2-nitro-p-phenylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

ASSESSMENT OF THE ACUTE TOXICITY AND POTENTIAL IRRITANCY OF HAIR DYE CONSTITUENTS

Author:

G. K. LLOYO, M. P. LIGGETT, S. R. KYNOCH and R. E. DAVIES

Year:

1977

Bibliographic source:

Fd Cosmet. Toxicol. Vol. 15, pp. 607-610. 1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-nitro-p-phenylenediamine

EC Number:

226-164-5

EC Name:

2-nitro-p-phenylenediamine

Cas Number:

5307-14-2

Molecular formula:

C6H7N3O2

IUPAC Name:

2-nitrobenzene-1,4-diamine

Details on test material:

- Name of test material (as cited in study report):2 nitro p phenylene diamine - Substance type:Organic - Physical state:Solid- PurityNo data- Impurities (identity and concentrations):No data

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:

other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3

Controls:

not specified

Amount / concentration applied:

2.5% (w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.

Duration of treatment / exposure:

no data

Observation period:

72-hr observation period

Number of animals:

3

Details on study design:

SCORING SYSTEM: Based on the definition of skin irritation given in the (Code of Federal Regulations, Title 16, Sec. 1500.41).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hrs

Score:

0

Reversibility:

no data

Remarks on result:

other: No irritation was observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine.According to the Code of Federal Regulations, Test for Skin Irritants, the primary irritation index for 2 nitro p phenylene diamine was scored as 0 , due to the no irritation observed during the 72 hour observation period.

Executive summary:

The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine. The albino rabbits used for the assessment of irritation potential were of the New Zealand White strain.

The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41). Each of the twelve compounds to be tested was applied as a 2.5% (w/v) preparation to the intact and abraded skin of three animals.

The primary irritation index was estimated to be 0 for test material as it showed no response to treatment during the 72-hr observation period.Based on the above information the test substancecan be classified as "not irritating: ,in accordence with CLP criteria.