Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

6.46 µg/L

Assessment factor:

50

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

4.1 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.646 µg/L

Assessment factor:

500

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

388 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

38.8 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:

11.1 mg/kg soil dw

Assessment factor:

10

Extrapolation method:

assessment factor

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

PNECs are based on the following data for the test substance:

Test type	Results
Microorganisms, activated sludge	3h-NOEC respiration: 993.2 mg/L
Short-term studies
Daphnia magna	21d-EC50: 1.40 mg/L
Danio rerio	96h-LC50: 1.34 mg/L
Pseudokirchneriella subcapitata	72h-ErC50: 0.41 mg/L
Chronic studies
Pseudokirchneriella subcapitata	72h-ErC10: 0.323 mg/L
Daphnia magna	No long-term effects were observed during the chronic daphnia test.
Terrestrial studies
Eisenia fetida	56d-NOEC reproduction, biomass, mortality: 993.2 mg/kg soil dw

As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used du derive the PNEC freshwater. With the same motivation, an AF of 500 has been used for the derivation of PNEC marine.

 

According to REACH Annex IX, long-term toxicity testing for daphnia and fish (according to TG OECD 211 and 210) has been proposed with two Testing Proposal in order to perfrom these studies with standard OECD medium. An Algae study (OECD 201) with a similar substance is available to assess the inhibition of the growth of the freshwater green alga Pseudokirchneriella subcapitata in a standard medium. Due to the complex structure of the test item, and the very low solubility the WSF approach was used for ecotoxicity testing. When the full dataset in standard medium will be available, the key value for chemical safety assessment will be re-assessed. 

 

No tests were performed with sediment organisms. The PNECs for this sediment is derived using the equilibrium partitioning method.

 

For the terrestrial compartment, one long-term study (OECD 222) is available showing no effects as the 56-d NOEC of the substance was = 993.2 mg/kg dw. According to the guidance, when only one test result with soil dwelling organisms is available the risk assessment is performed both on the basis of this result using assessment factors and on the basis of the equilibrium partition method (EPM , see above; Kp,soil = 30068). From both PECsoil/PNECsoil ratios the highest one is chosen for the risk characterisation. Therefore, the PNEC was calculated both based on the long term study as well as the EPM. The PNEC soil based on EC10 from earthworm reproduction test (OECD 222, reliability 1) and an assessment factor of 100. This would result in a PNEC of 9.93 mg/kg dw. PNEC soil based on the EPM is derived from PNEC freshwater, using the equilibrium partitioning method and resulting in a PNEC soil of 38,5 mg/kg dw. As the PEC soil is independent of the calculation method, the PNEC soil derived from the long term study will result in the highest PECsoil/PNECsoil ratios and is therefore chosen for the risk characterization: the PNECsoil is 9.93 mg/kg dw.

Conclusion on classification

For classification purposes Ecotoxicity, Biodegradability and Bioconcentration have to be considered.

 

Ecotoxicity

Due to intrinsic properties of the test substance, river water ecotoxicity tests are available on the registered susbtance. As river water has a mitigating effect on ecotoxicity due to sorption to DOC and suspended matter, a factor of 10 should be applied to the L(E)Cx and NOEC to correct for the lower ecotoxicity observed. Algae are in general the most sensitive species and are therefore the basis for classification of N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate]. It should be noted that the 21day-daphnia EC50 is included in the table below for classification purposes as a worst-case for acute toxicity in river water tests.

 

The classification is based on the following aquatic toxicity data for the test substance:

Test type	Results	Correction for river water with factor 10
Short-term studies
Danio rerio	96h-LC50: 1.34 mg/L	134 µg/L
Daphnia magna	21d-EC50 adult mortality: 1.40 mg/L	140 µg/L
Pseudokirchneriella subcapitata	72h-ErC50: 410 ug/L	41 µg/L
Chronic studies
Daphnia magna	21 -NOEC = 1.35 mg/L	0.135 mg/L
Pseudokirchneriella subcapitata	72h-ErC10: 323 µg/L	32.3 µg/L

 

Biodegradability

The substance is rapidly biodegradable in the environment as demonstrated according to an OECD TG 301 F test. The biodegradation percentage was >60% after 28 days.

 

Conclusion classification according to CLP Regulation 1272/2008

Based on the results of the acute aquatic toxicity (values < 1 mg/L) the substance is classified with Category Acute 1 (M-factor 10).

Reliable chronic toxicity data are available for crustacea and algae with chronic EC10 resp 1.35 mg/L and 0.323 mg/L. In addition the substance is readily biodegradable. Based on the lowest results of the chronic aquatic toxicity (0.01 < corrected ErC10 < 0.1 mg/L) and since the substance is rapidly biodegradable, the substance is classified with Category Chronic 2.