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EC number: 276-038-9
CAS number: 71808-53-2
are based on the following data for the test substance:
Microorganisms, activated sludge
3h-EC10respiration: 10.9 mg/L
21d-EC50: 0.465 mg/L
96h-LC50: 1.84 mg/L
72h-ErC50: 0.414 mg/L
72h-ErC10: 0.121 mg/L
21d-NOECreprod: 0.268 mg/L
PNEC freshwater has been derived on the basis of aquatic toxicity data
determined in tests employing river water. The river water data are
based on nominal concentrations. The rationale behind the use of river
water tests is the strong sorption to organic matter and test vessels of
the substance. The derived PNECbulkwill be compared to the PECbulk(which
includes the fraction adsorbed onto suspended matter) in the risk
characterisation. The same approach has been used for other cationic
PNECaquatic bulk is calculated using the assessment factor proposed by
the REACH guidance. 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 toxicity to fish in
acute tests, it is considered unlikely that long term fish toxicity will
be critical for the PNEC derivation. Hence any additional toxicity
testing with fish will not add scientific value to the ecotoxicity
profile 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
the ecotoxicity data it is justified to apply a safety factor of 10 for
the derivation of the PNECaquatic,bulk. With the same motivation, AF of
100 has been used for the derivation of PNEC marine.
tests were performed with sediment organisms or terrestrial organisms.
The PNECs for those compartments were derived using the equilibrium
partitioning theory and Koc. All relevant substance characteristics were
entered into EUSES version 2.1.2 to produce PNECsediment for the
freshwater and marine compartment as wel as PNECsoil. Since
PNECfreshwater is based on the bulk concentration present in surface
water, a recalculation was necessary to PNECfreshwater,dissolved before
application of the equilibrium partitioning method. The following
equation was used:
= PNECfreshwater,bulk/ (1+ Kpsusp*SUSPwater*10-6)
PNECfreshwater,bulk = 12.1 µg/L,
5496 L/kg (EUSES) and
= 15 mg/L.
resulting PNECfreshwater,dissolved = 11.2 µg/L.
PNECfreshwater,sediment, PNECmarine, sediment and PNECsoil were then
calculated with EUSES employing PNECfreshwater,dissolved of
PNEC for sediment is than calculated applying the EPM:
PNECsed = Ksusp-water*
PNECaquatic dissolved* 1000 * 1 / RHOsusp
dissolved = 11.2 µg/L
Ksusp-water = 1374
RHOsusp = 1150
kg/m3(TGD, equ. 18)
13.35 mg/kg ww
61.4 mg/kg dw
Despite of the low bioaccumulation potential a PNECoral can be
calculated using the acute NOAEL of 18.75 mg/kg bw a.i.
PNECoral = (NOAEL * Convmammal)/AF
= (18.75*20)/300 = 1.25 mg/kg
20 (Rat > 6 weeks)
AF = 300 (acute study)
For classification purposes
Ecotoxicity, Biodegradability and Bioconcentration have to be
to intrinsic properties of quaternary ammonium ethoxylates, river water
ecotoxicity tests deliver reproducible test results with limited
uncertainty. As river water has a mitigating effect on ecotoxicity due
to sorption of the quaternary ammonium ethoxylates to DOC and suspended
matter, a factor of 10 should be applied to the L(E)Cx and NOEC to
correct for the lower ecotoxicity observed. Algae are in general the
most sensitive species and are therefore the basis for classification of
the quaternary ammonium, C12-18-alkylbis(hydroxyethyl)methyl, chloride. It
should be noted that the 21day-daphnia EC50 is included in the table
below for classification purposes as a worst-case for acute toxicity in
river water tests.
The classification is based on the following aquatic toxicity data for
the test substance:
Correction for river water with factor 10
21d-EC50immobility: 465 µg/L
72h-ErC50: 413.5 µg/L
21d-NOECreprod: 268 µg/L
72h-ErC10: 121 µg/L
The substance is rapidly biodegradable in the environment as
demonstrated with a Closed bottle test according to OECD TG 301 D. The
biodegradation percentage was 70% after 28 days.
The very low log Kow of -0.12 suggests that the substance has a
low bioaccumulation potential.
Conclusion classification according to CLP Regulation 1272/2008
Based on the results of the acute aquatic toxicity (values < 1
mg/L) the substance is classified with Category Acute 1 (M-factor 10).
Based on the results of the chronic aquatic toxicity ( 0.01 <
ErC10 < 0.1 mg/L) and since the substance has a low
bioaccumulation potential and is rapidly biodegradable, the substance is
classified with Category Chronic 2 (no M-factor).
Classification according to 67/548/EEC (DSD)
Acute aquatic toxicity is < 1 mg/l and the substance is rapidly
biodegradable and has a low bioaccumulation potential (log Kow of
-0.12). Therefore the substance is classified with N:R50.
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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