Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
cattle
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
10 minutes
Duration of post- treatment incubation (in vitro):
2 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Test Item: (R)-3,7-dimethyl-1,6-octadien-3-ol
Value:
64.94
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
This in vitro study was performed to assess corneal damage potential of (R)-3,7-dimethyl-1,6-octadien-3-ol by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item (R)-3,7-dimethyl-1,6-octadien-3-ol was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour 30 minutes (Exp.1) and 1 hour (Exp. 1c and 1d) and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.

Four experiments were performed. The first experiment (Exp. 1) was not sufficient for classification because 1 of the 3 replicates of the test item gave a discordant prediction from the mean of all 3 replicates and the IVIS of the discordant replicate was higher than 65. Therefore a further experiment had to be performed.
This second experiment (Exp. 1b) was discontinued, because of an opacitometer error. The raw data of this invalid test run are kept in the GLP-archive, but are not reported.
Then a third experiment (Exp. 1c) was performed. The result of the third experiment gave a non-concordant prediction from the first testing run (based upon the mean IVIS value).
Therefore a fourth and final testing run (Exp. 1d) was conducted to resolve equivocal pre-dictions and to classify the test item.

The test item was tested pure.
Under the conditions of this study and the combination of the results of these three ex-periments lead to the result that the test item (R)-3,7-dimethyl-1,6-octadien-3-ol induced serious eye damage on the cornea.