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Toxicological information

Eye irritation

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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:
2013
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

Constituent 1
Chemical structure
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

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.