Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.116 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.39 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.012 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.191 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:
10 mg/kg soil dw
Assessment factor:
100

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Log Kow: 5 to > 10 (KOWWIN v1.68)

Water solubility: < 0.05 mg/L (EU Method A.6)

Biodegradation: 60 - 63 % in 28 days (OECD 301B)

BCF: < 17 L/kg (BCFBAF v3.01 - Arnot-Gobas estimate and experimental data) 

Aquatic acute toxicity:

For fish: 96h, LC50 (C. carpio): LL50 = 39 mg/L (OECD 203)

For algae: 72h, ErL50 (P. subcapitata): > 100 mg/L (OECD 201)

For crustacea: no data

Aquatic chronic toxicity:

For fish: not data

For algae: 72h, NOErL (P. subcapitata) = 10 mg/L (OECD 201)

For crustacea: 21d, NOEC (D. magna) = 5.8 mg/L (OECD 211)

 

Non-Classification justification according to CLP

Based on the data above, Multi constituent ester of pentaerythritol 2-ethylhexanoate is considered rapidly degradable. The acute aquatic toxicity L(E)C50 values are above the solubility of the substance in water for fish, algae and daphnia. Valid chronic toxicity data are available for algae and Daphnia – showing that the NOEC values are above the solubility of the substance in water. Therefore, Multi constituent ester of pentaerythritol 2-ethylhexanoate 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).

 

Non-Classification justification according to DSD

Based on the data above, Multi constituent ester of pentaerythritol 2-ethylhexanoate is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is above the solubility of the substance in water for fish, algae and daphnia. Therefore, Multi constituent ester of pentaerythritol 2-ethylhexanoate does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.