Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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 journals

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Toluene-2,5-Diamine, Toluene-2,5-Diamine Sulfate, and Toluene-3,4-Diamine
Author:
Cosmetic Ingredient Review (CIR)
Year:
1992
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY; Volume 11, Number 4,1992; Mary Ann Liebert, Inc., Publishers

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations (CFR, Title 16, Sec. 1500.42).
Principles of method if other than guideline:
Ocular irritation study of 2-methylbenzene-1,4-diamine was conducted on New Zealand White rabbits to observe its eye irritating effects.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Toluene-2,5-Diamine
- Molecular formula: C7H10N2
- Molecular weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Toluene-2,5-Diamine
- Molecular formula: C7H10N2
- Molecular weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
2.5% aqueous solution
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
24 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
- Area of exposure: test chemical was instilled into the conjunctival sacs of three rabbits.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with water.

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
fully reversible
Remarks:
after 24 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Mild conjunctival inflammation was observed; however, these reactions did not persist for more than 24 h.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Mild conjunctival inflammation was observed; however, these reactions did not persist for more than 24 h.
Since the effects observed were reversible after 24 hours,2-methylbenzene-1,4-diamine(CAS No:-95-70-5) was considered to be not irritating to the eyes of New Zealand Whiterabbits.
Executive summary:

An eye irritation study was carried out in 3 New Zealand White rabbits to assess the irritation potency of 2-methylbenzene-1,4-diamine(CAS No:-95-70-5) according to the procedure prescribed in Code of Federal Regulations (CFR, Title 16, Sec. 1500.42).2-methylbenzene-1,4-diaminewas instilled into the conjunctival sacs of three rabbits. After 10 seconds of exposure, the eyes were rinsed with water. Mild conjunctival inflammation was observed; however, these reactions did not persist for more than 24 h.

Since the effects observed were reversible after 24 hours,2-methylbenzene-1,4-diamine(CAS No:-95-70-5) was considered to be not irritating to the eyes of New Zealand White rabbits.