Document ID: chunk:federal_register_of_legislation:F2013C00288:reg:1:p11
Version: federal_register_of_legislation:F2013C00288
Segment Type: reg
Provision Reference: reg 1 (pt 11/14)
Character Range: 2718275–2721672

carcinogen. US EPA has classified technical penta‑BDE and technical octa‑BDE as Group D—not classifiable.

2.4.2         Review of Available Values/Information
Review of PBDEs, in particular, penta‑BDE and octa‑BDE by NICNAS (2007), indicated there is insufficient information on the carcinogenic potential of these PBDEs, and that the overall conclusion relating to penta‑BDE is that it is not genotoxic. Further review of octa‑BDE, PBDE mixtures and penta‑BDE (JECFA 2006) suggests that PBDE mixtures and individual congeners are not genotoxic. On the basis of the available information, it is considered appropriate that a threshold doseresponse approach be adopted for PBDEs.

The following are available for the lower BDEs from Level 1 Australian and International sources:
Source                Value                                          Basis/Comments
Australian
ADWG (NHMRC 2004)     No evaluation available
OCS (2012)            No evaluation available
NICNAS (2007)         No ADI/TDI established                         Based on review of PBDEs and available studies, the highest toxicity was associated with penta‑BDE associated with neurodevelopmental effects in pups and dams where the LOAELs were 0.8 mg/kg/day in pups and 0.06 mg/kg/day in dams.
FSANZ (2007)          No ADI/TDI established                         Review of dietary intakes considered a margin of exposure (MoE) approach where a threshold value of 0.1 mg/kg/day was considered, based on a review by JECFA.
International
JECFA (2006)          No ADI/TDI established                         Due to the complexity of PBDEs and the lack of adequate data, a provisional maximum tolerable daily intake or provisional tolerable weekly intake has not been derived for PBDEs. Limited data suggests that, for more toxic PBDE congeners, adverse effects would be unlikely to occur in rodents at doses less than approximately 0.1 mg/kg/day.
WHO (2011)            No evaluation available
Health Canada (2006)  No ADI/TDI established                         A threshold value of 0.8 mg/kg/day was identified for penta‑BDE, based on neurobehavioural effects in neonatal mice, considered the critical effects and appropriate for undertaking a MoE approach to the assessment of risk.
ATSDR (2004)          No chronic duration MRLs derived               No chronic duration MRLs have been derived for lower brominated BDEs, due to insufficient data.
                                                                     An intermediate duration oral MRL of 0.007 mg/kg/day has been derived on the basis of a LOAEL of 2 mg/kg/day associated with liver effects in rats exposed to penta‑BDE.
                                                                     An intermediate duration inhalation MRL of 0.006 mg/m3 has been derived based on a NOAEL of 1.1 mg/m3 for thyroid effects in rats exposed to commercial octa‑BDE mixture.
US EPA (IRIS 2012)    RfD = 0.0001 mg/kg/day for penta‑BDE (BDE‑99)  RfD established (in 2008) for BDE‑99 (penta‑BDE) on the basis of a benchmark dose approach and a BMDL1SD of 0.29 mg/kg/day associated with neurobehavioral effects in mice, and an uncertainty factor of 3000.
                                                                     Hexa‑BDE RfD established (in 2008) for BDE‑153 on the basis of a NOAEL of 0.45 mg/kg/day associated with neurobehavioral effects in mice, and an uncertainty