Registration Dossier

Diss Factsheets

Administrative data

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:
Physicochemical features of a substance likely influence its absorption rate. Test substance is expected to have a low potential for skin absorption due to:
- physical state, i.e. dry particulates
- high molecular weight, i.e above 300 au
- high water solubility and low logPow, i.e above 10 g/l and below -1 respectively, indicating that the substance may be too hydrophilic to cross the lipid-rich environment of the stratum corneum and penetrate to the epidermis.
On these bases, a low potential for dermal uptake is expected.

Moreover, an experimental study in vitro (oecd 428) reported in (1) may be considered as a qualitative indication of low permeation through the skin.

Moreover, in acute toxicity study by oral route, where higher absorption is expected, test item showed a very low toxicity with LD50 > 8000 mg/kg bw. Based on this result, dermal route was considered as not toxicologically relevant and it was not investigated.

(1) Opinion of the scientif committee on cosmetic products and non-food products intended for consumers concerning Acid Red 18 - COLIPA no. 175, SCCNFP/0792/04

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion