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EC number: 629-732-4
CAS number: 1224966-13-5
are poorly soluble in water and also have a strong tendency to adsorb to
negatively charged surfaces such as suspended matter, algae and test
vessels or organic material (including dissolved organic matter such as
humic acids). Many cationic substances in general but long chain
amidoamines/imidazolines in particular rank among the most difficult
substances to test in environmental toxicology. Standard guideline
studies are inappropriate to test substances with such properties and
the current REACH Guidance Documents do not provide sufficient guidance
concerning bioavailability and exposure assessment for cationic
surface-active substances like the amidoamines/imidazolines as these
were written with normal hydrophobic chemicals in mind, failing to take
into account the lack of bioavailability that occurs in the environment
with these substances.
long-term aquatic ecotoxicity tests with amidoamines/imidazolines were
therefore performed in river water to allow a PECaquatic,bulk/PNECaquatic,bulk
approach and is considered to be conservative but more
environmentally realistic than the standard method. This approach is
based on PEC estimations representing ‘total aquatic concentrations’. To
characterize the risk to the aquatic compartment the PECaquatic,bulk
is compared with the PNECaquatic,bulk derived from
river water ecotoxicity studies (ECETOC, 2001).
order to class standard laboratory toxicity study valid, it is of
particular importance that - besides information on test substance, test
method / conditions and test organism used - suitable precautions are
taken to prevent the loss of test substance by adsorption and that
exposure concentrations are based upon measured levels.
ecotoxicity tests performed using the bulk approach, however,
adsorption to suspended matter and DOC is acceptable and only adsorption
to glassware should be accounted for. For a valid bulk approach test the
concentration-effect relationship should be based on the sum of adsorbed
and dissolved substance in the volume of the medium tested. One of the
advantages of the bulk approach tests with these difficult substances is
that in the presence of suspended matter, humic acids and/or algae, the
residual sorption to glassware will be negligible. The results of these
bulk approach tests are therefore much easier to interpret, more
environmental realistic, and if compared to PECbulk clearly
provide a more appropriate assessment of risks for the environment. All
effect values given are therefore based on the nominal test item
PNECaquatic bulk should 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. However based on the observed lower/comparable
toxicity to fish not only for the amidoamines/imidazolines but also for
primary fatty amines and mono and dialkyl quats it is considered
unlikely that fish toxicity will be critical for this category of
substances. A very low acute to chronic ratio is observed in the
long-term daphnia test. 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 and that based on the weight of
evidence available on ecotoxicity data for several cationic surfactants
a safety factor of 10 may be applied for the derivation of the PNECaquatic,bulk.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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