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:
guideline study

Data source

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

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
Test material form:
liquid

Test animals / tissue source

Species:
other: cow
Details on test animals or tissues and environmental conditions:
Bovine eyes from young cattle were obtained from the
slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands),
where the eyes were excised by a slaughterhouse employee as
soon as possible after slaughter.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item was applied as it is (750 μl) directly on top of the corneas
Duration of treatment / exposure:
Corneas were incubated in a horizontal position for 10+/- 1 minutes at 32 +/- 1°C
Duration of post- treatment incubation (in vitro):
Subsequently the corneas were incubated for 120 +/- 10 minutes at 32 +/- 1°C.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
11
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
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 45 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.
GR-50-3010 induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 11 after 10 minutes of treatment.
Executive summary:

GR-50-3010 induced ocular irritation through both endpoints, resulting in a mean in vitro

irritancy score of 11 after 10 minutes of treatment. This is insufficient to classify as Cat 1 based on GHS criteria and is well below the classification threshold. It is also above the threshoold for non-classification. Therefore the substance has been classified as Cat 2 irritant to the eye which is considered sufficiently protective based on current evidence and avoids the need for additional animal data.