2-methoxy-5-nitroanilinium chloride

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 journals

Data source

Reference

Reference Type:

publication

Title:

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

Author:

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

Year:

1977

Bibliographic source:

Food and Cosmetics Toxicology, Volume 15, Issue 6, December 1977, Pages 607-610

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41)

Principles of method if other than guideline:

To assess the dermal irritancy potential of 4-nitrobenzene-1,2-diamine in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-nitro-o-phenylenediamine

EC Number:

202-766-3

EC Name:

4-nitro-o-phenylenediamine

Cas Number:

99-56-9

Molecular formula:

C6H7N3O2

IUPAC Name:

4-nitrobenzene-1,2-diamine

Test material form:

solid

Details on test material:

Name of the test chemical: 4-nitrobenzene-1,2-diamine
Common Name: 4-nitro-o-phenylenediamine
Molecular Weight: 153.14 g/mol
Molecular Formula: C6H7N3O2
InChI: 1S/C6H7N3O2/c7-5-2-1-4(9(10)11)3-6(5)8/h1-3H,7-8H2
Substance Type: Organic
Physical State: Solid

Specific details on test material used for the study:

Name of the test chemical: 4-nitrobenzene-1,2-diamine
Common Name: 4-nitro-o-phenylenediamine
Molecular Weight: 153.14 g/mol
Molecular Formula: C6H7N3O2
InChI: 1S/C6H7N3O2/c7-5-2-1-4(9(10)11)3-6(5)8/h1-3H,7-8H2
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

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:

single exposure

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 vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation were observed in the 72 hours observation period

Any other information on results incl. tables

Table: Results of the skin and eye irritancy studies on rabbits

Compound	Skin Irritation (Primary Irritation Index)	Eye Irritation **
4-nitro-o-phenylenediamine	0	±

**Categorized as + or - according to whether extrapolation of the result would be expected to give a positive or negative in the Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

None of the rabbits treated with 4-nitro o-phenylenediamine showed any signs of irritation during the 72 hours observation period. The Primary Irritation Index was 0.0.
Based on the scores and observations, 4-nitro-o-phenylenediamine was considered to be not irritating to albino New Zealand White rabbit skin.

Executive summary:

The dermal irritancy potential of 4-nitro o-phenylenediamine in rabbits. The study was conducted as per Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41).2.5% (w/v) Suspension of 4-nitro o-phenylenediamine in 0.5% aqueous gum tragacanth, containing 0.05% Na₂SO₃was applied to the intact and abraded skin of3 New Zealand White albino rabbits. The rabbits were observed for signs of irritation till 72 hours and the reactions were scored based on the definition of skin irritation given in the  (Code of Federal Regulations, Title 16, Sec.1500.41).

None of the rabbits treated with 4-nitro o-phenylenediamine showed any signs of irritation during the 72 hours observation period. The Primary Irritation Index was 0.0.

Based on the scores and observations, 4-nitro-o-phenylenediamine was considered to be not irritating to albino New Zealand White rabbit skin.