Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.064 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
15.4 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:
0.06 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

The substance is not classified as hazardous to the environment when compared to CLP criteria for acute toxicity or chronic toxicity in readily biodegradable substances. The lowest long-term NOEC value is 3.2 mg/L in Daphnia and, in the absence of a valid scientific method, the Log Pow of 7.73 at 25 °C for octadec-9-enoic acid (oleic acid) has been selected as the applicable key value.

The average molecular weight for the most abundant basic form of the test item is 1972 g/mol and, because this is higher than 1100 g/mol, it provides an indicator that the aquatic BCF of the respective substance is lower than 2000 L/kg (see ECHA Guidance on Information requirements and chemical safety assessment Chapter R11: PBT assessment (Version 1.1; November 2012). However, the substance will dissociate in the environment and it is more appropriate to consider the selected log Kow for the free acid. ECHA guidance on determination of bioaccumulation potential states that, at very high log Kow (> 6), a decreasing relationship between BCF and Log Kow is observed. Since the log Kow value associated with the free acid (7.73) is approaching the cut off value of 10 cited in REACH guidance as a value suggesting that that BCF in aquatic organisms would be less than 2000 L/kg, bioaccumulation is not expected. Further evidence of very limited uptake stems from the long term Daphnia and algae NOEC values, which are far greater than the determined water solubility of the substance.

Conclusion on classification

The substance is readily biodegradable and does not fulfil the criteria for classification as an acute or chronic aquatic hazard under the terms of Regulation (EC) No. 1272/2008.