Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
UVCB
Specific details on test material used for the study:
Batch: SH00085512

Test animals / tissue source

Species:
cattle
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 ul
Duration of treatment / exposure:
10 +/- 1 minute
Duration of post- treatment incubation (in vitro):
120 +/- 10 minutes

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
0.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

The corneas treated with Cedrene Washed showed opacity values ranging from -0.5 to 0.6 and permeability values were -0.001. The corneas were clear after the 10 minutes of treatment with Cedrene Washed. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -0.6 to 0.6 after 10 minutes of treatment with Cedrene Washed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

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 61 and within two standard deviations of the current historical positive control mean (Appendix 3).

It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Cedrene Washed did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.1 after 10 minutes of treatment.