Registration Dossier
Registration Dossier
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EC number: 224-427-9 | CAS number: 4355-11-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437
- Principles of method if other than guideline:
- "The Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohexanediacetic acid
- EC Number:
- 224-427-9
- EC Name:
- Cyclohexanediacetic acid
- Cas Number:
- 4355-11-7
- Molecular formula:
- C10H16O4
- IUPAC Name:
- 2-[1-(carboxymethyl)cyclohexyl]acetic acid
- Details on test material:
- - Name of test material (as cited in study report):1,1-cyclohexanediacetic acid
- Physical state: white powder
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- bovine corneas
Test system
- Vehicle:
- physiological saline
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- no observation period
- Number of animals or in vitro replicates:
- total 12 corneas: 3 for the test substance, 3 for the vehicle control; 3 for the negative control, 3 for the positive control
Results and discussion
In vivo
Results
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Score:
- 12.1
Any other information on results incl. tables
The opacity value of the test item was 121, 15 x Permeability value was 0.013 which resulted in an MS of 12.1.
The opacity value of the vehicle control “Glycerol” was 7.7, 15 x Permeability value was 0.573 which resulted in an MS of 8.2 thus demonstrating that Glycerol had no adverse effects on the test system.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test substance is considered to be not an ocular corrosive or severe irritant.
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