Registration Dossier
Registration Dossier
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EC number: 200-920-4 | CAS number: 75-97-8
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
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,3-dimethylbutanone
- EC Number:
- 200-920-4
- EC Name:
- 3,3-dimethylbutanone
- Cas Number:
- 75-97-8
- Molecular formula:
- C6H12O
- IUPAC Name:
- 3,3-dimethylbutanone
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 µl of pure substance
- Duration of treatment / exposure:
- 42h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of Run 1
- Value:
- 76.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: result beyond the acceptabilit criteria
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of Run 2
- Value:
- 24.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The irritant potential was determined according to OECD 439 guideline on human reconstructed epidermis. The study shows that the mean percent viability of the treated tissues was 24.5%.
In regards with GHS criteria, the substance has to be classified in Cat. 2 "irritation to skin". - Executive summary:
The irritant potential was determined according to OECD 439 guideline on human reconstructed epidermis. The study shows that the mean percent viability of the treated tissues was 24.5%.
In regards with GHS criteria, the substance has to be classified in Cat. 2 "irritation to skin".
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