2-[[4-[bis(2-hydroxyethyl)amino]-o-tolyl]azo]-5-nitrobenzonitrile

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:

Final Report on the Safety Assessment of Disperse Black 9

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

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of Disperse Black 9 in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

EC Number:

243-987-5

EC Name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

Cas Number:

20721-50-0

Molecular formula:

C16H20N4O2

IUPAC Name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

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)

Specific details on test material used for the study:

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 or test system 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, Disperse Black 9 can be considered not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of Disperse Black 9 was assessed in rabbits.0.5 ml of semi permanent dye containing 0.38% (wt/wt) Disperse Black 9 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, Disperse Black 9 can be considered not irritating to rabbit skin.