Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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