Registration Dossier
Registration Dossier
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EC number: 209-876-0 | CAS number: 596-03-2
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:
- other: Data is from opinions on health and safety risks (chemical, biological, mechanical and other physical risks)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Eye irritation in rabbits was evaluated according to Draize et al. Erythrosine (0.2 ml) was instilled into the conjunctival sac of eye of six rabbits. Eyes were observed immediately after application for any reactions.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythrosine- Molecular formula: C20H6I4Na2O5- Molecular weight : 879.86 g/mol- InChl Key (if other than submission substance): RAGZEDHHTPQLAI-UHFFFAOYSA-L-Substance type- Organic- Physical state: Solid (powder)
Constituent 1
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
- 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 applicableREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableSCORING 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:
- other: no any 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:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Erythrosine (16423-68-0) was found to be not irritating to the eyes when treated to rabbit for 4 weeks.
- 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.
Therefore, Erythrosine (16423-68-0) was assessed to be not irritating to the eyes of rabbits when treated for 4 weeks.
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