Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
16.71 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:
5.3 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 oral is based on the NOAEl from a 28 -day study with rats aged 6 weeks.

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. 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 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 PNECaquatic,bulk

Conclusion on classification

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. Some test results for tests performed in reconstituted lab water are available and these endpoints can therefore directly be used for classification purposes. As hydrolysis test has been performed after ecotoxicity testing the effect data which were based on nominal test concentrations were corrected based on the observed test concentrations. For the old data where no monitoring data was available the effect data were assumed to be 50% of the nominal as a worst-case.

Table Available 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)

 

Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products

68910-93-0

3750

>357

156.6

740

1171

743.3

35.7

15.6 

Figures given in bold are based on read across; figures given in italic and underlined are performed in reconstituted lab water and these are therefore not corrected.

Biodegradability

For amidoamines/imidazolines no ready biodegradability results have been obtained. . Biodegradation in excess of 60% was only achieved for1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs. (68442-97-7) after 60 days in a GLP test (van Ginkel, 2010). Based on the >60% observed for1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs.diethylene triamine and also based on the biodegradability result from diethylentriamine it self (SIDS) the DETA based imidazoline is completely biodegraded to CO2H2O and NO3.

Rapid hydrolysis ofTall oil, reaction products with tetraethylenepentamine (68555-22-6) has been observed at 50 °C. At pH 4, 7 and 9 half-life’s were observed of respectively 5.7, 1.2 and 0.6 h. Based on these observations all nominal effect data of the ecotoxicity tests were recalculated to realistic exposure data.

Imidazolines are most likely first degraded by hydrolysis (see instantaneous start of degradation) and the degradation products are further degraded by micro-organisms/hydrolysis until CO2, H2O and the starting polyethyleneamine are remaining. In the absence of half-life’s based on hydrolysis under ambient conditions it is not possible to assess the persistency of the imidazolines properly.

  

Bioaccumulation potential

No measured BCF fish is available for the amidoamines/imidazolines. Standard OECD 305 tests are technically very complicated with these strongly sorbing unstable substances. One measured log Kow value has been determined for1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs. (68442-97-7). This value of 2.2 indicates a low bioaccumulation potential. As all amidoamines/imidazolines are hydrolyzed and degraded to CO2, H2O and the starting polyethyleneamine it is very unlikely that these substances will have a high bioaccumulation potential.

This leads to the following environmental classification according 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