Registration Dossier
Registration Dossier
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EC number: 613-755-1 | CAS number: 65193-87-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- 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
In vitro test system
- Test system:
- human skin model
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 92
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean value of cell viability was recorded to be 92 % (rounded). The test item was thus shown to be not irritating to reconstructed human skin in vitro.
- Executive summary:
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 92 % (rounded). The test item was thus shown to be not irritating to reconstructed human skin in vitro.
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