Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

HBCDD was negative for the induction of mutagenicity in the Ames test (with and without activation), in in vitro genotoxicity assays in mammalian cells and in in vitro chromosome aberration and in vivo mouse micronucleus tests. The tests were conducted according to standardised guidelines and GLP. One study (Helleday et al., 1999) using an invalidated method of unknown applicability and assigned a reliability score of 4 reported a positive result (the test substance resulted in a 1.9 fold recombinogenic response in SPD8 assay compared to the control). However, the effects were small compared to known recombinogenic agents and the biological significance of the effects with regard to the in vivo situation remains unclear.


Short description of key information:
Multiple Ames tests, in vitro Chromosome Aberration, in vivo Mouse Micronucleus:

Gudi, R. and Schadly, E. H. (1996). Chromosome aberrations in human peripheral blood lymphocytes. Report no.: G96AO61.342. Report date: 1996-11-12.

Pinto, M. (1990). FR-1206: Assessment of mutagenic potential in histidine auxotrophs of Salmonella typhimurium (The AMES test). Report no.: DSB/128/1206. Report date: 1990-05-28.

Engelhardt G. and Hoffman H. (2000). Cytogenetic Study In-Vivo with Hexabromocyclododecane in the mouse micronucleus test after two intraperitoneal administrations. Report no.: 26M0100/004018. Report date: 2000-11-07.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

HBCCD was negative for mutagenicity in the Ames, in vitro chromosome abberation, in vitro mouse lymphoma and in vivo mouse micronucleus studies. Therefore the substance does not meet the criteria for classification according to 67/548/EEC and EC Regulation 1272/2008.