Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.002 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.054 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:
0.108 mg/kg soil dw
Extrapolation method:
assessment factor

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 test: 70% (ThCO2) in 28 days (OECD 301B)

Log Kow: 3.99 (OECD 117)

Acute toxicity:

- to Fish: LC50 (96h) = 0.16 mg/L for Oryzias latipes (OECD 203)

- to Algae: ECr50 (72 h) > 0.4 mg/L for Pseudokirchneriella subcapitata (OECD 201)

- to Crustacea: EC50 (48 h) = 9 mg/L for Daphnia magna (OECD 202)

Chronic toxicity:

- to Fish: not available

- to Algae: NOEC (72h) = 0.021 mg/L for Pseudokirchneriella subcapitata (OECD 201)

- to Crustacea: not available

 

Classification justification according to CLP

Based on the data above, the substance is considered rapidly biodegradable. The acute aquatic toxicity LC50 is < 1 mg/L for Oryzias latipes. No long-term data are available for fish and Daphnia, the NOEC is < 0.1 mg/L for Pseudokirchneriella subcapitata. The substance needs to be classified and labelled as environmental hazard Acute Cat. 1 and Chronic Cat. 2 according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: not assignable

 

Classification justification according to DSD

Based on the data above, PEMB is considered to be rapidly degradable. The acute aquatic toxicity LC50 is < 1 mg/L for fish. Therefore PEMB has been classified and labelled as environmental hazard R50/R53 according to the Directive 67/548/EEC.