Registration Dossier
Registration Dossier
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EC number: 263-196-9 | CAS number: 61791-64-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422E (Dentritic Cell Line Activation: h-CLAT)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Two out of three from Direct Peptide Reactivity Assay (DPRA), ARE-Nrf2 Luciferase test method and Dentritic Cell Line Activation (hCLAT)
Test material
- Reference substance name:
- Amines, N-coco alkyltrimethylenedi-, acetates
- EC Number:
- 263-196-9
- EC Name:
- Amines, N-coco alkyltrimethylenedi-, acetates
- Cas Number:
- 61791-64-8
- Molecular formula:
- H17-37C8-18NH(CH2)3NH2. (H3CCOOH)2
- IUPAC Name:
- Amines, N-coco alkyltrimethylenedi-, acetates
- Test material form:
- solid
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Run / experiment:
- other:
- Remarks on result:
- other: investigation is ongoing (the results of two concordant studies will determine the overall prediction)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Investigation of skin sensitisation in vitro is ongoing. The results of two concordant studies will determine the overall prediction and, the substance is classified for skin sensitisation as a precaution until results become available. This decision was made because consideration of an analogue substance as a cosmetic ingredient concluded that sensitisation was likely following occupational exposure.
- Executive summary:
Investigation of skin sensitisation in vitro is ongoing. The results of two concordant studies will determine the overall prediction and, the substance is classified for skin sensitisation as a precaution until results become available. This decision was made because consideration of an analogue substance as a cosmetic ingredient concluded that sensitisation was likely following occupational exposure.
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