Registration Dossier

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

In conclusion, based on the available data,1,3-dioxepane is not classified regarding carcinogenicity according to Directive 67/548/EC (DSD) and Regulation (EC) No 1272/2008 (GHS, CLP).

Additional information

No carcinogenicity study is available for 1,3-dioxepane.

In accordance with column 2 of REACH Annex X, a carcinogenicity study (required in section 8.9.1) does not need to be conducted as1,3-dioxepane is not classified as mutagen category 3. There is no evidence from the repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.