Registration Dossier

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:

Upon dissolution in aqueous media at physiologically relevant concentrations and pH conditions, the only aqueous antimony species emerging from all considered trivalent antimony substances is the trivalent antimony cation. In vitro bioaccessibility testing in various artificial body fluids (Hedberg et al., 2010) has shown that diantimony tris(ethylene glycolate) compared to diantimony trioxide has a lower release rate of antimony ions, thus read-across warrants an intrinsic conservatism.

With respect to systemic toxicity, read-across from diantimony trioxide toward diantimony tris(ethylene glycolate) is justified.

Please also refer to the study results presented in section 4.8 and 7.1.1 of the technical dossier (IUCLID) and in section 1.3 and 5.1.1 of the CSR.

The following conclusions can be drawn for diantimony trioxide and by read across, also for diantimony tris(ethylene glycolate):

There is a complete absence of any human studies of adequate quality that can be used for assessing the sensitising potential of diantimony trioxide. However, there is one reliable animal study (Chevalier, 2005), performed according to TG 406 and GLP, which shows that diantimony trioxide has no sensitising properties.

Migrated from Short description of key information:

Diantimony trioxide is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:

Key study

Respiratory sensitisation

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

Based on an industry survey, during many years of industrial practice no cases of hypersensitivity were observed till now by workers exposed exclusively to diantimony trioxide or diantimony tris(ethylene glycolate).

Migrated from Short description of key information:

Diantimony trioxide is not a respiratory sensitiser.

Justification for classification or non-classification

Sensitisation:

 

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

 

Moore, G.E.(1994) – Buehler method in guinea pigs

The incidence of sensitisation after the challenge application was 0/20. Thus, the classification criteria according 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 many years of industrial practice no cases of hypersensitivity were observed till now by workers exposed exclusively to diantimony trioxide. Thus, no classification as respiratory sensitiser according to regulation (EC) 1272/2008 is required.