Registration Dossier

Administrative data

Description of key 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.

 

Sodium hexahydroxoantimonate is not eye irritating in vivo and not skin irritating in vivo.

An acute inhalation toxicity test with extended observation (i.e. 14 days post exposure) did not reveal any respiratory irritation (please refer to the endpoint study record for acute inhalation toxicity).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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 irritation 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.

Justification for selection of skin irritation / corrosion endpoint:

Key study

Justification for selection of eye irritation endpoint:

Key study

Justification for classification or non-classification

Skin irritation:

Reference Robertson (2005) is considered as the key studies for skin irritation and will be used for classification. The overall irritation results are as follows:

erythema, 0-72h after application: mean score=0.0

oedema, 0-72h after application: mean score=0.0

The classification criteria according to regulation (EC) 1272/2008 as irritating to skin are not met since the mean erythema and oedema score after 24, 48 and 72h was 0.0, hence no classification required.

 

Eye irritation:

Reference Leuschner(2009) is considered as the key study for eye irritation and will be used for classification. The overall irritation results are as follows:

Corneal opacity, iritis, conjunctival redness and conjunctival oedema, 24, 48 and 72h after application: mean score=0.0

The classification criteria according to regulation (EC) 1272/2008 as irritating to eyes are not met since the mean score after 24, 48 and 72h was 0.0, hence no classification required.

 

Respiratory irritation:

The justification for non classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure as given in the acute toxicity section.

No data on the respiratory irritation after repeated exposure are available. However, due to the fact that in an acute inhalation toxicity testing at the limit dose of 5.4mg/L no relevant pulmonary changes were observed in the 5 localisations of the lung neither in the rats sacrificed 14 days after exposure nor the rats sacrificed 24 hours after exposure one may safely assume that sodium hexahydroxoantimonate, sodium antimonate and antimony pentoxide are void of any irritating potential towards the respiratory tract.