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Toxicological information


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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.