Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation: data waiving
Eye irritation: data waiving

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

No studies of dermal irritation / corrosion have been performed with the substance and none are proposed, based on scientific considerations and for reasons of animal welfare. In accordance with section 8.1, column 2, Annex VII of Regulation (EC) No. 1907/2006, the in-vitro skin irritation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the skin. In accordance with section 8.1.1, column 2, Annex VIII of Regulation (EC) No. 1907/2006, the in-vivo skin irritation study does not need to be conducted as the substance is classified as corrosive to the skin and the substance is a strong base (pH≥11.5).

Eye irritation

No studies on eye irritation have been 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) No. 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 skin. In accordance with section 8.2.1, column 2, Annex VIII of Regulation (EC) No. 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≥11.5).

Justification for classification or non-classification

Skin irritation:

The test substance should be classified as corrosive to the skin by worst case (pH >11.5). Therefore, the in vivo skin irritation was not conducted due to animal welfare. Hence, the substance has to be classified as skin corrosive 1A substance and labelled with H314: Causes severe skin burns and eye damage.

 

Eye irritation:

The test substance is classified as corrosive to the skin by default. 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 was 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 are available and which may be inhaled. This applies for strontium hydroxide.