Registration Dossier
Registration Dossier
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EC number: 235-460-3 | CAS number: 12236-25-8
Eye irritation
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:
- 1 986
- 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 ocular irritation potential of Disperse Black 9 in rabbits
- GLP compliance:
- not specified
Test material
- 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)
Constituent 1
- 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.
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