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:

According to OECD TG 406, Maximisation test of Magnusson and Kligman was accomplished and concluded that test material did not induce skin sensitisation in guinea pigs (Driscoll, 1997). Although the GPMT was not recommended by REACH now, the existing data provided sufficient and valid results to make a reliable predication.

This study was utilized as a key study in substance sensitisation evaluation due to the high adequacy, reliability and relevance to this endpoint. Therefore, no further in vivo testing is needed for hazard identification such as LLNA due to animal welfare reasons.

The following information is taken into account for any hazard / risk assessment:

The BDP was non-sensitising to the skin of guinea pigs. (OECD TG 406)


Migrated from Short description of key information:
non-sensitising

Respiratory sensitisation

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

Respiratory sensitisation

Respiratory sensitisation test was not conducted.

The following information is taken into account for any hazard / risk assessment:

Respiratory sensitisation test was not conducted.

clusive evidence that BDP was considered as a non-skin sensitizer.


Migrated from Short description of key information:
Respiratory sensitisation
Respiratory sensitisation test was not conducted.
The following information is taken into account for any hazard / risk assessment:
Respiratory sensitisation test was not conducted.
Justification for classification or non classification
According to the existing results on acute skin sensitisation test in laboratory animals, there is conclusive evidence that BDP was considered as a non-skin sensitizer.

Justification for classification or non-classification

According to the existingresults on acute skin sensitisation test in laboratory animals,thereis conclusive evidence that BDP was considered as a non-skin sensitizer.