Registration Dossier
Registration Dossier
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EC number: 200-606-7 | CAS number: 65-30-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
Data source
Reference
- Reference Type:
- other: Secondary Literature
- Title:
- FAO EVALUATION FOR THE TEST CHEMICAL
- Author:
- FAO
- Year:
- 2 013
- Bibliographic source:
- FAO Evaluation, 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 405 and EPA OPPTS 870.2400.
- Principles of method if other than guideline:
- To evaluate the eye irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 428-040-8
- EC Name:
- -
- Cas Number:
- imidacloprid (ISO)
- Molecular formula:
- C9H10ClN5O2
- IUPAC Name:
- imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: imidacloprid (ISO)
IUPAC Name: 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine
Molecular formula: C9H10ClN5O2
Molecular Weight: 255. g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Sex: female
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.08 g of ground test substance
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- No additional details mentioned
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no details mentioned
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
Any other information on results incl. tables
Results of the acute toxicological studies:
Guideline |
Number of animals |
Dose |
Method |
Observations and results |
OECD 405 and EPA OPPTS 870.2400 |
3 female rabbits |
0.08 g of ground test substance. |
Single instillation via the ocular route. |
test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
- Executive summary:
An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits.The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation.In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
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