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EC number: 236-747-6 | CAS number: 13473-26-2
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:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
Data source
Reference
- Reference Type:
- other: Secondary source
- Title:
- Eye irritation potential of test chemical
- Author:
- Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)
- Year:
- 2 004
- Bibliographic source:
- , European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP), 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the ocular irritation potential of test chemical according to OECD 405 Guideline.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one
- EC Number:
- 236-747-6
- EC Name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one
- Cas Number:
- 13473-26-2
- Molecular formula:
- C20H4Br4Cl4O5
- IUPAC Name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Acid Red 92
- Molecular formula: C20H2Br4Cl4O5Na2
- Molecular weight : 829.66 g/mol
- Substance type: Organic
- Physical state: Red powder
- Purity: 94.0 - 99.5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Sex: Male and female
Test system
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Duration of treatment: 17 days
Duration of exposure: No data available - Observation period (in vivo):
- 1, 24, 48 and 72 hours, as well as 7 and 10, 14 and 17 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3 animals (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: Eye
- % coverage: No data available
- Type of wrap if used: No data available
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available
SCORING SYSTEM: Corneal opacity, iris, redness and chemosis of the conjunctivae
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: 1 and 2
- Time point:
- other: 24-72 hr
- Score:
- 0
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- other: 24-72 hr
- Score:
- 0.1
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 24-72 hr
- Score:
- 0
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 24-72 hr
- Score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 24-72hr
- Score:
- 1.3
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and
chemosis. A slight corneal opacity, affecting up to the whole area of the cornea, was also apparent in one animal from 24 hours to 10 days after treatment, A light to marked red staining
was also observed in the treated eye of all animals during the first 7 days after treatment.All ocular effects were reversible and were no longer evident 17 days after treatment - Other effects:
- No corrosion was observed at any of the measuring intervals.
Any other information on results incl. tables
The individual mean scores were as follows:
Sr no |
Parameter 0bserved for 24h,48h and 72h |
1st |
2nd |
3rd |
animal |
||||
1 |
cornea opacity |
0.0 |
0.0 |
0.1 |
2 |
iris |
0.0 |
0.0 |
0.0 |
3 |
conjunctiva redness |
2.0 |
2.0 |
2.0 |
4 |
conjunctiva chemosis |
1.3 |
1.3 |
1.3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. A light to marked red staining was also observed in the treated eye of all animals during the first 7 days after treatment. All ocular effects were reversible and were no longer evident 17 days after treatment. The test chemical did not induce significant or irreversible damage to the rabbit eyes.Hence, test chemical can be considered not irritating to rabbit eyes.
- Executive summary:
Primary eye irritation study was conducted on male and female New Zealand Albino rabbits to evaluate the irritating nature of the test material.
100 mg/0.1g of the test compound was instilled into one eye each of three young adult rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 10, 14 and 17 days after test item application.The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. A slight corneal opacity, affecting up to the whole area of the cornea, was also apparent in one animal from 24 hours to 10 days after treatment, A light to marked red staining was also observed in the treated eye of all animals during the first 7 days after treatment. All ocular effects were reversible and were no longer evident 17 days after treatment. No abnormal findings were observed in the iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. Test chemical did not induce significant or irreversible damage to the rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.
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