Registration Dossier
Registration Dossier
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EC number: 271-766-3 | CAS number: 68607-67-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 mins - 42 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study to GLP, 2017
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Schiff bases, C11-14-tert-alkyl methylene
- EC Number:
- 271-766-3
- EC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Cas Number:
- 68607-67-0
- Molecular formula:
- C14H29N
- IUPAC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot number HMK/370/12/1
Storage conditions Room temperature (15 – 25°C)
Purity/Assay Active >98%
Appearance Straw to Yellow Clear Bright Liquid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 μL undiluted liquid
- Duration of treatment / exposure:
- 15 minutes exposure
- Duration of post-treatment incubation (if applicable):
- 42 hours followed by MTT exposure of 3 hours.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- > 9.2 - < 10.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Positive control was in the range of 8.2 - 14.3 and considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Considered irritting to the skin.
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