Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Attached to this record is provided a statement in which the registrant declares the sole cosmetic use of this substance.
Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009) establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the EU finished cosmetic products and ingredients included in cosmetic products which were tested on animals for cosmetics purposes (marketing ban). A testing ban on finished cosmetic products applies since 11 September 2004; a testing ban on cosmetic ingredients or combination of ingredients applies since 11 March 2009. A marketing ban for products containing ingredients tested outside the EU applies since 11 March 2013, irrespective of the availability of alternative non-animal tests. In general terms, the provisions of the REACH apply to substances and preparations used in cosmetic products. However, REACH shall apply without prejudice to the CR as regards testing involving vertebrate animals within the scope of the CR (Article 2/4/b). Moreover, the above statement is confirmed by ECHA in the “Interface between REACH and Cosmetics regulations 2014a” factsheet (ECHA-14-FS-04-EN). Knowing that the test substance is only and exclusively used in the formulation for cosmetic purposes, no animal testing is possible toassess the acute oral toxicity endpoint, and therefore this in vivo study is not conducted.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion