Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.269 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:
0.528 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
16.7 mg/kg food
Assessment factor:
30

Additional information

Conclusion on classification

The classification of biphenyl is harmonized both according to the the CLP and the DSD regulation. In Annex I of the Dangerous Substance Directive 67/548/EC, biphenyl is classified as N, R50/53. In Annex VI of the CLP Regulation (EC) 1272/2008, biphenyl is classified as H410 (Aquatic Chronic 1) and also receives the GHS09 pictogram for environmental hazards.

This harmonized classification is in accordance with the experimental test results provided in this dossier. The lowest acute E/LC50 was a 48-h LC50 of 0.36 mg/L for the aquatic invertebrate Daphnia magna, which is below 1 mg/L, resulting in the R50 classification under the DSD and the redundant classification as H400 (Aquatic Acute 1) under the CLP regulation. The classification as R50/53 under the DSD regulation is based on the fact that, additionally, the substance has a log Kow >= 3 (and the experimentally derived BCF is not <= 100 L/kg). The classification as H410 under the CLP regulation is based on the fact that, additionally, the substance has a log Kow >= 4 and a BCF >= 500 L/kg. The key log Kow value for biphenyl used in the CSA is 4.008 at 25° and the key experimentally derived BCF is 1900 L/kg, which are both above the thresholds proposed by both the DSD and the CLP regulation.