Registration Dossier

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:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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.