Registration Dossier
Registration Dossier
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EC number: 284-219-9 | CAS number: 84812-94-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA study not available and the lead registrant for EC 290-476-8 considered it appropriate to read-across to another similar substance.
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 239-032-7
- EC Name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 14960-06-6
- Molecular formula:
- C18H35NO4.Na
- IUPAC Name:
- Beta-Alanine, N-(2-carboxyethyl)-N-dodecyl-, monosodium salt
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence of sensitisation observed.
- Executive summary:
No evidence of sensitisation observed. Even when considering the absence of key data in the published report, the conclusions made at the time by those undertaking the review are that the substance can be used in dermally applied cosmetic products. Human monitoring is also reported and no evidence of sensitising effects is reported.
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