Registration Dossier
Registration Dossier
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EC number: 630-330-6 | CAS number: 21715-46-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Remarks:
- KeratinoSens method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Principles of method if other than guideline:
- KeratinoSens method
- GLP compliance:
- not specified
- Type of study:
- other: KeratinoSens method
- Justification for non-LLNA method:
- The test method described in this Test Guideline can be used to support the discrimination between skin sensitisers (i.e. UN GHS Category 1) and non-sensitisers in the context of IATA. The level of reproducibility in predictions that can be expected from the test method is in the order of 85% within and between laboratories. The accuracy (77% -155/201), sensitivity (78% -71/91) and specificity (76% -84/110) of the KeratinoSensTM for discriminating skin sensitisers (i.e. UN GHS Cat. 1) from non-sensitisers when compared to LLNA results were calculated by considering all of the data submitted to EURL ECVAM for evaluation and peer-review of the test method.
Test material
- Reference substance name:
- 6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
- EC Number:
- 630-330-6
- Cas Number:
- 21715-46-8
- Molecular formula:
- C17H18Cl2N2O
- IUPAC Name:
- 6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Details on the study design:
- Keratinocytes test based on the signaling pathway Keap1-Nrf2-ARE coupled to the luciferase reporter gene
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: IC70 (viability)
- Value:
- 18.29
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Imax (induction)
- Value:
- 2.62
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Repetition 1: Imax is higher than 1.5. However, at the EC1.5 concentration (19.59 μg/ml) viability is lower than 70%. The repetition is considered as negative.
Repetition 2: Imax is higher than 1.5. However, at the EC1.5 concentration (24.08 μg/ml) viability is lower than 70%. The repetition is considered as negative.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sensitization is determined accordine OECD 438. Under the retained experimental conditions, the test item should be classified as not sensitizer.
- Executive summary:
Sensitization is determined accordine OECD 438. Under the retained experimental conditions, the test item should be classified as not sensitizer.
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