3,4-dicyanoaniline

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 amended report of the safety assessment of toluene-2,5-diamine, toluene-2,5-diamine sulfate, and toluene-3,4-diamine as used in cosmetics

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2010

Bibliographic source:

International Journal of Toxicology; 2010 May;29(3 Suppl):61S-83S

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin irritation study of chemical 2,5-Diaminotoluene (CAS no: 95-70-5) was conducted on New Zealand White rabbit to assess its skin irritation potential.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-p-phenylenediamine

EC Number:

202-442-1

EC Name:

2-methyl-p-phenylenediamine

Cas Number:

95-70-5

Molecular formula:

C7H10N2

IUPAC Name:

2-methylbenzene-1,4-diamine

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

Specific details on test material used for the study:

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Not specified

Test system

Type of coverage:

not specified

Preparation of test site:

other: Intact and abraded

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

2.5%

Duration of treatment / exposure:

72 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Not specified

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0.3

Reversibility:

fully reversible

Remarks on result:

other: Slight erythema and edema were observed at intact sites of all the animals. One rabbit ha very slight erythema at the abraded site. No signs of irritation were observed after 72 hours.

Irritant / corrosive response data:

Slight erythema and edema were observed at intact sites of all the animals. One rabbit ha very slight erythema at the abraded site. No signs of irritation were observed after 72 hours.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

No signs of irritation were observed after 72 hours. Hence the chemical 2,5-Diaminotoluene (CAS no: 95-70-5) was considered to be not irritating to the New Zealand White rabbits’ eye.

Executive summary:

Skin irritation study of chemical2,5-Diaminotoluene (CAS no:95-70-5) was conducted on New Zealand White rabbit to assess its skin irritation potential.

 

When thetest material was applied at a dose of 2.5% on intact and abraded skin of three rabbit,Slight erythema and edema were observed at intact sites of all the animals and one rabbit ha very slight erythema at the abraded site. No signs of irritation were observed after 72 hours. The primary irritation index was estimated to be 0.3.

 

Since all the observed effects were not persisted after 72 hours, the chemical2,5-Diaminotoluene (CAS no:95-70-5) was considered to be not irritating to the New Zealand White rabbits’ eye.