Registration Dossier
Registration Dossier
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EC number: 946-856-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26/03/2018 to 30/04/2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- February, 04th, 2015
- Principles of method if other than guideline:
- The test item absorbs in the same wavelength as the MTT range. In order to assess a possible interference, control on the test item range of dilution was carried out under the same conditions as the test but the MTT was not added to the culture well.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Details on the study design:
- The test consists in evaluating the activation of AKR1C2 in transformed keratinocytes (KeratinoSens™), by monitoring the induction of the luciferase gene fused to AKR1C2. The luciferase produced by the cells complexes with luciferin which, in the presence of ATP, produces light measured in relative light units (RLU).
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: two
- Parameter:
- other: Induction
- Remarks:
- of luciferase activity
- Value:
- 2.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the retained experimental conditions the test item may be classified as potential skin sensitizer.
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