Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity testing was conducted with sodium hexahydroxoantimonate.

Based on the fact that diantimony pentoxide, sodium hexahydroxoantimonate and sodium antimonate contain antimony in the pentavalent oxidation state and that water solubility testing as well as transformation dissolution testing has shown similar dissolution pattern of pentavalent antimony cations form all three substances, read-across among the pentavalent antimony compounds (i.e. sodium hexahydroxoantimonate, sodium antimonate and diantimony pentoxide) is considered justified.

Short description of key information:

Sodium hexahydroxoantimonate did not induce an increase in mutation frequency in bacteria, micronuclei in cultured human lymphocytes and gene mutation in the tk locus of the L5178Y mouse lymphoma cell line. Therefore pentavalent antimony compounds such as sodium hexahydroxoantimonate, sodium antimonate and antimony pentoxide are considered as non-clastogenic and non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The references Stone (2010) and Whitwell (2010) are considered as the key studies for in vitro mammalian genetic toxicity and the reference Spruth (2015) as the key study for bacterial reverse mutation. All key studies will be used for classification purposes. The overall results are as follows:

Sodium hexahydroxoantimonate did not show an increase in the mutation frequency in the bacterial reverse mutation assay when tested up to the maximum concentration of 5000 µg/plate following the pre-incubation an plate incorporation protocol in the presence and absence of metabolic activation.

Sodium hexahydroxoantimonate did not show a significant or dose-dependent increase in micronuclei in cultured human lymphocytes up to the maximum dose of 540 µg/mL.

Sodium hexahydroxoantimonate did not show a significant or dose-dependent increase in mutations in cultured mouse lymphoma cells (L5178Y) up to the maximum dose of 570 µg/mL.

The classification criteria according to regulation (EC) 1272/2008 as germ cell mutagen are also not met.

Further testing of in vivo genetic toxicity tests for

pentavalent antimony compounds such as sodium hexahydroxoantimonate, sodium antimonate and antimony pentoxide

is not considered necessary.