Registration Dossier
Registration Dossier
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EC number: 203-836-6 | CAS number: 111-12-6
Eye irritation
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:
- 2 017
- 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
- 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
Constituent 1
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.
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