Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.004 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.004 mg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.017 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.002 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:

0.003 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Conclusion on classification

According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

A read-across approach was applied to this substance and data was compiled from representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.

Environmental fate and pathways

Biodegradation

Readily biodegradable: 85.2% within 28 d(OECD 301 B); read-across

Bioaccumulation

log Kow = 3.10 (salt, EPISuite v4.11, KOWWIN v1.68)

 

Aquatic acute toxicity

Fish

LC50 (96 h) = 0.37 mg/L (nominal, OECD 203, D. rerio); read-across

Aquatic invertebrates

EC50 (48 h) = 0.43 mg/L (geometric mean measured, OECD 202, D. magna); read-across

Algae

ErC50 (72 h) = 6.3 mg/L(measured initial, OECD 201, D. subspicatus); read-across

 

Aquatic chronic toxicity

Algae

NOErC (72 h) = 0.91 mg/L (measured initial, OECD 201, D. subspicatus); read-across

 

CLP

Based on the available data listed above, the most sensitive acute effect concentration was obtained for fish, with an LC50 (96 h) of 0.37 mg/L (nominal). Thus, the substance needs to be classified as environmental hazard Category Acute 1, according to the Regulation (EC) No 1272/2008 (CLP) and following amendments (ATPs).

M-factor for acute aquatic toxicity: 1

The NOErC (72 h) = 0.91 mg/L for algae is the only chronic aquatic effect concentration available. In addition, the substance is readily biodegradable and has a log Kow of 3.10. Since the substance has a pKa of 3.96, it is predominantly present in its ionized form at environmentally relevant pH values (4 - 9. Therefore, the log Kow of 3.10 for the ionized form (salt) was retained as key value. Thus, the substance is classified and labelled as long-term aquatic hazard Category Chronic 3, according to Regulation (EC) No. 1272/2008 (CLP) and following amendments (ATPs).

M-factor for chronic aquatic toxicity: not applicable.