Registration Dossier
Registration Dossier
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EC number: 273-535-2 | CAS number: 68988-63-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 July 2020 - 30 July 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Specific details on test material used for the study:
- ColaTeric CNA-40 batch/lot # 7752OI19 (31.5% active in aqueous solutions)
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- Positive control:
- cinnamic aldehyde
- Positive control results:
- Pass
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean lysine depletion
- Value:
- 0.643 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean cystein depletion
- Value:
- 1.79 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Outcome of the prediction model:
- no or minimal reactivity [in chemico]
- Conclusions:
- The test item was classified as negative with no or minimal reactivity.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 July 2020 - 23 July 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
- Specific details on test material used for the study:
- ColaTeric CNA-40 batch/lot # 7752OI19 (31.5% active in aqueous solution)
- Negative control:
- other: DMSO
- Positive control:
- cinnamic aldehyde [442D]
- Positive control results:
- > 1.5 fold in at least one concentration. Pass (3/5).
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- EC 1.5 [442D]
- Value:
- 23.813 µM
- Cell viability:
- < 1.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Conclusions:
- ColaTeric CNA-40 was classified as Negative according to the KeratinoSens prediction model.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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