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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Skin sensitisation testing was conducted with diantimony pentoxide.

Based on the fact that diantimony pentoxide, sodium hexahydroxoantimonate and sodium antimonate all contain antimony in the pentavalent oxidation state and that the bioaccessibility data in five different artificial body fluids as reported under section 7.1 Basic toxicokinetics show a similar dissolution pattern, read-across among the pentavalent antimony compounds (i.e. sodium hexahydroxoantimonate, sodium antimonate and diantimony pentoxide) is considered justified.

Migrated from Short description of key information:

The Local lymph Node Assay demonstrated that EFR-6N (Diantimony pentoxide) does not have a potential to cause skin sensitisation (see 5.5.3).

Justification for selection of skin sensitisation endpoint:

Key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Justification for selection of respiratory sensitisation endpoint:

Based on an industry survey, during long-year industrial practice no cases of hypersensitivity were observed till now by workers exposed exclusively to sodium hexahydroxoantimonate, sodium antimonate and antimony pentoxide.

Justification for classification or non-classification

Sensitisation:

The reference Robertson (2005) is considered as the key study on skin sensitisation and will be used for classification. The overall sensitisation results are as follows:

Local lymph node assay (LLNA) in mice

SIs of less than 3.0 were observed at all test concentrations of diantimony pentoxide (2.5, 5, 10 %). Therefore, an EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of the study was not calculable. Thus, the classification criteria acc. to regulation (EC) 1272/2008 as skin sensitizer are not met since 0% of the test animals responded.

 

Respiratory sensitisation:

Based on an industry survey, during long-year industrial practice no cases of hypersensitivity were observed till now by workers exposed exclusively to sodium hexahydroxoantimonate, sodium antimonate or antimony pentoxide . Thus, no classification as respiratory sensitiser according to regulation (EC) 1272/2008 is required.

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