Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-404-7 | CAS number: 106-50-3
Carcinogenicity
Administrative data
Description of key information
Dermal: Mice were exposed dermally to the test substance at 0, 5, or 10%, 2 times per week, for 135 weeks. No tumours were observed.
Key value for chemical safety assessment
Justification for classification or non-classification
No carcinogenicity was observed in a 135 -wk bioassay in mice when tested with the test substance via dermal exposure (primary exposure route). The substance does not need to be classified for carcinogenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Additional information
In accordance with ECHA guidance R.7a, where it is stated that carcinogenicity data should be obtained with the actual route of exposure, information from a dermal toxity study was included as key information.
Female mice (50/group) were exposed dermally on the interscapular skin to 0.2 mL of the test substance 2 times/week for 135 weeks. In addition, 100 mice were not treated and served as controls, and 40 mice were treated with DMBA and served as positive controls. Mice were checked weekly, and lesions and tumours were recorded. In addition, a complete necropsy was performed, and skin, grossly observed tumours, and lesions of the lung, liver, and kidney were studied histologically. No treatment-related effects were observed in body weight, clinical signs, food consumption, or mortality. No treatment-related epidermal hyperplasia, ulcerations, dermatitis, or tumours was observed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
