Directive 98/8/EC concerning the placing biocidal
products on the market
Inclusion of active substances in Annex IA or I to Directive 98/8/EC
Assessment Report
NITROGEN
Product-type 18
(Insecticides)
28 November 2008
Annex I and IA - IRELAND
Nitrogen (PT 18)
Assessment report (Doc I)
Finalised in the Standing Committee on Biocidal Products at its meeting on 28 November
2008 in view of its inclusion in Annex I and IA to Directive 98/8/EC
CONTENTS
1.
STATEMENT OF SUBJECT MATTER AND PURPOSE ........................................4
1.1. Procedure followed ............................................................................................4
1.2. Purpose of the assessment report .......................................................................5
1.3. Overall conclusion in the context of Directive 98/8/EC....................................5
2.
OVERALL SUMMARY AND CONCLUSIONS.......................................................6
2.1. Presentation of the Active Substance ................................................................6
2.1.1.
Identity, Physico-Chemical Properties & Methods of Analysis .........6
2.1.2.
Intended Uses and Efficacy .................................................................6
2.1.3.
2.1.2.1.
Field of use envisaged / Function and organism(s) to be
controlled .............................................................................6
2.1.2.2.
Effects on target organisms..................................................6
2.1.2.3.
Humaneness .........................................................................7
Classification and Labelling ................................................................7
2.2. Summary of the Risk Assessment......................................................................7
2.2.1.
2.2.2.
3.
Human Health Risk Assessment..........................................................7
2.2.1.1.
Hazard identification ...........................................................7
2.2.1.2.
Effects assessment ...............................................................8
2.2.1.3.
Exposure assessment............................................................9
2.2.1.4.
Risk characterisation..........................................................10
Environmental Risk Assessment .......................................................11
2.2.2.1.
Fate and distribution in the environment ...........................11
2.2.2.2.
Effects assessment .............................................................12
2.2.2.3.
PBT assessment .................................................................12
2.2.2.4.
Exposure assessment..........................................................12
2.2.2.5.
Risk characterisation..........................................................12
DECISION.................................................................................................................12
3.1. Background to the Decision.............................................................................12
3.2. Decision regarding Inclusion in Annex I and IA.............................................13
3.3. Elements to be taken into account by Member States when authorising
products 14
3.4. Requirement for further information ...............................................................14
3.5. Updating this Assessment Report ....................................................................14
4.
APPENDIX I IDENTITY, PHYSICO-CHEMICAL PROPERTIES.......................16
APPENDIX II: LIST OF ENDPOINTS ............................................................................17
Chapter 1:
Identity, Physical and Chemical Properties, Classification and
Labelling ..........................................................................................................17
Chapter 2:
Methods of Analysis ..........................................................................20
Chapter 3:
Impact on Human Health ...................................................................22
Chapter 4:
Fate and Behaviour in the Environment ............................................25
Chapter 5:
Effects on Non-target Species............................................................27
Chapter 6:
Other End Points................................................................................30
Appendix IV: List of studies......................................................................................33
NITROGEN
1.
Product-type 18
28 November 2008
STATEMENT OF SUBJECT MATTER AND PURPOSE
1.1.
Procedure followed
This assessment report has been established as a result of the evaluation of nitrogen as producttype 18 (insecticide), 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.
Nitrogen (CAS no. 7727-37-9) was notified as an existing active substance, by Rentokil Initial
plc, hereafter referred to as the applicant, in product-type 18.
Commission Regulation (EC) No 1451/2007 of 4 December 20072 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 7(1) of that Regulation, Ireland 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 nitrogen as an active
substance in product-type 18 was 30 April 2006, in accordance with Article 9(2) of Regulation
(EC) No 1451/2007.
On 28 April 2006, the Irish competent authorities received a dossier from the applicant. The
Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on
31 July 2007.
On 13 November 2007, the Rapporteur Member State submitted, in accordance with the
provisions of Article 14(4) and (6) of Regulation (EC) No 1451/2007, 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
13 November 2007. The competent authority report included a recommendation for the
inclusion of nitrogen in Annex I and IA to the Directive for product-type 18.
In accordance with Article 16 of Regulation (EC) No 1451/2007, the Commission made the
competent authority report publicly available by electronic means on 13 November 2007. 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 the
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 1451/2007 of 4 December 2007 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. OJ L 325, 11.12.2007, p. 3
NITROGEN
Product-type 18
28 November 2008
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
nitrogen in Annex I and IA to Directive 98/8/EC and consulted the Standing Committee on
Biocidal Product on 28 November 2008.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the present assessment
report contains the conclusions of the Standing Committee on Biocidal Products, as finalised
during its meeting held on 28 November 2008.
1.2.
Purpose of the assessment report
This assessment report has been developed and finalised in support of the decision to include
nitrogen in Annex I and IA to Directive 98/8/EC for product-type 18. The aim of the
assessment report is to facilitate the authorisation and registration in Member States of
individual biocidal products in product-type 18 that contain nitrogen. 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 nitrogen for the product-type 18, which will fulfil the requirements laid down in
Article 5 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
NITROGEN
Product-type 18
28 November 2008
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.
2.
OVERALL SUMMARY AND CONCLUSIONS
2.1.
2.1.1.
Presentation of the Active Substance
Identity, Physico-Chemical Properties & Methods of Analysis
An acceptable method of analysis for the determination of the active substance as manufactured
has been provided. Analytical methods in the environmental matrices have not been submitted
since it has been shown that there is no mechanism for nitrogen to be released directly into the
aquatic or terrestrial compartments, under normal conditions of use. The nitrogen released to
the air compartment cannot be differentiated from atmospheric nitrogen. In any case the
nitrogen used, as a biocide will have been extracted from the atmosphere during manufacture
without being chemically changed, in any way (except physical state), and then released back
to the atmosphere.
2.1.2.
2.1.2.1.
controlled
Intended Uses and Efficacy
Field of use envisaged / Function and organism(s) to be
Nitrogen is a broad-spectrum insecticide for the eradication of stored product pests, wooddestroying insects, textile pests and other arthropods.
Nitrogen is used for control of arthropod pests that affect commodities, such as; museum
artefacts (wooden items, textiles, etc), stored foods, machinery, etc. It is particularly important
for very high value commodities such as certain museum artefacts, which may be adversely
affected by other fumigants. While normally treatment of wooden artefacts (frames of “old
masters”) would require PT8 inclusion, it seems appropriate to limit the inclusion to PT18 on
account of the limited and specialised use of nitrogen
In addition, in order to facilitate the work of Member States in granting or reviewing
Authorisations/registrations, 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.
2.1.2.2.
Effects on target organisms
It is established that 100% mortality was achieved after eleven days at 11-19°C and 50-66%
RH for T. pellionella and A. verbasci. This is consistent with published data. Data will be
required against other target species at product authorisation
The mode of action of nitrogen is through the exclusion of oxygen which the target insects
require for respiration, and not through any direct effect on the insect's physiology. Given this
NITROGEN
Product-type 18
28 November 2008
mode of action, it is highly unlikely that the target insects would be able to develop a
mechanism for resistance
2.1.2.3.
Humaneness
The question of humanness is not an issue as the target organisms are all classified ad
arthropods.
2.1.3.
Classification and Labelling
Nitrogen does not classify on basis of study results from studies presented in the dossier and in
accordance with the principles detailed in Annex VI of Council Directive 67/548/EEC (with
amendments and adaptations).
2.2.
2.2.1.
2.2.1.1.
Summary of the Risk Assessment
Human Health Risk Assessment
Hazard identification
Nitrogen is an inert substance and does not exert a direct toxicological effect. Nitrogen acts by
the physiological effect of simple asphyxia on the target species within a Controlled
Atmosphere Treatment (CAT) bubble. The biocide action of nitrogen is due to its displacement
of oxygen from an atmospheric oxygen level of 20.8% to levels < 0.2% v/v in the CAT bubble.
The level of oxygen is the critical factor. Victims exposed to atmospheres deficient in oxygen,
i.e. <19%, will begin to display signs and symptoms of oxygen-deficient exposure of air due to
an increase in nitrogen.
In this dossier, a justification for non-submission of data was provided for all of the
toxicological endpoints. The following points justified the waivers provided:
Nitrogen forms 78.1% v/v of the earth’s atmosphere and all non-aquatic life on earth is
constantly exposed to an atmosphere containing 78.1% v/v nitrogen gas for their entire life
cycle. This demonstrates that atmospheric levels of nitrogen do not exhibit any adverse
toxicological, metabolic or environmental effects.
The principle route of exposure for the use of nitrogen as a biocide is by the inhalation route. It
should be noted that there is not a significant difference in the concentration of nitrogen
between inhaled and exhaled human breath. Therefore, the human body absorbs an
insignificant amount of nitrogen.
It was not technically feasible to measure acute oral or dermal toxicity, skin or eye irritation or
skin sensitisation of a gas, as there are no approved guidelines.
It is scientifically unjustified to measure acute toxicity by the inhalation route for nitrogen,
since it is inert and not intrinsically hazardous. Based on available information on nitrogen,
mainly its expected use, its safe history as a food additive and its essential role in the human
body there is reasonable certainty of no harm being caused from exposure to nitrogen.
NITROGEN
Product-type 18
28 November 2008
The exposure to an atmosphere containing very high levels of nitrogen could result in
asphyxiation through displacement of oxygen. It is appropriate to address the issues relating to
exposure levels of concern of nitrogen through appropriate structure related, engineering and
workplace administrative controls, use of necessary protective equipment, the securing of the
integrity of the CAT bubble and provision and operating of oxygen level monitoring systems in
a strictly restricted area of pre-determined suitable size such that only authorised fumigation
personnel can enter.
Based on information including; the negligible exposure and health risk posed under normal
circumstances and appropriate structure related, engineering and workplace administrative
controls including specific operator training in the hazards of inert gases, implementation of
safe working practices and safe systems of work to avoid asphyxiation, the availability of
personal protective equipment and emergency procedures, it is concluded exposure to nitrogen
during this transfer process is being duly considered and the health risk is minimised to the
required level. Consequently, the justifications provided for non-submission of data are
accepted.
2.2.1.2.
Effects assessment
Nitrogen gas is an inert substance and is present in the atmosphere at a level of 78.1%. It does
not exhibit a direct toxicological effect and has no toxicological profile. It acts by simple
asphyxia. If the level of nitrogen increases, this will lead to a reduction in the level of oxygen
to below normal atmospheric levels of 20.8%. Therefore, the level of oxygen is the critical
factor.
Any depletion of oxygen below 20.8% must be treated with concern. 19% oxygen
concentration is currently considered to be the safe working limit in the UK and below this
level the atmosphere is considered to oxygen deficient. The situation is considered hazardous
as soon as the oxygen concentration is less than 19%. Effects can be observed in humans in an
oxygen deficient atmosphere as follows: from decreased ability to work strenuously and
impaired coordination at 15-19.5% oxygen content, to deeper respiration, increased pulse rate
and impaired coordination, perception and judgement at 12–15.0% oxygen concentration.
There is a further increase in the rate and depth of respiration, an increase in pulse rate and
performance failure and poor judgement at 10-12%. The self-rescue threshold is set at 10% v/v
oxygen. This level of oxygen gives the person about 10 minutes to leave the affected area.
After which the person begins to suffer with the effects of hypoxia and will be unlikely to be
able to self-rescue. However, it is extremely unlikely that this level of oxygen will be fatal or
have any lasting effects even if the person remains in the affected atmosphere for several hours.
The risk of death due to asphyxia hugely increases at an oxygen concentration below 10%, with
recovery of a victim depending on the length of exposure in the oxygen deficient atmosphere
and the proportion of oxygen present at the time. Mental failure, nausea, fainting and
unconsciousness occur at 8.0-10.0% concentration. Eight minutes exposure to 6-8% oxygen
levels may be fatal in 50-100% of exposures and six minutes exposure to 6-8% oxygen levels
may be fatal in 25-50% of cases. Recovery after treatment can occur after four to five minutes
exposure to 6-8% oxygen levels.
NITROGEN
Product-type 18
28 November 2008
At 4.0–6.0% oxygen immediate loss of consciousness occurs if exposure is not stopped rapidly.
The effects are coma in 40 seconds, with convulsions and death. Oxygen depletion in the body
is rapid and inhalation of only 2 breaths of >94% nitrogen can cause sudden loss of
consciousness and death. The asphyxiating effect of inert gases takes place without any
preliminary sign that could alert a victim and the speed of the onset of effects is dictated by the
oxygen concentration.
2.2.1.3.
Exposure assessment
Professional users are not exposed to an oxygen deficient atmosphere under the normal
conditions of use of nitrogen as a biocide. However, after the Controlled Atmosphere
Treatment (CAT) bubble is set-up and its integrity is established and checked, a number of
tasks are identified that have potential for exposure to an oxygen deficient atmosphere and these
tasks require necessary controls to be in place to ensure operator safety. These tasks, carried
out by the professional user, have potential for operator exposure and are as follows:
Initial refilling of the CAT bubble to achieve suitably low concentration levels of
oxygen and suitably high nitrogen concentration levels.
-
Refilling during the treatment phase to maintain oxygen and nitrogen levels as required.
The introduction of oxygen scavengers. (moist iron (ferrous) oxide and potassium
chloride)
-
Oxygen monitoring during treatment.
-
Bubble venting at the end of the treatment phase.
The atmosphere within the CAT bubble, under normal conditions, will be slightly lower than ambient
atmospheric pressure. This means that normal atmosphere is likely to flow into the bubble, rather than
bubble atmosphere flowing out. The pressure inside the bubble would need to be considerably greater
than ambient atmospheric pressure for a significant volume of bubble atmosphere to vent at the cut site.
Therefore primary human exposure to an oxygen deficient atmosphere as a result of the use of oxygen
scavengers is extremely unlikely to occur. This is mitigated by the fact that it is unlikely that a
significant amount of the bubble atmosphere will escape
The controls required include appropriate structure, engineering and workplace administrative
controls. The professional user must have specific operator training in the hazards of inert
gases. In addition, the implementation of safe working practices, safe systems of work
including a permit to work and air monitoring in the closed environment must be in place to
ensure minimum risk. In addition, the availability of personal protective equipment if required
is essential. It is concluded exposure to nitrogen is being duly considered and the health risk is
minimised to the required level if all the necessary procedures, controls and equipment are in
place.
NITROGEN
Product-type 18
28 November 2008
Bystanders are not exposed to an oxygen deficient atmosphere under the normal conditions of
use of nitrogen as a biocide. The tasks where there is potential for bystander exposure to an
oxygen deficient atmosphere were identified and these tasks are as follows:
- Initial refilling of the CAT bubble to achieve suitably low concentration levels of oxygen
and suitably high nitrogen concentration levels.
-
Refilling during the treatment phase to maintain oxygen and nitrogen levels as required.
-
CAT bubble venting at the end of the treatment phase.
Incidental bystander exposure comprises people who may enter a fumigation risk area without
authority at the steps along the fumigation process where there is potential for exposure to an
oxygen deficient atmosphere. It is required that appropriate measures to protect bystanders
during fumigation and venting of treated areas are put in place. To do this it is required to put
appropriate controls in place to avoid this scenario including implementation of safe working
practices and safe systems of work to avoid asphyxiation is essential. It is concluded exposure
to nitrogen is being duly considered and the health risk is minimised to the required level if all
the necessary procedures and controls are in place.
2.2.1.4.
Risk characterisation
Professional users are not exposed to an oxygen deficient atmosphere under the normal
conditions of use of nitrogen as a biocide.
The risk assessment shows that even in a worst-case scenario, where professional users may be
exposed to an oxygen deficient atmosphere, the self-rescue threshold of 10% v/v oxygen will
not be breached provided that the room is at least 2 times the volume of the CAT bubble. A
margin of safety of 2 is deduced between the normal atmospheric oxygen levels and the selfrescue oxygen threshold of 10%. This margin of safety is small, however for the following
number of reasons it is concluded that the dangers of exposure and the health risk is minimised
to the required level:
- A number of necessary and appropriate workplace administrative, structure related and
engineering controls are required to be in place to ensure safety.
- Professional users must be specifically trained in the hazards of using inert gases, in the
implementation of safe working practices, emergency procedures and safe systems of work
including a permit to work. This level of training and use of procedures will ensure that any
risk is minimised to appropriate levels.
- A Controlled Atmosphere Treatment (CAT) is conducted in an area that is secured such
that only authorised personnel trained in the use of nitrogen as a fumigant can enter and gaining
access to this room is strictly restricted. This means systems are in place, which aim to prevent
non-professionals who are not aware of the risks or safety procedures associated, enter the
fumigation risk area.
The fumigation risk area is monitored for oxygen levels with visual and audible alarms,
which indicate if the oxygen levels fall below 19% v/v.
NITROGEN
Product-type 18
28 November 2008
The area around the CAT bubble is defined, in terms of the rooms dimensions it is
contained within and is called the fumigation risk area. The fumigation risk area must be at
least two times the volume of the CAT bubble. From this information, the professional user
will be fully aware of the possibility of the time it would take for the room to drop to the selfrescue oxygen threshold of 10% in a worst case-scenario. This information will form an
important part of the emergency procedure.
The fumigation risk area is required to have good ventilation to the open air. Even
though ventilation may be difficult to characterise, it increases the possibility of preventing the
oxygen concentration in the atmosphere falling below the self-rescue threshold, although to
what extent may be difficult to define.
Taking these factors into account, the use of nitrogen as a fumigant insecticide by trained
Rentokil Initial operatives does not present an adverse inhalation risk. If all of the above
procedures, controls and measures are in place it is concluded that exposure to nitrogen is being
duly considered and the health risk is minimised to the required level.
Secondary exposure to bystanders is expected to be even lower than that of professional users.
In a worst-case scenario, both risks might be comparable.
2.2.2.
2.2.2.1.
Environmental Risk Assessment
Fate and distribution in the environment
This product (PT18) is intended for use as an insecticidal fumigant. Acceptable waivers have
been submitted for all compartments on the basis that nitrogen occurs naturally in the
environment comprising 78.1 %v/v in the atmosphere. The nitrogen cycle is well understood in
each environmental compartment. Nitrogen is not intrinsically hazardous under ambient
conditions; it is not classified as hazardous according to EC Directive 67/548/EEC. The
formulation, Nitrogen Controlled Atmosphere Treatment (NCAT), contains 99.8% v/v nitrogen
as a colourless and odourless fumigant that is applied in a sealed fumigation containment area
by professional applicators. Nitrogen acts by simple asphyxia to kill the target pests by
reducing oxygen content to less than 0.2% v/v oxygen in the sealed treatment area (hypoxic
atmosphere). Following use of the NCAT formulation the nitrogen in the sealed fumigation
area will be vented to the atmosphere, where it will be rapidly dissipated from the immediate
area.
Nitrogen is only sparingly soluble in fresh water: 0.00216% w/w at 15°C. It is also only
sparingly soluble in seawater: 15.1285 mL of N2 per L of seawater at 5°C. Considering that the
atmosphere above any water body or land mass is 78.1% v/v nitrogen it is unlikely that
increased levels of nitrogen will be observed in aquatic/terrestrial systems since atmospheric
nitrogen levels will not be influenced by nitrogen use as a biocide. Even if nitrogen were to be
released directly into soil or sediment, it will attain equilibrium within the air spaces by passive
diffusion after a short time. Nitrogen, when bubbled through water, will only displace oxygen
if forced through the water under pressure; this will not happen from the normal use of nitrogen
as a biocide.
NITROGEN
Product-type 18
28 November 2008
The nitrogen from the controlled atmosphere containment area will be vented to atmosphere.
Therefore, the use of nitrogen as a biocide will never elevate levels beyond normal
environmental ranges. Therefore PEC values were set to zero by environmental fate and
behaviour for all compartments.
Nitrogen does not have any intrinsic properties that suggest it will bioaccumulate in the
environment. In addition, nitrogen is not classified as hazardous to health according to EC
Directive 67/548/EEC, nor is there any indications of toxicity such as endocrine disruption.
There are no additives, solvents or other non-active substances present, which will affect the
ecotoxicological profile of nitrogen.
2.2.2.2.
Effects assessment
Not applicable
2.2.2.3.
PBT assessment
Not applicable
2.2.2.4.
Exposure assessment
Not applicable
2.2.2.5.
Risk characterisation
The toxicity profile of nitrogen, coupled with the fact that it is ubiquitous and unlikely to
accumulate in the environment, means that there is no risk of secondary poisoning. Given the
level of exposure expected in all environmental compartments from the use of nitrogen as a
biocide (PT18) and its intrinsic characteristics and ubiquitous distribution in the environment, it
is considered that there is no risk to the environment and safe uses of the NCAT product are
identified
1.1.1.
List of endpoints
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 most important endpoints, as identified
during the evaluation process, are listed in Appendix II.
3.
3.1.
DECISION
Background to the Decision
The applicant has submitted the nitrogen dossier for its use as an insecticide for Nitrogen
Controlled Atmosphere Treatment. The product acts as a fumigation system. Nitrogen acts by
simple asphyxia, to kill the target pests. Nitrogen is used to replace the majority of the oxygen
in the controlled atmosphere containment area.
NITROGEN
Product-type 18
28 November 2008
There are two types of controlled atmosphere treatment (CAT) bubble that can be used: ƒ
The permanent bubble: These typically range from 3m3 to 30m3. They are constructed
from plastic coated aluminium.
ƒ
The single use bubble: These are constructed around the artefacts that require treatment
and can therefore be any size. However, they typically range from 3m3 – 30m3. They are
constructed from sheets of plastic coated aluminium that are heat-sealed together in situ.
Nitrogen is used for control of arthropod pests that affect commodities, such as; museum
artefacts (wooden items, textiles, etc), stored foods, machinery, etc. It is particularly important
for very high value commodities such as certain museum artefacts, which may be adversely
affected by other fumigants. While normally treatment of wooden artefacts (frames of “old
masters”) would require PT8 inclusion, it seems appropriate to limit the inclusion to PT18 on
account of the limited and specialised use of nitrogen.
The evaluation of the dossier led to the following conclusions concerning nitrogen as
insecticide:
ƒ
The active substance has a minimum specification of ≥ 99.99% w/w nitrogen.
ƒ
There is no concern regarding the physico-chemical properties.
In its use as an insecticide, nitrogen is presented as a ready-to-use fumigant insecticide, at a
concentration of 99.8% v/v. In its application as an insecticide, submitted studies have
demonstrated a sufficient degree of efficacy against the target organisms. The biocidal action of
nitrogen is to replace the majority of the oxygen in the controlled atmosphere containment area.
Nitrogen is an inert substance and does not exert a direct toxicological effect. The level of
oxygen is the critical factor.
Given the effectively zero level of exposure expected in all environmental compartments from
the use of nitrogen as a pesticide (PT18), it is considered that there is no risk to the
environment and safe uses of the NCAT product are identified.
No classification and labelling is proposed for nitrogen, given the lack of critical endpoints in
terms of adverse effects on health and environment, and of physico-chemical properties.
3.2.
Decision regarding Inclusion in Annex I and IA
An inclusion to Annex I is recommended for nitrogen as an active substance in insecticides,
product-type 18, and is subject to the following requirements according to Article 10 (2):
1. The minimum degree of purity for Nitrogen is 99.99 % (v/v).
2. The demonstrated target species are insects and other relevant target arthropods.
NITROGEN
Product-type 18
28 November 2008
3. Product may only be sold to and used by professionals trained to use them. Safe
working practices and safe systems of work must be in place to ensure minimum risk,
including the availability of personal protective equipment if necessary.
4. A Controlled Atmosphere Treatment (CAT) is conducted in an area that is secured such
that only authorised personnel trained in the use of nitrogen as a fumigant can enter and
gaining access to this room is strictly restricted. Prior to undertaking any fumigation
with nitrogen, a risk assessment is undertaken, and part of this process defines both the
“fumigation area” and “risk area”. The “fumigation area” is defined as the area taken up
with the fumigation bubble itself as this defines the actual space that contains the
infested articles/artefacts that are to be fumigated. The “risk area” is the area that, after
appropriate consideration, is considered at risk of harmful oxygen depletion following
nitrogen escape should there be a failure of the fumigation process.
5. The fumigation risk area is monitored for oxygen levels with visual and audible alarms,
which indicate if the oxygen levels fall below 19% v/v.
6. A visual and audible alarm is to be worn on the operators PPE. The operator must also
be equipped with an escape SCBA to allow safe evacuation from the risk area, if
necessary.
3.3.
Elements to be taken into account by Member States when authorising
products
3.4.
1
The purity of the active substance submitted in the dossier is > 99.99 % (v/v).
The conclusions have been derived on the basis of the risk assessment carried
out with this value.
2
The applicant supported use strictly restricted to professionals
3
For forthcoming product dossiers, Members States shall consider the need of
further information in terms of nitrogen content and device (bubble)
characterisation and the introduction of oxygen scavengers.
Requirement for further information
There are no outstanding information requirements.
3.5.
Updating this Assessment Report
This assessment report may need to be updated periodically in order to take account of
scientific developments and results from the examination of any of the information referred to
NITROGEN
Product-type 18
28 November 2008
in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and
finalised in connection with any amendment of the conditions for the inclusion of nitrogen in
Annex I and IA to the Directive.
NITROGEN
4.
Product-type 18
28 November 2008
APPENDIX I IDENTITY, PHYSICO-CHEMICAL PROPERTIES
CAS No.
7727-37-9
EINECS No.
231-783-9 III-A2
Common name:
Nitrogen
Synonyms:
Dinitrogen, diatomic nitrogen, diazyne.
Molecular formula:
N2
Purity:
≥ 99.99% w/w nitrogen,
Structural formula:
N≡N
Molecular mass:
28.01 g/mol
Nitrogen is a colourless gas with no discernible odour. Nitrogen has a melting point of -210°C
and a boiling point of –195.8°C. Nitrogen is only sparingly soluble in water and has a water
solubility of 0.00216% w/w at 15°C. Nitrogen is thermodynamically stable. Nitrogen is an
inert molecule and only reacts, under ambient conditions, in the presence of a catalyst (e.g.
lighting, nitrogen fixing bacteria, etc). Nitrogen is not known to be incompatible with any
specific packaging material. Nitrogen is not considered to be flammable, explosive or
oxidising. Nitrogen does not classify from a phys.chem. point of view.
NITROGEN
Product-type 18
28 November 2008
APPENDIX II: LIST OF ENDPOINTS
Chapter 1:
Labelling
Identity, Physical and Chemical Properties, Classification and
Active substance (ISO Common Name)
Nitrogen
Product-type
18
Identity
Chemical name (IUPAC)
Nitrogen
Chemical name (CA)
Nitrogen
CAS No
7727-37-9
EC No
231-783-9
Other substance No.
None known.
Minimum purity of the active substance as
manufactured (g/kg or g/l)
999 g/kg
Identity of relevant impurities and additives
(substances of concern) in the active substance as
manufactured (g/kg)
There are no impurities present at 1 g/kg or higher.
There are not additives present.
Molecular formula
N2
Molecular mass
28.01 g/mol
Structural formula
N≡N (Smiles code)
NITROGEN
Product-type 18
28 November 2008
Physical and chemical properties
Melting point (state purity)
-210°C (not reported)
Boiling point (state purity)
-195.8˚C (not reported)
Temperature of decomposition
Not applicable.
Appearance (state purity)
Colourless, odourless gas (not reported)
Relative density (state purity)
Relative density = 0.967
Surface tension
Not applicable.
Vapour pressure (in Pa, state temperature)
Not applicable.
Henry’s law constant (Pa m3 mol -1)
Not applicable.
Solubility in water (g/l or mg/l, state temperature)
0.00216% w/w (at 15°C)
Solubility in organic solvents (in g/l or mg/l, state
temperature)
Methanol: 0.02371% w/w (at 10°C)
Hexane: 0.04460% w/w (at 10°C)
Stability in organic solvents used in biocidal
products including relevant breakdown products
Not applicable. There are no organic solvents used in
the manufacture of the representative product Nitrogen
Controlled Atmosphere Treatment.
Partition coefficient (log POW) (state temperature)
Log Pow = 8.08 (ca. 25°C, isobutanol and water)
Log Pow = 4.66 (ca. 25°C, olive oil and water)
Hydrolytic stability
temperature)
(DT50)
(state
pH
and
Not applicable.
Dissociation constant
The water solubility of nitrogen has been determined
(refer to Document IIIA, Section 3.5 Solubility in water).
The dissociation constant should only be determined if
water solubility cannot be measured (see Document IIIA
section 3.6).
UV/VIS absorption (max.) (if absorption > 290 nm
state ε at wavelength)
113 nm
NITROGEN
Product-type 18
28 November 2008
Photostability (DT50) (aqueous, sunlight, state pH)
Not applicable due to UV absorption maxima.
Document IIIA section 7.1.1.1.2 for justification.
Quantum yield of direct phototransformation in
water at Σ > 290 nm
Not applicable.
Flammability
Not flammable.
Explosive properties
Not explosive.
See
NITROGEN
Product-type 18
28 November 2008
Classification and proposed labelling
with regard to physical/chemical data
Not classified as hazardous.
with regard to toxicological data
with regard to fate and behaviour data
with regard to ecotoxicological data
Chapter 2:
Methods of Analysis
Analytical methods for the active substance
Technical active substance (principle of method)
It is not possible to detect nitrogen gas itself. The
method of analysis for the nitrogen gas extracted from
the atmosphere determines the levels of impurities
(oxygen, carbon monoxide, carbon dioxide, total
hydrocarbons and water), the balance must be nitrogen.
This gives a minimum purity of nitrogen gas of at least
99.9968% v/v.
Impurities in technical active substance (principle
of method)
Not applicable. There are no additives present in
nitrogen. There are no impurities present in nitrogen
above the concentration limit of 1g/kg, and no impurities
of toxicological or ecotoxicological significance present
below the concentration limit of 1g/kg.
Analytical methods for residues
Soil (principle of method and LOQ)
Not applicable. There is no mechanism for nitrogen to
be released directly into soil from normal use as a
biocide. The use of nitrogen as a biocide will not never
elevate the levels of nitrogen beyond normal
atmospheric ranges.
Air (principle of method and LOQ)
Please refer to “Technical active substance (principle of
method) (Annex IIA, point 4.1) above. It is not possible
to differentiate between the nitrogen gas used as a
biocide and atmospheric nitrogen.
Water (principle of method and LOQ)
Not applicable. There is no mechanism for nitrogen to
be released directly into water from normal use as a
biocide. The use of nitrogen as a biocide will never
elevate the levels of nitrogen beyond normal
atmospheric ranges.
Body fluids and tissues (principle of method and
LOQ)
No analytical method has been submitted for body
fluids. A method is only required when the active
substance is classified as toxic or highly toxic. Nitrogen
is not classified as such according to EC Directive
67/548/EEC, and therefore it is not necessary to submit
an analytical method to detect nitrogen residues in
animal and human body fluid and tissues.
Food/feed of plant origin (principle of method and
LOQ for methods for monitoring purposes)
Not applicable. The use of nitrogen as a biocide will
never increase the levels of nitrogen beyond normal
atmospheric ranges. It is not possible to differentiate
between the nitrogen gas used as a biocide and
atmospheric nitrogen.
NITROGEN
Product-type 18
Food/feed of animal origin (principle of method
and LOQ for methods for monitoring purposes)
28 November 2008
Not applicable. The use of nitrogen as a biocide will
never increase the levels of nitrogen beyond normal
atmospheric ranges. It is not possible to differentiate
between the nitrogen gas used as a biocide and
atmospheric nitrogen.
NITROGEN
Chapter 3:
Product-type 18
28 November 2008
Impact on Human Health
Absorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption:
Not applicable, nitrogen is a gas.
Rate and extent of dermal absorption:
Not applicable, nitrogen is a gas.
Distribution:
The principle route of exposure to nitrogen is via the
inhalation route. The concentration of nitrogen between
inhaled and exhaled human breath is not significantly
different. Also, nitrogen is only sparingly soluble in
water. Therefore an insignificant amount of nitrogen is
absorbed into the human body.
Potential for accumulation:
There is no data available to suggest that nitrogen has the
potential to accumulate in the human body.
Rate and extent of excretion:
Not applicable, nitrogen is only sparingly soluble in
water and an insignificant amount is absorbed into the
human body.
Toxicologically significant metabolite(s)
Not applicable. No toxicologically significant
metabolites arise form the metabolism of nitrogen.
Acute toxicity
Rat LD50 oral
Not applicable, nitrogen is a gas.
Rat LD50 dermal
Not applicable, nitrogen is a gas.
Rat LC50 inhalation
Not applicable. Nitrogen acts by simple asphyxia and is
inert and not intrinsically hazardous.
Skin irritation
Not applicable, nitrogen is a gas.
Eye irritation
Not applicable, nitrogen is a gas.
Skin sensitization (No test method used and no
result)
Not applicable, nitrogen is a gas.
Repeated dose toxicity
Species/ target / critical effect
Not applicable. Nitrogen acts by simple asphyxia and is
inert and not intrinsically hazardous.
Lowest relevant oral NOAEL / LOAEL
Not applicable. Nitrogen acts by simple asphyxia and is
inert and not intrinsically hazardous.
Lowest relevant dermal NOAEL / LOAEL
Not applicable. Nitrogen acts by simple asphyxia and is
inert and not intrinsically hazardous.
NITROGEN
Product-type 18
28 November 2008
Lowest relevant inhalation NOAEL / LOAEL
Not applicable. Nitrogen acts by simple asphyxia and is
inert and not intrinsically hazardous.
Genotoxicity
In vitro gene mutation study in bacteria
Not applicable, nitrogen is inert and not intrinsically
hazardous.
In vitro cytogenicity study in mammalian cells
Not applicable, nitrogen is inert and not intrinsically
hazardous.
In vivo mammalian cytogenetic test in cells other than
bone marrow
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Carcinogenicity
Species/type of tumour
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Lowest dose with tumours
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Reproductive toxicity
Species/ Reproduction target / critical effect
Not applicable, nitrogen is inert and not intrinsica
hazardous.
Lowest relevant reproductive NOAEL / LOAEL
Not applicable, nitrogen is inert and not intrinsica
hazardous.
Species/Developmental target / critical effect
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Developmental toxicity
Lowest relevant developmental NOAEL / LOAEL
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Neurotoxicity / Delayed neurotoxicity
Species/ target/critical effect
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Lowest relevant developmental NOAEL / LOAEL.
Not applicable, nitrogen is inert and not intrinsically
NITROGEN
Product-type 18
28 November 2008
hazardous.
Other toxicological studies
...............................................................................
Not applicable, nitrogen is inert and not intrinsically
hazardous.
Medical data
...............................................................................
Not applicable, nitrogen is inert and not intrinsically
hazardous. The atmosphere already contains 78.1% v/v
nitrogen, all non-aquatic life on Earth is constantly
exposed to nitrogen gas for their entire life cycle.
Summary
Value
Non-professional user
-
ADI (acceptable daily intake, external long-term
reference dose)
Not applicable, no residues
left
after
treatment.
Nitrogen is exempt from
EPA food residue tolerance
on all raw agricultural
commodities. Nitrogen is a
Permitted
Miscellaneous
Additive in Foods (Serial
No. E941) without stated
limits.
AOEL-S (Operator Exposure)
Not applicable. The critical
factor is the level of oxygen
in the atmosphere. Workers
must
evacuate
the
fumigation risk area if the
oxygen monitoring devices
detect an oxygen deficient
atmosphere, ie. one with less
than 19% v/v oxygen.
ARfD (acute reference dose)
Not applicable, as not
intended to be applied in
water.
Professional user
-
Reference value for inhalation (proposed OEL)
-
Reference value for dermal absorption
-
Study
Safety
factor
NITROGEN
Product-type 18
28 November 2008
Acceptable exposure scenarios (including method of calculation)
Professional users
Under normal conditions of use, there will not be exposure
to an oxygen deficient atmosphere (<19% v/v oxygen).
However, the worst-case exposure scenario shows that a
closed room containing a CAT bubble would need to be at
least 2 times the volume of the CAT bubble for the oxygen
concentration to drop to the self-rescue threshold of 10%
v/v oxygen. This gives a Margin Of Safety of 2.08.
Since the room containing a CAT bubble must have either
natural or forced ventilation, this will significantly
increase the MOS.
For full details, please refer to Document IIC section
12.2.2.3
Production of active substance:
-
Formulation of biocidal product
-
Intended uses
-
Secondary exposure
-
Non-professional users
Not applicable. The representative product, Nitrogen
Controlled Atmosphere Treatment, is for professional use
only.
Indirect exposure as a result of use
Under normal conditions of use, there will not be exposure
to an oxygen deficient atmosphere (<19% v/v oxygen).
Bystanders will be excluded from the treatment area.
For full details, please refer to Document IIC section 12.3
Chapter 4:
Fate and Behaviour in the Environment
Route and rate of degradation in water
Hydrolysis of active substance and relevant
metabolites (DT50) (state pH and temperature)
Not applicable, nitrogen is hydrolytically stable.
Photolytic / photo-oxidative degradation of active
substance and resulting relevant metabolites.
Not applicable.
Readily biodegradable (yes/no)
No.
Biodegradation in seawater
Nitrogen is not intended for use or released to the marine
environment.
Non-extractable residues
Not applicable, nitrogen is not intended to be used or
released to the aquatic environment.
NITROGEN
Product-type 18
28 November 2008
Distribution in water / sediment systems (active
substance)
Not applicable, nitrogen is not intended to be used or
released to the aquatic environment.
Distribution
(metabolites)
Not applicable, nitrogen is not intended to be used or
released to the aquatic environment.
in
water/sediment
systems
Route and rate of degradation in soil
Mineralisation (aerobic)
Data on fate and behaviour in soil is not required as
nitrogen is not intended to be used or released directly to
the soil, therefore these studies are not required.
The data end points for ready biodegradability (Document
IIIA, section 7.1.1.2.1) and inherent biodegradability
(Document IIIA, section 7.1.1.2.2) do not show
biodegradability and do not indicate the need to conduct
studies on the fate and behaviour of nitrogen in soil.
Laboratory studies (range or median, with
number of measurements, with regression
coefficient)
Please refer to “Mineralisation (aerobic)” (above).
Field studies (state location, range or median with
number of measurements)
Please refer to “Mineralisation (aerobic)” (above).
Anaerobic degradation
Please refer to “Mineralisation (aerobic)” (above).
Soil photolysis
Please refer to “Mineralisation (aerobic)” (above).
Non extractable residues
Please refer to “Mineralisation (aerobic)” (above).
Relevant metabolites – name and/or code, % of
applied a.i. (range and maximum)
Please refer to “Mineralisation (aerobic)” (above).
Soil accumulation and plateau concentration
Please refer to “Mineralisation (aerobic)” (above).
Adsorption/desorption
Ka, Kd
Not applicable, nitrogen will not be released to soil or
sediment.
Kaoc, Kdoc
Not applicable, nitrogen will not be released to soil or
sediment.
pH dependence (yes / no) (if yes type of
dependence)
Not applicable, nitrogen will not be released to soil or
sediment.
NITROGEN
Product-type 18
28 November 2008
Fate and behaviour in air
Direct photolysis in air
Not applicable, nitrogen already forms 78.1% v/v of the
atmosphere.
Quantum yield of direct photolysis
Not applicable.
Photo-oxidative degradation in air
Not applicable.
Volatilisation
Not applicable.
Monitoring data, if available
Soil (indicate location and type of study)
Data not available, there is no mechanism for soil
exposure.
Surface water (indicate location and type of
study)
Data not available, there is no mechanism for soil
exposure.
Ground water (indicate location and type of
study)
Data not available, there is no mechanism for soil
exposure.
Air (indicate location and type of study)
Data not available, there is no mechanism for soil
exposure.
Chapter 5:
Effects on Non-target Species
Toxicity data for aquatic species (most sensitive species of each group)
Species
Time-scale
Endpoint
Toxicity
Fish
Not applicable, nitrogen is only sparingly soluble in water and is inert and not intrinsically
hazardous
Invertebrates
Not applicable, nitrogen is only sparingly soluble in water and is inert and not intrinsically
hazardous
Algae
Not applicable, nitrogen is only sparingly soluble in water and is inert and not intrinsically
hazardous
Microorganisms
Not applicable, nitrogen is only sparingly soluble in water and is inert and not intrinsically
hazardous
Effects on earthworms or other soil non-target organisms
NITROGEN
Product-type 18
28 November 2008
Acute toxicity to …………………………………..
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significent
exposure risk to the terrestrial compartment.
Reproductive toxicity to …………………………
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment.
NITROGEN
Product-type 18
28 November 2008
Effects on soil micro-organisms
Nitrogen mineralization
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment
Carbon mineralization
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment
Effects on terrestrial vertebrates
Acute toxicity to mammals
Acute
Dietary
toxicity
toxicity
Reproductive
toxicity
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment
to
birds
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment. Nitrogen,
under normal conditions of use, will not elevate the
levels of nitrogen beyond normal atmospheric or
terrestrial ranges or lead to bioaccumulation or
secondary poisoning.
to
birds
Please refer to “Acute toxicity to birds” (above).
birds
Please refer to “Acute toxicity to birds” (above).
to
Effects on honeybees
Acute oral toxicity
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment. Nitrogen,
under normal conditions of use, will not elevate the
levels of nitrogen beyond normal atmospheric or
terrestrial ranges.
Acute contact toxicity
Please refer to “Acute oral toxicity” (above).
Effects on other beneficial arthropods
Acute oral toxicity
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment. Nitrogen,
under normal conditions of use, will not elevate the
levels of nitrogen beyond normal atmospheric or
terrestrial ranges.
Acute contact toxicity
Please refer to “Acute oral toxicity” (above).
Please refer to “Acute oral toxicity” (above).
Acute toxicity to …………………………………..
NITROGEN
Product-type 18
28 November 2008
Bioconcentration
Bioconcentration factor (BCF)
Not applicable, the information on the environmental
exposure scenario for nitrogen indicates no significant
exposure risk to the terrestrial compartment. Nitrogen,
under normal conditions of use, will not elevate the
levels of nitrogen beyond normal atmospheric or
terrestrial ranges.
Depration time (DT50)
Please refer to “Bioconcentration factor (BCF)” (above).
(DT90)
Level of metabolites (%) in organisms accounting
for > 10 % of residues
Chapter 6:
Please refer to “Bioconcentration factor (BCF)” (above).
Other End Points
There are no other relevant data available on nitrogen that has not been summarised elsewhere in
this document.
NITROGEN
Product-type 18
28 November 2008
Appendix III: List of Intended Uses
Product type
Insecticide (PT18)
Claim of the participant
Nitrogen is a broad-spectrum insecticide for the eradication of stored product pests, wooddestroying insects, textile pests and other arthropods.
Target organisms:
Acanthoscelides obsoletus (bean weevil)
Acarus siro (flour mite)
Amyelois transitella (navel orangeworm)
Anthrenus flavipes (furniture carpet beetle)
Anthrenus verbasci (varied carpet beetle)
Blattella germanica (German cockroach)
Callosobruchus chinensis (pea & bean beetle)
Carpophilus ligneus (dried fruit beetle)
Cryptolestes ferrugineus (flat grain beetle)
Cryptolestes pusiluss (flat grain beetle)
Dermestes lardarius (larder beetle)
Ephestia cautella (warehouse moth)
Ephestia elutella (warehouse moth)
Ephestia kuehniella (mill moth)
Incisitermes minor (western drywood termite)
Lasioderma sericorne (cigarette beetle)
Lyctus brunneus (powderpost beetle)
Lyctus linearis (powderpost beetle)
Oryzaephilus mercator (merchant grain beetle)
NITROGEN
Product-type 18
28 November 2008
Oryzaephilus surinamensis (saw-toothed grain beetle)
Periplaneta americana (American cockroach)
Plodia interpunctella (Indian meal moth)
Rhyzopertha dominica (lesser grain borer)
Sitophilus granarius (grain weevil)
Sitophilus oryzae (rice weevil) Sitophilus zeamais (maize weevil)
Sitotroga cerealella (rice moth)
Supella longipalpa (brown-banded cockroach)
Tenebrio molitor (lesser mealworm beetle)
Thermobia domestica (firebrat)
Tinea pellionella (case-bearing clothes moth)
Tineola bisselliella (common clothes moth)
Tribolium castaneum (rust-red flour beetle)
Tribolium confusum (confused flour beetle)
Trogoderma glabrum
Trogoderma granarium (khapra beetle)
Trogoderma inclusum (cabinet beetle)
Trogoxylon prostomoides (powderpost beetle)
Tyroglyphus farinae = Acarus siro (flour mite)
Concentration: The active substance is used at a 99.9%
Categories of users: Professional operators
Type of application:The product is applies as a gas with the articles/products to be treated in a
CAT bubble
NITROGEN
Product-type 18
28 November 2008
Appendix IV: 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. For studies marked Yes (i) data protection is claimed under Article 12.1(c) (i), for studies marked
Yes (ii) data protection is claimed under Article 12.1(c) (ii). 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 / Author(s)5
Reference
No4
Year
Title6
Data
Source (where different from company) Protection
Company
Claimed
Report
No. (Yes/No)
GLP (where relevant)
Owner
(Un)Published
4 Section Number/Reference Number should refer to the section number in Doc III-A or III-B. If the study is nonkey, 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 crossreference to PPP references then an additional column can be inserted).
5 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.
6 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.
NITROGEN
Product-type 18
Section No / Author(s)5
Reference
No4
Year
28 November 2008
Title6
Data
Source (where different from company) Protection
Company
Claimed
Report
No. (Yes/No)
GLP (where relevant)
Owner
(Un)Published
III-A 6.1/01
Flucke
W,
Thyssen J
& 1987
XXX 1111 / Acute Toxicity Studies.
Yes
Organics Inc
No
Organics Inc
Organics Inc
Report
Non-GLP
AT-
414-87
Unpublished
(A6_AT_acutetox_rat_414_87)
(Doc II-A
section 3.2,)
Rensor D
1979a
Short-term toxicity study with XXXX
Toxicol. Letters
Non-GLP
Published
22:
9-17
NITROGEN
Product-type 18
28 November 2008