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Ecotoxicological Summary

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Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.207 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.045 µg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 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

For the aquatic compartment long-term daphnia and algae tests were performed following two different approaches, the WAF approach and the Bulk approach. For both approaches the PNEC values for the different compartments are based on measured data applying assessment factors. The PNEC sediment is based on the sediment-water lumbriculus toxicity test using spiked sediment according to OECD TG 225 applying the default assessment factor.


 


The PNECaquatic WAF is calculated using the assessment factor proposed by the TGD. As long-term EL10 values 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 200 μg/L all parental daphnids were immobile within five days, without reproduction, while at the next concentration of 80 µg/L not only there is no immobilisation, but there is no detrimental effect on reproduction when compared to the control. These observations result in the derivation of a EL10 of 133 µg/L demonstrating a low acute-to-chronic ratio for daphnia. A low acute-to-chronic ratio is indicative of a non-specific mode of action and is often associated with non- 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 observed 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. Based on this argumentation it is considered justified to waive the long-term fish also because further refinement of the effect assessment is not considered necessary based on the outcome of the chemical safety assessment. For amidoamines/imidazolines an assessment factor of 10 is therefore used for the derivation of the PNECaquatic,WAF.


However because the long-term fish test is a standard information requirement according to Annex IX registrations a long-term toxicity to fish test according to OECD 210 and the requirements of OECD GD 23 (ENV/JM/MONO(2000)6/REV1) has been proposed.


 


 


The PNECaquatic bulk  can similar to the PNECaquatic, WAF be calculated using exactly the same procedure.  The use of natural river water instead of standard test medium as described in ECETOC Technical Report “Environmental Risk Assessment of difficult substances” (TR 88, 2003) has no impact on PNECaquatic derivation. Only for the calculation of the risk (RCR), the PNECaquatic, Bulk should be compared with the PECaquatic, Bulk which is very simple to calculate e.g for wide dispersive use the PECaquatic, Bulk = PECSTP/dilution factor thereby elegantly bypassing the erroneous calculation of the dissolved concentration. Thus, besides to a much easier quantification of the exposure concentrations during the ecotoxicity tests, tests according to the bulk approach were performed because the partitioning of cationic surfactants to soil, sediment or suspended matter too complex to develop an appropriate alternative Equilibrium Partitioning Method (EPM, di Toro, 2008) formula. The use of the Bulk approach thus elegantly bypasses the deficiencies on both the exposure and effect side.


For the Bulk approach, the long-term aquatic ecotoxicity tests were thus performed using natural river water instead of standard test medium. For the derivation of the PNECaquatic, Bulk similar as for the PNECaquatic, WAF, endpoints (NOECs) from species representing two trophic levels are available (algae and daphnia) and based on REACH guidance R.10 an assessment factor of 50 may be used for the calculation of the PNEC.


Similar as for the WAF approach a low acute to chronic ratio for daphnia is observed and the same argumentation is used to consider the use of an assessment factor of 10 justified.


 

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 to DOC and suspended matter a factor of 10 was applied to the EL(C)50 for C&L to 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 EC50 for daphnia is available this endpoint serves as basis for the acute classification of the amidoamines/imidazolines as a worst-case.


 


Table Available algae, daphnia and fish test results (Klimisch 1, 2 and 4) for AAI-DETA.


 






























Amidoamines/ imidazolines



CAS number



96 h


Fish


LC50


(µg/L)



72 h algae


ERC50/ErL50(µg/L)



72 h algae


ERC10/ ErL10 (µg/L)



48 h daphnia


EC50


(µg/L)



21 d adult daphnia


EC50/EL50


(µg/L)



21 d daphnia


EC10/EL10 NOEC


(µg/L)



EC50corr(µg/L) (corrected for Classification with Factor 10)/based on loading



EC10corr(µg/L) (corrected for Classification with Factor 10)/based on loading



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



1226892-43-8



190



505/44.7



343/20.7



180



311/111



270/34.3



50.5/44.7



27/20.7



The figures in bold are the bulk approach test results. The under-lined figures are the WAF approach test results. The figures given in Italic are old test results.


 


By applying an additional assessment factor of 10 on the bulk approach tests for the potential mitigation of the aquatic toxicity by river water constituents like DOC and suspended matter exactly the same environmental classification for AAI-DETA is obtained as based on the results obtained with the WAF approach.


 


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 long-term effects


M factor chronic 1