Registration Dossier
Registration Dossier
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EC number: 613-755-1 | CAS number: 65193-87-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-cyanoethyl 3-oxobutanoate
- EC Number:
- 613-755-1
- Cas Number:
- 65193-87-5
- Molecular formula:
- C7H9NO3
- IUPAC Name:
- 2-cyanoethyl 3-oxobutanoate
Constituent 1
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- 2.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the entire data for the test item no classification for serious eye damage/eye irritation according to Regulation (EC) No. 1272/2008 (CLP) is required.
- Executive summary:
For determination of corneal damage opacity as well as tissue permeability was measured after a 10 minutes exposure time and a 2 hours post exposure incubation period. Based on these data, in comparison to the negative control, the In Vitro Irritancy Score (IVIS) value was calculated to be 2.2 which is below the IVIS cut-off threshold of 55 and thus identifying the test item as not inducing serious eye damage. The results of the positive (1 % sodium hydroxide) and negative (isotonic saline) controls confirmed the validity of the test system.
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