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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

short-term repeated dose toxicity: oral
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.
Waiving of animal testing requirements for human health endpoints is proposed, since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion