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:

No skin sensitization data of sufficient quality are available for tungsten blue oxide (target substance). However, skin sensitization data are available for tungsten trioxide (source substance), which will be used for read-across. Due to similar water solubility, in vitro bioaccessibility in synthetic sweat fluid simulating dermal exposure, and available toxicity data for the target and source substances, the resulting toxicity potential would also be expected to be similar, so read-across is appropriate between these substances. In addition, read-across is appropriate for this endpoint because the classification and labelling is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar or more conservative for the target substance. For more details, refer to the attached description of the read-across approach.

Migrated from Short description of key information:

No skin sensitization data of sufficient quality are available for tungsten blue oxide. However, data are available for tungsten trioxide, which will be used for read-across. In a skin sensitization study conducted on guinea pigs and according to OECD 406, tungsten trioxide was deemed to be not sensitising.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

Although no study data specifically evaluating the potential respiratory sensitisation effects are available, based on the lack of human case reports indicating that tungsten blue oxide is a respiratory sensitiser, as well as negative responses observed in both the skin sensitisation and skin irritation animal studies, tungsten blue oxide is not likely to be a respiratory sensitiser

Justification for classification or non-classification

No skin sensitization data of sufficient quality are available for tungsten blue oxide. However, a skin sensitization test of sufficient quality and tested in accordance with standard methodology was available for tungsten trioxide. The results of this study showed that tungsten trioxide did not cause skin sensitization in Guinea Pigs. Therefore, based on read-across, no classification is required for the skin sensitization endpoint for tungsten blue oxide. No respiratory sensitization study is available for tungsten blue oxide. Therefore, classification cannot be made due to lack of data. However, this endpoint is not required for REACH registration.