Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to OECD Guidelines, with no deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Principles of method if other than guideline:
There were no deviations from standard operating procedures that affected the integrity of the study.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Batch VE00416256
Purity 99.4%
Expiry date 06 March 2018

Test animals / tissue source

Species:
other: Bovine eyes were used as soon as possible after slaughter.
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The test item was applied as it is (750 μl) directly on top of the corneas.
Duration of treatment / exposure:
Topical application for 10 minutes.

Results and discussion

Any other information on results incl. tables

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 55 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. LINALOOL OXIDE induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 41 after 10 minutes of treatment.

Since LINALOOL OXIDE induced an IVIS > 3 ≤ 55, no prediction on the classification can be made

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Eye irritant Cat 2 Criteria used for interpretation of results: EU
Conclusions:
Based on the IVIS of 41, the substance is considered an eye irritant.