Registration Dossier
Registration Dossier
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EC number: 305-632-3 | CAS number: 94891-32-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON TEST CHEMICAL
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 007
- Bibliographic source:
- Scientific Committee on Consumer Safety (SCCS)-SCCP/1102/07
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- To assess the eye irritation potential of test chemical on rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 222-656-9
- EC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3567-66-6
- Molecular formula:
- C16H13N3O7S2.2Na
- IUPAC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Common Name: Acid Red 33
- Molecular formula: C16H13N3O7S2.2Na
- Molecular weight : 467.389 g/mol
- Smiles notation : [Na+].[Na+].Nc1cc(S(=O)(=O)[O])cc2cc(S(=O)(=O)[O-])c(N=Nc3ccccc3)c(O)c12
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Common Name: Acid Red 33
- Molecular formula: C16H13N3O7S2.2Na
- Molecular weight : 467.389 g/mol
- Smiles notation : [Na+].[Na+].Nc1cc(S(=O)(=O)[O])cc2cc(S(=O)(=O)[O-])c(N=Nc3ccccc3)c(O)c12
- Substance type: Organic
- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.2 ml of a 10% aqueous solution (20 mg)
- Duration of treatment / exposure:
- test material was applied twice daily, five times weekly
- Observation period (in vivo):
- four weeks
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- six or more albino rabbits
- Details on study design:
- SCORING SYSTEM: Draize
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 20 days
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material caused intense colouring of the iris, lasting for 2 to 7 days
Any other information on results incl. tables
|
Before 1 application on day: |
3 days after last application |
1st hour after 1st application on day 5 |
|||
Irritation score |
2 |
5 |
10 |
20 |
0 |
2 |
0 |
0 |
0 |
0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The chemical caused intense coloring of the iris, lasting for 2 to 7 days. The mean Draize score 3 days after last application was 0.0
Based on the observations and Draize scores, the test material was considered to be not irritating to rabbit eyes. - Executive summary:
The eye irritation potential of test chemical was assessed in rabbits. About 0.2 ml of a 10% aqueous solution (20 mg) or suspension of chemical was applied twice daily, five times weekly, for four weeks to the conjunctival sac of one eye of each of a group of six or more albino rabbits (40 applications). One hour after each application, the eyes were examined for evidence of staining and the irritation was scored according to Draize.
The chemical caused intense coloring of the iris, lasting for 2 to 7 days. The mean Draize score 3 days after last application was 0.0
Based on the observations and Draize scores, the test material was considered to be not irritating to rabbit eyes.
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