Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 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
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.25 mg/L
Assessment factor:
100

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNECfreshwateris derived from three chronic toxicity data: two calculated NOEC values (fish, daphnid) and a measured 72- ErC10 for algae. For deriving PNEC, the EC10 of algae is preferred over NOEC and growth rate is preferred over biomass (REACH guidances R10 and R7b). The PNEC is based on the data presented in table 1.

Endpoint

Value (mg/l)

Source

Water solubility

101

measured

Algae 72h-ErC10

7.05

OECD 201 growth rate

Fish NOEC

0.15

Ecosar v1.1

Daphnid NOEC

2

Ecosar v1.1

Table 1 Parameter values used for derivation of PNEC

When three chronic values are available, an assessment factor of 10 may be used. However the value for the most sensitive species (fish) is an estimated value. As a safe approach, an assessment factor of 50 is applied to this lowest NOEC value of 0.153 mg/l. The resulting PNECfreshwateris 3 µg/l.

Conclusion on classification

Bis(2-butoxyethyl) adipate is not classified for the aquatic environment. The acute toxicity is above 1 mg/l, the substance is readily biodegradable and the log Pow is below 4. The NOEC values for fish, Daphna and algae are above 0.1 mg/l.