Registration Dossier

Diss Factsheets

Administrative data

Description of key information

An in vitro skin irritation study (EpiSkinTM) and an in vitro skin corrosion study (OECD 431) were performed with the substance, which indicated that the test substance is corrosive to the skin. Eye corrosion is assumed due to worst case consideration based on pH (pH 13.0; 1% solution) and skin corrosion result.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

An in vitro skin irritation and an in vitro skin irritation study were conducted with barium sulfide. Both studies are fully valid and stand alone studies to cover the endpoint on skin irritation. No in vivo study is required.

Eye irritation

No studies on eye irritation were performed with the substance and none are proposed, based on scientific considerations and for reasons of animal welfare. In accordance with section 8.2, column 2, Annex VII of regulation (EC) 1907/2006), the in-vitro eye irritation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the eyes. In accordance with section 8.2.1, column 2, Annex VIII of regulation (EC) 1907/2006), the in-vivo eye irritation study does not need to be conducted as the substance is classified as corrosive to the skin and it is provided that the registrant classified the substance as eye irritant. Furthermore, the substance is a strong base (pH 13.0; 1% solution).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation:

The study by Heppenheimer (2010) is an in vitro skin corrosion study in accordance with OECD 431, is considered the key study for skin corrosion, and will be used for classification.

The classification criteria according to regulation (EC) 1272/2008 as corrosive to skin are met since the mean viability after a treatment period of 60 min decreased to 12.5% (threshold 15%), hence classification as corrosive to skin is required. Barium sulfide has to be classified as skin corr. 1A and labelled with H314: Causes severe skin burns and eye damage.

 

Eye irritation:

The test substance is corrosive to skin which was confirmed by an in vitro skin corrosion study. Therefore, the in vivo eye irritation was not conducted due to animal welfare. Hence, the substance has to be classified as eye damage 1 and labelled with H318: Causes serious eye damage which is already covered by the labelling H314: Causes severe skin burns and eye damage

Respiratory irritation:

The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. For substances and mixtures classified as skin corrosive, the additional labelling EUH071: Corrosive to the respiratory tract should be used due to the fact that no acute inhalation test data is available.