Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.01 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.1 mg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3 810 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.73 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
761 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

NExBTL renewable diesel is not classified as ”Toxic” or ”Harmful” with at least R48 or R60-R64, hence no formal assessment of secondary poisoning is required. However a PNECoral has been derived for the record, which demonstrates no concern with regard to possible secondary poisoning.

Conclusion on classification

According to the CLP regulation Table 4.1.0., a substance is categorized as hazardous for aquatic environment if LC50 > 10 to < 100 mg/l (Chronic Category 3) or if it is lipophilic (log Kow ≥ 4) and not rapidly biodegradable ("Safety net" classification, Chronic Category 4). Since LC50 of all the acute toxicity tests was ≥ 100 mg/l and the test material was found readily biodegradable in OECD CO2 evolution test 301B, the test material is not classified as hazardous to aquatic environment. According to DSD regulation, the test material is not classified as hazardous to aquatic environment either.