Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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