Registration Dossier

Ecotoxicological information

Ecotoxicological Summary

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.04 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.004 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
29.6 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.96 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.67 mg/kg food
Assessment factor:
300

Additional information

The acute tests on rainbow trout, Daphnia magna and algal were all Static Limit Tests for the low solubility of BDP. The tests were all performed with nominal concentration of the test material of 1.0 mg/L.The results of these tests indicate that the BDP is not toxic to this species up to the limits of its water solubility. Furthermore, two longterm tests on fish and daphnia were conducted repectively in accordance with OECD TG 210 and 211. The results of both tests showed the NOECs were both over 0.4 mg/l, which were also above the water solubility of BDP. According to final decision from ECHA, long-term toxicity test to earthworms were also conducted (OECD TG 222). It was determined the NOECs of mortality and reporductivity for adult earthworm were both above 1000 mg/kg.

Conclusion on classification

The substance is currently classified as Aquatic Chronic Category 4 under the CLP Regulation (EC) No 1272/2008, and R53 under the Directive 67/548/eec.

However, data presented in this dossier are consistent with no classification for the environment being necessary. The fish, Daphnia and algae acute E(L)C50 values all above 1 mg/l, which was above the water solubility of BDP, though there is no evidence of ready degradability in standard tests. In addition no hazard effect was found in the long term toxicity tests to daphnia and fish, even up to the concentration of water solubility limit of BDP (0.4 mg/l). Based on these results available the substance needs not to be classified for the environment since it shows no potential to bioaccumulate and no chronic toxicity effects at the solubility limits of the substance. This is also supported by the proposal for Harmonised Classification and Labelling submitted by the UK CA (HSE) (CLH Report for EC No. 425-220-8, http://echa.europa.eu/consultations/harmonised_cl_en.asp, published on 25-Nov-2011).