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EC number: 230-528-9
CAS number: 7173-62-8
Alkyl-1,3-diaminopropanes 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 substances.
The 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).
In 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.
For ecotoxicity tests performed using
thebulkapproach, 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 of (Z)-N-9
-octadecenylpropane-1,3 -diamine and N-C16-18-alkyl-(evennumbered) C18
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.
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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