Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.28 mg/L
Assessment factor:
1 000
PNEC freshwater (intermittent releases):
2.8 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.028 mg/L
Assessment factor:
10 000

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: screening tests: 9.51% (CO2 evolution) after 28 days (EPA OTS 796.3260)

Log Pow: 0.444 (EU method A.8)

 

Acute toxicity

- to fish: LC50 (96 h) = 1140 mg/L, Lepomis macrochirus (OECD 203)

- to invertebrates (crustacea): EC50 (48 h) = 290 mg/L, Daphnia magna (OECD 202, EU Method C.2)

- to algae: ErC50 (96 h) = 280 mg/L, Pseudokirchneriella subcapitata (OECD 201, EU Method C.3)

 

Chronic toxicity:

- to fish: not available

- to invertebrates: not available

- to algae: NOEC (96 h) = 75 mg/L, Pseudokirchneriella subcapitata (OECD 201, EU Method C.3)

 

Classification justification according to CLP

Based on the data above, NPBT is considered to be not rapidly biodegradable. The acute aquatic toxicity values, L(E)C50, are > 100 mg/L for fish, invertebrates and algae. Valid chronic toxicity data is available for algae with a NOEC > 10 mg/L. Therefore, NPBT does not need to be classified and labelled as environmental hazard according to the regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Classification justification according to DSD

Based on the data above, NPBT is considered to have low potential for bioaccumulation but is not rapidly biodegradable. The acute aquatic toxicity L(E)C50 is > 100 mg/L for fish, invertebrates and algae. The available aquatic chronic data on algae is > 10 mg/L. Therefore the substance does not need to be classified and labelled as environmental hazard according to the Directive 67/548/EEC.