Registration Dossier
Registration Dossier
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EC number: 266-235-8 | CAS number: 66204-44-2
Carcinogenicity
Administrative data
Description of key information
No data are available on carcinogenicity of the substance. A long-term carcinogenicity study on the substance is lacking but data are available on subchronic toxicity (only local effects at the site of 1st contact) and mutagenic effects (mutagenic in vitro but no systemic mutagenic effects in vivo) of the substance. Due to the supposed hydrolysis of the substance within the body fluids, all long-term effects and also carcinogenic effects are assumed to be related to the products of hydrolysis.
Key value for chemical safety assessment
Justification for classification or non-classification
So far no labelling exist for the substance because the content of free formaldehyde is <1%; use concentrations were hydrolysis will occur are low and released formaldehyde is assumed to be again <1%.
Additional information
No long-term carcinogenity study on experimental animals is available for the substance. However, the compound is assumed to hydrolyse rapidly within the body. Effects for hydrolysis products in adequate dilutions are supposed. As the database for formaldehyde is good no test for carcinogenicity is required. Assuming that the discussed mutagenic effects of the reaction product are based on formaldehyde no tumour formation is expected at non-irritant concentrations.
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.
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