Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 317.75 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
231.78 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:
462.06 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Reliable studies are available for Daphnia (Inveresk 2001b, Inveresk Research, 2001d, Harlan Laboratories 2010 and 2014), fish (Inveresk 2001a, Inveresk Research, 2001c, Harlan Laboratories 2014) and algae (Inveresk 2001c, Inveresk Research, 2001e, Harlan Laboratories 2014). The studies available are for Resin acids and rosin acids, esters with pentaerythritol, Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, hydrogenated, Me esters and Resin acids and rosin acids, esters with ethylene glycol.

Conclusion on classification

Substances in the Rosin esters category with lower molecular weights are more toxic to aquatic organisms than those with higher molecular weights. 

The substances with the lowest molecular weights in the category are Resin acids and rosin acids, Me esters and Resin acids and rosin acids, hydrogenated, Me esters. The lowest EC50 available for these substances is 27 mg/L, from a Daphnia study with the test material Resin acids and rosin acids, hydrogenated, Me esters (Inveresk 2002). This result is read across to Resin acids and rosin acids, Me esters for classification purposes. As this EC50 is > 1 mg/L an acute environmental classification is not appropriate. Neither Resin acids and rosin acids, Me esters or Resin acids and rosin acids hydrogenated Me esters are readily biodegradable therefore as the lowest EC50 is >10 <100 mg/L a chronic classification of Chronic Category 3 is applied for both substances in accordance with the CLP regulation.

For substances within the category with higher molecular weights than Resin acids and rosin acids, Me esters and Resin acids and rosin acids, hydrogenated, Me esters the EL50 values were determined to be higher than the highest loading rate tested in all studies. Therefore, none of the other category members are classified for the environment based on acute ecotoxicity results.

For higher molecular weight esters (with molecular weights higher than for the Methyl esters), no effects were seen at the limit of solubility in acute ecotoxicity studies and therefore no environmental classification is assigned. The need for chronic ecotoxicity testing will be assessed as part of the toxicity assessment in the ongoing PBT assessment of Category substances.

Substance name CAS number Ecotoxicity data Environmental classification
Acute fish  Acute Daphnia Algae
Low molecular weight esters Rosin, methyl ester 68186-14-1       Chronic category 3
Rosin, hydrogenated, methyl ester 8050-15-5 LL50: >1000 mg/L (Inveresk 2001) EL50: 27 mg/L (Inveresk 2001) EL50: >1000 mg/L (Inveresk 2001) Chronic category 3
High molecular weight esters Rosin, ethylene glycol ester 68512-65-2 LL50: >100 mg/L (Harlan 2014) EL50: >100 mg/L (Harlan 2014) EL50: >100 mg/L (Harlan 2014) Not classified
Rosin, diethylene glycol ester 68153-38-8       Not classified
Rosin, hydrogenated triethylene glycol ester 68648-53-3       Not classified
Rosin, triethylene glycol ester 8050-25-7       Not classified
Rosin, glycerol ester 8050-31-5   EL50: >100 mg/L (Inveresk 2001)   Not classified
Rosin, hydrogenated, glycerol ester 65997-13-9       Not classified
Rosin, pentaerythritol ester 8050-26-8 LL50: >1000 mg/L (Inveresk 2001) EL50: >100 mg/L (Harlan 2010) EL50: >1000 mg/L (Inveresk 2001) Not classified
Rosin, hydrogenated, pentaerythritol ester 64365-17-9       Not classified
Rosin, oligomers, glycerol ester 68475-37-6       Not classified
Rosin, oligomers, pentaerythritol ester 65997-12-8       Not classified