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:

HBCDD did not induce sensitisation in a mouse local lymph node assay or in a guinea pig maximisation study. Both studies were conducted according to international guidelines and GLP using a composite of commercial products from three manufacturers (i.e. Albemarle, Chemtura and ICL-IP). Earlier studies performed in Japan using a test substance of unknown composition reported positive results. These studies were not conducted according to GLP nor current guidelines. For the test substance provided by Albemarle, Chemtura and ICL-IP it can be concluded that HBCDD does not have skin sensitising potential. This was also concluded in the EU Risk Assessment Report (EC, 2008).


Migrated from Short description of key information:
The following information is available for this endpoint:
Guinea pig maximisation: Wenk, M. L. (1996). Maximisation test in Guinea Pigs. Report no.: M96AO61.1X64. Report date: 1996-11-08.

Mouse local lymph node assay: Woolhiser, M. R. and Anderson, P. K. (2003). Hexabromocyclododecane: Contact sensitisation potential via the local lymph node assay (including a primary irritancy screen) using CBA/J mice. Report no.: 031013. Report date: 2003-07-14.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No information was available for respiratory sensitisation. As HBCDD is not a skin sensitiser and no cases of respiratory sensitisation have been reported in the literature, the substance is unlikely to have respiratory sensitisation potential.


Migrated from Short description of key information:
No information was available for respiratory sensitisation. As the substance is not skin sensitising and no cases of respiratory sensitisation have been reported in the literature, HBCDD is unlikely to have a respiratory sensitisation potential.

Justification for classification or non-classification

Based upon the results of the key study (Woolhiser and Anderson, 2003), HBCDD does not meet the criteria for classification according to 67/548/EEC and EC Regulation 1272/2008.