4-nitro-o-toluidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

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: the procedure prescribed in Code of Federal Regulations (CFR, Title 16, Sec. 1500.42).

Principles of method if other than guideline:

Skin irritation study of 2-methylbenzene-1,4-diamine was conducted on New Zealand White rabbits to observe its irritation efficacy.

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): 2-methylbenzene-1,4-diamine [Toluene-2,5-Diamine]
- Molecular formula: C7H10N2
- Molecular weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No Data Available

Test system

Type of coverage:

not specified

Preparation of test site:

other: intact and abraded skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

2.5%

Duration of treatment / exposure:

single exposure

Observation period:

72 hours

Number of animals:

3

Details on study design:

No Data Available

Results and discussion

In vitro

Other effects / acceptance of results:

No Data Available

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0.3

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One rabbit had very slight erythema at the abraded site. The primary irritation index was estimated at 0.3. No signs of irritation were observed after 72 h

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The primary irritation index of 2-methylbenzene-1, 4-diamine (CAS No: - 95-70-5) was 0.3 and no signs of irritation were observed after 72h.
2-methylbenzene-1, 4-diamine can be considered not irritating to the skin of New Zealand White rabbits.

Executive summary:

Primary dermal irritation study was carried out in 3 New Zealand White rabbits to assess the irritation potency of test chemical 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-diamine as applied as a 2.5% (w/v) preparation to the intact and abraded skin of each rabbits and skin reactions were noted after 72 hours.

 One rabbit had very slight erythema at the abraded site.

The primary irritation index of  2-methylbenzene-1, 4-diamine (CAS No: - 95-70-5) was 0.3 and no signs of irritation were observed after 72h.

2-methylbenzene-1, 4-diamine can be considered not irritating to the skin of New Zealand White rabbits.