Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.5 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
384 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10 mg/kg sediment dw
Assessment factor:
500
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
98 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
222 mg/kg food
Assessment factor:
90

Additional information

DecaBDE has negligible solubility in water (<0.1 ug/L), and minimal partitioning to this media in the environment is predicted. Aquatic organism toxicity is not expected. DecaBDE's database is populated by studies having high no adverse effect levels. For example, the mammalian repeated dose NOAEL is at least 1000 mg/kg bw/d, and terrestrial and sediment studies reported even higher NOAELs. The studies on which these NOAELs are based were performed using the commercial DecaBDE product as test article, and, examined by default, any impurities in the product and metabolites. The high NOAELs indicate the BDE-209 congerner, impurities in the commercial product and/or metabolites are not of concern. These impurities and possible metabolites are captured in the PNEC for secondary poisoning (222 mg/kg food), because the repeated dose NOAEL was used in its calculation.

Conclusion on classification

DecaBDE is not toxic to the aquatic, terrestrial and sediment organisms tested. It has little to no potential for bioaccumulation, and recent work indicates doses above ca. 2 mg/kg bw do not result in higher internal expsoures. Field studies have not indicated a potential to biomagnify. A concern for possible secondary poisoning from metabolites is not justified given the high NOAELs (>=1000 mg/kg) in long term mammalian, terrestrial and sediment-dwelling organisms. Speculation that DecaBDE may be metabolized to toxic substances is not supported by DecaBDE's extensive database, which includes lifetime mammalian studies.