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EC number: 276-038-9
CAS number: 71808-53-2
Quaternary ammonium compounds,
C12-18-alkylbis(hydroxyethyl)methyl, chlorides are poorly soluble in
water and 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). Quaternary
ammonium compounds with long alkyl chains 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 ecotoxicity testing for cationic
surface-active substances like these quaternary ammonium compounds as
these were written with neutral 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 Quaternary ammonium
compounds, C12-18-alkylbis(hydroxyethyl)methyl were therefore performed
in river water to allow a PECaquatic,bulk/PNECaquatic,bulk approach and
are considered to be 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).
The difficulties encountered with the standardised ecotoxicity
tests for these surfactants are avoided by the use of river water tests.
For ecotoxicity tests performed with riverwater 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. The
PNECbulk provides a more environmentally realistic estimation than the
PNEC based on dissolved concentrations in reconstituted lab water.
The PNECbulk should be compared to the PECbulk. All effect values given
are therefore based on the nominal test item concentrations.
For some aquatic toxicity endpoints,
supporting information is obtained from the related Quaternary ammonium
compounds, C14 alkylbis(hydroxyethyl)methyl, chlorides and Quaternary
ammonium compounds, C12 alkylbis(hydroxyethyl)methyl. These
substances have the same basic structure consisting of quaternary
ammonium having one methyl, two ethoxy groups and one fatty acid derived
alkyl chain. The only difference consists of differing chain lengths
(range of C12 - C18 alkyl chains, or C12 and C14 alkyl chains pure,
respectively). The available aquatic data seem to suggest that
acute toxicity depends on chain length and saturation. Increasing chain
length leads to a lower bioavailability and less toxicity to biota.
Therefore it is considered justified to use read-across from data of
substances with C12 or C14 chain to the substance with a range of
various C12 – C18 alkyl chains. The read-across has been
used solely as supporting information for the acute toxicity to aquatic
invertebrates and algae.
It should be noted that the 21d-EC50 for daphnia, river water has
been included as a worst case for the short term EC50-daphnia, river
water. The effect concentrations are based on the active ingredient
An overview of the most relevant results is presented in the table.
KEY Study (Rel. 2)
96h-LC50 = 1.84 mg a.s./L, reconst lab water
(C12 - supporting evidence)
70505 -47 -9
48h-EC50 = 0.74 mg a.s./L, reconst lab water
21d-EC50 = 0.465 mg a.s./L, river water
72h-ErC50 = 0.414 mg a.s./L, river water
72h-ErC10 = 0.121 mg a.s./L, river water
21d-NOEC = 0.268 mg a.s./L Reproduction,
21d-EC50 = 0.465 mg a.s./L
3h-EC50 = 28.8 a.s mg/L
3h-EC10 =10.9 mg a.s./L
Acute toxicity results are available for three taxonomic groups
(fish, invertebrates and algae). Long term toxicity results are
available for aquatic invertebrates and algae. As fish is clearly less
sensitive than daphnia and algae towards the substance, no further long
term testing with fish is proposed to avoid further vertebrate testing.
Moreover cationic surfactants are known to have a low bioaccumulation
potential based on their chemical structure. The very low
bioaccumulation potential does not trigger the need for long term fish
testing either. Therefore long term fish testing has been waived.
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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