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

Materials and methods

Test guideline
Qualifier:
according to
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 the test chemical in rabbits
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-amino-4-nitrophenol
- Substance type: Organic
- Physical state: solid
- InChI: 1S/C6H6N2O3/c7-5-3-4(8(10)11)1-2-6(5)9/h1-3,9H,7H2
- Smiles: Nc1cc(ccc1O)[N+](=O)[O-]

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The albino rabbits used for the assessment.

Test system

Type of coverage:
other: intact and abraded skin
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 hrs
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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the animals treated showed any response to treatment

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 **

99 -57 -0

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 the test chemical showed any signs of irritation during the 72 hours observation period. The Primary Irritation Index was 0.0.
Based on the scores and observations, the test chemical was considered to be not irritating to albino New Zealand White rabbit skin.
Executive summary:

The dermal irritancy potential of the test chemical was evaluated 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 the test chemical in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3was applied to the intact and abraded skin of 3 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 the test chemical showed any signs of irritation during the 72 hours observation period. The Primary Irritation Index was 0.0.

Based on the scores and observations, the test chemical was considered to be not irritating to albino New Zealand White rabbit skin.