Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.04 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:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Read across statement for toxicological and ecotoxicological endpoints

 

Depending on the raw material source (in nature occurring natural oils and fats) Fatty acid methyl esters can vary in their chain length distribution. Such products are typical UVCB substances. Nevertheless the toxicological and ecotoxicological profile derive from the individual components within the UVCB. In order to avoid extensive testing and duplication of animal tests the industry took the approach to test a representative Fatty acid methyl ester, Fatty acid, C16-C18 and C18-unsatd., me esters (EC 267-015-4; CAS 67762-38-3), with a broad chain length distribution and read across the test results to Fatty acids, vegetable-oil, Me esters (EC 273-606-8; CAS 68990-52-3).

Conclusion on classification

None of the studies shows a value leading to classification for the environement both according to 67/548 and to CLP regulation.