Registration Dossier

Administrative data

Description of key information

According to the data requirements as laid out in Column 2, Section 8.9.1, Annex X of regulation (EC) 1907/2006 a carcinogenicity study may be considered in case (a) the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and (b) 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 preneoplastic lesions. Since none of the afore mentioned criteria are fulfilled for pentavalent antimony compounds such as sodium hexahydroxoantimonate, sodium andimonate and antimony pentoxide, and a 90-day repeated dose toxicity study via oral application with sodium hexahydroxoantimonate showed no evidence of induction of  hyperplasia and/or preneoplastic lesions up to the limit dose of 1000 mg/kg/d (Hansen, 2013), testing for carcinogenicity for this substance is waived.

Key value for chemical safety assessment

Justification for classification or non-classification

Additional information