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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
other: as mentioned below
Principles of method if other than guideline:
To assess the ocular irritation potential of Disperse Black 9 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)
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 / tissue source

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the powdered dye
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
The eyes were observed and scored at 1, 2, 3, and 7 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Ocular reactions were scored at 1, 2, 3, and 7 days; Maximum Score = 110

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed in the treated eyes of rabbits at any time point.

Any other information on results incl. tables

Table: Ocular Irritation Study of Disperse Black 9

Material tested

Concentration

Species

Number

Observations and conclusions

Disperse Black 9

100 mg powdered dye

Rabbit

6

All scores of 0.0 (max =110); not irritating

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No signs of irritation were observed in the treated eyes of rabbits at any time point.
The scores obtained at 1, 2, 3, and 7 days were 0.0. Hence, Disperse Black 9 can be considered to be not irritating to rabbit eyes.
Executive summary:

The ocular irritation potential of Disperse Black 9 was assessed in rabbits. 100 mg of the powdered dye was instilled in one eye of 6 rabbits and the other eye served as control. The treated eyes were observed and scored at 1, 2, 3, and 7 days. The maximum attainable score was 110.

No signs of irritation were observed in the treated eyes of rabbits at any time point.

The scores obtained at 1, 2, 3, and 7 days were 0.0. Hence,Disperse Black 9 can be considered to be not irritating to rabbit eyes.