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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
determination of eye irritation potential of test chemical
Author:
Burnett CL et. al.
Year:
2010
Bibliographic source:
International Journal of Toxicology,2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate eye irritation potential of test chemical on rabbit’s eye.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name: 2-methyl-p-phenylenediamine
InChI: 1S/C7H10N2/c1-5-4-6(8)2-3-7(5)9/h2-4H,8-9H2,1H3
Smiles: Cc1cc(ccc1N)N
- Molecular formula :C7H10N2
- Molecular weight :122.17 g/mol
- Substance type:Organic

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified

Test system

Vehicle:
other: 0.05 %aqueous sodium sulphite (0.1mL pH 7.0)
Controls:
not specified
Amount / concentration applied:
2.5% (0.1mL)
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
1 hr, Days 1, 2, 3, 4, and 7.
Number of animals or in vitro replicates:
3
Details on study design:
Washing (if done): eye was rinsed with 50 mL of lukewarm water
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Reversibility:
not fully reversible within:
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular lesions were observed in treated rabbits.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
No ocular lesions were observed in treated rabbits. Hence the test chemical was considered to be not irritating to the rabbits’ eye.
Executive summary:

An eye irritation study was conducted to assess its eye irritation potential of test chemical. The test material was installed onto the eyes of rabbits in the concentration 0.1 mL of a 2.5% w/v in aqueous sodium sulphite (pH 7.0) for 10 sec. After 10 seconds the eye was rinsed with 50 mL of lukewarm water. The treated eyes were evaluated and scored by Draize scoring system at 1 hr and then at Days 1, 2, 3, 4, and 7. Since none of the treated rabbit produced any ocular lesions, the test chemical was considered to be not irritating to the rabbits’ eye.