Amides, from C18-unsatd. fatty acids and polyethylenepolyamines

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

30.7 µg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

6.12 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

3.07 µg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

2.3 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

119.8 mg/kg sediment dw

Assessment factor:

1

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

11.98 mg/kg sediment dw

Assessment factor:

1

Extrapolation method:

equilibrium partitioning method

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

9.44 mg/kg soil dw

Assessment factor:

100

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

1.6 mg/kg food

Assessment factor:

300

Additional information

All endpoints are based on measured data applying assessment factors, with PNEC sediment calculated using the equilibrium partition coefficient method.

The PNEC_{aquatic bulk} is calculated using the assessment factor proposed by the TGD. As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. Based on the observed comparable or lower toxicity to fish for amidoamines/imidazolines it is considered unlikely that fish toxicity will be critical for this category of substances. In addition is the acute to chronic ratio for daphnia small indicating no systemic effects. This observation is consistent with the known effects of cationic surfactants on aquatic organisms, where toxicity is associated with physical binding to respiratory

membranes. This explains the steep concentration curves seen and the lack of intermediate chronic effects on reproduction.

Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the amidoamines/imidazolines other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare. This means that it is proposed to waive the long term fish unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment.

For amidoamines/imidazolines a safety factor of 10 is applied for the derivation of the PNEC_aquatic,bulk

Conclusion on classification

Environmental classification justification

Ecotoxicity

Due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver more reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the amines toand suspended matter a factor of 10 should be applied to the L(E) C₅₀to correct for the lower ecotoxicity observed.

Amidoamines/ imidazolines	CAS number	96 h Fish LC50 (µg/L)	72 h algae ERC50(µg/L)	72 h algae ERC10/ NOEC (µg/L)	48 h daphnia EC50 (µg/L)	21 d daphnia EC50 (µg/L)	21 d daphnia EC10/ NOEC (µg/L)	EC50corr(µg/L) (corrected for Classification with Factor 10)	EC10corr(µg/L) (corrected for Classification with Factor 10)
AAI-TEPA (Fatty acids C18 unsat, reaction products with tetraethylenepentamine)	1226892-45-0	190	612	379	240 490	775	307	61.2	30.7

Biodegradability

For amidoamines/imidazolines no ready biodegradability results have been obtained.

 This leads to the following environmental classification for amidoamines/imidazolines

Acute aquatic hazard H400 : Very toxic to aquatic life

M factor acute 10

Chronic(long-term) aquatic hazard Chronic Category 1 H410: Very toxic to aquatic life with longterm effects

M factor chronic 1