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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:
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:
Final Report on the Safety Assessment of test chemical
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1986
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 5, Number 3, 1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of the test chemical in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Name of the test chemical: 2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol
Common Name: Disperse Black 9
Molecular Formula: C16H20N4O2
Molecular Weigth:300.36 g/mol
Substance Type:Organic
Physical State: Solid (orange powder)

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data available

Test system

Type of coverage:
open
Preparation of test site:
other: intact
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 ml of semi permanent dye containing 0.38% (wt/wt) Disperse Black 9
Duration of treatment / exposure:
single exposure
Observation period:
Sites were scored at 24 and 72 hours
Number of animals:
6
Details on study design:
SCORING SYSTEM: Sites were scored at 24 and 72 hours. Maximum score = 4

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were noted on the skin

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No signs of irritation were noted on the rabbit skin. The primary irritation index was reported to be 0.0.
Based on the scores and observations, the test chemical can be considered not irritating to rabbit skin.
Executive summary:

The dermal irritation potential of the test chemical was assessed in rabbits.0.5 ml of semi permanent dye containing 0.38% (wt/wt) test chemical was applied to the intact skin of 6 rabbits and observed for signs of irritation. The dermal reactions were observed and scored at 24 and 72 hours. The maximum score for dermal reactions was 4.

No signs of irritation were noted on the rabbit skin. The primary irritation index was reported to be 0.0.

Based on the scores and observations,the test chemical can be considered not irritating to rabbit skin.