Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 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:
0.005 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Five ecotoxicology relevant studies were conducted for Biphenyl-4,4'-diol. The lowest determined endpoint was based the daphnia reproduction test that provided a NOEC of 0.108 mg/L. Suitable assessment factor have been applied for calculating PNECs for freshwater, marinewater and STPs. PNECs for freshwater sediment, marine sediment, and soil have been calculated using equilibrium partitioning for the purpose of completeness.

Conclusion on classification

CLP:

The substance is rapidly degradable and does not bioaccumulate (log Pow < 4).

The substance is not classified for acute aquatic toxicity since all EC50 are > 1 mg/L.

There a long term toxicity test was carried out on Daphnia and the NOEC was 0.108 mg/L. Chronic toxicity was assigned based on the NOEC and the fact that the substance is rapidly degradable. Chronic toxicity category 3 was assigned.

 

DSD:

The substance is not readily degradable and does not bioaccumulate (log Pow < 3).

The LC50 for Daphnia (lowest LC50) is 1.76 mg/L.

R51/53 was therefore assigned.

The lowest acute EC50value was 1.76 mg/L for the aquatic invertebrate Daphnia magna and therefore the EC50is between 1 and <10 mg/L, based on acute exposure the acute hazard classification of toxic (R51) should be allocated. Based on the results of the chronic Daphnia reproduction test the EC50was considered to be 0.390 mg/L, biphenyl-4,4'-diol was not readily biodegradable during testing and therefore the long term classification of R53 should be allocated.