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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:
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:
2007
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
Name:
Unnamed
Type:
Constituent
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
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.