Registration Dossier
Registration Dossier
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EC number: 239-635-5 | CAS number: 15578-26-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- as poder
- Duration of treatment / exposure:
- 3min, 60 min
- Duration of post-treatment incubation (if applicable):
- 3min, 60 min
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 41
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 16.3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 4.8
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- The outcome of the study predicted, that the test substance is corrosive to skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Data from OECD 412 study show no adverse effect
Justification for selection of eye irritation endpoint:
mechanical irritation of cornea by stubstance
Effects on eye irritation: irritating
Justification for classification or non-classification
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