Registration Dossier
Registration Dossier
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EC number: 600-141-3 | CAS number: 1009-22-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-bromo-4-fluorophenyl)acetamide
- EC Number:
- 600-141-3
- Cas Number:
- 1009-22-9
- Molecular formula:
- C8H7BrFNO
- IUPAC Name:
- N-(2-bromo-4-fluorophenyl)acetamide
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg; skin was moistened with 25 µL sterile deionised water
NEGATIVE CONTROL
- Amount(s) applied: 30 µL
POSITIVE CONTROL
- Amount(s) applied: 30 µL - Duration of treatment / exposure:
- 3 and 60 min
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- duplicates for treatment (both exposure periods)and control groups
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 85.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 101
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- In this in vitro skin corrosion test in EpiDerm™ tissue, the mean cell viability compared to the negative control was 85.9% after 3 min exposure and 101.0% after 60 min exposure with the test substance. All validity criteria were within acceptable limits. In conclusion, the test substance was not corrosive to human epidermis tissue and does not have to be classified according to EU classification criteria.
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