Registration Dossier

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)

Respiratory sensitisation

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

Justification for classification or non-classification

Sensitisation:

The reference Stitzinger (2010) 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 (1.2 – 1.5) were observed at all test concentrations of barium chloride dihydrate (5, 10, 25 %) and no dose response could be observed. 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 and barium sulfate should not be labelled as such.

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 barium sulphate. Thus, no classification as respiratory sensitiser according to regulation (EC) 1272/2008 is required.