Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 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
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. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl oct-2-ynoate
EC Number:
203-836-6
EC Name:
Methyl oct-2-ynoate
Cas Number:
111-12-6
Molecular formula:
C9H14O2
IUPAC Name:
methyl oct-2-ynoate
Test material form:
liquid

Test animals / tissue source

Species:
cattle
Strain:
not specified
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
Duration of treatment / exposure:
10 mins
Number of animals or in vitro replicates:
3 replicates per group

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
-1.5
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 Folione showed opacity values ranging from -1.2 to -0.9 and permeability values ranging from -0.049 to -0.008. The corneas were clear after the 10 minutes of treatment with Folione. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1.7 to -1.3 after 10 minutes of treatment with Folione.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Folione did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -1.5 after 10 minutes of treatment.

Since Folione induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.