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EC number: 696-364-9
CAS number: 133779-11-0
are poorly soluble in water and also have a strong tendency to adsorb to
negatively charged surfaces such as suspended matter and test vessels or
organic material (including dissolved organic matter such as humic
acids). Many cationic substances in general but long chain alkyl
polyamines 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 alkyl-1,3-diaminopropanes 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
long-term aquatic ecotoxicity tests with alkyl-1,3-diaminopropanes were
therefore performed in river water to allow a PECaquatic,bulk/PNECaquatic,bulkapproach
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,bulkis compared with
the PNECaquatic,bulkderived 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 PECbulkclearly
provide a more appropriate assessment of risks for the environment. All
effect values given are therefore based on the nominal test item
Data of other diamines have been used as weight of
evidence in the evaluation of the aquatic toxicity. All alkyl-1,3
-diamines under consideration consist of carbon, hydrogen and nitrogen
only. The basic structure includes a hydrocarbon chain with a 1,3
-propanediamine group at the end of the chain. The main difference
consists of differing chain lengths (C12 -18)and slight
variations in the degree of saturation in the alkyl chain. The available
ecotox data reveal a comparable toxicity independent of the alkyl chain
length. Therefore a read-across approach is considered justified.
should be noted that the fish studies are the only studies performed
with reconstituted lab water, while the studies with Daphnia and
algae were performed with river water. Studies performed in river water
show in general a factor of 5 lower toxicity due to the mitigation by
river water constituents. Daphnia and algae are more sensitive than fish
even if the results of river water tests for Daphnia and algae are
compared with test results in reconstituted lab water for fish. It was
decided not to repeat the fish study in natural river water for ethical
reasons. The use of an assessment factor of 10 is therefore more
difficult to justify but a factor of 5 or higher difference in toxicity
is considered to be sufficient to support the use of an assessment
factor of 10 instead of 50 in the derivation of the PNECaquatic.
The difference in sensitivity between fish and daphnia/algae is
supported by results from comparable substances like primary alkyl
amines and quats.
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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