposition on melting~165°C (99.3%, w/w)
Appearance (state purity)
Pale yellow solid (99.3% pure)
Light tan or sand coloured opaque solid (96.7% tech)
Pale amber/brown solid in the form of a soft, granular
powder, containing coarse particles and some larger
aggregates (83.0% wet paste)
Vapour pressure (state temperature, state purity)
<5.7 x 10-6 Pa at 20°C (99.7% pure)
Henry’s law constant
<5.1 x 10-7 Pa m3/ mol at 20ºC
Solubility in water (state temperature, state
purity and pH)
160 mg/L in unbuffered water at 2 0ºC
2200 mg/L at pH 4.8 at 20ºC (99.7% pure)
1500 mg/L at pH 6.9 at 20ºC (99.7% pure)
2200 mg/L at pH 9 at 20ºC (99.7% pure)
Solubility in organic solvents
(state temperature, state purity)
Solvent in g/L at 20°C (96.7% tech)
acetonitrile
117.0
acetone
93.3
1,2-dichloroethane
66.3
ethyl acetate
18.6
methanol
4.6
toluene
3.1
xylenes
1.6
n-heptane
<0.5
Surface tension
(state concentration and temperature, state
purity)
61.5 – 61.6 mN/m at 21.0 ± 0.5°C (90% saturated
solution) (99.7% pure)
72.5 mN/m at 20ºC (90% saturated solution) (96.7% tech)
Partition coefficient
(state temperature, pH and purity)
At 20ºC
unbuffered water : 0.11
pH 5 : -1.1
pH 7 and 9 <-1.0 (99.7% pure)
Dissociation constant (state purity)
pKa 3.12 at 20ºC
0.6503 (associated) and 0.3404 (dissociated)
ε(M-1cm-1), respectively at 254 nm (99.7% pure)
UV/VIS absorption (max.) incl. 
(state purity, pH)
At 256 nm
ε(M-1cm-1) = 2.24 x 10-4
No UV adsorption maxima>290 nm. (99.3% pure in
methanol)
Flammability (state purity)
not highly flammable (96.7% tech)
Explosive properties (state purity)
not considered explosive (96.7% tech)
Oxidising properties (state purity)
not considered oxidising (96.7% tech)
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Summary of representative uses evaluated, for which all risk assessments needed to be completed (mesotrione)
(Regulation (EU) N° 284/2013, Annex Part A, points 3, 4)
Crop
and/o
r
situati
on
(a)
Member
State
or
Country
Product
name
Maize
EU N&S
Callisto
100SC
(A1273
9A)
F
G
or
I
(b
)
Pests or
Group of
pests
controlled
(c)
Preparatio
n
Typ Con
e
c.
(da.s.
f)
(i)
F
annual
broadleave
d
weeds and
some
annual
grasses
such as
SC
Echinochlo
a crus-galli
a)
b)
c)
d)
e)
f)
g)
h)
100
g/L
Application
method
kind
(f-h)
range of
growth
stages
& season
(j)
number
minmax
(k)
Foliar
spray
applicati
on
using a
hydrauli
c
vehiclemounted
spray
equipm
ent
BBCH 1218
1
applicati
on per
crop/sea
son
For crops, the EU and Codex classifications (both) should be taken into account;
where relevant, the use situation should be described (e.g. fumigation of a structure)
Outdoor or field use (F), greenhouse application (G) or indoor application (I)
e.g. biting and sucking insects, soil born insects, foliar fungi, weeds
e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008.
Catalogue of pesticide
All abbreviations used must be explained
Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the planttype of equipment used must be indicated
i)
j)
k)
l)
m)
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Interval
between
application
(min)
na
Application rate per
treatment
kg
Water
kg
a.s
L/ha
a.s./ha
/hL
min-max
minminmax
max
(l)
(l)
30 to
200- 400
120 to
75 g
L/ha
150 g
as/hL
as/ha
PHI
(days)
(m)
Remarks
na
-
g/kg or g/L. Normally the rate should be given for the active substance (according to
ISO) and not for the variant in order to compare the rate for same active substances
used in different variants (e.g. fluoroxypyr). In certain cases, where only one
variant is synthesised, it is more appropriate to give the rate for the variant
(e.g. benthiavalicarb-isopropyl).
Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of
Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information
on season at time of application
Indicate the minimum and maximum number of applications possible under practical
conditions of use
The values should be given in g or kg whatever gives the more manageable number
(e.g. 200 kg/ha instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha
PHI - minimum pre-harvest interval
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Further information, Efficacy
Effectiveness (Regulation (EU) N° 284/2013, Annex Part A, point 6.2)
Sufficient information has been provided on the
effectiveness of mesotrione for the representative
uses.
Adverse effects on field crops (Regulation (EU) N° 284/2013, Annex Part A, point 6.4)
Sufficient information has been provided to
establish there are no adverse effects for the
representative uses.
Observations on other undesirable or unintended side-effects (Regulation (EU) N°
284/2013, Annex Part A, point 6.5)
Sufficient information has been provided to
establish there are no undersirable effects for the
representative uses.
Groundwater metabolites: Screening for biological activity (SANCO/221/2000-rev.10final Step 3 a Stage 1)
Activity against target organism
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MNBA
AMBA
No
No
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Methods of Analysis
Analytical methods for the active substance (Regulation (EU) N° 283/2013, Annex Part A,
point 4.1 and Regulation (EU) N° 284/2013, Annex Part A, point 5.2)
Technical a.s. (analytical technique)
HPLC with UV DAD detection
Impurities in technical a.s. (analytical
technique)
R287431 HPLC-MS/MS
R287432 HPLC-MS/MS
1,2-dichloroethane GC-FID
Plant protection product (analytical technique)
Mesotrione: HPLC-UV
Analytical methods for residues (Regulation (EU) N° 283/2013, Annex Part A, point 4.2 &
point 7.4.2)
Residue definitions for monitoring purposes
Food of plant origin
Mesotrione
Food of animal origin
Not required (provisional)
Soil
Mesotrione and metabolite A (open)
Sediment
Mesotrione and metabolite A (open)
Water surface
Mesotrione and metabolite A (open)
drinking/ground
Mesotrione and metabolite A (open)
Air
Mesotrione
Body fluids and tissues
Mesotrione
Monitoring/Enforcement methods
Food/feed of plant origin (analytical technique
and LOQ for methods for monitoring purposes)
QuEChERS
LC-MS/MS (LOQ 0.01 mg/kg)
Maize forage (high water), maize kernel (dry),
oilseed rape (high oil) and orange (high acid)
ILV in maize forage (high water) and maize kernel
(dry)
LC-MS/MS
Food/feed of animal origin (analytical
technique and LOQ for methods for monitoring
purposes)
QuEChERS
Soil (analytical technique and LOQ)
Single method
LC-MS/MS (LOQ 0.01 mg/kg) in all animal matrices
LC-MS/MS:
Mesotrione:
LOQ 0.002 mg/kg
MNBA: LOQ 0.002 mg/kg
AMBA: LOQ 0.002 mg/kg
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Water (analytical technique and LOQ)
Single method
LC-MS/MS (surface and ground water, ILV available
for drinking water)
Mesotrione:
LOQ 0.05 µg/L
MNBA: LOQ 0.05 µg/L
AMBA: LOQ 0.05 µg/L
Air (analytical technique and LOQ)
LC-MS/MS
Mesotrione:
Body fluids and tissues (analytical technique
and LOQ)
LOQ 0.45 µg/m3
QuEChERS
LC-MS/MS (LOQ 0.01 mg/kg in blood)
Classification and labelling with regard to physical and chemical data (Regulation (EU) N°
283/2013, Annex Part A, point 10)
Substance
Mesotrione
Harmonised
classification
according
to
Regulation (EC) No 1272/2008 and its
Adaptations to Technical Process [Table 3.1 of
Annex VI of Regulation (EC) No 1272/2008 as
amended]7:
Not classified
Peer review proposal8 for harmonised
classification according to Regulation (EC) No
1272/2008:
No classification proposed.
7
8
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.
It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with
Regulation (EC) No 1272/2008. Proposals for classification made in the context of the evaluation procedure under Regulation
(EC) No 1107/2009 are not formal proposals.
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Impact on Human and Animal Health
Absorption, distribution, metabolism and excretion (toxicokinetics) (Regulation (EU) N°
283/2013, Annex Part A, point 5.1)
Rate and extent of oral absorption/systemic
bioavailability
~70% based on comparison of excretion patterns
after oral vs. intravenous administrations in rats
treated with 1 mg/kg bw
50% based on radioactivity excreted in urine and
cage-wash in mice treated with 1 mg/kg bw via the
oral route
Toxicokinetics
Low dose- Cmax 0.25, Tmax 0.5h, Plasma T1/2 1.6
High dose- Cmax 40, Tmax 1.5h, Plasma T1/2 1.8
Distribution
Widely distributed (and kidneys have the highest
distribution)
Potential for bioaccumulation
No evidence of bioaccumulation.
Rate and extent of excretion
Rat: >80% within 72 h, mainly via urine (43-67%,
23-37% via faeces, 2-14% via bile in rats)
Mouse: ~80% within 72 h (36-59% via urine, 2146% via faeces within 72h
Metabolism in animals
Not extensively metabolised (~90% in urine
unchanged, up to 5% hydroxylated metabolites,
MNBA and AMBA); MNBA and AMBA generated by
gut microflora can be reabsorbed and contribute to
the hydroxylated metabolites in urine or excreted in
faeces.
In vitro metabolism
Data gap for interspecies comparative in vitro
metabolism study including human metabolism
No in vitro data but a human volunteer study
confirms absorption and excretion similar to
rodents.
Toxicologically relevant compounds
(animals and plants)
Mesotrione
Toxicologically relevant compounds
(environment)
Mesotrione
AMBA
Acute toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.2)
Rat LD50 oral
> 5000 mg/kg bw
Rat LD50 dermal
> 2000 mg/kg bw
Rat LC50 inhalation
> 4.75 mg/L air /4 h (nose only)
Skin irritation
Non-irritant
Eye irritation
Non-irritant
Skin sensitisation
No evidence of skin sensitisation (M&K)
Phototoxicity
Not phototoxic
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Short-term toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.3)
Target organ / critical effect
Rat: Eye (corneal
tyrosinaemia)
opacity
due
to
Mouse: decreased bodyweight gain and
haematology effects (decrease in RBC
count, increase in MCH and MCV).
STOT
RE 2
H373
Dog: tyrosine levels that are potentially
associated with adverse effects and
changes in biochemical and urinary
parameters that plateau at the high dose
levels
Relevant oral NOAEL
90-day rat: 0.47 mg/kg bw per day
90-day mouse: 61.5mg/kg bw per day
1 year, dog: 10 mg/kg bw per day
Relevant dermal NOAEL
No data – study not reliable
Relevant inhalation NOAEL
No data - not required
Genotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.4)
In vitro studies
Bacterial
negative
Reverse
Mutation
assay-
In vitro cytogenetic assay in human
lymphocytes- equivocal
In vitro mutagenicity with L5178Y mouse
lymphoma cells- negative
In vivo studies
Mouse Micronucleus- negative
Photomutagenicity
Not required
Potential for genotoxicity
Mesotrione is unlikely to be genotoxic
Long-term toxicity and carcinogenicity (Regulation (EU) N°283/2013, Annex Part A,
point 5.5)
Long-term effects (target organ/critical effect)
Rat: increased
opacity
incidence
of
corneal
Mouse: decreased body weight
Relevant long-term NOAEL
2-year, rat: 0.06 mg/kg bw per day
18-month, mouse: 49.7 mg/kg bw per
day
Carcinogenicity (target organ, tumour type)
Rat:
thyroid
follicular
adenoma
(secondary to increased levels of plasma
tyrosine)
Mouse: no tumours
Mesotrione is unlikely to pose a hazard to
humans
Relevant NOAEL for carcinogenicity
2-year, rat: 7.7 mg/kg bw per day;
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18-month, mouse: > 898mg/kg bw per
day
Reproductive toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.6)
Reproduction toxicity
Reproduction target / critical effect
Parental toxicity:
Rat: changes in organ weight (kidney,
liver, testes), cloudy eyes (secondary to
tyrosinaemia)
Mice: increased tyrosinaemia of >800 µM
Reproductive toxicity:
Rat: decreased litter size
Mice: reduction in successful mating
Offspring’s toxicity
Rat: ocular effects
Mice: increased
weights
Relevant parental NOAEL
testes
and
kidney
0.3 mg/kg bw per day (rat)
10 mg/kg bw per day (mouse)
Relevant reproductive NOAEL
0.3 mg/kg bw per day (rat)
10 mg/kg bw per day (mouse)
Relevant offspring NOAEL
0.3 mg/kg bw per day (rat)
2 mg/kg bw per day (mouse)
Developmental toxicity
Developmental target / critical effect
Rat:
Maternal toxicity: Decreased weight gain
(>10%)
Developmental
toxicity:
Increased
incidence of minor skeletal defects and
reduced ossification
Mouse:
Maternal toxicity: None at highest dose
level
Repr.
2
Developmental
ossification
H361d
toxicity:
Delayed
Rabbit:
Maternal toxicity: abortion
Developmental
toxicity:
ossification in all dose groups
Reduced
Relevant maternal NOAEL
Rat: 100 mg/kg bw per day (LOAEL)
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Mouse: 600 mg/kg bw per day
Rabbit: 100 mg/kg bw per day
Relevant developmental NOAEL
Rat: 100 mg/kg bw per day (LOAEL)
Mouse: 150 mg/kg bw per day
Rabbit: 100 mg/kg bw per day (LOAEL)
Neurotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.7)
Acute neurotoxicity
No evidence of neuropathology in an
acute study in the rat.
NOAEL: 2000 mg/kg bw
Repeated neurotoxicity
No evidence of neuropathology in a subchronic study in the rat.
NOAEL: 5000 ppm (equivalent to 403
mg/kg bw per day in males and 467
mg/kg bw per day in females)
Sciatic nerve demyelination was reported
in a chronic rat study but this was
associated with increased plasma tyrosine
concentration.
Additional studies (e.g. delayed neurotoxicity,
developmental neurotoxicity)
None
Other toxicological studies (Regulation (EU) N° 283/2013, Annex Part A, point 5.8)
Supplementary studies on the active substance
Mechanistic studies show that the toxic effects of
the a.s are largely attributable to increased plasma
tyrosine levels following HPPD inhibition. Tyrosine
levels are increased to a greater extent in rats
(particularly males) due to differences in the
activity of enzymes in the tyrosine catabolic
pathway. Studies show that the mouse is more
predictive of the response in humans.
Human volunteer study (single oral dose) shows a
NOAEL of 0.5 mg/kg bw
28-day immunotoxicity study in mice:
No effect on spleen cell number or suppression of
the humoral immune response to the sheep T-cell
dependent antigen sRBC by mesotrione.
NOAEL 1168 mg/kg bw per day, the highest dose
tested.
No immunotoxic effects observed on the overall
database.
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Endocrine disrupting properties
Based on proposed classification as Repr. Cat 2 and
effects observed on the endocrine organs (changes
in testes and epididymides weight and thyroid
andonomas in females) according to the interim
criteria mesotrione may be considered to have
endocrine distrupting properties.
Data gap to clarify the ED properties of mesotrione
Studies performed on metabolites or impurities
MNBA
Rat, acute oral LD50> 5000mg/kg bw
Rat, acute dermal LD50> 2000mg/kg bw
Skin irritation- non-irritating
Eye irritation- moderate (H319)
Skin sensitisation- skin sensitiser (LLNA) (H317)
In vitro genotoxicity:
- (-) bacterial reverse mutation assay
- (-)
lymphocytes
cytogenetic
assay
in
human
In vivo genotoxicity
- (-) UDS
- (-) bone marrow micronucleus
28-day oral study in rats:
NOAEL 1000mg/kg bw per day, the highest dose
tested
90 day oral study in rats:
NOAEL 51 mg/kg bw per day, based on decreased
bodyweight and food consumption in males; slight
(less pronounced than mesotrione) inhibition of
HPPD at  51 mg/kg bw per day.
→ MNBA presents a lower toxicity profile compared
with mesotrione
AMBA
Rat acute oral LD50 > 5000 mg/kg bw
In vitro genotoxicity:
- (-) bacterial reverse mutation assay
- (+) human lymphocytes in the absence of
metabolic activation
In vivo genotoxicity:
not tested
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Medical data (Regulation (EU) N° 283/2013, Annex Part A, point 5.9)
No detrimental effects on health in manufacturing
personnel
Accidental/intentional/occupational exposures- 52
cases in total with none to moderate severity for
human health effects. One case of ingestion which
was severe but no direct link to the product
containing mesotrione.
Summary9 (Regulation (EU)
N°1107/2009, Annex II, point 3.1 and
3.6)
Value
Study
Uncertainty
factor
(mg/kg bw (per
day))
Acceptable Daily Intake (ADI)
0.011
Mouse multigeneration
200
Acute Reference Dose (ARfD)
0.021
Mouse multigeneration
100
Acceptable Operator Exposure Level (AOEL)
0.0052
Mouse multigeneration
Overall 4003
(200 + 50%3)
1
2
3
Same value as the first review (European Commisssion 2003b)
During the first review, the AOEL was set at 0.015 based on the same mouse multigeneration NOAEL and UF of 100, 70%
correction for oral absorption
Including correction for limited oral absorption/bioavailability (50%).
Dermal absorption (Regulation (EU) N° 284/2013, Annex Part A, point 7.3)
Callisto 100SC (A12739A) SC formulation
containing 100 g/L mesotrione
Concentrate: 0.1%
0.48 g/L spray dilution (1/200): 3%
0.24 g/L spray dilution (1/400) 5%
Based on a human in vitro study
Exposure scenarios (Regulation (EU) N° 284/2013, Annex Part A, point 7.2)
Operators
Use: maize, tractor mounted equipment, application
rate 150 g a.s./ha
Exposure estimates (model):
% of AOEL
UK POEM
Without PPE:
340
PPE (gloves mixing/loading and application):
64
German model
Without PPE:
90
On the basis of the classification of the product as
an eye irritant (H319) the use of a faceshield when
handling the concentrate would also be required.
9
If available include also reference values for metabolites
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Workers
76% of the AOEL for re-entry workers
(EUROPOEM II worker re-entry model)
Bystanders and residents
Vapour exposure = 12% of AOEL (based on
surrogate data)
Drift Exposure = 2% of the AOEL (based on
surrogate data)
Children’s exposure to fallout = 1% of the AOEL
(based on published drift data and EPA SOPs)
Classification with regard to toxicological data (Regulation (EU) N° 283/2013, Annex Part
A, Section 10)
Substance :
Mesotrione
Harmonised classification according to
Regulation (EC) No 1272/2008 and its
Adaptations to Technical Process [Table 3.1 of
Annex VI of Regulation (EC) No 1272/2008 as
amended]10 :
Not classified
Peer review proposal for harmonised
classification according to Regulation (EC) No
1272/200811:
STOT-RE 2 - H373: May cause damage to organs
through prolongedor repeated exposure (eye)
10
11
Repro. 2 – H361d: Suspected of damaging the
unborn child
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.
It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with
Regulation (EC) No 1272/2008. Proposals for classification made in the context of the evaluation procedure under Regulation
(EC) No 1107/2009 are not formal proposals.
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Residues in or on treated products food and feed
Metabolism in plants (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.1, 6.5.1,
6.6.1 and 6.7.1)
Primary
crops
(Plant groups covered)
Crop groups
Crop(s)
Fruit crops
n.a.
Root crops
n.a.
Leafy crops
n.a.
Application(s)
DAT (days)
Forage: 27
280–307 g a.s./ha
(pre-emergence)
Cereals/grass crops
Maize
161–164 g a.s./ha
(post- emergence)
Fodder: 154
Grain: 154
Forage: 28
Fodder: 125
Grain: 125
Foliage: 90
Peanut
305–327 g a.s./ha
(pre-emergence)
Hay: 153 –
154
Nutmeat:
154 – 169
796–836 g a.s./ha
(pre-emergence)
Forage: 28
218–226 g a.s./ha
(pre-emergence)
Pulses/Oilseeds
Herbicide
tolerant
soya bean
218–226 g a.s./ha
(pre-emergence)
followed by 128–130 g
a.s./ha
(postemergence)
Hay: 42
Seed:
124
123-
Forage:28
Hay: 51
Seed: 90
Forage: 22
224–230 g a.s./ha
(post- emergence)
Hay: 40
Seed: 110 118
Miscellaneous
Studies conducted with mesotrione labelled on cyclohexane-2-14C and
phenyl-U-14C.
Rotational
crops
(metabolic pattern)
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Crop groups
Crop(s)
PBI (days)
Comments
Root/tuber crops
Radish
120, 300
Leafy crops
Broad
leaves
Endive
120, 300
Mesotrione labelled on
cyclohexane-2-14C and
phenyl-U-14C
was
applied separately at a
rate of 164 g a.s./ha to
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Cereal (small grain)
Wheat
120, 300
bare soil.
The 300 DAT crops
were not harvested.
Other
Rotational crop and
primary
crop
metabolism similar?
Metabolism similar to primary crops.
Processed
commodities
(standard
hydrolysis
study)
Conditions
20 min, 90°C, pH 4
60 min, 100°C, pH 5
20 min, 120°C, pH 6
Residue
pattern
in
processed commodities
similar
to
residue
pattern
in
raw
commodities?
Hydrolysis studies addressing the nature of the residues in processed
commodities are not triggered (mesotrione residue levels in maize grain
<0.01 mg/kg).
Plant residue definition for monitoring (RD-Mo)
Mesotrione (cereals and pulses/oilseeds only)
Plant residue definition for risk assessment
(RD-RA)
Food commodities:
pulses/oilseeds only)
Mesotrione
(cereals
and
Feed commodities: Mesotrione and AMBA (including
its conjugates) (Cereals, pulses and oilseeds only –
Conventional crops) – Provisional.
Conversion factor (monitoring to risk
assessment)
Not applicable
Metabolism in livestock (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.2, 6.2.3,
6.2.4, 6.2.5 6.7.1)
Animals covered
Animal
Dose
(mg/kg bw/d)
Duration
(days)
N
rate/comment
Laying hen
-
-
-
Goat/Cow
0.4
7
200 N (beef cattle)
(phenyl-U-14C
AMBA)
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130
N
cattle)
Pig
-
-
-
Fish
-
-
-
44
(dairy
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Livestock metabolism studies are not triggered considering the
estimated dietary burden calculation with regard to AMBA
conjugates residues in maize forage, fodder and total residues in
maize grain from the metabolism data. This assessment has to
be reconsidered pending the outcome of data gap set for
clarification of the genotoxic potential of AMBA and of its
toxicological profile.
A fish metabolism study is also not requested.
Time needed to reach a plateau concentration
in milk and eggs (days)
Day 5
Animal residue definition for monitoring (RDMo)
Not required
(provisional)
for
the
representative
use
Animal residue definition for risk assessment
(RD-RA)
Not required
(provisional)
for
the
representative
use
Conversion factor (monitoring to risk
assessment)
Not applicable
Metabolism in rat and ruminant similar
(Yes/No)
Yes
Fat soluble residues (Yes/No)
AMBA residues in muscle (<0.01 mg/kg) and in fat
free muscle (0.003-0.018 mg/kg). AMBA is not
expected to be fat soluble.
Residues in succeeding crops (Regulation (EU) N° 283/2013, Annex Part A, point 6.6.2)
Confined rotational crop study
(Quantitative aspect)
Bare soil application of mesotrione labelled
respectively on cyclohexane-2-14C and phenyl-U-14C
at a dose rate of 164 g a.s./ha (1N). At 120 day
plant back interval (PBI), TRRs are very low in all
crop parts: <0.01 mg/kg in wheat grain and radish
root, 0.012 mg/kg in broad-leaves endive and up to
0.033 mg/kg in wheat forage and straw.
Metabolites’ identification at 300 d PBI not further
investigated.
Field rotational crop study
Not triggered considering the very low TRRs in
rotational crops after a bare soil application at ca.
1N rate and considering also the low to moderate
persistence of mesotrione, MNBA and AMBA.
US rotational crop field trials were conducted on
pulses/oilseeds (soya bean), leafy vegetables
(endive), root vegetables (radish) and cereals
(small grains (wheat)) after bare soil application at
0.34 kg a.s./ha or after bare soil application
(0.34 kg a.s./ha ) followed by a post-emergence
application (0.22 kg a.s./ha). Residues of
mesotrione and of MNBA were < 0.01 mg/kg in all
crop parts.
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Stability of residues (Regulation (EU) N° 283/2013, Annex Part A, point 6.1)
Plant
products
(Category)
Commodity
T
Stability (Months)
(°C)
Mesotrione
MNBA
High water content
Maize forage
-18°C±5°C
31
42
Maize grain
-18°C±5°C
42
42
High oil content
High
content
protein
High starch content
High acid content
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Summary of residues data from the supervised residue trials (Regulation (EU) N° 283/2013, Annex Part A, point 6.3)
Crop
Region/
Indoor
(a)
Residue levels (mg/kg) observed in the
supervised residue trials relevant to the
supported GAPs
(b)
Recommendations/comments
(OECD calculations)
MRL
proposals
(mg/kg)
HR
(mg/kg)
(c)
STMR
(mg/kg)
(d)
Representative uses
Maize
N EU/ Outdoor
Forage:13x<0.01
0.01*
0.01
0.01
Silage: 13x<0.01
Grain: 15x<0.01
Maize
S EU/ Outdoor Forage: 15x<0.01
0.01*
0.01
0.01
Silage: 19x<0.01
Grain: 19x<0.01
A data gap is set for clarification of the genotoxic potential of AMBA and of its toxicological profile (see section 2). Pending the outcome of the requested data on the toxicological
relevance of this compound, maize residue trials for the determination of the residues of AMBA conjugates in feed items may be needed.
MRL application
Not relevant
Summary of the data on formulation equivalence:
No further consideration required.
Summary of data on residues in pollen and bee products (Regulation (EU) No 283/2013, Annex Part A, point 6.10.1)
No residue data available.
A data gap was identified for the determination of the residues in pollen and bee products for human consumption.
(a) NEU or SEU for northern or southern outdoor trials in EU member states (N+SEU if both zones), Indoor for glasshouse/protected crops, Country if non-EU location.
(b) Residue levels in trials conducted according to GAP reported in ascending order (e.g. 3x <0.01, 0.01, 6x 0.02, 0.04, 0.08, 3x 0.10, 2x 0.15, 0.17). When residue definition for monitoring and
risk assessment differs, use Mo/RA to differentiate data expressed according to the residue definition for Monitoring and Risk Assessment.
(c) HR: Highest residue. When residue definition for monitoring and risk assessment differs, HR according to residue definition for monitoring reported in brackets (HRMo).
(d) STMR: Supervised Trials Median Residue. When residue definition for monitoring and risk assessment differs, STMR according to definition for monitoring reported in brackets (STMRMo).
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Inputs for animal burden calculations
Inputs for OECD dietary burden calculation; mesotrione
Feed commodity
Representative uses
Maize grain
Maize fodder
Maize forage
Median dietary burden
(mg/kg) Comment
Maximum dietary burden
(mg/kg) Comment
0.01
0.01
0.01
0.01
0.01
0.01
Inputs for OECD dietary burden calculation; AMBA (including its conjugates)
Feed commodity
Representative uses
Maize grain
Maize fodder
Maize forage
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Median dietary burden
(mg/kg) Comment
Maximum dietary burden
(mg/kg) Comment
0.014
0.014
0.301
(provisio
nal)
0.043
(provisio
nal)
0.301
(provisio
nal)
0.043
(provisio
nal)
48
Total residues from the
metabolism data.
Maximum residue levels
of total AMBA (including
its conjugates) recovered
from the metabolism
data. Pending clarification
of the genotoxic potential
of AMBA and of its
toxicological profile GAPcompliant residue trials
for the determination of
AMBA conjugates
residues in maize fodder,
forage may be needed
and the livestock dietary
burden to be revised
accordingly.
EFSA Journal 2016;14(3):4419
Peer review of the pesticide risk assessment of the active substance mesotrione
Residues from livestock feeding studies (Regulation (EU) N° 283/2013, Annex Part A, points 6.4.1, 6.4.2, 6.4.3 and 6.4.4)
Animal dietary burden calculations in line with OECD Guideline 505 and OECD Guidance, series on pesticides No 73
Dietary burden calculation – Mesotrione
MRL calculations
Highest expected
intake
(mg/kg bw/day)
(mg/kg DM for fish)
Intake >0.004 mg/kg bw
Feeding study submitted
Ruminant
Beef cattle
Dairy cattle
Representative
feeding level (mg/kg
bw/d, mg/kg DM for fish)
and N rates
Muscle
Fat
Meat(b)
Liver
Kidney
Milk(a)
Eggs
Method of calculation(c)
Level
(a)
:
:
(c)
:
(b)
0.001
0.001
No
Not triggered
Estimated
HR(a) at 1N
Ram/Ewe
Lamb
Pig/Swine
Breeding
Finishing
0.0001
0.0001
No
Not triggered
Beef: N
Dairy: N
MRL
proposals
Level
Estimated
HR(a) at 1N
0.0003
0.0002
No
Not triggered
Lamb: N
Ewe: N
MRL
proposals
Level
Estimated
HR(a) at 1N
Poultry
Broiler
Layer
Turkey
0.001
0.001
0.0004
No
Not triggered
N rate
Breed/Finish
MRL
proposals
Level
Estimated
HR(a) at 1N
Fish
Carp
Trout
Fish intake >0.1 mg/kg DM
No
Not triggered
B or T: N
Layer: N
MRL
proposals
Level
Estimated
HR(a) at 1N
N rate
Carp/Trout
MRL
proposals
Estimated HR calculated at 1N level (estimated mean level for milk).
HR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry
The OECD guidance document on residues in livestock (series on pesticides 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf),
by intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals
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49
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Peer review of the pesticide risk assessment of the active substance mesotrione
STMR calculations
Median expected
intake
(mg/kg bw/d)
(mg/kg DM for fish)
Representative
feeding level (mg/kg
bw/d, mg/kg DM for fish)
and N rates
Ruminant
Beef cattle
Dairy cattle
Pig/Swine
Breeding
Finishing
0.0005
0.0007
Ram/Ewe
Lamb
0.0001
0.0001
Level
Beef: N
Dairy: N
Level
Lamb : N
Ewe: N
Level
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
0.0003
0.0002
N rate
Breed/Fini
sh
Estimated
STMR(b)
at 1N
Poultry
Broiler
Layer
Turkey
0.001
0.001
0.0004
Fish
Carp
Trout
Level
B or T: N
Layer: N
Level
N rate
Carp/Trout
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Muscle
Fat
Meat(a)
Liver
Kidney
Milk
Eggs
Method of calculation(c)
(a)
:
:
(c)
:
(b)
STMR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry
When the mean level is set at the LOQ, the STMR is set at the LOQ.
The OECD guidance document on residues in livestock (series on pesticide 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf),
by intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals.
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50
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Peer review of the pesticide risk assessment of the active substance mesotrione
Dietary burden calculation – AMBA (including its conjugates) (Provisional)
MRL calculations
Highest expected
intake
(mg/kg bw/d)
(mg/kg DM for fish)
Intake >0.004 mg/kg bw
Feeding study submitted
Ruminant
Beef cattle
Dairy cattle
Representative
feeding level (mg/kg
bw/d, mg/kg DM for fish)
and N rates
Muscle
Fat
Meat(b)
Liver
Kidney
Milk(a)
Eggs
Method of calculation(c)
Level
(a)
:
:
c)
:
(b)
0.002
0.003
No
Not triggered
Estimated
HR(a) at 1N
Ram/Ewe
Lamb
Pig/Swine
Breeding
Finishing
0.0001
0.0001
No
Not triggered
Beef: N
Dairy: N
MRL
proposals
Level
Estimated
HR(a) at 1N
0.002
0.0002
No
Not triggered
Lamb: N
Ewe: N
MRL
proposals
Level
Estimated
HR(a) at 1N
Poultry
Broiler
Layer
Turkey
0.001
0.001
0.0004
No
Not triggered
N rate
Breed/Finish
MRL
proposals
Level
Estimated
HR(a) at 1N
Fish
Carp
Trout
Fish intake >0.1 mg/kg DM
No
Not triggered
B or T: N
Layer: N
MRL
proposals
Level
Estimated
HR(a) at 1N
N rate
Carp/Trout
MRL
proposals
Estimated HR calculated at 1N level (estimated mean level for milk).
HR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry
The OECD guidance document on residues in livestock (series on pesticides 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf),
by intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals.
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51
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Peer review of the pesticide risk assessment of the active substance mesotrione
STMR calculations
Median expected
intake
(mg/kg bw/d)
(mg/kg DM for fish)
Representative
feeding level (mg/kg
bw/d, mg/kg DM for fish)
and N rates
Ruminant
Beef cattle
Dairy cattle
Pig/Swine
Breeding
Finishing
0.0024
0.0029
Ram/Ewe
Lamb
0.0001
0.0001
Level
Beef: N
Dairy: N
Level
Lamb : N
Ewe: N
Level
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
0.002
0.0002
N rate
Breed/Fini
sh
Estimated
STMR(b)
at 1N
Poultry
Broiler
Layer
Turkey
0.001
0.001
0.0004
Fish
Carp
Trout
Level
B or T: N
Layer: N
Level
N rate
Carp/Trout
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Mean level
in feeding
level
Estimated
STMR(b)
at 1N
Muscle
Fat
Meat(a)
Liver
Kidney
Milk
Eggs
Method of calculation(c)
(a)
:
:
c)
:
(b)
STMR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry
When the mean level is set at the LOQ, the STMR is set at the LOQ.
The OECD guidance document on residues in livestock (series on pesticide 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf),
by intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals.
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52
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Peer review of the pesticide risk assessment of the active substance mesotrione
Conversion Factors (CF) for monitoring to risk assessment
Not applicable
Processing factors (Regulation (EU) N° 283/2013, Annex Part A, points 6.5.2 and 6.5.3)
Not required, mesotrione residues do not exceed 0.01 mg/kg
Consumer risk assessment (Regulation (EU) N° 283/2013, Annex Part A, point 6.9)
Including all uses (representative uses and uses related to an MRL application)
Not relevant as an application for maximum residue levels on mesotrione was not submitted as part of
the renewal dossier.
Consumer risk assessment limited to the representative uses – Considered as not finalised
(clarification on the genotoxic potential of AMBA and of its toxicological profile is requested – section
2).
ADI
0.01 mg/kg bw per day
TMDI (% ADI), according to EFSA PRIMo
Highest TMDI: 0.2% ADI
B)
NTMDI (% ADI), according to (to be specified)
-
IEDI (% ADI), according to EFSA PRIMo
-
NEDI (% ADI), according to (to be specified)
-
Factors included in the calculations
-
ARfD
0.02 mg/kg bw
IESTI (% ARfD, according to EFSA PRIMo)
Highest IESTI: 0.3% ARfD
NESTI (% ARfD, according to (to be specified)
-
Factors included in IESTI and NESTI
-
(WHO Cluster diet
Proposed MRLs (Regulation (EU) No 283/2013, Annex Part A, points 6.7.2 and 6.7.3)
Code(a)
Commodity/Group
Plant commodities
Representative uses
500030
Maize
MRL/Import tolerance(b) (mg/kg) and Comments
0.01 *
MRL
(a): Commodity code number, as listed in Annex I of Regulation (EC) No 396/2005
(b): MRLs proposed at the LOQ, should be annotated by an asterisk (*) after the figure.
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Environmental fate and behaviour
Route of degradation (aerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point
7.1.1.1)
Mineralisation after 100 days
up to 75.2% after 58 d, [14C-Cyclohexane]-label
(n12= 1)
up to 27.5% after 63d, 37.6% after 121 d [14CPhenyl]-label (n= 2)
Non-extractable residues after 100 days
up to 15.2%% after 21d, [14C- Cyclohexane]-label
(n= 1)
up to max. 37.6% after 28 d and 37%AR after 56 d
(Miller et al, 97) and
up to 34.1% after 63 d, 25.9% after 121 d[14CPhenyl]-label (n= 2) (Subba Rao, 96)
Metabolites requiring further consideration
- name and/or code,% of applied (range and
maximum)
MNBA (0.7- 57.2%AR) max at 28 days.
AMBA (1.8-9.7%AR) max at 23 days
[14C- Phenyl]-label
Route of degradation (anaerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A,
point 7.1.1.2)
Mineralisation after 100 days
up to 16.1% after 30 d, [14C- Cyclohexane]-label
(n= 1)
<0.5% after 59 d, [14C- Phenyl]-label (n= 1)
Non-extractable residues after 100 days
up to 23.4% after 30 d, [14C- Cyclohexane]-label
(n= 1)
up to 17% after 59 d, [14C- Phenyl]-label (n= 1)
Metabolites
that
may
require
further
consideration for risk assessment - name
and/or code,% of applied (range and
maximum)
[14C- Cyclohexane]-label
None identified
[14C- Phenyl]-label
AMBA 40.7% at 30 days declining to 21.9% at 59
days. (n=1)
MNBA not detected
Sterile conditions: 0%AR CO2 after 121 d, 12%AR
unextracted, <0.1% MNBA or AMBA (n=1)
[14C- Phenyl]-label
Sterile conditions: ≤1% CO2 after 180 d, 14.2-28%
unextracted over 180 days, no metabolites
reported, (n= 1) [14C- Cyclohexane]-label
12
n corresponds to the number of soils.
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Route of degradation (photolysis) on soil (Regulation (EU) N° 283/2013, Annex Part A,
point 7.1.1.3)
Metabolites
that
may
require
further
consideration for risk assessment - name
and/or code,% of applied (range and
maximum)
[14C- Phenyl]-label, irradiated moist soil
MNBA up to 20.3% at 16 experimental days (n= 1)
AMBA up to 8.3% at 13 experimental days (n=1)
[14C- Phenyl]-label, irradiated moist soil
Mineralisation at study end
7% after13 experimental days, (n= 1)
Non-extractable residues at study end
[14C- Phenyl]-label, irradiated moist soil
35.2% after 16 experimental days, (n= 1)
Rate of degradation in soil (aerobic) laboratory studies active substance (Regulation
(EU) N° 283/2013, Annex Part A, point 7.1.2.1.1 and Regulation (EU) N° 284/2013,
Annex Part A, point 9.1.1.1)
Parent
Dark aerobic conditions - Modelling Endpoints
Soil type
pH*)
t. oC/% MWHC
water
sandy loam
(ERTC)
loam
(Toulouse)
clay loam
(Pickett Piece)
clay loam
(721)
silty clay loam
(722)
silt loam
(723)
loamy sand
(724)
loam
(725)
clay loam
(727)
sandy loam
(728)
silt loam
(729)
clay loam
(730)
silty clay loam
(731)
silty clay loam
(732)
silty clay loam
(741)
silty clay loam
(742)
silt loam
Richmond
(Vispetto
&
Tovshteyn, 1997)
silt loam
DT50 /DT90
(days)
DT50 (d)
St.
20 C pF2/
10 kPa**)
(χ )
Method of
calculation
2
6.4
20°C /19a
11.6/ 38.5
8.2
18
SFO
7.7
20°C /25a
4.3/ 14.3
4.0
16.4
SFO
7.1
20°C /28a
5.3/ 17.7
5.3
6.5
SFO
5.6
25°C /28a
20.2 /(67.1)
32.3
4.1
SFO
5.7
25°C /30a
10.3/ (34.2)
16.5
3.9
SFO
5.4
25°C /26a
17.6/ (58.5)
28.2
3.4
SFO
4.8
25°C /14a
23.8/ (78.9)
31.1
4.3
SFO
5.8
25°C /25a
6.1/ 20.3
9.5
7.6
SFO
5.1
25°C /28a
20.8/ (69.2)
32.4
6.4
SFO
5.9
25°C /25a
7.2/ 24
9.7
5.6
SFO
5.6
25°C /26b
12.7/ (42.2)
20.3
1.6
SFO
5.3
25°C /28a
17.1/ (56.9)
26.9
8.9
SFO
6.1
25°C /30a
14.1/ (46.9)
22.6
1.0
SFO
5.0
25°C /30a
14.0/ (46.4)
22.4
5.3
SFO
5.7
25°C /30a
28.7/ (95.3)
44.3
4.5
SFO
7.2
25°C /34.4a
9.7/ (32.1)
15.5
5.5
SFO
6.2
25°C /32.04b
13.2/ 44.0
14.68
3.1
SFO
11.8/ 39.3
(Average
DT50ref
of
15.5 & 13.9
4.9
SFO
6.2
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25°C /32.04b
55
EFSA Journal 2016;14(3):4419
Peer review of the pesticide risk assessment of the active substance mesotrione
Richmond
(Subba-Rao, 1996)
days given
identical soil
descriptions
in these 2
studies).
silt loam
6.1
20°C /32.04b
Richmond
(Miller, 1997)
Geometric mean (if not pH dependent)
pH dependence
14.2/ 47.2
11.5
4.6
Yes - degradation
increasing pH.
SFO
increases
with
DT50 y = -9.766x pH + 77.692
r2 0.4687
(non-log)
*) Measured in [medium to be stated, usually calcium chloride solution or water]
**) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7
a
FOCUS default; bmeasured pF2
Rate of degradation in soil (aerobic) laboratory studies transformation
products (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.2 and
Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.1)
MNBA
Dark aerobic conditions - Modelling Endpoints
Soil type
pH*)
t. oC /% MWHC
DT50 /DT90
(days)
DT50 (d)
St.
20 C pF2/
10kPa**)
(χ2)
Method of
calculation
/30a
0.6/1.89
1.0
10
SFO
/25a
0.5/1.5
0.8
10.8
SFO
/25a
5.1/16.97
6.9
3.1
/26b
1.66/5.52
2.7
3.88
Decline from
peak
SFO
/28a
2.81/9.35
4.4
14.17
SFO
/30a
15.7/52.3
25.2
1.6
SFO
/19a
6.2/20.7
4.4
21.89
/25a
5/16.65
4.6
13.08
/32.04b
1.1/3.67
1.3
11.2
Decline from
peak
Decline from
peak
SFO
/32.04b
6.3/21.03
5.1
20.13
water
silty clay loam
5.7
25°C
(722)
loam
5.8
25°C
(725)
sandy loam
5.9
25°C
(728)
silt loam
5.6
25°C
(729)
clay loam
5.3
25°C
(730)
silty clay loam 6.1
25°C
(731)
sandy loam
6.4
20°C
(ERTC)
loam
7.7
20°C
(Toulouse)
silt loam
6.2
25°C
Richmond
(Subba-Rao, 1996)
silt loam
6.1
20°C
Richmond
(Miller, 1997)
Geometric mean (if not pH dependent)
pH dependence
*) Measured in [medium to be stated, usually calcium chloride solution or water]
**) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7
a
FOCUS default; bmeasured pF2
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56
Decline from
peak
3.4
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AMBA
Soil type
Wisborough
Dark aerobic conditions - Modelling Endpoints
pH*)
t. oC/% MWHC
DT50/DT90
DT50 (d)
water
(d)
20 C pF2/
10kPa**)
4.9
20°C /
7.8
3.7
Wisconsin
6.4
20°C /
33/109
23.5
7.98
East Anglia
7.9
20°C /
58.7/195
47.4
3.66
Spinks
6.7
20°C /
10.2/34
9.7
6.94
DFOP
DT90/3.32
DFOP
K2
DFOP
K2
FOMC
Richmond
Richmond
6.2
25°C /
13.6/45.2
16.0
14.8
SFO
6.1
20°C /
>1000
>1000
26.6
SFO
Geometric mean (if not pH dependent)
pH dependence
St.
(χ2)
Method
of
calculation
5.52
14.5
No
*) Measured in [medium to be stated, usually calcium chloride solution or water]
**) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7
a
FOCUS default; b measured pF2
italics - outlier
Rate of degradation field soil dissipation studies (Regulation (EU) N° 283/2013, Annex
Part A, point 7.1.2.2.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.1)
From original DAR, not relied on for renewal
Parent
Soil
type
(indicate if bare
or cropped soil
was used).
clay loam (bare
soil)
Aerobic conditions
Location
pHa
(country or ))
USA state).
Depth
(cm)
DT50
(days)
actual
DT90
(days)
actual
St.
(χ2)
DT50
(days)
Normb).
Method
of
calculation
France
6.0
0-10
7
73
-
-
clay
soil)
(bare
Italy
6.1
0-10
5
59
-
-
sandy loam (bare
soil)
Italy
8.0
0-10
4
39
-
-
sandy loam (bare
soil)
Germany
6.2
0-10
7
78
-
-
loam (bare soil)
Germany
5.8
0-10
/
/
-
-
loam (bare soil)
Germany
7.0
0-10
3
36
-
-
sandy clay
(bare soil)
Germany
6.9
0-10
3
38
-
-
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
sqrt 1st order
linear
regression
loam
loam
Geometric mean (if not pH dependent)
pH dependence
a)
b)
-
Not reported
Measured in [medium to be stated, usually calcium chloride solution or water]
Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7, values are DegT50matrix
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Soil accumulation (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.2.2 and
Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.2)
Soil accumulation and plateau concentration
Not triggered. Same as initial PECsoil.
Rate of degradation in soil (anaerobic) laboratory studies active substance (Regulation
(EU) N° 283/2013, Annex Part A, point 7.1.2.1.3 and Regulation (EU) N° 284/2013,
Annex Part A, point 9.1.1.1)
Parent
Soil type
Dark anaerobic conditions
o
pHa)
t.
C
/%
MWHC
Wisconsin silt loam
cyclohexane-label
6.2
25°C/
Wisconsin silt loam
phenyl-label
6.2
25°C/
DT50
/
DT90
(days)
4 days / 14
days
DT50 (d)
20 Cb)
St.
(χ2)
Method
of
calculation
r2=
0.98
first order
(linear
least
squares fit of
natural log of
concentration
vs. Sampling
interval).
first order
(linear
least
squares fit of
natural log of
concentration
vs. Sampling
interval).
r2=
0.97
4 days / 12
days
Geometric mean (if not pH dependent)
a)
b)
Measured in [medium to be stated, usually calcium chloride solution or water]
Normalised using a Q10 of 2.58
Rate of degradation on soil (photolysis) laboratory active substance (Regulation (EU) N°
283/2013, Annex Part A, point 7.1.1.3
Parent
Soil type
Gartenacker
loam (moist)
a)
Soil photolysis
o
pHa)
t.
C
/%
MWHC
8.4 (water) 20°C/ 39 at pF2
7.2 (CaCl2)
DT50/DT90
(d)
calculated at ºN
ca 22 days at 37°N;
ca 24 days at 50°N
Measured in [medium to be stated, usually calcium chloride solution or water]
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58
St.
(χ2)
n/a
Method
of
calculation
SFO
(net
photolytic
degradation
i.e.
irradiated
rate
constant minus dark
control rate constant)
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Peer review of the pesticide risk assessment of the active substance mesotrione
Soil adsorption active substance (Regulation (EU) N° 283/2013, Annex Part A, point
7.1.3.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)
Parent
Soil Type
OC%
Wisborough Green
2.63
silty clay loam
Wisconsin
1.58
silt loam
Toulouse
1.79
clay
Garonne
1.03
loam
Visalia
0.53
sandy loam
Wisconsin
1.28
silt loam
ERTC
0.58
sandy loam
Pickett Piece
3.31
clay loam
Garonne
0.87
loam
Champaign (1:2 ratio)
3.0
silty clay loam
Geometric mean (if not pH dependent)
Arithmetic mean (if not pH dependent)
Median
Worst case
pH dependence
a)
Soil
pHa)
5.1
Kd
(mL/g)
Kdoc
(mL/g)
KF
(mL/g)
4.46
KFoc
(mL/g)
171
1/n
6.2
0.74
47
0.921
6.5
1.25
70
0.915
7.8
0.15
14
0.971
8.2
0.13
25
0.959
6.1
0.61
48
0.947
6.4
0.33
57
0.950
7.1
0.97
29
0.932
7.7
0.16
18
0.954
4.4
6.16
354
0.94
0.902
0.94
14
Yes, sorption decreases as pH increases.
Kfoc
y= 8583.4e-0785x (log) r2 0.8977
Measured in [medium to be stated, usually calcium chloride solution or water]
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Soil adsorption transformation products (Regulation (EU) N° 283/2013, Annex Part A,
point 7.1.3.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)
MNBA
Soil Type
OC%
Wisborough Green
2.63
silty clay loam
Wisconsin
1.58
silt loam
Worst case
Geometric mean (if not pH dependent)
Arithmetic mean (if not pH dependent)
pH dependence
a)
b)
Soil
pHa)
5.1
Kd
(mL/g)
Kdoc
(mL/g)
6.2
KF
(mL/g)
0.16
KFoc
(mL/g)
6.1
1/n
0.05
3.2
0.61
3.2
-
0.9b
0.32
No
Measured in [medium to be stated, usually calcium chloride solution or water]
FOCUS default
Soil adsorption transformation products (Regulation (EU) N° 283/2013, Annex Part A,
point 7.1.3.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)
AMBA
Soil Type
OC%
Wisborough Green
2.63
silty clay loam
Wisconsin
1.58
silt loam
Toulouse
1.79
clay
Garonne
1.03
loam
Visalia
0.53
sandy loam
Arithmetic mean (if not pH dependent)
Soil
pHa)
5.1
Kd
(mL/g)
KF
(mL/g)
3.2
KFoc
(mL/g)
122
1/n
6.2
0.71
44.9
0.85
6.5
0.91
51.0
0.85
7.8
0.18
18.1
0.82
8.2
0.12
23.9
0.90
pH
dependent
(51.9)
18.1
Yes, sorption decreases as pH increases.
Kfoc
y = 1865e-0.563x (log) r2 0.9062
Worst case
pH dependence
a)
Kdoc
(mL/g)
0.83
0.85
Measured in [medium to be stated, usually calcium chloride solution or water]
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Soil adsorption transformation products (Regulation (EU) N° 283/2013, Annex Part A,
point 7.1.3.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)
SYN 546974
Soil Type
OC%
Gartenacker
1.8
Loam
18 Acres
2.2
Sandy Clay Loam
Marysville
1.6
Clay Loam
Sarpy
1.7
Silt loam
Seven Springs
0.6
Loamy sand
Arithmetic mean (if not pH dependent)
Worst case
pH dependence
Soil
pHa)
7.2
Kd
(mL/g)
Kdoc
(mL/g)
KF
(mL/g)
30.63
KFoc
(mL/g)
1702
1/n
5.7
220.07
10003
0.96
7.6
432.49
27031
0.96
6.5
376.10
22124
0.88
5.2
19.56
3260
0.84
13000
0.89
0.82
No
Mobility in soil column leaching active substance (Regulation (EU) N° 283/2013, Annex
Part A, point 7.1.4.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)
Column leaching
NOT REQUIRED
Mobility in soil column leaching transformation products (Regulation (EU) N° 283/2013,
Annex Part A, point 7.1.4.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point
9.1.2.1)
Column leaching
NOT REQUIRED
Lysimeter / field leaching studies (Regulation (EU) N° 283/2013, Annex Part A, points
7.1.4.2 / 7.1.4.3 and Regulation (EU) N° 284/2013, Annex Part A, points 9.1.2.2 /
9.1.2.3)
Lysimeter/ field leaching studies
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NOT REQUIRED
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Hydrolytic degradation (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.1.1
Hydrolytic degradation of the active substance
and metabolites > 10%
pH 5: ≥ 96.3%AR parent at 25°C over 30 days
pH 4: ≥ 91.7%AR parent at 50°C over 4 days
(14C- Cyclohexane and
14
C- Phenyl-labels)
stable
pH 7: ≥ 96.8%AR parent at 25°C over 30 days
pH 7: ≥ 97.2%AR parent at 50°C over 4 days
14
C- Cyclohexane and
14
C- Phenyl-labels)
stable
pH 9: : ≥ 96.4%AR parent at 25°C over 30 days
pH 9: ≥ 95.5%AR parent at 50°C over 4 days
(14C- Cyclohexane and
14
C- Phenyl-labels)
stable
Aqueous photochemical degradation (Regulation (EU) N° 283/2013, Annex Part A, points
7.2.1.2 / 7.2.1.3)
Photolytic degradation of active substance and
metabolites above 10%
Direct photolysis (Eya, B.K., 1995):
DT50 of 81-88 days at 40oN
DT50 of 89-97 days at 50oN.
No major metabolites found.
Quantum yield of direct phototransformation in
water at  > 290 nm
Not reported
Indirect photolytic degradation of active
substance and metabolites above 10%
Indirect photolysis (Oliver, R.G., 2005):
DT50 of 19.5 days at 40oN
DT50 of 20.5 days at 50oN
No metabolites >10%AR found
‘Ready biodegradability’ (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.1)
Readily biodegradable
(yes/no)
No data.
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62
Not readily biodegadable
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Aerobic mineralisation in surface water (Regulation (EU) N° 283/2013, Annex Part A,
point 7.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.2.1)
Parent
System
identifier
(indicate
fresh,
estuarine
marine)
pH
wate
r
phas
e
pH
sed
t.
o b
C
DT50 /DT90 whole
sys.
(suspended
sediment test)
At study Normali
temp
sed to
(20oCb)
12oCc)
St.
(χ2)
Group A, low
conc
(Natural water)
Group B, high
conc
(Natural
water)
Group C high
conc, sterilised
(natural water)
Group
D,
reference
(Natural water)
Group E, low
conc
(Natural water
& sed)
7.3
N/A
20
N/A
N/A
N/A
7.3
N/A
20
N/A
N/A
7.3
N/A
20
N/A
7.3
N/A
20
7.3
7.4
Group F, high
conc
(Natural water
& sediment)
Group G, high
conc, sterilised
(Natural water
& sed)
Group
H,
reference
(Natural water
& sed
7.3
a)
b)
c)
or
DT50 /DT90
Water (pelagic
test)
At
Normal
stud
ised to
y
12oCc)
temp
(20o
Cb)
382/1 712.7/2
270
413
St.
(χ2)
Method
of
calculation
3.06
SFO
N/A
329/1
090
613.8/2
071
3.66
SFO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
20
253/842
472
/1599.8
2.63
N/A
N/A
N/A
SFO
7.4
20
228/758
425
/1440.2
1.87
N/A
N/A
N/A
SFO
7.3
7.4
20
N/A
N/A
N/A
N/A
N/A
N/A
7.3
7.4
20
N/A
N/A
N/A
N/A
N/A
N/A
a)
)
Measured in [medium to be stated, usually calcium chloride solution or water]
Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C.
Normalised using a Q10 of 2.58 to 12 oC for the purpose of the application of Guidance on Information Requirements and
Chemical Safety Assessment. Chapter R11: PBT/vPvB assessment (ECHA, November 2014).
Metabolite
MNBA
(NOA437130)
*
System
identifier
(indicate
fresh,
estuarine
or
marine)
Max in total system 9.7% after 60 days (n=2, 11.3%, 8.1%).
No DT50 values calculated; no clear decline phase observed
pH
wate
r
phas
e
pH
sed
t.
o b
C
DT50 /DT90 whole
sys.
(suspended
sediment test)
At study Normali
temp
sed to x
o c)
C
St.
(χ2)
Group A, low
conc
(Natural water)
Group B, high
7.3
N/A
20
N/A
N/A
7.3
N/A
20
N/A
N/A
a)
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)
63
St.
(χ2)
Method of
calculation
N/A
DT50 /DT90
Water
(pelagic test)
At
Nor
stud
malis
y
ed to
temp x oCc)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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conc
(Natural
water)
Group E, low
conc
(Natural water &
sed)
Group F, high
conc
(Natural water &
sediment)
a)
b)
c)
*
7.3
7.4
20
N/A
N/A
N/A
N/A
N/A
N/A
N/A
7.3
7.4
20
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Measured in [medium to be stated, usually calcium chloride solution or water]
Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C
Normalised using a Q10 of 2.58 to the temperature of the environmental media at the point of sampling. (note temp of x
should be stated).
No other major metabolites observed in aerobic mineralisation study
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Mineralisation and non extractable residues (for parent dosed experiments)
System
identifier
(indicate
fresh,
estuarine
or
marine)
Group A, low
conc
(Natural water)
Group B, high
conc
(Natural
water)
Group E, low
conc
(Natural water
& sed)
pH
water
phase
pH
sed
Mineralisation
x% after n days.
(end
of
the
study).
Non-extractable
residues. max x%
after
n
d
(suspended
sediment test)
Non-extractable
residues. max x%
after n days (end of
the study) (suspended
sediment test)
7.3
N/A
ND (CO2 after 60
days)
n.r
n.r
7.3
N/A
0.3% (CO2 after 60
days)
n.r
n.r
7.3
7.4
ND (CO2 after 60
days)
n.r
n.r
Group F, high
conc
(Natural water
& sediment)
7.3
7.4
0.3% (CO2 after 60
days)
n.r
n.r
n.r = Not reported
Water / sediment study (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.3 and
Regulation (EU) N° 284/2013, Annex Part A, point 9.2.2)
Parent
Water
/
sediment
system
(radiolabel)
Distribution (max in water 98.7% after 0 d. Max. sed 4.3% after 1d)
pH
pH
t.
DT50
St. DT50
St. DT50
St.
wate
sed oC
/DT90
(χ
/DT90
(χ
/DT90
(χ
a)
2
2
2
r
whole
)
water
)
sed
)
c)
phas
sys.
e
Basing (Phenyl)
7.86
20
2.6
6.8 2.5
6.2 n/a
n/
a
Basing
20
4.2
13. 4.2
13. n/a
n/
(Cyclohexane)
3
3
a
Virginia (Phenyl) 7.40
20
5.5
12. 5.3
13. n/a
n/
3
5
a
Virginia
20
7.2
14. 7.0
13. n/a
n/
(Cyclohexane)
4
4
a
Calwich
8.4/7. 7.6
20
6.6
4.5 6.7
3.4 n/a
n/
(Phenyl)
8
a
(aero
bic/an
aerobi
c)
Swiss (Phenyl)
7.4/7. 6.1
20
11.1
3.5 11.0
3.3 n/a
n/
5
a
(aero
bic/an
aerobi
c)
Geometric mean at 20oCb)
5.6
5.5
n/a
a)
b)
Method of
calculatio
n
SFO
SFO
SFO
SFO
SFO
SFO
Measured in [medium to be stated, usually calcium chloride solution or water]
Normalised using a Q10 of 2.58
Metabolite
MNBA
Distribution (max in water 7.4%* after 3 days. Max. sed <1%*). Max in total system 7.4%
after 3 days.
*Detected in Cary., 1999. Not detected in Graham R, 2013
kinetic formation fraction (kf/kdp): Not available
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Water
sediment
system
n/a
/
pH
wate
r
phas
e
n/a
pH
sed
t.o
C
DT50
/DT90
whole
sys.
St.
(χ
2
)
DT50
/DT90
water
St.
(χ
2
)
DT50
/DT90
sed
St.
(χ
2
)
Method of
calculatio
n
n/a
n/a
n/a
n/
a
n/a
n/
a
n/a
n/
a
n/a
a)
Geometric mean at 20oCb)**
a)
b)
**
n/a
n/a
Metabolite
AMBA
Distribution (max in water 15.8% after 46 d. Max. sed
24.6% after 46 days,
kinetic formation fraction (kf/kdp): Not available
Water
/ pH
pH
t.
DT50
St. DT50
sediment
wate
sed oC
/DT90
(χ /DT90
a)
2
system
r
whole
water
)
phas
sys.
e
n/a
n/a
n/a
n/a n/a
n/
n/a
a
Geometric mean at 20oCb)*
n/a
n/a
*
n/a
Measured in [medium to be stated, usually calcium chloride solution or water]
Normalised using a Q10 of 2.58
1000 day default value used in risk assessment
1000 days default value used in risk assessment
Metabolite
SYN546974
n/a
8.8 % after 46 d). Max in total system
St.
(χ
2
)
DT50
/DT90
sed
St.
(χ
2
)
Method of
calculatio
n
n/
a
n/a
n/
a
n/a
n/a
n/a
Distribution (max in water 9.4% after 29 d. Max. sed 25.6% after 102 d). Max in
33% after 29 days.
kinetic formation fraction (kf/kdp): Not available
Water /
pH
pH
t.
DT50
St. DT50
St. DT50
St.
sediment
wate
sed oC
/DT90
(χ
/DT90
(χ
/DT90
(χ
a)
2
2
2
system
r
whole
)
water
)
sed
)
phas
sys.
e
n/a
n/a
n/a
n/a n/a
n/
n/a
n/
n/a
n/
a
a
a
Geometric mean at 20oCb)
n/a
n/a
n/a
*
1000d default value used in risk assessment
total system
Method of
calculatio
n
n/a
n/a
Mineralisation and non extractable residues (from parent dosed experiments)
Water/
pH
pH
Mineralisation
Non-extractable
Non-extractable
sediment
water
sed
x% after n d. residues in sed. residues in sed. max
system
phase
(end
of
the max x% after n d
x% after n d (end of
study).
the study)
Basing (Phenyl)
7.86
5.5
73.7 (101 DAT)
73.7 (101 DAT)
Basing
27.8
63.8 (101 DAT)
63.8 (101 DAT)
(Cyclohexane)
Virginia (Phenyl) 7.40
15.6
64.5 (101 DAT)
64.5 (101 DAT)
Virginia
26.8
48.4 (28 DAT)
44.7 (101 DAT)
(Cyclohexane)
Calwich
8.4/7.8 7.6
6.3
60.7 (102 DAT)
60.7 (102 DAT)
(Phenyl)
(aerobi
c/anae
robic)
Swiss (Phenyl)
7.4/7.5 6.1
11.4
45.0 (102 DAT)
45.0 (102 DAT)
(aerobi
c/anae
robic)
Fate and behaviour in air (Regulation (EU) N° 283/2013, Annex Part A, point 7.3.1)
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Direct photolysis in air
Not studied - no data requested
Photochemical oxidative degradation in air
DT50 of 17.635 hours (1.5 days) derived by the
Atkinson model (AOP version 1.8). OH (12h)
concentration assumed = 1.5 x 106 OH/cm3
Volatilisation
from plant surfaces (BBA guideline): <10% after 24
hours
from soil surfaces (BBA guideline): <10% after 24
hours
Metabolites
not applicable
Residues requiring further assessment (Regulation (EU) N° 283/2013, Annex Part A,
point 7.4.1)
Environmental occurring residues requiring
further assessment by other disciplines
(toxicology and ecotoxicology) and or requiring
consideration for groundwater exposure
Soil: Mesotrione, AMBA, MNBA
Surface water: mesotrione,
SYN546974.
Sediment:
mesotrione,
SYN546974.
MNBA,
MNBA,
AMBA
AMBA
and
and
Ground water: Mesotrione, AMBA, MNBA
Air: Mesotrione
Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A,
point 7.4.2)
See section 5, Ecotoxicology
Monitoring data, if available (Regulation (EU) N° 283/2013, Annex Part A, point 7.5
Soil (indicate location and type of study)
n/a
Surface water (indicate location and type of
study)
n/a
Ground water (indicate location and type of
study)
n/a
Air (indicate location and type of study)
n/a
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PEC soil (Regulation (EU) N° 284/2013, Annex Part A, points 9.1.3 / 9.3.1)
Parent
DT50 (d): 43.4 days (applicant used representative
worst case laboratory after normalisation. The RMS
accepted this as conservative and as no impact on
initial PECsoil, but notes that the corresponding
value before normalisation of 34.3 days should
have been used).
Method of calculation
Kinetics: DFOP
Field or Lab: representative worst case from
laboratory studies before normalisation.
Application data
Crop: maize
Depth of soil layer: 5cm
Soil bulk density: 1.5g/cm3
% plant interception: 25%
Number of applications: 1
Interval (d): not applicable
Application rate(s): 150 g a.s./ha
PEC(s)
(mg/kg)
Single
application
Actual
Initial
Short term
24h
2d
4d
Long term
7d
14d
28d
50d
100d
Plateau
concentration
0.150
0.148
0.149
-
-
0.145
0.141
0.134
0.148
0.145
0.142
-
-
0.120
0.096
0.067
0.030
0.150 mg/kg (same
as for initial PECsoil)
0.134
0.121
0.103
0.075
-
-
Metabolite - MNBA
Method of calculation
Single
application
Time weighted
average
Multiple
application
Actual
Multiple
application
Time weighted
average
Molecular weight relative to the parent: 245 (c.f.
0.72)
DT50 (d): x days - n/a
Kinetics: n/a
Field or Lab: n/a
Application data
PEC(s)
(mg/kg)
Application rate assumed: 46.33 g/ha (assumed
MNBA is formed at a maximum of 57.2% of the
applied dose) 112.5 *c.f. 0.72 * 0.572
Single
application
Actual
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Single
application
Time weighted
average
68
Multiple
application
Actual
Multiple
application
Time weighted
average
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Initial
Short term
24h
2d
4d
Long term
7d
28d
50d
100d
Plateau
concentration
0.062
-
-
-
-
-
-
-
-
-
-
-
-
n/a
Metabolite - AMBA
Molecular weight relative to the parent: 215 (c.f.
0.63)
Method of calculation
DT50 (d): x days - n/a
Kinetics: n/a
Field or Lab: n/a
Application data
Application rate assumed: 6.87 g/ha (assumed
AMBA is formed at a maximum of 9.7% of the
applied dose) 112.5 *c.f. 0.63 *0.097
PEC(s)
(mg/kg)
Single
application
Actual
Single
application
Time weighted
average
Multiple
application
Actual
Multiple
application
Time weighted
average
Initial
Short term
24h
2d
4d
Long term
7d
28d
50d
100d
Plateau
concentration
0.009
-
-
-
-
-
-
-
-
n/a
-
-
-
PEC ground water (Regulation (EU) N° 284/2013, Annex Part A, point 9.2.4.1)
Method of calculation and type of study ( e.g.
modelling, field leaching, lysimeter)
For FOCUS gw modelling, values used –
Modelling using FOCUS model(s), with appropriate
FOCUSgw scenarios, according to FOCUS guidance.
Model(s) used: PEARL v4.4.4. and PELMO v.5.5.3
Crop: Maize
Crop uptake factor: 0
Water solubility (mg/L): 160 at pH 7 and 20°C
Vapour pressure: 0 Pa at 20°C
parent DT50 :
pH dependence of degradation, therefore different
values simulated:
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EFSA Journal 2016;14(3):4419
Peer review of the pesticide risk assessment of the active substance mesotrione
(i) 4 d (shortest normalised laboratory DT50)
(ii) acid value for pH 5.1 (10th percentile maize crop
area) - DT50 = 27.88 d (linear),
(iii) alkali value for pH 7.9 (90th percentile maize
crop area) - DT50 = 5.4 d (linear),
(iv) intermediate pH 6.5 14.2 d (linear),
(normalisation to 10kPa or pF2, 20 C with Q10 of
2.58 and Walker equation coefficient 0.7).
KfOC: pH dependence of
different values simulated:
sorption,
therefore
(i) worst case Koc 14 l/kg with 1/n 0.97 for that soil
(ii) acid value for pH 5.1 (10th percentile maize crop
area) - Kfoc 156.6 l/kg (log) median 1/n = 0.94
(iii) alkali value for pH 7.9 (90th percentile maize
crop area) - 17.39 l/kg (log), Kfom 10.12 l/kg,
median 1/n = 0.94
(iv) intermediate pH 6.5 - 52.2 l/kg (log)
Transformation rate to MNBA (PELMO):
pH 5.1 linear 0.0249
pH 6.5 linear 0.0488
pH 7.9 linear 1.2836
shortest DT50 0.173
Metabolites:
MNBA
DT50:3.4 days (SFO, normalised, geometric mean
DT50lab)
worst case (of n = 2): Kfoc 3.2 l/kg, Kfom 1.86
l/kg, FOCUS default 1/n = 0.90
Formation fraction: 1.0 from parent
Transformation rate 0.0510 to AMBA, 0.1529 to CO2
AMBA
DT50: 14.5 days (SFO normalised, geometric mean
DT50lab)
(i) worst case Koc 18.1 l/kg with 1/n 0.82 for that
soil
(ii) acid value for pH 5.1 (10th percentile maize crop
area) - Kfoc 105.61 l/kg (log), arithmetic mean 1/n
= 0.85
(iii) alkali value for pH 7.9 (90th percentile maize
crop area) - Kfoc 21.8 L/kg (log), arithmetic mean
1/n = 0.85
(iv) intermediate pH 6.5 –48.02 l/kg (log)
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Formation fraction: 0.25 from MNBA
Transformation rate 0.0478 to CO2
Gross application rate: 150 g/ha.
Crop growth stage: BBCH 12 (RMS assumed 14
days after emergence)
Canopy interception 25%:
Application rate net of interception: 112.5 g/ha.
No. of applications: 1
Time of application (absolute or relative application
dates): relative - 7 days after emergence
Worst case (lowest) Kfoc value for mesotrione (14 l/kg) and AMBA (18.1 l/kg) with the
corresponding 1/n values (0.97 and 0.82), with the shortest normalised DT 50 for
mesotrione (4 d) to represent worst case for metabolite formation:
PEARL 4.4.4
PECGW (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
<0.001
0.004
HAMBURG
<0.001
<0.007
0.033
KREMSMUNSTER
<0.001
0.002
0.034
OKEHAMPTON
0.002
0.008
0.085
PIACENZA
<0.001
<0.001
0.004
PORTO
<0.001
<0.001
<0.001
SEVILLA
<0.001
<0.001
<0.001
THIVA
<0.001
<0.001
0.004
PELMO v5.5.3
PECGW (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
<0.001
0.001
HAMBURG
<0.001
0.001
0.011
KREMSMUENSTER
<0.001
0.003
0.031
OKEHAMPTON
0.005
0.014
0.081
PIACENZA
<0.001
0.001
0.010
PORTO
<0.001
<0.001
0.001
SEVILLA
<0.001
<0.001
<0.001
THIVA
<0.001
<0.001
<0.001
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Results for pH 5.1
PEARL 4.4.4
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
0.0076
<0.001
HAMBURG
0.0065
0.0986
0.0239
KREMSMUNSTER
0.0030
0.0207
0.0029
OKEHAMPTON
0.0083
0.0489
0.0078
PIACENZA
0.0046
0.0144
0.0036
PORTO
<0.001
0.0137
<0.001
SEVILLA
<0.001
0.0013
<0.001
THIVA
<0.001
0.0018
<0.001
PELMO v5.5.3
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
0.006
0.001
HAMBURG
0.006
0.121
0.015
KREMSMUNSTER
0.003
0.030
0.003
OKEHAMPTON
0.007
0.075
0.008
PIACENZA
0.008
0.027
0.005
PORTO
0.002
0.030
0.001
SEVILLA
<0.001
0.002
<0.001
THIVA
<0.001
0.004
<0.001
Results for pH 6.5
PEARL 4.4.4
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
0.0059
0.0082
0.0022
HAMBURG
0.0249
0.0635
0.0295
KREMSMUNSTER
0.0175
0.0176
0.0124
OKEHAMPTON
0.0407
0.0494
0.0229
PIACENZA
0.0083
0.0047
0.0045
PORTO
0.0016
0.0029
<0.001
SEVILLA
<0.001
0.0002
<0.001
THIVA
0.0013
0.0014
<0.001
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PELMO v5.5.3
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
0.003
0.006
0.001
HAMBURG
0.018
0.050
0.016
KREMSMUNSTER
0.015
0.025
0.011
OKEHAMPTON
0.047
0.059
0.021
PIACENZA
0.013
0.012
0.008
PORTO
0.002
0.005
0.001
SEVILLA
<0.001
<0.001
<0.001
THIVA
0.001
0.002
<0.001
Results for pH 7.9
PEARL 4.4.4
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
<0.001
0.0020
HAMBURG
<0.001
0.001
0.0171
KREMSMUNSTER
<0.001
<0.001
0.0182
OKEHAMPTON
<0.001
0.0039
0.0460
PIACENZA
<0.001
<0.001
0.0029
PORTO
<0.001
<0.001
<0.001
SEVILLA
<0.001
<0.001
<0.001
THIVA
<0.001
<0.001
<0.001
PELMO v5.5.3
PECgw (µg/L)
Scenario
MST
MNBA
AMBA
CHATEAUDUN
<0.001
<0.001
0.001
HAMBURG
<0.001
<0.001
0.006
KREMSMUNSTER
<0.001
0.001
0.019
OKEHAMPTON
<0.001
0.010
0.043
PIACENZA
<0.001
<0.001
0.006
PORTO
<0.001
<0.001
0.001
SEVILLA
<0.001
<0.001
<0.001
THIVA
<0.001
<0.001
<0.001
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PEC(gw) From lysimeter / field studies – NOT REQUIRED
Parent
Annual
(µg/L)
average
Metabolite X
Annual
(µg/L)
average
1st year
2nd year
3rd year
-
-
-
1st year
2nd year
3rd year
-
-
-
PEC surface water and PEC sediment (Regulation (EU) N° 284/2013, Annex Part A, points
9.2.5 / 9.3.1)
Parent
Version control no. of FOCUS calculator:
Parameters used in FOCUSsw step 1 and 2
Molecular weight (g/mol): 339
KOC (mL/g):
156.7 (log fit, pH 5.1 value)
52.2 (log fit, pH 6.5 value)
17.4 (log fit, pH 7.9 value)
KOM (mL/g):
90.9 (log fit, pH 5.1 value)
30.3 (log fit, pH 6.5 value)
10.1 (log fit, pH 7.9 value)
DT50 soil (d):
27.88 (linear fit, pH 5.1 value)
14.2 (linear fit, pH 6.5 value)
0.54 (linear fit, pH 7.9 value)
DT50 water/sediment system (d): 5.6
DT50 water (d): 5.5
DT50 sediment (d): 5.6
Crop interception (%): 25%
Parameters used in FOCUSsw step 3 (if
performed)
Version control no.’s of FOCUS software:
Water solubility (mg/L): 160 at pH 7 and 20°C
Vapour pressure: 1.0E-10 Pa at 20°C
Kom/Koc (mL/g): As in step 1 & 2
1/n: 0.94
Q10=2.58, Walker equation coefficient 0.7
Crop uptake factor: 0.0
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DT50 water (d): 5.6
DT50 sediment (d): 1000
DT50 soil (d): As in step 1 & 2
Application rate
Crop and growth stage: maize BBCH 12
Number of applications: 1
Interval (d): N/A
Application rate(s): 150 g a.s./ha
Application window:
14-34 days after emergence
Step 1
Mesotrione
pH 5.1 log
pH 5.1 linear
pH 6.5 log
pH 6.5 linear
46.18
pH 7.9
log
50.25
pH 7.9
linear
51.38
PECsw (µg/l)
42.74
41.23
48.13
PECsed (µg/kg)
64.81
76.08
24.40
38.98
8.50
0.00
RMS maximum PECsw and PECsed values following FOCUS Step 2 modelling of mesotrione
Step 2
Compartment
NE (Oct-feb)
NE (Mar-may)
NE (June-Sept)
SE (Oct-feb)
SE (Mar-may)
SE (June-Sept)
Mesotrione
pH 5.1
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
14.81
23.14
6.38
9.95
6.38
9.95
12.00
18.74
12.00
18.74
9.19
14.34
pH
6.5
15.23
7.94
6.58
3.42
6.58
3.42
12.35
6.43
12.35
6.43
9.46
4.93
pH
7.9
1.38
0.16
1.38
0.16
1.38
0.16
1.38
0.16
1.38
0.16
1.38
0.16
FOCUS step 3 modelling
Maximum PECsw values following FOCUS Step 3 modelling of Mesotrione
Use
Scenario
Water
body
Maize
1*150
g/ha
D3
D4
D4
D5
D5
D6
R1
Ditch
Pond
Stream
Pond
Stream
Ditch
Pond
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PECsw (µg/l)
pH 5.1
0.786
0.088
0.682
0.046
0.690
0.785
0.116
pH 6.5
0.786
0.034
0.681
0.034
0.678
0.790
0.075
pH 7.9
0.786
0.032
0.678
0.032
0.673
0.783
0.032
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R1
R2
R3
R4
Stream
Stream
Stream
Stream
2.461
1.860
4.900
5.185
1.676
3.417
6.125
5.973
0.740
0.730
0.801
0.728
Maximum PECsw (7d twa) values following FOCUS step 3 modelling of Mesotrione
Use
Scenario
Water
body
Maize
1*150
g/ha
D3
D4
D4
D5
D5
D6
R1
R1
R2
R3
R4
Ditch
Pond
Stream
Pond
Stream
Ditch
Pond
Stream
Stream
Stream
Stream
PECsw (µg/l)
pH 5.1
0.112
0.087
0.114
0.044
0.032
0.092
0.095
0.226
0.173
0.532
0.560
pH 6.5
0.113
0.026
0.018
0.026
0.016
0.096
0.061
0.167
0.307
0.594
0.644
pH 7.9
0.113
0.025
0.010
0.031
0.005
0.089
0.012
0.039
0.032
0.098
0.079
Maximum PECsed values following FOCUS step 3 modelling of Mesotrione
UNase
Scenario
Water
body
Maize
1*150
g/ha
D3
D4
D4
D5
D5
D6
R1
R1
R2
R3
R4
Ditch
Pond
Stream
Pond
Stream
Ditch
Pond
Stream
Stream
Stream
Stream
PECsed (µg/kg)
pH 5.1
0.193
0.175
0.148
0.098
0.118
0.181
0.126
0.556
0.495
1.019
1.399
pH 6.5
0.120
0.025
0.048
0.028
0.038
0.123
0.046
0.217
0.541
0.788
0.977
pH 7.9
0.079
0.010
0.023
0.010
0.014
0.070
0.012
0.052
0.029
0.079
0.087
Maximum PECsed (7d twa) values following FOCUS step 3 modelling of Mesotrione
Use
Scenario
Water
body
Maize
1*150
g/ha
D3
D4
D4
D5
D5
D6
R1
R1
R2
R3
R4
Ditch
Pond
Stream
Pond
Stream
Ditch
Pond
Stream
Stream
Stream
Stream
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PECsed (µg/kg)
pH 5.1
0.106
0.175
0.147
0.098
0.118
0.103
0.096
0.125
0.190
0.476
0.557
pH 6.5
0.065
0.025
0.023
0.028
0.024
0.076
0.046
0.081
0.181
0.325
0.371
pH 7.9
0.075
0.010
0.004
0.010
0.002
0.034
0.012
0.015
0.010
0.033
0.033
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Step 4 modelling for spray and run-off mitigation
Maximum PECsw values following FOCUS step 4 modelling of Mesotrione (10 m
Buffer, mitigating for spray drift) using SWAN V3.0.0 (pH 5.1)
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R1, pH
5.1
Stream
2.461
Maximum PECsw PECsw values following FOCUS step 4 modelling of Mesotrione
(10 m buffer, mitigating for spray drift and run-off*) using SWAN V3.0.0 (pH 5.1)
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R1, pH
5.1
Stream
1.114
* VFS, 60% run-off reduction. Fractional reduction in run-off volume and run-off flux were set to 0.6, fractional reduction in
erosion mass and erosion flux were set to 0.85
Maximum PECsw values following FOCUS step 4 modelling of Mesotrione (20 m
Buffer, mitigating for spray drift) using SWAN V3.0.0 (pH 5.1, log)
Use
Scenario
Water
body
Maize
1*150
g/ha
R1, pH
5.1 log
Stream
PECsw
(µg/l)
pH 5.1
log
2.469
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R1, pH
5.1
Stream
2.461
Maximum PECsw values following FOCUS step 4 modelling of Mesotrione (20 m
buffer, mitigating for spray drift and run-off*), (pH 5.1, log)
Use
Scenario
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Water
body
PECsw
(µg/l)
pH 5.1
log
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Peer review of the pesticide risk assessment of the active substance mesotrione
Maize 1*150 g/ha
R1, pH
5.1 log
Stream
0.584
* VFS, 80% run-off reduction. Fractional reduction in run-off volume and run-off flux were set to 0.8, fractional reduction in
erosion mass and erosion flux were set to 0.95
Use
Scenario
Water
body
PECsw
(µg/l)
Maize 1*150 g/ha
R1, pH
5.1
Stream
0.583
* VFS, 80% run-off reduction. Fractional reduction in run-off volume and run-off flux were set to 0.8, fractional reduction in
erosion mass and erosion flux were set to 0.95
For the D3 and D6 scenarios, a 5 m buffer zone was introduced as a mitigation measure:
Maximum PECsw values following FOCUS Step 4 modelling of Mesotrione (5 m
Buffer, mitigating for spray drift) using SWAN V3.0.0 (pH 6.5)
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
D3, pH
6.5 log
D6, pH
6.5 log
Ditch
0.258
Ditch
0.262
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
D3, pH
6.5
D6, pH
6.5
Ditch
0.258
Ditch
0.264
The 5 metre buffer zone is sufficient to refine the risk for these scenarios. These scenarios have not
been considered further.
For the R2, R3 and R4 scenarios, mitigation measures of 10 and 20 m buffer, both with and without
run-off reduction (fractional reduction in run-off volume and run-off flux, and fractional reduction in
erosion mass and erosion flux) were run.
RMS maximum PECsw values following FOCUS step 4 modelling of
Mesotrione (10 meter buffer, mitigating for spray drift) using SWAN V3.0.0 (pH 6.5)
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Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R2, pH
6.5
Stream
3.417
R3, pH
6.5
R4, pH
6.5
Stream
6.125
Stream
5.973
Maximum PECsw values following FOCUS Step 4 modelling of Mesotrione (10 m buffer,
mitigating for spray drift and run-off*) using SWAN V3.0.0 (pH 6.5, log)
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R2, pH
6.5
Stream
1.503
R3, pH
6.5
R4, pH
6.5
Stream
2.769
Stream
2.716
* VFS, 60% run-off reduction. Fractional reduction in run-off volume and run-off flux were set to 0.6, fractional reduction in
erosion mass and erosion flux were set to 0.85
Maximum PECsw values following FOCUS Step 4 modelling of Mesotrione (20 m
Buffer, mitigating for spray drift) using SWAN V3.0.0 (pH 6.5)
Use
Scenario
Water
body
PECsw
(µg/l)
Maize
1*150
g/ha
R2, pH
6.5
Stream
3.417
R3, pH
6.5
R4, pH
6.5
Stream
6.125
Stream
5.973
Maximum PECsw values following FOCUS Step 4 modelling of Mesotrione (20 m
buffer, mitigating for spray drift and run-off *) (pH 6.5)
Use
Scenario
Water
body
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PECsw
(µg/l)
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Maize
1*150
g/ha
R2, pH
6.5
Stream
0.779
R3, pH
6.5
R4, pH
6.5
Stream
1.447
Stream
1.423
* VFS, 80% run-off reduction. Fractional reduction in run-off volume and run-off flux were set to 0.8, fractional reduction in
erosion mass and erosion flux were set to 0.95
Metabolite MNBA
Molecular weight: 245
Params used in FOCUSsw step 1 and 2
Soil or water metabolite: Soil/water
Koc/Kom (mL/g): 3.2/1.74
DT50 soil (d): 3.6
DT50 water/sediment system (d): 1000
DT50 water (d): 1000
DT50 sediment (d): 1000
Crop interception (%): 25%
Maximum occurrence observed (% molar basis with
respect to the parent)
Total Water and Sediment: 7.9
Soil: 57.2
Params used in FOCUSsw Step 3 (if performed)
N/A; FOCUS Step 3 not performed
Application rate
Crop and growth stage: BBCH 12 onwards
Number of applications: 1
Interval (d): N/A
Application rate(s): 150 g a.s./ha
Application window: N/A
Main routes of entry
Metabolite AMBA
Molecular weight: 215
Params used in FOCUSsw step 1 and 2
Soil or water metabolite: Soil/water
Koc (mL/g):
101.5 (linear fit, pH 5.1 value)
59.7 (linear fit, pH 6.5 value)
18.0 (linear fit, pH 7.9 value)
105.6 (log fit, pH 5.1 value)
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48.0 (log fit, pH 6.5 value)
21.8 (log fit, pH 7.9 value)
Kom (mL/g):
58.9 (linear fit, pH 5.1 value)
34.6 (linear fit, pH 6.5 value)
10.4 (linear fit, pH 7.9 value)
61.3 (log fit, pH 5.1 value)
27.9 (log fit, pH 6.5 value)
12.7 (log fit, pH 7.9 value)
DT50 soil (d): 14.5
DT50 water/sediment system (d): 1000
DT50 water (d): 1000
DT50 sediment (d): 1000
Crop interception (%): 25%
Maximum occurrence observed (% molar basis with
respect to the parent)
Total Water and Sediment: 24.6
Soil: 9.7
Params used in FOCUSsw step 3 (if performed)
N/A; FOCUS Step 3 not performed
Application rate
Crop and growth stage: BBCH 12 onwards
Number of applications: 1
Interval (d): N/A
Application rate(s): 150 g a.s./ha
Application window: N/A
Main routes of entry
Metabolite SYN 546974
Molecular weight: 291
Params used in FOCUSsw step 1 and 2
Soil or water metabolite: Soil/water
Koc/Kom (mL/g): 27031/7438.5
DT50 soil (d): 0.1*
DT50 water/sediment system (d): 1000
DT50 water (d): 1000
DT50 sediment (d): 1000
Crop interception (%): 25%
Maximum occurrence observed (% molar basis with
respect to the parent)
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Total Water and Sediment: 33.0
Soil: 1.0E-10*
*Not observed in soil, default values used for
FOCUS steps 1 & 2
Params used in FOCUSsw step 3 (if performed)
N/A; FOCUS Step 3 not performed
Application rate
Crop and growth stage: BBCH 12 onwards
Number of applications: 1
Interval (d): N/A
Application rate(s): 150 g a.s./ha
Application window: N/A
Main routes of entry
Step 1
Compartment
Surface water
Sediment
Step 2
NE (Mar-may)
(June-
SE (Oct-feb)
SE (Mar-may)
SE
Sept)
20.66
0.66
Compartment
NE (Oct-feb)
NE
Sept)
MNBA
(June-
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
Surface water
Sediment
AMBA
pH 5.1
log
pH 5.1
linear
pH
log
2.91
3.04
2.92
2.94
3.18
0.88
AMBA
pH 5.1
log
pH 5.1
linear
pH 6.5
log
1.03
1.08
0.53
0.55
0.53
0.55
0.86
0.90
0.86
0.90
0.70
1.04
1.04
0.53
0.53
0.53
0.53
0.87
0.87
0.87
0.87
0.70
0.73
0.70
MNBA
3.49
0.11
1.44
0.05
1.44
0.05
2.81
0.09
2.81
0.09
2.13
0.07
SYN546976
6.5
pH 6.5
linear
3.06
1.82
pH
7.9
log
3.24
0.41
pH
7.9
linear
3.22
0.58
0.39
2.85
SYN546976
1.13
0.31
0.58
0.16
0.58
0.16
0.94
0.25
0.94
0.25
0.76
pH
6.5
linear
1.09
0.65
0.56
0.33
0.56
0.33
0.91
0.54
0.91
0.54
0.73
pH
7.9
log
1.15
0.15
0.59
0.07
0.59
0.07
0.96
0.12
0.96
0.12
0.77
pH
7.9
linear
1.14
0.21
0.58
0.10
0.58
0.10
0.96
0.17
0.96
0.17
0.77
0.39
2.84
0.39
2.84
0.39
2.84
0.39
2.84
0.39
2.84
0.39
0.21
0.43
0.10
0.14
2.84
Estimation of concentrations from other routes of exposure (Regulation (EU) N°
284/2013, Annex Part A, point 9.4)
Method of calculation
N/A
PEC
Maximum concentration
N/A
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Ecotoxicology
Effects on birds and other terrestrial vertebrates (Regulation (EU) N° 283/2013, Annex
Part A, point 8.1 and Regulation (EU) N° 284/2013, Annex Part A, point 10.1)
Species
Birds
Bobwhite quail
(Colinus virginianus)
Test substance
Time scale
End point
Toxicity
a.s.
Acute
LD50
Mallard duck
(Anas platyrhynchos)
Bobwhite quail
(Colinus virginianus)
Bobwhite quail
(Colinus virginianus)
Mallard duck
a.s.
Short-term
a.s.
Short-term
a.s.
Long-term
NOEL
LC50
NOEC
LC50
NOEC
NOEC
>2000 mg a.s./kg bw
(corrected to 3776 mg a.s./kg
bw)
2000 mg a.s./kg bw
>5200 mg/kg diet
5200 mg/kg diet
>5200 mg/kg diet
5200 mg/kg diet
3000 mg a.s./kg diet
a.s.
Long-term
NOEL
120 mg a.s./kg diet
= 20.6 mg a.s./kg bw/d
a.s.
Preparation
MNBA
AMBA
a.s.
Acute
Acute
Acute
Acute
Long-term
LD50
LD50
LD50
LD50
NOEL
>5000 mg a.s./kg bw
>2000 mg formulation/kg bw
>5000 mg MNBA/kg bw
>5000 mg AMBA/kg bw
2.5 mg a.s./kg feed
= 0.3 mg a.s./kg bw/d
(Anas platyrhynchos)
Mammals
Rat
Rat
Rat
Rat
Rat
Endocrine disrupting properties (Annex Part A, points 8.1.5):
Based on proposed classification as Repr. Cat 2 and effects observed on the endocrine organs (changes in testes
and epididymides weight and thyroid andonomas in females) according to the interim criteria mesotrione may be
considered to have endocrine distrupting properties.
#
The limit value for the product is in the same order of magnitude as the limit toxicity value for the active
substance (>2000 mg prod./kg bw vs. > 5000 mg a.s./kg bw, respectively) and there is no indication that the
formulation would be more toxic compared to the active substance mesotrione. Therefore the risk assessment
below is carried out with the LD50 >5000 mg a.s./kg bw derived from the study on the a.s.
Additional higher tier studies (Annex Part A, points 10.1.1.2):
[To be provided if the tier 1 risk assessment fails]
The applicant provided a detailed refined long-term risk assessment for mammals and a range of studies for
identification of focal species and PT values. The results of 3 monitoring studies indicate that the omnivorous
wood mouse (Apodemus sylvaticus) and the herbivorous European brown hare (Lepus europaeus) are
appropriate focal species for maize at the early stages after germination. From the results of 2 monitoring studies
a maximum PT of 0.139 has been taken for the omnivorous wood mouse in early maize for use in risk
assessment. No reliable quantitative estimate of the DT50 for mesotrione on maize could be determined from the
residue decline study, therefore the default value of 10 days has been considered in the risk assessment.
Terrestrial vertebrate wildlife (birds, mammals, reptile and amphibians) (Annex Part A, points 8.1.4, 10.1.3):
Endpoints based on relevant available data presented below
Toxicity/exposure ratios for terrestrial vertebrates (Regulation (EU) N° 284/2013, Part A,
Annex point 10.1)
Maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Growth
stage
Indicator
species
or
focal
Screening step (Birds)
all
small omnivorous bird
all
small omnivorous bird
Tier 1 (Birds)
BBCH 10-29
Medium granivorous bird
“gamebird”
BBCH 10-19
Small insectivorous/worm
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Time scale
DDD
(mg/kg
bw/day)
TER
Trigger
Acute
Long-term
23.8
5.15
159
4.0
10
5
Long-term
3.0
86.2
5
Long-term
5.7
45.5
5
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BBCH 10-29
BBCH 10-29
BBCH 10-19
feeding species “thrush”
Small omnivorous bird
“lark”
Medium
herbivorous/granivorous
bird “pigeon”
Small insectivorous bird
“wagtail”
Long-term
10.9
23.8
5
Long-term
22.7
11.4
5
Long-term
11.3
22.9
5
Acute
(mesotrione)
Long-term
(mesotrione)
20.46
>244
10
5.75
0.0522
5
Long-term
(mesotrione)
Long-term
(mesotrione)
Long-term
(mesotrione)
0.333
0.901
5
5.75
0.0522
5
0.620
0.484
5
0.086
3.49
5
1.44
0.208
5
Higher tier (Birds)
not required
Screening step (Mammals)
All
Small herbivorous mammal
All
Small herbivorous mammal
Tier 1 (Mammals)
BBCH 10-19
Small insectivorous
mammal “shrew”
BBCH 10-29
Small herbivorous mammal
"vole”
BBCH 10-29
Small omnivorous mammal
“mouse”
Higher tier (Mammals)
PT for wood mouse, maize BBCH 10-16:
Shortcut value for wood mouse:
7.8
BBCH 12-18
Wood mouse
(Apodemus sylvaticus)
RUD for “lagomorphs”:
54.2
FIR/bw (based on a 3230 g male hare):
BBCH 12-18
“lagomorph”
feeding on maize shoots
0.139
Long-term
(mesotrione)
0.334
Long-term
(mesotrione)
Risk from bioaccumulation and food chain behaviour
not relevant – Log KOW < 3 for mesotrione, MNBA and AMBA as well as SYN546974 (estimated)
Risk from consumption of contaminated water
Scenarios
Indicator or focal species
Leaf scenario
Time
scale
Acute
Birds
PECdw x DWR
TER
Trigger
not relevant
Puddle scenario, Screening Step
1) Application rate (g a.s./ha)/relevant endpoint < 50 (KOC < 500 L/kg), TER calculation not needed
2) Application rate (g a.s./ha)/relevant endpoint < 3000 (KOC  500 L/kg), TER calculation not needed
Scenarios
Indicator or focal species Time
PECpuddlexDWR
TER
scale
Puddle scenario
Birds
Acute
not needed
Case 1
(0.04)
Puddle scenario
Mammals
Acute
not needed
Case 1
(<
0.03)
Puddle scenario
Birds
Long-term
not needed
Case 1
(7.3)
Puddle scenario
Mammals
Long-term
not needed
Case 1
(500)
Trigger
(< 50)
(< 50)
(< 50)
(< 50)
Puddle scenario, Tier 1
Scenarios
Indicator or focal species
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Time
scale
84
PECpuddlexDWR
TER
Trigger
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Puddle scenario
$
Mammals
Long-term
0.08784 $
3.42
5
Considering the worst case KFOC value of 14 L/kg
Toxicity data for all aquatic tested species (Regulation (EU) N° 283/2013, Annex Part A,
points 8.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.2)
Group
Laboratory tests
Fish
Rainbow trout
(Oncorhynchus
mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Fathead minnow
(Pimephales promelas)
Test
substance
Time-scale
(Test type)
End point
Toxicity1
(mg test substance/L)
mesotrione
Acute 96-hr
(static)
Mortality, LC50
>120 (nom)
mesotrione
Acute 96-hr
(static)
Chronic 36-d
(flowthrough)
Acut
96-hr
(static)
Acut
96-hr
(static)
Mortality, LC50
>120 (nom)
NOEC
(physical symptoms)*
12.5 (nom)
Mortality, LC50
71 (nom)
Mortality, LC50
>120 (nom)
Acut
96-hr
(static)
Mortality, LC50
150 (nom)
Acute 48-h
(static)
Acute 48-h
(static)
Chronic 21-d
(semi-static)
Acute 48-h
(static)
Acute 48-h
(static)
EC50
>622 (mm)**
EC50
49 (nom)
NOEC
(reproduction & length)
EC50
180 (nom)
EC50
160 (nom)
EbC50
ErC50
NOECb
EbC10
EbC20
3.5 (nom)
13 (nom)
0.75 (nom)
0.692 (nom) L
0.958 (nom) L
EbC50
ErC50
NOECb,r
EbC10
EbC20
72 (nom)
> 100 (nom)
10 (nom)
4.6 (2005) (nom) L
NE (2005) (nom) L
EbC50
ErC50
38 (nom)
42 (nom)
mesotrione
Common carp
(Cyprinus carpio)
Rainbow trout
preparation
Rainbow trout
AMBA
(Oncorhynchus
mykiss)
(Oncorhynchus
mykiss)
MNBA
Aquatic invertebrates
Water flea
mesotrione
(Daphnia magna)
Water flea
preparation
(Daphnia magna)
Water flea
mesotrione
Water flea
MNBA
Water flea
AMBA
(Daphnia magna)
(Daphnia magna)
(Daphnia magna)
Sediment-dwelling organisms
not triggered
Algae
Green microalgae
mesotrione
(Pseudokirchneriella
subcapitata)
Green microalgae
(Pseudokirchneriella
subcapitata)
Green microalgae
(Pseudokirchneriella
Callisto
SC
MNBA
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100
Chronic 120hr
(stat
ic)
120-hr
120-hr
120-hr
72-hr
72-hr
Chronic 96hr
(stat
ic)
96-hr
96-hr
72/96-hr
72-hr
72-hr
Chronic 72hr (static)
85
130 (nom)
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subcapitata)
Green microalgae
AMBA
Chronic 72hr (static)
Higher plant
Gibbous duckweed
(Lemna gibba)
mesotrione
14-d chronic
(semi-static)
Gibbous duckweed
(Lemna gibba)
Callisto
SC
7-d chronic
(semi-static)
Gibbous duckweed
(Lemna gibba)
MNBA
7-d chronic
(semi-static)
Gibbous duckweed
(Lemna gibba)
AMBA
7-d chronic
(semi-static)
Gibbous duckweed
(Lemna gibba)
SYN546974
7-d chronic
(semi-static)
(Pseudokirchneriella
subcapitata)
100
Further testing on aquatic organisms
NOECb,r
ErC10
ErC20
EbC50
ErC50
NOECb,r
EyC10
EyC20
32 (nom)
33.4 (nom)
34.9 (nom)
9.4 (nom)
14 (nom)
7.7 (nom)
2.58 (nom)
4.04 (nom)
EbC50 (for frond no.)
EbC50 (for dry weight)
NOECb (for dry weight)
EyC10 (for dry weight)
EyC20 (for dry weight)
ErC50 (for dry weight)
EyC50 (for dry weight)
NOEC (for all)
EyC10 (for frond no.)
EyC20 (for frond no.)
ErC50 (for both)
EyC50 (for both)
NOEC (for frond no.)
EC10 (for all)
EC20 (for all)
ErC50 (for both)
EyC50 (for both)
NOEC (for both)
EyC10 (for frond no.)
EC20 (for all)
ErC50 (for both)
EyC50 (for frond no.)
NOEC (for frond no.)
EyC10 (for frond no.)
EyC20 (for frond no.)
0.022 (nom)
0.0077 (nom)
0.002 (nom)
0.0014 (nom)
0.0022 (nom)
0.117 (nom)
0.0269 (nom)
0.0114 (nom)
0.00461 (nom)
0.0108 (nom)
> 97 (mm)
> 97 (mm)
3.3 (mm)
> 97 (mm)
> 97 (mm)
> 90 (mm)
> 90 (mm)
90 (mm)
24 (mm)
> 90 (mm)
> 95 (mm)
93 (mm)
2.9 (mm)
9.9 (mm)
21 (mm)
[To report a short summary of mesocosms and SSD assessments and to include the associated AF for the
representative use and explain the reason (briefly)]
Not needed
Potential endocrine disrupting properties (Annex Part A, point 8.2.3)
[list evidence/indication on the potential for endocrine disrupting properties]
Cannot be concluded – no defined criteria
1
L
NE
*
**
(nom) – nominal concentration; (mm) – mean measured concentration;
– the lowest value, estimation was carried out on all available timescales;
– not estimated;
Physical symptoms: loss of balance, less activity, spinal deformity, skin lesions and internal bleeding;
In the LoEP of Review Report of mesotrione (January 2013, SANCO/1416/2001 - Final), the value of > 900 mg
mesotrione/L was misreported for acute invertebrate toxicity.
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Bioconcentration in fish (Annex Part A, point 8.2.2.3)
logPO/W
Steady-state bioconcentration factor (BCF)
(total wet weight/normalised to 5% lipid
content)
Uptake/depuration kinetics BCF
(total wet weight/normalised to 5% lipid
content)
Annex VI Trigger for the bioconcentration factor
Clearance time (days) (CT50)
(CT90)
Level and nature of residues (%) in organisms
after the 14 day depuration phase
Higher tier study
Mesotrion
e
0.11
-
MNBA
AMBA
SYN546974
-1.3
-
0.32
-
1.62*
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Not needed
* based on total 14C or on specific compounds
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Toxicity/exposure ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2)
FOCUS SW Step 1-3 TERs for mesotrione – on maize at BBCH 12-18, 1 x 150 g a.s./ha
Scenario
PEC global
max
(µg/L)
Fish acute
Fish
chronic
Aquatic
invertebrate
s
Aquatic
invertebrate
s prolonged
Algae
Higher plant
Sed.
dweller
prolonged
Microcosm
/
Mesocosm
Oncorhynchus
mykiss/ Lepomis
macrochirus
Lepomis
macrochirus
Daphnia
magna
Daphnia
magna
Pseudokirchnerie
lla subcapitata
Lemna gibba
Not
triggered
Not
triggered
LC50
> 120 000 µg/L
NOEC
12 500 µg/L
EC50
> 622 000
µg/L
NOEC
180 000 µg/L
EC50
3500 µg/L
EC50
7.7 µg/L
NOEC
NOEC
> 2335
243
> 12101
3502
68.1
0.145
FOCUS Step 1
51.4
FOCUS Step 2
North Europe
(pH 6.5)
South Europe
(pH 6.5)
FOCUS Step 3*
D3 / ditch
(all pH)
D4 / pond
(pH 5.1)
D4 / stream
(pH 5.1)
D5 / pond
(pH 5.1)
D5 / stream
(pH 5.1)
D6 / ditch
(pH 6.5)
R1 / pond
(pH 5.1)
R1 / stream
(pH 5.1)
R2 / stream
(pH 6.5)
15.23
0.506
12.35
0.786
9.79
0.088
87.5
0.682
11.3
0.046
167
0.690
11.2
0.790
9.75
0.116
66.4
2.461
3.13
3.417
2.25
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R3 / stream
(pH 6.5)
R4 / stream
(pH 6.5)
Trigger**
6.125
1.26
5.973
1.29
100
10
100
10
10
10
10
* [Only scenarios where the trigger is not met at FOCUS SW Step 1-2 should be included in Step 3.]
** [If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
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FOCUSsw step 4 - TERs for mesotrione – on maize at BBCH 12-18, 1 x 150 g a.s./ha
Organisms
Indicate
species:
Toxicity endpoint: 7.7
µg/L
Mitigation options
Higher plant – Lemna gibba
[x] m non-spray buffer zone
(corresponding
reduction)
FOCUS Step 4*
D3 / ditch (pH 6.5)
D6 / ditch (pH 6.5)
R1 / stream (pH 5.1)
R2 / stream (pH 6.5)
R3 / stream (pH 6.5)
R4 / stream (pH 7.9)
to
≤
95%
drift
5 m non-spray buffer zone
5 m non-spray buffer zone
(20 m non-spray buffer zone)
(20 m non-spray buffer zone)
(20 m non-spray buffer zone)
(20 m non-spray buffer zone)
[x] m vegetated buffer strip
(corresponding
to
≤
90%
reduction)
–
–
20
20
20
20
m
m
m
m
vegetated
vegetated
vegetated
vegetated
buffer
buffer
buffer
buffer
run-off
PECsw
(x.xx
µg/L)
0.258
0.264
0.583
0.779
1.447
1.423
strip
strip
strip
strip
*[Only scenarios where the trigger is not met at FOCUSsw step 3 should be included in step 4].
TER
Trigger
29.8
29.2
13.2
9.88
5.32
5.41
10
10
10
10
10
10
FOCUS SW Step 1 TERs for MNBA – on maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Scenario
PEC global
max
(µg/L)
Fish acute
Fish chronic
Aquatic
invertebrates
Aquatic
invertebrates
prolonged
Algae
Higher
plant
Sed. dweller
prolonged
Microcosm
/
Mesocosm
Oncorhynchus
mykiss
Not triggered
Daphnia
magna
Not triggered
Pseudokirchneriella
subcapitata
Lemna gibba
Not triggered
Not
triggered
LC50
>
120 000
µg/L
NOEC
EC50
130 000 µg/L
NOEC
EC50
38 000 µg/L
EC50
>
µg/L
NOEC
NOEC
1839
10
> 4695
10
97 000
FOCUS Step 1
Trigger**
20.66
> 5808
100
10
6292
100
10
10
**[If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
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FOCUS SW Step 1 TERs for AMBA – on maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Scenario
PEC global
max
(µg/L)
Fish acute
Fish chronic
Aquatic
invertebrates
Aquatic
invertebrates
prolonged
Algae
Higher
plant
Sed. dweller
prolonged
Microcosm
/
Mesocosm
Oncorhynchus
mykiss
Not triggered
Daphnia
magna
Not triggered
Pseudokirchneriella
subcapitata
Lemna gibba
Not triggered
Not
triggered
LC50
150 000 µg/L
NOEC
EC50
160 000 µg/L
NOEC
EC50
9400 µg/L
EC50
>
µg/L
NOEC
NOEC
2901
10
> 27 778
10
10
90 000
FOCUS Step 1
Trigger**
3.24
46 296
100
10
49 383
100
10
**[If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
FOCUS SW Step 1 TER for SYN546974 – on maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Scenario
PEC global
max
(µg/L)
Fish acute
Fish chronic
Aquatic
invertebrates
Aquatic
invertebrates
prolonged
Algae
Higher
plant
Sed. dweller
prolonged
Microcosm
/
Mesocosm
Not triggered
Not triggered
Not triggered
Not triggered
Not triggered
Lemna gibba
Not triggered
Not
triggered
LC50
NOEC
EC50
NOEC
EC50
EC50
93 000
NOEC
NOEC
100
10
100
10
10
FOCUS Step 1
Trigger**
0.39
238 462
10
10
**[If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
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FOCUS GW TER for MNBA – on maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Scenario
FOCUS PELMO
pH 5.1; Hamburg
Trigger**
PEC global
max
(µg/L)
0.121
Fish acute
Fish chronic
Aquatic
invertebrates
Aquatic
invertebrates
prolonged
Algae
Higher plant
Sed. dweller
prolonged
Microcosm /
Mesocosm
Oncorhynchus
mykiss
Not triggered
Daphnia
magna
Not triggered
Pseudokirchneriell
a subcapitata
Lemna gibba
Not
triggered
Not
triggered
LC50
> 120 000 µg/L
NOEC
EC50
130 000 µg/L
NOEC
EC50
38 000 µg/L
EC50
> 97 000 µg/L
NOEC
NOEC
> 991735.5
100
1074380
100
10
10
314 050
10
> 801652.9
10
10
**[If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
FOCUS GW TER for AMBA – on maize at BBCH 12-18, 1 x 150 g mesotrione/ha
Scenario
FOCUS PEARL
worst case sorption
and lowest parent
DT50; Okehampton
Trigger**
PEC global
max
(µg/L)
0.085
Fish acute
Fish
chronic
Aquatic
invertebrat
es
Aquatic
invertebrate
s prolonged
Algae
Higher plant
Sed.
dweller
prolonged
Microcosm
/
Mesocosm
Oncorhynchus
mykiss
Not triggered
Daphnia
magna
Not triggered
Pseudokirchneriell
a subcapitata
Lemna gibba
Not
triggered
Not
triggered
LC50
150 000 µg/L
NOEC
EC50
160 000 µg/L
NOEC
EC50
9400 µg/L
EC50
> 90 000 µg/L
NOEC
NOEC
110 588
>1058824
1764706
100
1882353
10
100
10
10
10
10
**[If the Trigger value has been adjusted during the risk assessment, it should always be clear on what basis the risk assessment has been performed, i.e. what the AF value is and for which
organism and endpoint it refers.]
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Effects on bees (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.1 and Regulation
(EU) N° 284/2013 Annex Part A, point 10.3.1)
Species
Test substance
Apis mellifera
a.s.
Callisto 100 SC
(A12739A)
Time scale/type of
endpoint
Acute
Acute
a.s.
Acute
Callisto 100 SC
(A12739A)
Acute
Callisto 100 SC
(A12739A)
Callisto 100 SC
(A12739A)
End point
toxicity
Oral
(LD50)
Oral
(LD50)
toxicity
> 11 µg/bee
toxicity
79.7 µg a.s./bee
(equivalent to 877.4 µg
A12739A /bee)*
Contact toxicity
(LD50)
Contact toxicity
(LD50)
Chronic
10 day-LD50
Bee
brood
development
(7 day study; with
dietary exposure on
days 3, 4, 5 and 6)
NOEDlarvae
(NOED = 25.0
a.s./bee)
> 100 µg/bee
µg
52.5 µg a.s./bee
(equivalent to 578.2 µg
A12739A /bee)
(NOED = 32.4 µg
a.s./bee)
19.2 µg a.s./bee/day**
(LD20
=
11.8
a.s./bee/day)
µg
(LD10
=
9.2
a.s./bee/day)
µg
(NOED
=
8.1
a.s./bee/day)
57.8 µg a.s./larva
µg
(LD50 =
a.s./larva)
118.5
µg
(LD20 =
a.s./larva)
39.185
µg
(LD10 =
a.s./larva)
18.836
µg
*
As uncertainties were noted around this endpoint (poor fitting of the oral 48-hour mortality data curve) the lower limit of
the 95% confidence interval (42.86 µg a.s./bee) was used for the risk assessment reported below.
** The following deviation from the EFSA (2013) should be taken into account: i) the reference item test did not result in ≥
50% effects at any concentration; ii) bees did not belong to a single colony.
Potential for accumulative toxicity: not assessed
Semi-field test (Cage and tunnel test)
None
Field tests
None
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Risk assessment for – Maize (BBCH 12 – 18) at 150 g a.s./ha x 1 application
The following risk assessment was carried out according to EFSA (2013).
Risk assessment for bees from contact and oral dietary exposure - Maize (BBCH 12 – 18) at
150 g a.s./ha x 1 application
Species
Test substance
Scenario
Risk quotient
Screening level assessment
Apis mellifera
a.s.
Not relevant
ETRacute adult oral
Apis mellifera
a.s.
Not relevant
HQcontact
Apis mellifera
Preparation
Not relevant
ETRacute adult oral
Apis mellifera
Preparation
Not relevant
HQcontact
Apis mellifera
Preparation
Not relevant
ETRchronic adult oral
Apis mellifera
Preparation
Not relevant
ETRlarvae
Tier 1 level assessment – Maize (BBCH 12 – 18) at 150 g a.s./ha x 1 application
Apis mellifera
a.s.
treated crop
ETRchronic adult oral
Apis mellifera
a.s.
weeds
ETRchronic adult oral
Apis mellifera
a.s.
field margin
ETRchronic adult oral
Apis mellifera
a.s.
adjacent crop
ETRchronic adult oral
Apis mellifera
a.s.
succeeding crop
ETRchronic adult oral
HQ/ETR
Trigger
0.1
1.5
0.03
2.9
0.59
0.01
0.2
42
0.2
42
0.03
0.2
0.01
0.02
0.0002
0.0001
0.003
0.03
0.03
0.03
0.03
0.03
Risk assessment for honeybees from consumption of contaminated water
Species
Test substance
Risk quotient
ETR
Screening level risk assessment from exposure to residues in guttation fluid (water solubility = 2200
Apis mellifera
a.s.
ETRacute adult oral
0.59
Apis mellifera
a.s.
ETRchronic adult oral
0.705
Apis mellifera
a.s.
ETRlarvae
3.04
Risk assessment from exposure to residues in surface water (FOCUS step 1 PECsw of 51.38 µg/L)
Apis mellifera
a.s.
ETRacute adult oral
0.00001
Apis mellifera
a.s.
ETRchronic adult oral
0.00003
Apis mellifera
a.s.
ETRlarvae
0.0001
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Trigger
mg/L)
0.2
0.03
0.2
0.2
0.03
0.2
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Effects on other arthropod species (Regulation (EU) N° 283/2013, Annex Part A, point
8.3.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.3.2)
Laboratory tests with standard sensitive species
Species
Test
Substance
Callisto 100
(A12739A)
Typhlodromus pyri
Aphidius rhopalosiphi
Callisto 100
(A12739A)
SC
SC
End point
Toxicity
Mortality, LR50
93.11 g/ha
Reproduction, ER50
> 81 g/ha
Mortality, LR50
43.56 g/ha
Reproduction, ER50
> 25.6 g/ha
First tier risk assessment for – Maize (BBCH 12 – 18) at 150 g a.s./ha x 1 application
HQ in-field
HQ off-field1
Trigger
Typhlodromus pyri
Effect
(LR50 g/ha)
93.11
1.61
0.045
2
Aphidius rhopalosiphi
43.56
3.44
0.095
2
Test substance
Species
Callisto 100 SC
(A12739A)
Callisto 100 SC
(A12739A)
1
Based on a drift distance of 1 m
Extended laboratory tests, aged residue tests
Test
substance,
substrate
Callisto 100 SC
(A1273
9A),
Leaf
discs
Time
scale
Dose
(g/ha)1,2
End point
% effect3,
ER50
14 days
Mortality,
reproduction
Callisto 100 SC
(A12739A),
Barley seedlings
48
hours
Aleochara
bilineata
Adult
Callisto 100 SC
(A12739A), Soil
67 days
Pardosa sp.
Adult
Callisto 100 SC
(A12739A), Soil
21 days
11, 20.7
25, 36.2
12, 19.0
12, 41.6
19, 47.4
42, 56.9
0, n.d.
0, n.d.
0, - 9.6
3.3, - 3.5
3.3, - 8.0
6.5
24.5
11.7
7.4
10.1
9, -2.2
3, -2.2
3, -2.2
9, -2.2
26, 6.7
41, 13.3
> 150
Adult
9.4
18.8
37.5
75.0
150.0
300.0
44.4
66.7
100.0
150.0
225.0
12.5
25.0
50.0
100.0
200.0
4.7
9.4
19.0
37.5
75.0
150.0
Species
Life
stage
Typhlodromus
pyri
Protonymph
Aphidius
rhopalosiphi
1
Mortality,
reproduction
Reproduction
Mortality,
feeding
4
> 225
> 200
> 150
initial residues
dose is expressed in units of a.s. (g a.s./ha)
3
negative values indicate an increase relative to the control and positive values a decrease relative to the control
4
Where multiple values are presented, seperated by commas, the first value in each row relates to the first end point and the
second value the second end point in the end points column.
2
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Risk assessment for – Maize (BBCH 12 – 18) at 150 g a.s./ha x 1 application, based on
extended lab test or aged residue tests
Species
Typhlodromus pyri
Aphidius rhopalosiphi
Aleochara bilineata
Pardosa sp.
1
ER50 (g/ha)
> 150
> 225
> 200
> 150
In-field rate
150
150
150
150
No off-field assessment conducted as it passed at first tier assessment
Off-field rate1
n/a
n/a
n/a
n/a
Semi-field tests
None
Field studies
None
Additional specific test
None
Effects on non-target soil meso- and macro fauna; effects on soil nitrogen transformation
(Regulation (EU) N° 283/2013, Annex Part A, points 8.4, 8.5, and Regulation (EU) N°
284/2013 Annex Part A, points 10.4, 10.5)
Test
organism
Test substance
Earthworms acute
Eisenia fetida Mesotrione
Eisenia fetida
MNBA
Earthworms chronic
Eisenia fetida Callisto 100 SC
(A12739A)
Application
method of
test a.s./
OM1
Time scale
End point
Toxicity
Mixed with
soil as a
solution
/
10%
-
Acute
Mortality
LC50 > 2000
mg a.s./kg d.w.
soil
Acute
Mortality
LC50 > 1000
mg a.s./kg d.w.
soil
Mixed with
soil as a
solution
/
10%
Chronic
Reproduction
NOEC = 125 mg
A12739A
/kg
d.w. soil
(equivalent
to
10.85
mg
a.s./kg d.w. soil)
EC10,
number
of
number
of
= 68.1
mg A12739A /kg
d.w. soil
(equivalent
to
5.91 mg a.s./kg
d.w. soil)
juveniles
EC20,
= 174.9
mg A12739A /kg
d.w. soil
(equivalent
to
15.18
mg
juveniles
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Eisenia fetida
AMBA
Mixed with
soil using
quartz sand
/ 5%
Chronic
Reproduction
a.s./kg d.w. soil)
NOEC = 1050
mg /kg d.w. soil
EC10 = 1050 mg
/kg d.w. soil
EC20 = 1050 mg
/kg d.w. soil
Eisenia fetida
MNBA
Mixed with
soil using
quartz sand
/ 5%
Chronic
Reproduction
NOEC = 1050
mg /kg d.w. soil
EC10 > 1050 mg
/kg d.w. soil
EC20 > 1050 mg
/kg d.w. soil
Other soil macroorganisms
Folsomia
Callisto 100 SC
candida
(A12739A)
Mixed with
soil as a
solution /
5%
Chronic
(14 days)
Reproduction
NOEC = 50.54
mg a.s. /kg d.w.
soil
(equivalent to
556 mg
A12739A /kg
d.w. soil)
EC10 = 413 mg
A12739A /kg
d.w. soil
EC20 = 620 mg
A12739A /kg
d.w. soil
Hypoaspis
aculeifer
Callisto 100 SC
(A12739A)
Mixed with
soil as a
solution /
5%
Chronic
(28 days)
Mortality and
reproduction
NOEC = 90.9
mg a.s. /kg d.w.
soil
(equivalent to
1000 mg
A12739A /kg
d.w. soil)
EC10 > 1000 mg
A12739A /kg
d.w. soil
EC20 > 1000 mg
A12739A /kg
d.w. soil
1
Indicates whether the test substance was oversprayed or mixed with soil / indicates the organic content of the test soil
(e.g. 5% or 10%).
Higher tier testing (e.g. modelling or field studies)
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Nitrogen transformation
Callisto 100 SC
(A12739A)
Maximum tested rate
1.99 mg a.s./kg d.w.
soil (equivalent to
21.90
mg
A12739A/kg
d.w.
soil)
7.8% effect at day 28 at 0.53
mg
a.s./kg
d.w.
soil
(equivalent
to
5.84
mg
A12739A/kg d.w. soil)
AMBA
Maximum tested rate
1.13
mg
a.s./kg d.w.
soil
-7.6% effect at day 28 at 1.13
mg /kg d.w. soil
MNBA
Maximum tested rate
1.13
mg
a.s./kg d.w.
soil
-4.8% effect at day 28 at 1.13
mg /kg d.w. soil
Toxicity/exposure ratios for soil organisms
Maize (BBCH 12 – 18) at 150 g a.s./ha x 1 application
Test organism
Test substance
Time scale
Soil PEC1
Callisto 100 SC
(A12739A)
Chronic
1.635
AMBA
Chronic
0.009
17,000
5
MNBA
Chronic
0.062
120,000
5
TER
Trigger
Earthworms
Eisenia fetida
2
42
5
Other soil macroorganisms
Folsomia candida
Callisto 100 SC
(A12739A)
Chronic
days)
(14
1.635
2
340
5
Hypoaspis aculeifer
Callisto 100 SC
(A12739A)
Chronic
days)
(28
1.635
2
612
5
1
Maximum instantaneous PEC soil (mg/kg d.w. soil)
2
Formulation PEC soil
Effects on terrestrial non target higher plants (Regulation (EU) N° 283/2013, Annex Part
A, point 8.6 and Regulation (EU) N° 284/2013 Annex Part A, point 10.6)
Screening data
Not required for herbicides or plant growth regulators as ER 50 tests should be provided
Laboratory dose response tests
Test
substance
ER50 (g/ha)2
vegetative
vigour
ER50 (g/ha)2
emergence
Exposure1
Callisto 100
SC
(A12739A)
0.883
13.8
0.225
Allium cepa
8.93
33.2
39.69
Avena sativa
> 500
> 150
666.67
Species
Lactuca
(Worst
species)
sativa
case
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98
(g/ha)
TER3
Trigger
3.92
5
2
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Lolium perenne
> 500
> 125
555.56
Brassica oleracea
6.18
19.8
27.47
Brassica rapa
2.27
20.6
10.09
Cucmis sativa
1.53
> 150
6.80
Glycine max
6.70
> 150
29.78
Linum
usitatissimum
264
> 125
555.56
Lycopersicon
esculentum
1.50
19.7
6.67
1
exposure has been estimated based on Ganzelmeier drift data with a drift distance of 20 ms
2
expressed as units of active substance (g a.s./ha)
3
TER calculations based on worst case values of either vegetative vigour or seedling emergence test
results
Species Sensitivity Distribution (SSD) risk assessment: An SSD risk assessment was conducted using
the lowest endpoints for each species (biomass) from the vegetative vigour test. The model on the
www.webfram.com website was used to determine the HC5 (the concentration hazardous to 5% of
species). Where the TER is > 1 an acceptable risk is concluded.
HC5
0.173
a.s./ha
g
Drift
distance
(m)
PER
1
a
TER
TER
with
50% drift
reduction
nozzle b
TER
with
75% drift
reduction
nozzle b
TER
with
90% drift
reduction
nozzle b
4.155
0.04*
0.08*
0.17*
0.42*
5
0.855
0.2*
0.4*
0.81*
2.02
10
0.435
0.4*
0.8*
1.59
3.98
20
0.225
0.77*
1.54
3.08
7.69
* TER values lower than the trigger, indicating an unacceptable risk
a
exposure has been estimated based on Ganzelmeier drift data
b
TER values including the impact of drift reduction are listed for reference only and are not considered as part of the risk
assessment.
At a drift distance of 20 m with 50% drift reducing nozzles an acceptable risk was demonstrated
(TER = 1.54).
Extended laboratory studies : None
Semi-field and field test: Three semi-field studies were submitted, investigating four species. The
endpoints are summarised in the following table:
Study
Species
Porch et
(2004b)
al
et
al
Porch
Brassica rapa
Cucumis
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Days
after
application
ER50 Biomass (g a.s./ha)
Growth stage
Early
Mid
Late
21
1.70
24.7
>150
35
2.87
7.98
134
21
0.714
1.06
4.77
99
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sativa
(2004
a)
Porch
et
al
(2004
c)
Lactuca sativa
Lycopersicon
escule
ntum
35
*
*
*
21
1.65
n.t.
n.t.
35
2.25
6.29
5.23
21
4.87
n.t.
n.t.
35
5.66
4.46
5.29
n.t. – Not Tested
* The RMS evaluator considered these data points to be unreliable and therefore not suitable for the
purpose of risk assessment.
These data are discussed in the risk assessment. As an acceptable risk was demonstrated in the SSD
risk assessment the semi-field studies are included for information only.
Effects on biological methods for sewage treatment (Regulation (EU) N° 283/2013,
Annex Part A, point 8.8)
Test type/organism
end point
Activated sludge
EC50 ≥ 160 mg a.s./L
Pseudomonas sp
NOEC = 100 mg a.s./L
Monitoring data (Regulation (EU) N° 283/2013, Annex Part A, point 8.9 and Regulation
(EU) N° 284/2013, Annex Part A, point 10.8)
Available monitoring data concerning adverse effect of the a.s.
Available monitoring data concerning effect of the PPP.
Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A,
point 7.4.2) Ecotoxicologically relevant compounds1
Compartment
soil
Parent (Mesotrione)
water
Parent (Mesotrione)
sediment
Parent (Mesotrione)
groundwater
Parent (Mesotrione)
1
metabolites are considered relevant when, based on the risk assessment, they pose a risk comparable or higher than the
parent
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Classification and labelling with regard to ecotoxicological data (Regulation (EU) N°
283/2013, Annex Part A, Section 10)
Substance
Mesotrione
Harmonised
classification
according
to
Regulation (EC) No 1272/2008 and its
Adaptations to Technical Process [Table 3.1 of
Annex VI of Regulation (EC) No 1272/2008 as
amended]13:
H400; Very toxic to aquatic life;
H410; Very toxic to aquatic life with long lasting
effects
Peer review proposal14 for harmonised
classification according to Regulation (EC) No
1272/2008:
13
14
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.
It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with
Regulation (EC) No 1272/2008. Proposals for classification made in the context of the evaluation procedure under Regulation
(EC) No 1107/2009 are not formal proposals.
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Appendix B –
Code/trivial
name*
Used compound code(s)
Chemical name/SMILES notation**
Structural formula**
N
R287431
O
6-(methylsulfonyl)-7-nitro-9-oxo-9H-xanthene-1carbonitrile
O
-
+
N
O
O
O=N(=O)c1cc2c(cc1S(C)(=O)=O)Oc3cccc(C#N)c3C
2=O
O
S
CH3
O
N
O
R287432
6-(methylsulfonyl)-9-oxo-9H-xanthene-1-carbonitrile
O
CS(=O)(=O)c1ccc2c(c1)Oc3cccc(C#N)c3C2=O
O
S
CH3
O
1,2dichloroethane
1,2-dichloroethane
Cl
Cl
ClCCCl
O
OH
NH2
2-amino-4-(methylsulfonyl)benzoic acid
AMBA
O=S(C)(=O)c1cc(N)c(cc1)C(=O)O
O
S
O
O
CH3
OH
O
N
MNBA
O
4-(methylsulfonyl)-2-nitrobenzoic acid
O=S(C)(=O)c1cc(c(cc1)C(=O)O)N(=O)=O
O
S
O
CH3
O
4-hydroxy
mesotrione
4-hydroxy-2-[4-(methylsulfonyl)-2nitrobenzoyl]cyclohexane-1,3-dione
O
+
O
O
N
HO
O
O=C2CCC(O)C(=O)C2C(=O)c1ccc(cc1[N+]([O])=O)S(C)(=O)=O
O
S
CH3
O
O
O
5-hydroxy
mesotrione
O
+
O
N
5-hydroxy-2-[4-(methylsulfonyl)-2nitrobenzoyl]cyclohexane-1,3-dione
O=C2CC(O)CC(=O)C2C(=O)c1ccc(cc1[N+]([O])=O)S(C)(=O)=O
O
HO
O
S
O
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CH3
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Peer review of the pesticide risk assessment of the active substance mesotrione
O
SYN546974
OH
9-hydroxy-6-(methylsulfonyl)-3,4-dihydroacridin1(2H)-one
O
CS(=O)(=O)c1cc2nc3CCCC(=O)c3c(O)c2cc1
N
S
O
CH3
*The compound name in bold is the name used in the conclusion.
**ACD/Labs 2015 Release, Advanced Chemistry Development, Inc., Toronto, ON, Canada, www.acdlabs.com, 2015
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