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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 opinions on health and safety risks (chemical, biological, mechanical and other physical risks)

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON CI 45430 (Erythrosine)
Author:
Scientific Committee on Consumer Safety
Year:
2010
Bibliographic source:
Scientific Committee on Consumer Safety (SCCS),SCCS/1314/10, last updated 2010

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 Erythrosine 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 test material (as cited in study report): Erythrosine
- Molecular formula : C20H6I4Na2O5
- Molecular weight : 879.86 g/mol
-Substance type- Organic
- Physical state: Solid (powder)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Erythrosine
- Molecular formula : C20H6I4Na2O5
- Molecular weight : 879.86 g/mol
-Substance type- Organic
- Physical state: Solid (powder)

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.2 ml of a 10% aqueous solution
Duration of treatment / exposure:
twice daily, 5 days per week for 4 weeks
Observation period (in vivo):
One hour after each application
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
at least 6 albino rabbits
Details on study design:
TEST SITE
- Area of exposure: conjunctival sac of one eye
- % coverage: Not applicable
- Type of wrap if used: Not applicable

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
6
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation effects was observed
Other effects:
Erythrosine colour caused intense colouring of the iris and moderate conjunctival irritation. Staining lasted from 2 to 7 days. Erythrosine lake did not cause severe eye irritation but resulted in spotty staining in some animals and very slight but uniform staining in other animals

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Erythrosine colour caused intense colouring of the iris and moderate conjunctival irritation. Thus, erythrosine can be regarded as non-irritating to the rabbit eyes.
Executive summary:

Primary eye irritation potential was evaluated for the test chemical erythrosine. 0.2mL of 10% aqueous solution was applied in the conjuctival sac of one eye of a group of at least 6 albino rabbits. The application was repeated twice daily, 5 days per week for 4 weeks. One hour after each application the eyes were examined for evidence of staining and irritation was scored according to Draize. Three days after the last application, two animals of each group (erythrosine colour and erythrosine lake) were killed; upper lids were taken for microscopic examination. Eyeballs and posterior parts were examined grossly for evidence of staining or other abnormalities. Erythrosine colour caused intense colouring of the iris and moderate conjunctival irritation. Staining lasted from 2 to 7 days. Erythrosine lake did not cause severe eye irritation but resulted in spotty staining in some animals and very slight but uniform staining in other animals.

Erythrosine colour caused intense colouring of the iris and moderate conjunctival irritation. Thus, erythrosine can be regarded as non-irritating to the rabbit eyes.