Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
25.4 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.94 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
2.54 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
99.4 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
9.94 mg/kg sediment dw
Assessment factor:
1
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:
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:
2 mg/kg food
Assessment factor:
300

Additional information

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

The PNECaquatic bulkis 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. In addition, the daphnia reproduction test result shows that at 810 µg/L all parental daphnids were immobile within four days, without reproduction, while at the next concentration of 270 µg/L not only is there no immobilisation, but there is no detrimental effect on reproduction when compared to the control. These observations results in the derivation of a NOEC of 270 µg/L resulting in a low acute-to-chronic ratio. A low acute-to-chronic ratio is indicative of a non-specific mode of action and is often associated with not 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 PNECaquatic,bulk

Conclusion on classification

Biodegradability

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

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. Algae are in general the most sensitive species but because for most of the amidoamines/imidazolines only the 21 d EC50for daphnia is available this endpoint serves as basis for the acute classification of the amidoamines/imidazolines as a worst-case.

TableAvailable algae, daphnia and fish test results (Klimisch 1, 2 and 4) for the amidoamines/imidazoline.

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-DETA (Fatty acids, C18 unsat, reaction products with diethylenetriamine)

1226892-43-8

190

476

324

180

311

254

47.6

25

This leads to the following environmental classification according to CLP for amidoaamines/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