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:
Migrated from Short description of key information:
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 dichloride 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.

Justification for selection of skin sensitisation endpoint:
reliable GLP guideline study with barium dichloride dihydrate available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
During long-year industrial practice no cases of hypersensitivity were documented till now by workers exposed exclusively to barium chloride. Thus, no classification as respiratory sensitiser according to Regulation (EC) 1272/2008 is required.

Justification for classification or non-classification

Sensitisation:

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 chloride has not being labelled as such.

 

Respiratory sensitisation:

During long-year industrial practice no cases of hypersensitivity were documented till now by workers exposed exclusively to barium chloride. Thus, no classification as respiratory sensitiser according to Regulation (EC) 1272/2008 is required.