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):
0.052 mg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.62 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:
3.24 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

'Oils, vegetable, deodorizer distillates' demonstrates low toxicity for fish, algae and aquatic microorganisms in guideline-compliant testing using water accommodated fractions. Daphnia magna was identified as the most sensitive species with a 48 h EC50 = 5.17 mg/L (nominal) when tested under similar test conditions. As a result, it does not warrant acute aquatic hazard classification according to Regulation (EC) No 1272/2008.

For the aquatic long-term hazard assessment, no adequate chronic toxicity study was available with the any of the category member distillates. However, a 21 -d Daphnia study conducted with 'glycerides, C14 -18 and C16 -18 -unsatd. mono-, di- and tri-‘ which has similar chain length distribution as part of the glyceride constituent of ‘oils, vegetable, deodorizer distillates’did not show any effect on mortality, reproduction and growth. The 21 -d chronic NOEC for these effects was established at ≥10 mg/L (nominal). Considering this together with ready biodegradability potential of the substance, low estimated BCF values for the major constituents as well as the metabolic potential of fish to break down tiglycerides and its constituent fatty acids suggests that the substance will not bioaccumulate. Therefore, the substance does not qualify a chronic aquatic hazard classification according to Regulation (EC) No 1272/2008.

 

Nevertheless, the ‘oils, vegetable, deodorizer distillates’ can trigger an aquatic chronic 3 classification as per the CLP criteria for UVCB or mixtures if the C8 and/or C10 fatty acids (which are classified for this endpoint) exceeds 25% concentration limits. For details on the underlying study basis for the aquatic classification, refer to the ECHA RAC opinion published on the individual fatty acids.