Registration Dossier
Registration Dossier
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EC number: 701-354-5 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Remarks:
- Waiving
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- β-Alanine, N-(2-carboxyethyl)-N-[3-[(2-carboxyethyl)amino]propyl]-, N-C12-18-alkyl derivs., trisodium salt is being tested in an oral OECD422 study and the ECHA guidelines allow the calculation of a dermal DNEL based on the oral NOAEL. It assumes the same absorption dermally and orally, when it is most likely that dermal absorption will be less than oral due to its high water solubility. Therefore calculating the Dermal DNELS based on the Oral NOAEL is a conservative approach, that will ensure adequate protect form dermal exposure. Therefore it is not scientifically justified to do an additional repeat dose dermal study in animals.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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