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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.