Registration Dossier

Toxicological information

Endpoint summary

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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 recomended by REACH now, but the existing data provided sufficient and valid results to make a reliable predication .Moreover,the laboratory facilities which complying with OECD Principles of Good Laboratory Practice were utilized in order to ensure the consistency and reliability for the tests.

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


Migrated from Short description of key information:
The BDP was non-sensitising to the skin of guinea pigs.(OECD TG 406)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Respiratory sensitisation test was not conducted.

Migrated from Short description of key information:
Respiratory sensitisation test was not conducted.

Justification for classification or non-classification

According to the existing studies on acute skin sensitisation test in laboratory animals, which provide sound conclusive evidence that the

substance (CAS:5945-33-5 ) was considered as a non-skin sensitizer.