Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Terrestrial bioaccumulation is not expected based on the rat ADME study, negligible water and organic solvent solubility of the substance, high binding to particulates, and an in vitro study showing negligible solubility in cell culture media. Substances must first be in solution to be absorbed, and EBPs low solubility will limit its uptake. Particulate binding reduces bioavailability. Rat oral pharmacokinetic studies using 14C-EBP demonstrated elimination in the feces as the parent molecule and background levels of radioactivity in the blood, plasma, bile, tissues and urine. EBP's solubility in octanol is <0.002 mM x MW, which according to REACH Guidance, indicates a low potential for bioaccumulation.

Guerra et al. (2012) did not detect EBP in 13 peregrine falcon eggs collected in Spain from 2003 to 2006. McKinney et al. (2011)did not detect EBP in adipose of polar bears collected in East Greenland and Svalbard between 2005 – 2008.  Tlustos et al. (2010)reported decabromodiphenylethane was not detected in milk, eggs, fat and liver samples sampled in Ireland by the Food Safety Authority of Ireland. Analyses were performed by the Food and Environment Research Agency, York, UK. A total of 100 composite samples were prepared after collection of individual sub-samples at the production or processing stage. These included 30 milk samples, 20 egg samples, 38 samples of carcass fat taken from beef cattle, pigs, lambs, chickens and ducks, and 12 samples of liver (bovine, porcine, ovine, equine and avian). Samples were supplied by officers of the Department of Agriculture, Fisheries and Food at production level (slaughterhouse – fat and liver, farm/dairy tanker – milk, packing station – eggs. Analysis was via GC-HRMS using 13C-labelled surrogates.   The authors noted that a recent survey in the UK had also not detected the substance. 

Recent monitoring results from European studies in birds, eggs and fish muscle and liver were reviewed in the exposure assessment report (Fisk et al, 2019) attached to this dossier. Levels were either below detection or quantification limit or in the pg/g range.

In addition to birds’ eggs and fish muscle and liver, data are also available for shellfish at the local marine scale (<0.84 pg/g ww - 20.1 pg/g ww and 29 ± 50 pg/g), zebra mussel and zooplankton (both <LOD) at the local scale, and bird liver (<0.025 ng/g ww), seal blubber

(<0.12 - 0.30 ng/g ww, more than 80% < MDL) and polar bear adipose tissue (<0.13 ng/g ww) at the continental background scale. Data are also reported for tree bark (<LOD – 3.9 ng/g lipid) weight, or 0.13 ng/g using reported lipid %). As for the previous Nordic data, all concentrations reported in recent literature were either <LOD or in the range of pg/g.

Al these data do not indicate that EBP is not biomagnifying in environmental species and support the findings that it is not bioaccumulative.

References

Guerra et al. 2012. Emerging and historical brominated flame retardant in peregrine falcon (Falco peregrinus) eggs from Canada and Spain. Environment International 40:179-186.

McKinney et al. 2012. Flame retardants and legacy contaminants in polar bears from Alaska, Canada, East Greenland and Svalbard, 2005-2008. Environment International 37:365-374.

Tlustos et al. 2010. The emerging BFRs – hexabromobenzene (HBB), bis(246-tribromophenoxy)ethane (BTBPE) and decabromodiphenylethane (DBDPE) – in Irish foods. Organohalogen Compounds 72:1577-1579. 

Fernandes et al. 2010. The emerging BFRs – hexabromobenzene (HBB), bis(246-tribromophenoxy)ethane (BTBPE) and decabromodiphenylethane (DBDPE) – in UK and Irish foods. BFR Conference Kyoto, Japan.