Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Dermal absorption is unlikely because of the poor lipophilicity of L-4-hydroxyproline. It suggests that the substance is not likely to cross the stratum corneum. Moreover, the low volatility in combination with the high water solubility and the negative Log P value indicate that the substance may be too hydrophilic to cross the lipid rich stratum corneum and thus dermal uptake will be unlikely.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion