Registration Dossier

Administrative data

Description of key information

No data are available for carcinogenicity; however, testing is not considered necessary because:
• The substance does not have a wide-dispersive use (see Section 9 for further details);
• The substance is not classified for mutagenicity; and
• There is no evidence from the repeated dose studies that the substance is able to induce pre-neoplastic lesions. The key repeated dose inhalation study showed signs of minimal/mild hyperplasia in the bladder; however, these are not considered to be adverse (see discussion in Section 5.6). There is no evidence for genotoxicity of (3-chloropropyl)trimethoxy silane. Therefore, even if the hyperplastic changes are real (which is not known because it is not known whether the urinary bladder was inflated with fixative before examination), it is highly unlikely that the minimal/mild proliferative changes of the bladder are caused by a urinary bladder genotoxic carcinogen.

Key value for chemical safety assessment

Justification for classification or non-classification

Additional information