Directive 98/8/EC concerning the placing biocidal
products on the market
Inclusion of active substances in Annex I or IA to Directive 98/8/EC
Assessment Reporti
Powdered Corn Cob
Product-type PT 14
(Rodenticides)
September 2012
Annex I / IA – RMS Hellas
Powdered Corn Cob
Product-type PT 14
September 2012
Powdered Corn cob (PT 14)
Assessment report
Finalised in the Standing Committee on Biocidal Products at its meeting in view of its
inclusion in Annex I or IA to Directive 98/8/EC
CONTENTS
1.
2.
STATEMENT OF SUBJECT MATTER AND PURPOSE .................................................... 3
1.1.
Procedure followed ....................................................................................................... 3
1.2.
Purpose of the assessment report .................................................................................. 4
1.3.
Overall conclusion in the context of Directive 98/8/EC .............................................. 4
OVERALL SUMMARY AND CONCLUSIONS .................................................................. 6
2.1.
2.2.
3.
Presentation of the Active Substance ........................................................................... 6
2.1.1.
Identity, Physico-Chemical Properties & Methods of Analysis ................... 6
2.1.2.
Intended Uses and Efficacy ........................................................................... 8
2.1.3.
Classification and Labelling .......................................................................... 9
Summary of the Risk Assessment ................................................................................ 9
2.2.1.
Human Health Risk Assessment.................................................................... 9
2.2.2.
. Environmental Risk Assessment ............................................................... 12
DECISION............................................................................................................................. 15
3.1.
Background to the Decision........................................................................................ 15
3.2.
Elements to be taken into account by Member States when authorising
products 17
APPENDIX I: LIST OF ENDPOINTS .......................................................................................... 18
Chapter 1:
Identity, Physical and Chemical Properties, Classification
and Labelling ............................................................................ 18
Chapter 2:
Methods of Analysis .................................................................. 20
Chapter 3:
Impact on Human Health ........................................................... 21
Chapter 4:
Fate and Behaviour in the Environment .................................... 22
Chapter 5:
Effects on Non-target Species .................................................... 24
Chapter 6:
Other End Points ........................................................................ 25
APPENDIX II: LIST OF INTENDED USES ................................................................................ 26
TABLE: LIST OF INTENDED USES SUPPORTED BY THE SUBMITTED DATA ............... 26
APPENDIX III: LIST OF STUDIES ............................................................................................. 27
2
Powdered Corn Cob
Product-type PT 14
September 2012
1. STATEMENT OF SUBJECT MATTER AND PURPOSE
1.1. Procedure followed
This assessment report has been established as a result of the evaluation of corn cob as
product-type PT 14 ([Rodenticides]), carried out in the context of the work programme for
the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC
concerning the placing of biocidal products on the market1, with a view to the possible
inclusion of this substance into Annex I or IA to the Directive.
Powdered corn cob (CAS no. [none]) was initially notified as an existing active substance,
by Natrocell Technologies Limited in product-type PT14. Ιn 2009, Zea Sciences Limited,
hereafter referred to as the applicant, confirmed to the European Commission, ownership
of the dossier.
Commission Regulation (EC) No 2032/2003 of 4 November 20032 lays down the detailed
rules for the evaluation of dossiers and for the decision-making process in order to include
or not an existing active substance into Annex I or IA to the Directive.
In accordance with the provisions of Article 5(2) of that Regulation, Greece was designated
as Rapporteur Member State to carry out the assessment on the basis of the dossier
submitted by the applicant. The deadline for submission of a complete dossier for
Powdered corn cob as an active substance in Product Type PT14 was 28/3/2004, in
accordance with Annex V of Regulation (EC) No 2032/2003.
On 28/3/2004, RMS competent authorities received a dossier from the applicant. The
Rapporteur Member State accepted the dossier as complete for the purpose of the
evaluation on 6/12/2004.
On 22/10/2009, the Rapporteur Member State submitted, in accordance with the provisions
of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the
applicant a copy of the evaluation report, hereafter referred to as the competent authority
report. The Commission made the report available to all Member States by electronic
means on 21 September 2012. The competent authority report included a recommendation
for the inclusion of Powdered corn cob in Annex I and I / IA to the Directive for PT 14.
In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made
the competent authority report publicly available by electronic means on 21 September
2012. This report did not include such information that was to be treated as confidential in
accordance with Article 19 of Directive 98/8/EC.
In order to review the competent authority report and the comments received on it,
consultations of technical experts from all Member States (peer review) were organised by
1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing biocidal products on the market. OJ L 123, 24.4.98, p.1
2 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work
programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the
Council concerning the placing of biocidal products on the market and amending Regulation (EC) No
1896/2000. OJ L 307, 24.11.2003, p. 1
3
Powdered Corn Cob
Product-type PT 14
September 2012
the Commission. Revisions agreed upon were presented at technical and competent
authority meetings and the competent authority report was amended accordingly.
On the basis of the final competent authority report, the Commission proposed the
inclusion of Powdered corn cob in Annex I / IA to Directive 98/8/EC and consulted the
Standing Committee on Biocidal Product on
In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment
report contains the conclusions of the Standing Committee on Biocidal Products, as
finalised during its meeting held on.
1.2. Purpose of the assessment report
This assessment report has been developed and finalised in support of the decision to
include Powdered corn cob in Annex I and I / IA to Directive 98/8/EC for product-type
PT14. The aim of the assessment report is to facilitate the authorisation [/registration] in
Member States of individual biocidal products in product-type PT14 that contain powdered
corn cob In their evaluation, Member States shall apply the provisions of Directive
98/8/EC, in particular the provisions of Article 5 as well as the common principles laid
down in Annex VI.
For the implementation of the common principles of Annex VI, the content and
conclusions of this assessment report, which is available at the Commission website3, shall
be taken into account.
However, where conclusions of this assessment report are based on data protected under
the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of
another applicant, unless access to these data has been granted.
1.3. Overall conclusion in the context of Directive 98/8/EC
The overall conclusion from the evaluation is that it may be expected that there are
products containing powdered corn cob for the product-type PT14, which will fulfil the
requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is
however subject to:
i. compliance with the particular requirements in the following sections of this
assessment report,
ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and
iii. the common principles laid down in Annex VI to Directive 98/8/EC.
Furthermore, these conclusions were reached within the framework of the uses that were
proposed and supported by the applicant (see Appendix II). Extension of the use pattern
beyond those described will require an evaluation at product authorisation level in order to
3 http://ec.europa.eu/comm/environment/biocides/index.htm
4
Powdered Corn Cob
Product-type PT 14
September 2012
establish whether the proposed extensions of use will satisfy the requirements of Article
5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC.
5
Powdered Corn Cob
Product-type PT 14
September 2012
2. OVERALL SUMMARY AND CONCLUSIONS
2.1. Presentation of the Active Substance
2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis
2.1.1.1 Name, address of applicant of active substance
Applicant:
Name: Zea Sciences Limited
Address: The Barn Audley End Business Centre, Wendens Ambo, Saffron Walden, Essex
CB11 4JL UK
Telephone:
+44 (0) 1673 885138
Fax number:
+44 (0) 1673 885163
E-mail address: [email protected]
2.1.1.2 Identity of the active substance
Common name, synonym:
Powdered Corn cob.
CAS-No.:
None
EINECS-No.:
None
CIPAC:
None
IUPAC Name:
None
CA Name:
None
6
Powdered Corn Cob
Product-type PT 14
September 2012
Purity:
100% (Due to the nature of the active substance as
Powdered Corn Cob we can consider the central core of a
maize).
Molecular weight (g/mol):
Powdered corn cob is a naturally occurring composite
material and thus does not have specific molecular
weight.
Molecular formula:
Powdered corn cob is a naturally occurring composite
material and thus does not have a specific molecular
formula.
Structural formula:
Powdered corn cob is a naturally occurring composite
material and thus does not have a specific structural
formula
2.1.1.3 Physico-chemical properties of the active substance
Stripped corn cobs are ground into powder to produce the active substance corn cob. It is a
solid tan coloured powder with negligible odour. A melting point of 1204-1325°C has been
reported for 100% natural corn cob fractions. Powdered Corn cobs do not have a boiling point.
Powdered Corn cob is a carbohydrate material, poorly soluble in water and all solvents.
Powdered Corn cobs are very stable and are non-flammable at normal temperatures. If ignited,
combustion products may include components typical of wood smoke.
2.1.1.4 Methods of analysis
Analysis of the active substance as manufactured
An analytical method is not identifiable.
Formulation analysis
An analytical method is not identifiable.
7
Powdered Corn Cob
Product-type PT 14
September 2012
Residue analysis
Powdered corn cobs decompose mainly to sugars which are readily incorporated into
intermediary metabolism in the environment. Thus there are no residues which pose a threat to
human or animal health or the environment.
2.1.2. Intended Uses and Efficacy
Powdered corn cob is the main ingredient in Eradirat and Eradimouse, which are used as
rodenticides for the eradication of unwanted rats (Rattus norvegicus) and mice (Mus musculus),
respectively.
Based on the available data, Eradirat and Eradimouse, when consumed by rats and mice,
rapidly cause a state of dehydration. This leads to significant perturbation of normal
physiological feedback pathways because dehydration is accompanied not by an increase in
water intake but rather by a reduction in it. Several mechanisms are postulated for the
proximate cause of the dehydration, the most likely of which is passage of fluid across the
intestinal epithelium caused by the extremely absorptive nature of Powdered Corn Cob bait.
Based on combined experimental measurements and clinical observations, it appears that the
consumption of the active substance Powdered Corn Cob causes acute dehydration, with
consequent hypovolemia (i.e. reduced blood volume), reduced blood pressure, tissue ischemia
(oxygen deprivation), and circulatory shock leading to death.As it is stated in the Manual of
Decisions (See 2.3.11. Cellulose product as a rodenticide), “this mode of action is covered by
the Biocidal Products Directive, and these active substances have to be notified and evaluated.
For these particular products, the possibilities for justifying waiving of data as provided for in
Article 8(5) of the Directive should also be examined”.
As far as the Humaneness of powdered corn cob products is concerned, it is reported that
animals feeding on Powdered Corn Cob baits remain apparently normal for several days until
they become ‘huddled and lethargic’ in the last few hours before dying. The main external
symptoms observed were lethargy, piloerection and, occasionally, tremors. None of the
symptoms appeared to be noticeably severe, although this is not necessarily indicative of an
humane end-point.
As far as the efficacy is concerned, the Applicant has provided 18 efficacy studies, comprised
of 10 field trials and 8 laboratory studies. Of the field trials, 8 have been conducted against
small populations of rodents, however one was conducted against populations of 12 rats and 40
mice, and the last was against an estimated population of 60-70 rats. In all of these studies,
there was no take of the census bait after treatment, indicating 100 % control of the rodent
population (efficacy in a rodenticide field study is assessed by comparing how much of a
census bait is eaten before and after treatment - the less that is eaten after treatment, the better
the control)
The Applicant has also provided 8 no-choice laboratory studies, 6 against rats and 2 against
mice, where the test animals were provided with excess bait as their only food source. In all 8
studies 100 % mortality was recorded at the end of the test.
8
Powdered Corn Cob
Product-type PT 14
September 2012
While there are issues with this data package (such as the low target numbers in the field
studies, and because there are only no-choice tests available in the laboratory studies), the
overall data package still demonstrates that the active substance is capable of having an effect
on the target organisms.
While the data package is definitely not suitable to support a product authorisation (as further
data, including laboratory palatability and confirmatory field data against larger rodent
populations will be required), the current data package is suitable to demonstrate the innate
activity of the active substance, as required to recommend inclusion of the active substance
onto Annex I for this Product Type in terms of efficacy.
In addition, in order to facilitate the work of Member States in granting or reviewing
authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and
the common principles laid down in Annex VI of that Directive, the intended uses of the
substance, as identified during the evaluation process, are listed in Appendix II.
2.1.3. Classification and Labelling
Classification and labelling of the active substance
Based on the available data, no classification is currently used or proposed for powdered corn
cob concerning its physico-chemical, toxicological, environmental and ecotoxicological
properties in accordance with Annex I of Council Directive 67/548/EEC and the CLP
Regulation 1272/2008.
Classification of the products
No classification is proposed for the products EradiRat and EradiMouse concerning their
physico-chemical, toxicological, environmental and ecotoxicological properties in accordance
with Directive 1999/45/EC and the CLP Regulation 1272/2008.
2.2. Summary of the Risk Assessment
2.2.1. Human Health Risk Assessment
2.2.1.1.
Hazard identification
Several published reports have been submitted concerning mammalian toxicology of the
active substance. Most of them concern Cellulon fibres (a cellulose produced by bacterial
fermentation process) or microcrystalline cellulose. There are, also, feeding studies using
powdered corn cob as part of the diet of different species (e.g. rats, pigs, sheeps, cockerels,
lamps, cows etc.). Additionally, an evaluation report of the Joint FAO/WHO Expert
Committee on Food Additives has been submitted concerning cellulose.
Cellulose is the predominant substance in powdered corn cob, contained at levels of 4045%. The applicant has argued that cellulose is commonly used in many products intended
9
Powdered Corn Cob
Product-type PT 14
September 2012
for human and animal consumption and has been more widely studied than powdered corn
cob. Besides, cellulose has been characterized as G.R.A.S. (generally recognized as safe) by
the US FDA. The cellulose studies have been accepted by the Competent Authority, only as
indicative of the toxicity of corn cob. The subchronic studies in rats indicate that at level of
about 50% cellulose in the diet (about the same percentage as in powdered corn cob),
It is noted that the results of the submitted studies indicate that powdered corn cob do not
cause adverse effects when administered in a variety of animals including rats. On the
contrary, powdered corn cob administration may even be beneficial to the animals, even the
rodents. This fact seems not in accordance with the rodenticidal action of corn cob but it is
easily to be explained since the doses administered in the toxicity studies are much lower
that the amount of corn cob consumed in the efficacy studies. Based on the efficacy data,
the lethal dose is estimated to be 200-300 g/kg b.w., whereas based on the results of the
acute toxicity study of the product Eradirat (94% corn cob w/w) the LD50 is estimated to be
>15.1 g/kg b.w.
2.2.1.2.
Effects assessment
No conventional metabolism study was submitted. The waiving was accepted as
powdered corn cob is a natural product of low toxicity. Nine published reports investigating
the effects of powdered corn cob when fed to either rats, cockerels, ruffed grouse, chukar
partridge, bobwhite quail, sheep, lambs, pigs and ruminants have been submitted by the
applicant in order to address the ADME data. The submitted studies are considered
indicative of both the safe use of powdered corn cob as a feeding stuff and the low
digestibility of corn cob when fed to mammals.
As far as the acute oral toxicity of powdered corn cob is concerned, apart from the
FAO/WHO Report on microcrystalline cellulose, two published reports describing studies
conducted with either Cellulon fibres (a cellulose produced by bacterial fermentation
process) or microcrystalline cellulose have been submitted. Both substances were of low
acute toxicity when administered to rats or rabbits.
The skin and eye irritation of powdered corn cob was addressed by the submission of skin
and eye irritation studies conducted with Cellulon fiber, a cellulose produced by a bacterial
fermentation process and which most closely resembles powdered and microcrystalline
cellulose. The material tested caused no irritation effect when applied to rabbits.
Skin sensitization data were included in the Joint FAO/WHO Expert Committee on Food
Additives (1998) review of microcrystalline cellulose. The material tested exhibited no
sesnsitization potential.
The subchronic toxicity data included apart from the FAO/WHO Report on
microcrystalline cellulose, two published reports conducted with powdered corn cob: a 4week feeding study in hens and a 40-day feeding study in cattle. Besides, a subchronic
toxicity study conducted with Cellulon fibres was submitted from which it can be concluded
that administration of Cellulon fibre at dosages of 5 and 10% in the diet of rats for 13 weeks
did not induce any toxic effects.
The submitted studies are considered indicative of both the safe use of powdered corn
cob as a feeding stuff and the very low toxicity of powdered corn cob when fed to mammals.
10
Powdered Corn Cob
Product-type PT 14
September 2012
Based on the submitted short term toxicity data on powdered corn cob it is not possible to
establish a NOAEL/NOEL value, due to the absence of any toxic effects. Nevertheless, since
the test substance is a natural product of low toxicity the RMS considers that this is not a
significant deviation concerning the inclusion of the substance in the Annex I of Dir.
98/8/EC.
Apart from the genotoxicity data FAO/WHO Report on microcrystalline cellulose,
several published reports concerning in vitro tests conducted with either Cellulon fibres (a
cellulose produced by bacterial fermentation process), microcrystalline cellulose or powdered
corn cob have been submitted (Table 4.6). According to the results of these reports, the
tested substances demonstrate no genotoxic potential.
Carcinogenicity data were included in the Joint FAO/WHO Expert Committee on Food
Additives (1998) review of microcrystalline cellulose. The material tested exhibited no
carcinogenic potential.
The submitted reproductive toxicity data included the FAO/WHO Report on
microcrystalline cellulose and several published reports with dietary administration of
powdered corn cob in many species (female sheep, pigs, cows). Among the parameters
examined were weight at puberty and at first oestrus cycle, interval of puberty to first normal
oestrus cycle, weaning-to-oestrus intervals and individual and total litter birth weight. No
significant effect was noted on any of the reproductive parameters examined. These studies
are considered indicative of both the safe use of powdered corn cob as a feeding stuff and
the very low reproductive toxicity of powdered corn cob when fed to mammals.
Based on the submitted data on powdered corn cob it is not possible to establish a
reproductive NOAEL/NOEL value, due to the absence of any toxic effect. Nevertheless,
since the test substance is a natural product of low toxicity the RMS considers that this is not
a significant deviation concerning the inclusion of the substance in the Annex I of Dir.
98/8/EC.
In addition, in the FAO/WHO Report on microcrystalline cellulose, results of two
volunteer studies were reported. In both studies, no adverse effect to human was observed
after microcrystalline cellulose administration.
2.2.1.3.
Exposure assessment
Test sites could be either inside buildings or outside depending on the location of the
rat or mouse infestation. Loose pellets of Eradirat or Eradimouse should be placed in bait
stations within the infested areas. The finished product is made of food-grade ingredients
and is totally safe to handle for both professional users and the general public. Special
protective equipment is not required, but users are advised to wear gloves when dispensing
material to protect them from rodent-borne diseases within the infested area. Therefore the
dermal exposure will be negligible. As the biocidal product is provided as a pelleted dust
free product, there will be no inhalation exposure to the active substance in the finished
product when handling it. Secondary exposure is possible in case of accidental ingestion of
the pelleted product. According to the reverse reference scenario and if the minimum
efficacious amount of 200 g/kg bw/d is considered, a 10 kg infant would have to ingest 2 kg
of product, equivalent to the contents of >13 bait stations loaded at 150 g/station according
to the ‘Eradirat’ product label. It is also noted that the HUMAN EXPOSURE TO
BIOCIDAL PRODUCT (TNsG, June 2007) indicates that it should be assumed that an
11
Powdered Corn Cob
Product-type PT 14
September 2012
infant ingests a maximum of 5 g of bait, which is 400 times less than the 2 kg total dose
considered in the reverse reference scenario.
2.2.1.4.
Risk characterisation
Based on the submitted data on powdered corn cob, it is not possible to establish a
NOAEL/NOEL value, due to the absence of any toxic effect. The submitted studies of
cellulose have been accepted by the Competent Authority, only as indicative of the toxicity
of corn cob.
Based on the submitted data on cellulose, the subchronic studies in rats indicate that at
level of about 50% cellulose in the diet (about the same percentage as in powdered corn cob)
there are no toxicological effects. Therefore, it seems that the concentration of powdered
corn cob and its composition as a whole natural product is the source of the rodenticidal
effect. Since the rodenticidal action of powdered corn cob cannot be attributed solely to
cellulose, the cellulose studies cannot be used for the establishment of an Acceptable
Exposure Level (AEL).
Conclusively, the setting of and AEL is not possible. This fact is not considered a
significant deviation for the inclusion of the substance in the Annex I of BPD, since
powdered corn cob is a natural product of low toxicity. The same policy of the non
establishment of Reference Values has been followed also for many natural products of low
toxicity (e.g. sheep fat, hydrolyzed proteins, paraffin oils, fish oil, tall oils, etc) evaluated in
the frames of the Plant Protection Products Directive 91/414/EEC.
2.2.2. . Environmental Risk Assessment
2.2.2.1 Fate and distribution in the environment
Powdered corn cobs are composed of plant carbohydrate material, and are poorly soluble
in water and other solvents. They are very stable and do not become partitioned between
aqueous phases and organic surfaces of soils, sediments and sludge.
The most labile parameter of the quality of powdered corn cobs during storage is the
monosaccharide content. Monosaccharides start to break down much earlier than the
appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is
seen once the process of putrefaction is already considerably underway. Powdered corn cobs
stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of
cobs stored indoors for up to 5 months.
2.2.2.2. Effects assessment
Eradirat and Eradimouse are intended to be used by professional pest control officers and
the general public to eradicate unwanted rats and mice. Eradirat and Eradimouse can be used
both inside buildings and outdoors. When used outside, it is recommended that the product is
protected from moisture and where possible placed in the nesting burrows of the rats and mice
or in their feeding stations. A total of up to 150g of product should be used per rat baiting
point (plus loss and spillage) and around 50g of product per mouse baiting point. Feeding
12
Powdered Corn Cob
Product-type PT 14
September 2012
stations should be replenished daily. It is estimated that rodents die from consuming more than
200-300g/kg bodyweight over a period of several days.
Powdered corn cobs are composed of plant carbohydrate material, and are poorly soluble
in water and other solvents. They are very stable and do not become partitioned between
aqueous phases and organic surfaces of soils, sediments and sludge.
The most labile parameter of the quality of powdered corn cobs during storage is the
monosaccharide content. Monosaccharides start to break down much earlier than the
appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is
seen once the process of putrefaction is already considerably underway. Powdered corn cobs
stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of
cobs stored indoors for up to 5 months.
Cellulose was shown to have no hazardous effects on environmental organisms, indeed it,
and its breakdown products, can provide an important food source for various organisms.
Likewise, powdered corn cob is a natural plant material which decomposes mainly to sugars,
which are readily incorporated into intermediary metabolism in the environment and thus
present no hazard to environmental organisms.
2.2.2.2.1 Aquatic environment (fresh water & sediment)
See above.
2.2.2.2.2 Atmosphere
No data were submitted by the applicant. However, as powdered corn cob is a natural
plant material which decomposes to products which are readily incorporated into
metabolism, this route of exposure is not considered to pose any risks.
2.2.2.2.3 Terrestrial compartment
See above.
2.2.2.3. PBT assessment
Powdered corn cob cannot be regarded as fulfilling the PBT-criteria. Powdered corn cobs
are composed of plant material. They do not act as a chemical and become partitioned between
aqueous phases and organic surfaces of soils, sediments and sludge. If left outside cobs
decompose mainly to sugars which are readily incorporated into intermediary metabolism in
the environment. The most labile parameter of the quality of powdered com cobs during storage
is the monosaccharide content. Monosaccharides start to break down much earlier than the
appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is
seen once the process of putrefaction is already considerably underway. Powdered corn cobs
stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of
cobs stored indoors for up to 5 months.
Cellulose was shown to have no hazardous effects on environmental organisms, indeed it,
and its breakdown products, can provide an important food source for various organisms.
Likewise, powdered com cob is a natural plant material which decomposes mainly to sugars,
which are readily incorporated into intermediary metabolism in the environment and thus
present no hazard to environmental organisms.
The fate in water of dead plant material (containing cellulose) imported from the
surrounding drainage basin, where it is attacked by fungi and bacteria (some aquatic and some
13
Powdered Corn Cob
Product-type PT 14
September 2012
which were originally present in the plant material) it will be decomposed, mainly to sugars
which are readily incorporated into intermediary metabolism in the environment. Where
various essential nutritional elements such as nitrogen, phosphorus, calcium, magnesium and
potassium are in a high enough concentration not to limit growth, the fungi flourish, increasing
the amount of protein in the detritus, which provides a suitable food source for invertebrates
and, in turn, predatory fish. The ability of cellulose in the aquatic environment to degrade is
indicative of a low risk to aquatic systems as it effects more as a feed rather than a toxicant. It
does not biaccumulate as it is one of the waste by-products of corn, a food crop grown worldwide for both human and animal. The other ingredients in Eradirat and Eradimouse are
molasses and wheat flour (Eradirat only). They are both food stuffs and are also classified by
the US EPA as Minimal Risk Inerts.
2.2.2.4. Exposure assessment
Eradirat and Eradimouse are intended to be used by professional pest control officers and
the general public to eradicate unwanted rats and mice. Eradirat and Eradimouse can be used
both inside buildings and outdoors. When used outside, it is recommended that the product is
protected from moisture and where possible placed in the nesting burrows of the rats and mice
or in their feeding stations. A total of up to 150g of product should be used per rat baiting point
(plus loss and spillage) and around 50g of product per mouse baiting point. Feeding stations
should be replenished daily. It is estimated that rodents die from consuming more than 200300g/kg bodyweight over a period of several days.
Powdered corn cobs are composed of plant carbohydrate material, and are poorly soluble
in water and other solvents. They are very stable and do not become partitioned between
aqueous phases and organic surfaces of soils, sediments and sludge.
The most labile parameter of the quality of powdered corn cobs during storage is the
monosaccharide content. Monosaccharides start to break down much earlier than the
appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is
seen once the process of putrefaction is already considerably underway. Powdered corn cobs
stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of
cobs stored indoors for up to 5 months.
Cellulose was shown to have no hazardous effects on environmental organisms, indeed it,
and its breakdown products, can provide an important food source for various organisms.
Likewise, powdered corn cob is a natural plant material which decomposes mainly to sugars,
which are readily incorporated into intermediary metabolism in the environment and thus
present no hazard to environmental organisms.
Aquatic environment (fresh water & sediment)
See above.
Air
No data were submitted by the applicant. However, as powdered corn cob is a natural
plant material which decomposes to products which are readily incorporated into
metabolism, this route of exposure is not considered to pose any risks.
Terrestrial compartment
14
Powdered Corn Cob
Product-type PT 14
September 2012
See above.
2.2.2.5. Risk characterisation
Corn-on-the-cob is a food crop grown world-wide for both human and animal
consumption. One of the waste by-products, the stripped powdered corn cobs, is used for a
variety of purposes including animal bedding, fuel and animal feed. Powdered corn cobs
decompose mainly to sugars which are readily incorporated into intermediary metabolism in
the environment. Thus the active substance, powdered corn cob, clearly does not pose any
threat to the environment. In addition, the other ingredients are also human food substances
derived from plant products; molasses and wheat flour. They too do not pose any risk or hazard
to the environment.
Powdered corn cobs are composed of plant carbohydrate material, and are poorly soluble
in water and other solvents. They are very stable and do not become partitioned between
aqueous phases and organic surfaces of soils, sediments and sludge.
The most labile parameter of the quality of powdered corn cobs during storage is the
monosaccharide content. Monosaccharides start to break down much earlier than the
appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is
seen once the process of putrefaction is already considerably underway. Powdered corn cobs
stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of
cobs stored indoors for up to 5 months.
Cellulose was shown to have no hazardous effects on environmental organisms, indeed it,
and its breakdown products, can provide an important food source for various organisms.
Likewise, powdered corn cob is a natural plant material which decomposes mainly to sugars,
which are readily incorporated into intermediary metabolism in the environment and thus
present no hazard to environmental organisms.
Tests on terrestrial animals(included in the dossiers)such as dogs, cats, rabbits, ducks and
chickens all indicated that when ingested, no adverse effects are observed. The material is not
palatable to non-rodents.
Non-rodent species have consistently been found to not consume the same quantities of
the product as compared to commensal rodents on a g/Kg body weight basis. Indeed the
product is generally not palatable to non-rodents. The extensive non-target species testing,
extensive rodent control field trials as well as the inherent safety of the cellulose active
ingredient is justification for not specifically conducting field trials aimed at non species
effects. Field trials to date have not indicated any adverse effect on non-rodent species. In
addition, powdered corn cob products have been used extensively in industry for many years
without reported impact on animals(Physical properties. Chemical properties and the uses of
the Andersons' corn cob products, 2 nd edition, 1978, pages 215). Further tests on non-rodent
animals in field trials are unjustified from an efficacy as well as a humaneness perspective (see
efficacy and toxicology section).
3. DECISION
3.1. Background to the Decision
15
Powdered Corn Cob
Product-type PT 14
September 2012
The overall conclusion from the evaluation of powdered corn cob for use as a rodenticide
(PT14) for professional and non-professional users is that the substance fulfils the safety
requirements laid down in Article 10(1) of Directive 98/8/EC. It is expected that it will be
possible for MS to issue authorisations for products containing powdered corn cob in
accordance with the conditions laid down in article 5 (1) (b-d) of Directive 98/8/EC. Powdered
corn cob is therefore proposed for inclusion into Annex I and IA of that Directive.
The efficacy of powdered corn cob as a rodenticide against rat (Rattus norvegicus) and mouse
(Mus musculus) has been sufficiently demonstrated and the formulated products satisfy efficacy
evaluation requirements for Annex I listing of the active substance. As stated by the applicant,
further efficacy studies will be required, and will be presented at the stage of Product
Authorisation.
Powdered corn cob as a natural by-product of corn is of low toxicity to human health, based on
the results conducted either with corn cob or with cellulose which is the predominant ingredient
of corn cob (40-45%). Primary human exposure of corn cob is negligible since the products are
dust free pellets and no dermal exposure will occur since the use of gloves is recommended.
Secondary exposure may occur in case of accidental ingestion of the pellets but will cause no
adverse effects, since an infant should ingest an amount 2kg of bait which is 400 times higher
than the standard amount of 5gr bait assumed by the TNsG for human Exposure (June 2007) to
experience adverse effects. In any case it is recommended to keep the products away from
children.
The active substance is powdered corn cob. The data provided shows that neither the biocidal
products nor the active substance pose any risk to the environment.
Loose pellets of Eradirat or Eradimouse are placed in bait stations (or directly into burrows)
within the infested areas which can be either inside buildings or outside. Powdered corn cobs,
are poorly soluble (<10%) and naturally decompose mainly to sugars which are readily
incorporated into intermediary metabolism in the environment.
The Biocides Directive defines a low-risk biocidal product as: “A biocidal product which
contains as active substance(s) only one or more of those listed in Annex IA and which does
not contain any substance(s) of concern. Under the conditions of use, the biocidal product shall
pose only a low risk to humans, animals and the environment” (Article 2 (1) b)). Eradirat and
Eradimouse (active substance powdered corn cob) do not contain any substances of concern.
Furthermore, under the conditions of use, the biocidal active substance corn cob pose no risk to
humans, animals and the environment and thus should be included in Annex IA.
Powdered corn cobs, the by-product of the food crop corn-on-the-cob, have been used for many
years in a variety of products including animal feed and bedding, and fuel. The other
ingredients, molasses and wheat flour (Eradirat only), are human foodstuffs and thus are also
not hazardous materials.
3.2. Decision regarding Inclusion in Annex I
16
Powdered Corn Cob
Product-type PT 14
September 2012
On the basis of the proposed and supported use, it is concluded that the proposed use of powdered
corn cob as a rodenticide fulfils the safety requirements laid down in Article 5(1) of Directive
98/8/EC. It is therefore proposed that powdered corn cob to be included into Annex I and IA of the
Directive 98/8/EC as an active substance in rodenticide products (product type 14), with the
following provisions :
* In Annex I :
When assessing the application for authorisation of a product in accordance with Article 5 and
Annex VI, Member States shall assess, where relevant for the particular product, those uses or
exposure scenarios and those risks to human populations and to environmental compartments
that have not been representatively addressed in the Union level risk assessment.’
* In Annex IA :
Member States shall ensure that registrations are subject to the following condition: — Only
for use in the form of pellets in dry locations.
3.3. Elements to be taken into account by Member States when authorising products
Further efficacy studies regarding the biocidal products containing corn cob powdered should
be submitted.
17
Powdered Corn Cob
Product-type PT 14
September 2012
Appendix I: List of endpoints
Chapter 1:
Identity, Physical and Chemical Properties, Classification and
Labelling
Active substance (ISO Common Name)
Powdered Corn cob,
Product-type
14
Identity
Chemical name (IUPAC)
None
Chemical name (CA)
None
CAS No
None
EC No
None
Other substance No.
None
Minimum purity of the active substance as
manufactured (g/kg or g/l)
1000g/kg (Due to the nature of the active substance as
Corn Cob we can consider the core of a maize.)
Identity of relevant impurities and additives
(substances of concern) in the active substance as
manufactured (g/kg)
No substances of concern
Molecular formula
Powdered corn cob is a naturally occurring composite
material and thus does not have a molecular formula
Molecular mass
Powdered corn cob is a naturally occurring composite
material and thus does not have molecular mass.
Structural formula
Powdered corn cob is a naturally occurring composite
material and thus does not have a structural formula.
18
Powdered Corn Cob
Product-type PT 14
September 2012
Physical and chemical properties
Melting point (state purity)
100% natural corn cob fractions have a melting point of
1204-1325°C.
Boiling point (state purity)
n.a.
Temperature of decomposition
Due to the nature of the active substance it is expected to
be stable
Appearance (state purity)
Solid tan powder
Relative density (state purity)
0.288 – 0.416g/cm3 (woody portion of the corn cob)
(Bulk density)
Surface tension
n.a.
Vapour pressure (in Pa, state temperature)
3
n.a.
-1
Henry’s law constant (Pa m mol )
n.a.
Solubility in water (g/l or mg/l, state temperature)
Due to the nature of the active substance it is expected to
have poor solubility in water
Solubility in organic solvents (in g/l or mg/l, state
temperature)
Due to the nature of the active substance it is expected to
have poor solubility in all solvents.
Stability in organic solvents used in biocidal
products including relevant breakdown products
Due to the nature of the active substance it is expected to
have poor solubility in all solvents
Partition coefficient (log POW) (state temperature)
n.a.
Hydrolytic stability
temperature)
n.a.
(DT50)
(state
pH
and
Dissociation constant
n.a.
UV/VIS absorption (max.) (if absorption > 290 nm
state  at wavelength)
n.a.
Photostability (DT50) (aqueous, sunlight, state pH)
n.a.
Quantum yield of direct phototransformation in
water at  > 290 nm
n.a.
Flammability
Non highly flammable.
Explosive properties
No explosive properties based on the structure of the
compound and the percentage oxygen balance.
19
Powdered Corn Cob
Product-type PT 14
September 2012
Classification and proposed labelling
with regard to physical/chemical data
None
with regard to toxicological data
None
with regard to fate and behaviour data
None
with regard to ecotoxicological data
None
Chapter 2:
Methods of Analysis
Analytical methods for the active substance
Technical active substance (principle of method)
An analytical method for identification is not identifiable.
Impurities in technical active substance (principle
of method)
-
Analytical methods for residues
Corn cobs decompose mainly to sugars which are readily
incorporated into intermediary metabolism in the
environment. Thus there are no residues which pose a
treat to human or animal health or the environment. .
Furthermore an analytical method is not identifiable.
Soil (principle of method and LOQ)
Air (principle of method and LOQ)
Water (principle of method and LOQ)
Body fluids and tissues (principle of method and
LOQ)
Food/feed of plant origin (principle of method and
LOQ for methods for monitoring purposes)
Food/feed of animal origin (principle of method and
LOQ for methods for monitoring purposes)
20
Powdered Corn Cob
Chapter 3:
Product-type PT 14
Impact on Human Health
Absorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption:
No data, not required
Rate and extent of dermal absorption:
No data, not required
Distribution:
No data, not required
Potential for accumulation:
No data, not required
Rate and extent of excretion:
No data, not required
Toxicologically significant metabolite(s)
None
Acute toxicity
Rat LD50 oral
>15g/kg b.w.
Rat LD50 dermal
No data, not required
Rat LC50 inhalation
No data, not required
Skin irritation
Not irritating
Eye irritation
Not irritating
Skin sensitization (test method used and result)
Not sensitising
Repeated dose toxicity
Species/ target / critical effect
None
Lowest relevant oral NOAEL / LOAEL
Not established, not required
Lowest relevant dermal NOAEL / LOAEL
No data, not required
Lowest relevant inhalation NOAEL / LOAEL
No data, not required
Genotoxicity
No genotoxic potential
Carcinogenicity
Species/type of tumour
No carcinogenic potential
lowest dose with tumours
Not relevant
Reproductive toxicity
Species/ Reproduction target / critical effect
None
Lowest relevant reproductive NOAEL / LOAEL
Not established, not required
Species/Developmental target / critical effect
None
Developmental toxicity
Lowest relevant developmental NOAEL / LOAEL
Not established, not required
Neurotoxicity / Delayed neurotoxicity
21
September 2012
Powdered Corn Cob
September 2012
Product-type PT 14
Species/ target/critical effect
No data, not required
Lowest relevant developmental NOAEL / LOAEL.
No data, not required
Other toxicological studies
...............................................................................
No data, not required
Medical data
...............................................................................
No data, not required
Reference values
Value
Study
Assessment
factor
ADI (acceptable daily intake, external long-term
reference dose)
-
-
-
DWL (Drinking water limit
-
-
-
-
-
-
AEL short term
-
-
-
AEL medium-term
-
-
-
AEL long-term
-
-
-
ARfD (acute reference dose)
-
-
-
Reference value for inhalation (proposed OEL)
-
-
-
Reference value for dermal absorption
-
-
-
Non-professional user
AELs (Acceptable
reference dose):
Exposure
Limits.
Internal
Acceptable exposure scenarios (including method of calculation)
Production of active substance:
Not under the scope of the BPD
Professional and non professional users
No unacceptable exposure is foreseen
Chapter 4:
Fate and Behaviour in the Environment
Corn cobs decompose mainly to sugars which are readily incorporated into intermediary metabolism in the
environment. No further data were submitted by the applicant and thus no arithmetic end-points could be derived.
Route and rate of degradation in water
Hydrolysis of active substance and relevant
metabolites (DT50) (state pH and temperature)
pH______: No data available
pH______: No data available
pH______: No data available
Photolytic / photo-oxidative degradation of active
substance and resulting relevant metabolites
No data available
22
Powdered Corn Cob
Product-type PT 14
Readily biodegradable (yes/no)
No data available
Biodegradation in seawater
No data available
Non-extractable residues
No data available
Distribution in water / sediment systems (active
substance)
No data available
Distribution in
(metabolites)
No data available
water
/
sediment
systems
September 2012
Route and rate of degradation in soil
Mineralization (aerobic)
Laboratory studies (range or median, with number
of measurements, with regression coefficient)
DT50lab (20C, aerobic): No data available
DT90lab (20C, aerobic): No data available
DT50lab (10C, aerobic): No data available
DT50lab (20C, anaerobic): No data available
degradation in the saturated zone: No data available
Field studies (state location, range or median with
number of measurements)
DT50f: No data available
DT90f: No data available
Anaerobic degradation
No data available
Soil photolysis
No data available
Non-extractable residues
No data available
Relevant metabolites - name and/or code, % of
applied a.i. (range and maximum)
No data available
Soil accumulation and plateau concentration
No data available
Adsorption/desorption
Ka , Kd
No data available
Kaoc , Kdoc
pH dependence (yes / no) (if yes type of
dependence)
Fate and behaviour in air
Direct photolysis in air
No data available
Quantum yield of direct photolysis
No data available
Photo-oxidative degradation in air
Latitude: . No data available
.................
DT50 ..............
Volatilization
No data available
Monitoring data, if available
23
Season:
Powdered Corn Cob
Soil (indicate location and type of study)
No data available
Surface water (indicate location and type of study)
No data available
Ground water (indicate location and type of study)
No data available
Air (indicate location and type of study)
No data available
Chapter 5:
September 2012
Product-type PT 14
Effects on Non-target Species
Toxicity data for aquatic species (most sensitive species of each group)
Species
Time-scale
Endpoint
Fish
No data available
Invertebrates
No data available
Algae
No data available
Microorganisms
No data available
Effects on earthworms or other soil non-target organisms
Not applicable
Acute toxicity to …………………………………..
Not applicable
Reproductive toxicity to …………………………
24
Toxicity
Powdered Corn Cob
Product-type PT 14
Effects on soil micro-organisms
Nitrogen mineralization
Not applicable
Carbon mineralization
Not applicable
Effects on terrestrial vertebrates
Acute toxicity to mammals
Acute
Dietary
toxicity
toxicity
Reproductive
toxicity
No data available
to
birds
No data available
to
birds
No data available
birds
No data available
to
Effects on honeybees
Acute oral toxicity
Not applicable
Acute contact toxicity
Not applicable
Effects on other beneficial arthropods
Acute oral toxicity
Not applicable
Acute contact toxicity
Not applicable
Not applicable
Acute toxicity to …………………………………..
Bioconcentration
Bioconcentration factor (BCF)
No data available
Depration time (DT50)
No data available
(DT90)
Level of metabolites (%) in organisms accounting
for > 10 % of residues
Chapter 6:
No data available
Other End Points
25
September 2012
Powdered Corn Cob
September 2012
Product-type PT 14
Appendix II: List of Intended Uses
Table: List of Intended Uses supported by the submitted data
MG/PT
Field of use envisaged
Likely concentration at which
active substance will be used
MG03/Product type Eradirat and Eradimouse are intended for use by
14: Rodenticides for professional pest control officers and the general
public to eradicate unwanted rats (Rattus
rats and mice.
norvegicus) and mice (Mus musculus). Eradirat and
Eradimouse can be used both inside buildings and
outdoors. When used outside it is recommended that
the product is protected from moisture, and where
possible, placed down the nesting burrows of the rats
and mice or in their feeding stations.
Eradirat and Eradimouse were first marketed in the
EU (in the UK) in 2000. In 2000 approximately 40
tonnes of the product were imported into the EU, in
2001 approximately 64 tonnes were imported and in
both 2002 and 2003 approximately 120 tonnes of
product were imported. The products can now be
sold in the UK, Norway, Ireland, Italy and Germany.
26
A total of up to 150g of product
should be used per rat baiting point
(plus loss and spillage) and around
50g of product per mouse baiting
point. Feeding stations should be
replenished daily. It is estimated
that rodents die from consuming
more than 200-300g/kg bodyweight
over a period of several days.
Powdered Corn Cob
September 2012
Product-type PT 14
Appendix III: List of studies
Data protection is claimed by the applicant in accordance with Article 12.1(c) (i) and (ii) of Council
Directive 98/8/EC for all study reports marked “Y” in the “Data Protection Claimed” column of the
table below. These claims are based on information from the applicant. It is assumed that the
relevant studies are not already protected in any other Member State of the European Union under
existing national rules relating to biocidal products. It was however not possible to confirm the
accuracy of this information.
Section
No/
Reference
No
Author (s)
Year
A3/5
A3/12
A3/15
Α3/12
Andersons, The Cob 1978
Division Processing
Group, Ohio, USA
(editor Foley, K)
White, G.A
2011
Β3/8
White, G.A
2011
B5/01
Delmar Products Ltd
1995, Trial No 1
1995
B5/02
Delmar Products Ltd
1995, Trial No 2
1995
B5/03
Delmar Products Ltd
1995, Trial No 3
1996
Title
Source (where different from
company)
Company, Report No
GLP (where relevant)/(Un)
Published
Physical properties, Chemical
properties and uses of The
Andersons’ corn cob products,
unpublished
Examination of Powdered Corn
Cob
GC Laboratories Ltd
Report No J18496
GLP
Determination of particle size
of Powdered Corn Cob and
Eradirat
pellets,
and
determination of attrition and
friability characteristics of
Eradirat pellets.
GC Laboratories Ltd
Report No J18895
GLP
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 1
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 2
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 3
Not GLP, Unpublished
27
Data
protection
Claimed
Yes/No
Owner
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Powdered Corn Cob
September 2012
Product-type PT 14
B5/04
Delmar Products Ltd
1995, Trial No 4
1996
B5/05
Delmar Products Ltd
1995, Trial No 5
1996
B5/06
Delmar Products Ltd
1995, Trial No 6
1996
B5/07
Delmar Products Ltd
1995, Trial No 7
1996
B5/08
Delmar Products Ltd
1995, Trial No 8
1996
B5/09
Delmar Products Ltd
1995, Trial No 9
1996
B5/10
Delmar Products Ltd
1995, Trial No 10
1996
B5/11
Morgan DR, Eason 2002
CT
2002,
LC0203/053
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 4
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 5
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 6
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 7
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 8
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural
and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 9
Not GLP, Unpublished
The Orbis Molasses Pellet an
all natural and organic
rodenticide to control rats and
mice. Field test results and
appraisals
Trial No 10
Not GLP, Unpublished
Efficacy of Eradirat against
Sprague-Dawley rats
Landcare Research Contract
Report LC0203/053, Study
number GLP 02/10/01
GLP, Unpublished
28
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Powdered Corn Cob
September 2012
Product-type PT 14
B5/12
Kable JR
2002, GLP31745
2002
B5/13
Hoyer K
2002, GLP31755
2002
B5/14
Morgan DR, Eason 2002
CT
2003,
LC0203/061
B5/16
Prescott, Dr C.V &
Buckle, Dr A
2006
Prescott, Dr C.V &
Buckle, Dr A
2006
B5/17
Morgan DR 2002, 2002
LC0203/055
B5/18
Hoyer K
2002, GLP31754
2002
Effects of Eradirat on rats
when fed ad libitum
Celsius Laboratory Group,
Study ID number GLP31745
GLP, Unpublished
Confirming effects of Eradirat
on rats when fed ad libitum
Celsius Laboratory Group,
Study ID number GLP31755
GLP, Unpublished
Efficacy of Eradirat against
Sprague-Dawley
Laboratory
Rats and Assessment of Mode
of Action and Effects.
Landcare Research Contract
Report LC0203/061
Not GLP, Unpublished
Pilot field study investigating
the behaviour of Norway
Rats,
Rattus
norvegicus
(Berkenhout, 1769) on a mixed
farm in Wales when “Natrocell
Pro”
rodenticide
bait,
containing the active substance
powdered corn cob, was
applied.
Vertebrate Pests Unit, School
of Biological Sciences, The
University of Reading
Field efficacy evaluation of
“Natrocell Pro” rodenticide
bait, containing the active
substance powdered corn cob,
for the control of Norway Rats,
Rattus norvegicus (Berkenhout,
1769) infesting an agricultural
holding on the Anglo-Welsh
border.
Vertebrate Pests Unit, School
of Biological Sciences, The
University of Reading
Efficacy of Eradimouse against
Wild House Mice
Landcare Research Contract
Report LC0203/055
Not GLP, Unpublished
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Yes
Zea Sciences
Ltd
Effects of Eradimouse on mice
when fed ad libitum
Celsius Laboratory Group,
Study ID number GLP31754
GLP, Unpublished
Yes
Zea Sciences
Ltd
29
Powdered Corn Cob
September 2012
Product-type PT 14
B5/19
Morgan DR 2003, 2003
LC0203/121
Susceptibility of the chicken
(Gallus gallus) to Eradimouse.
Landcare Research Contract
Report LC0203/121
Study Number GLP03/01/03
GLP, Unpublished
Yes
Zea Sciences
Ltd
B5/20
Morgan DR 2003, 2003
LC0203/122
Yes
Zea Sciences
Ltd
B5/21
Morgan DR 2003, 2003
LC0203/117
Yes
Zea Sciences
Ltd
B5/22
Morgan DR 2003, 2003
LC0203/116
Yes
Zea Sciences
Ltd
B5/23
Morgan DR 2003, 2003
LC0203/115
Yes
Zea Sciences
Ltd
B5/24
Morgan DR 2003, 2003
LC0203/120
Yes
Zea Sciences
Ltd
B5/25
Morgan DR 2003, 2003
LC0203/118
Yes
Zea Sciences
Ltd
B5/26
Morgan DR 2003, 2003
LC0203/119
Susceptibility of the duck
(Anas
Platyrhynchos)
to
Eradimouse.
Landcare Research Contract
Report LC0203/122
Study Number GLP03/01/05
GLP, Unpublished
Susceptibility of the guinea pig
(Cavia
porcellus)
to
Eradimouse.
Landcare
Research Contract Report
LC0203/117
Study Number GLP03/01/06
GLP, Unpublished
Susceptibility of the European
rabbit (Oryctolagus cuniculus
cuniculus)
to
Eradirat.
Landcare Research Contract
Report LC0203/116
Study Number GLP03/01/07
GLP, Unpublished
Susceptibility of the brushtail
possum
(Trichosurus
vulpecula)
to
Eradirat.
Landcare Research Contract
Report LC0203/115
Study Number GLP03/01/01
GLP, Unpublished
Susceptibility of the ferret
(Mustela furo) to Eradirat.
Landcare Research Contract
Report LC0203/120
Study Number GLP03/01/08
GLP, Unpublished
Susceptibility of the cat (Felis
catus) to Eradirat.
Landcare Research Contract
Report LC0203/118
Study Number GLP03/01/02
GLP, Unpublished
Susceptibility of the dog
(Canis familiaris) to Eradirat.
Landcare Research Contract
Report LC0203/119
Study Number GLP03/01/04
GLP, Unpublished
Yes
Zea Sciences
Ltd
30
Powdered Corn Cob
B6/1
Rothstein EC 1994,
#9412329
September 2012
Product-type PT 14
1994
Acute oral toxicity study LD50
Leberco Testing Inc, Assay
#9412329
GLP, Unpublished
Yes
Zea Sciences
Ltd
i Section Number/Reference Number should refer to the section number in Doc III-A or III-B. If the study
is non-key, and hence not summarised in Doc III but mentioned in Doc II, it should be included in the
reference list alongside related references and its location in Doc II indicated in brackets. (If there is a
need to include a cross-reference to PPP references then an additional column can be inserted).
i Author’s Name should include the author’s surname before initial (s) to enable the column to be sorted
alphabetically. If the Human Rights Charter prevents author’s surnames on unpublished references being
included in non-confidential documents, then it will be necessary to consider including ‘Unpublished
[number/year & letter] ’ in Doc II, and both ‘ Unpublished [number/year & letter]’ and the ‘Authors
Name’ in the reference list’. This may necessitate the need for an additional column to state whether a
reference is unpublished which can then be sorted.
i Title, Source (where different from company), Company, Report No., GLP (where relevant),
(Un)Published should contain information relevant to each item (ideally on separate lines within the
table cell for clarity). If useful, the name of the electronic file containing the specific study/reference
could be added in brackets.
31