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 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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
The following information concerning identity and composition of the test item was provid-ed by the sponsor.
Name Methyl Cyclopentenolone
Batch no. D270001706002
Appearance white, crystal powder
Composition Methyl Cyclopentenolone
Purity >99.0%
Homogeneity homogeneous
Expiry date 07. Jun. 2018
Storage Room Temperature (20 ± 5°C)

The following additional information, provided by the sponsor too, was relevant to the
conduct of the study, according to OECD 437:

CAS No. 80-71-7
EINECS-No. 201-303-2
Chemical Class not stated
Volatility unknown
pH-value unknown
Stability in solvents H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: < 0.1 g/L; EtOH: >1 g/L; acetone: >1 g/L; CH3CN: >1 g/L; DMSO: >1 g/L

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Species:Bos primigenius Taurus (fresh bovine corneas)
Origin
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt So-lution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container.

Test system

Vehicle:
not specified
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
the test item could be applied directly on the cornea now.
Duration of treatment / exposure:
Exposure time on the corneas was 4 hours at 32 ± 1 °C.
Duration of post- treatment incubation (in vitro):
90 minutes
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 100.2
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