Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.005 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.048 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:
3.2 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
86.55 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:
172.55 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

Acute studies are available for fish, Daphnia and algae for various members of this category. Differences have been observed between substances reacted with fumaric acid and substance reacted with maleic anhydride when tested in ecotoxicological studies. Therefore, read across between fumarated and maleated substances has not been conducted for ecotoxicity endpoints.

 

Environmental classification is assessed based on data for the substance itself, where available, or using read across from another fumarated or maleated substance where data on the substance itself is not available. 

 

However, PNECs have been derived based on pooled data, with one set of PNECs derived to cover all maleated substances within the category and one set to cover all fumarated substances. The most sensitive result for any maleated rosin substance has been used as the key value for PNEC derivation.

Conclusion on classification

The available ecotoxicity results indicate that there may be differences in environmental toxicity between substances reacted with fumaric acid and substances reacted with maleic anhydride, although the reasons for this are not clear. Therefore, although maleated and fumarated substances are structurally similar and it is appropriate for these substances to be considered within a single category, for ecotoxicity endpoints read across is not conducted between fumarated and maleated substances.

 

The ecotoxicity of maleated substances is affected by the solubility of the test item, with more soluble substances rosin, maleated and resin acids and rosin acids, maleated sodium salts showing higher aquatic toxicity compared to the poorly soluble substance resin acids and rosin acids, maleated calcium salts. Therefore, ecotoxicity endpoints and environmental classification of resin acids and rosin acids, maleated calcium salts are completed based on data for the substance itself rather than using read across from more rosin, maleated or resin acids and rosin acids, maleated sodium salts.

 

Environmental classification of each of the maleated rosin substances is outlined below.

 

Rosin, maleated

 

Two acute Daphnia studies and one acute fish study are available for rosin, maleated. The lowest EC50 value for this substance is 9.3 mg/L. As this result is >1 mg/L an acute environmental classification is not appropriate for this substance. However, a chronic category 2 classification is assigned to this substance as it is not readily biodegradable and has an EC50 value between 1 and 10 mg/L.

 

Resin acids and rosin acids, maleated sodium salts

 

Acute fish,Daphniamagnaand algal studies are available for resin acids and rosin acids, maleated, sodium salts. The lowest EC50 from these studies is 4.8 mg/L, for fish. As this result is >1 mg/L an acute environmental classification is not appropriate for this substance. However, a Chronic category 2 classification is assigned to this substance as it is not considered to be readily biodegradable and has an EC50 value between 1 and 10 mg/L.

 

Resin acids and rosin acids, maleated calcium salts

 

Acute fish, Daphnia magna and algal studies are available for resin acids and rosin acids, maleated, calcium salts. EL50 values from these studies are all >100 mg/L. However, as this substance is of low solubility, is not readily biodegradable and has a log Kow value of >4 a "safety net" classification of Chronic Category 4 is assigned to resin acids and rosin acids, maleated, calcium salts.