Registration Dossier
Registration Dossier
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EC number: 215-686-9 | CAS number: 1344-08-7
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
The substance is not classified as mutagenic and there is no evidence from RA repeated dose studies that it is able to induce hyperplasia and/or pre-neoplastic lesion and thus do not need to be classified.
Additional information
In REACH Annex X column II it is stated: “A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
– the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and
– the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.”
The substance is not classified as mutagenic and there is no evidence from RA repeated dose studies that it is able to induce hyperplasia and/or pre-neoplastic lesions. Therefore performing a carcinogenicity study is not justified.
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.
