4-nitro-o-toluidine

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

2-methylbenzene-1,4-diamine

Cas Number:

95-70-5

Molecular formula:

C7H10N2

IUPAC Name:

2-methylbenzene-1,4-diamine

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.