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EC number: 292-562-0
CAS number: 90640-43-0
The PNECaquatic bulkis
calculated using the assessment factor approach proposed by the TGD.
As long-term NOECs from species
representing two trophic levels are available (algae and daphnia) and
these results cover the level showing the lowest EC50 in short term
tests, an assessment factor of 50 may be used. However based on the
observed lower toxicity to fish not only for the alkyl-1,3
-diaminopropanes but also for primary fatty amines and mono and dialkyl
quats it is considered unlikely that fish toxicity will be critical for
alkyl-1,3 -diaminopropanes. Hence any additional toxicity testing with
fish will not add scientific value to the ecotoxicity profile of the
alkyl-1,3-diaminopropanes 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
the use of safety factor of 10 is justified for the derivation of the
The PNECsediment and the PNECsoil are
derived on the basis of experimental data and the application of the
appropriate assessment factor according to REACH guidance.
For classification purposes Ecotoxicity,
Biodegradability and Bioconcentration have to be considered
Due to intrinsic properties of amine
containing cationic surfactants 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 amines to DOC
and suspended matter a factor of 10 should be applied to the L(E)Cx to
correct for the lower ecotoxicity observed. Algae are in general the
most sensitive species and are therefore for most of the
alkyl-1,3-diaminopropanes basis for classification. It should be noted
that the 21 day daphnia EC50(parental mortality) is included
in the table below for classification purposes as a worst-case in the
absence of reliable 48 day EC50values. The lowest chronic
NOEC for N, C12 -14-1,3
-diamine is 32 µg/L (21d daphnia test in riverwater). Correcting this
value for mitigation with the realistic worst-case correction factor of
10 leads to NOEC/EC10 for classification of 3.2 µg/L.
Available river water
EC50 data algae and chronic daphnia used for classification
72 h algae
21 d daphnia
EC50corr(µg/L) (corrected for Classification with Factor 10)
Amines, N-coco alkyltrimethylenedi-
in bold are based on read-across.
Available river water
EC10/NOEC data algae and chronic daphnia used for classification
EC10corr(µg/L) (corrected for Classification with Factor 10)
Based on the available studies on
biodegradation, the substances are estimated to be readily
biodegradable. The 10-days-window criterion does
not need to be evaluated for the cationic surfactants under
consideration as they are UVCB substances.
No measured BCF for fish is available.
Standard OECD 305 tests are technically not feasible with the strongly
sorbing easily biodegradable substances. The log Kow values provided in
the dossier are however acceptable. The BCF was therefore calculated
using the BCFBAF v3.0 estimation program as included in EPIweb v4.0. In
addition based on information of kinetics in mammals and for n-hexadecyl
amine in fish and the general properties of surfactants, a high
bioaccumulation potential is not expected.
Measured log Kow values for
alkyl-1,3,diaminopropane technical products and the calculated log BCF
based on the measured log Kow.
Calculated Log BCF (EPI v4.0)
Figures in bold are based on read-across
according to DSD (Dangerous Substance Directive 67/548/)
As all ecotoxicity values (corrected and
uncorrected) as given in Table 32 are below 1 mg/L. Based on these
results it is proposed to classify N, C12 -14
alkyl-1,3-diaminopropane as R50.
Alkyl-1,3-diaminopropanes are readily
biodegradable. The measured log Kow <3 and calculated BCF <100 L/kg
which means that an R53 does not need to be assigned.
This leads to the following
environmental classification according DSD for N, C12 -14
Classification according to CLP
(Classification, Labeling & Packaging Directive 1272/2008/EC)
As all acute ecotoxicity values
(corrected and uncorrected) as given in the Table above are below 1 mg/L
and the diamines are ‘readily biodegradable’ and have a low
bioaccumulation potential based on the measured log Kow values, the environmental
classification for N,C12 -14 -alkyl-1,3-diaminopropane is:
Acute (short-term) aquatic hazard
Acute Category 1
The corresponding M-factor is 100 based on the EC50 of
6.5 ug/L (72h algae riverwater test of 65 ug/L corrected with factor of
When chronic toxicity
data are available these should be used for classification for chronic
aquatic hazard. Considering the lower sensitivity of fish it is
considered justified to use the long-term daphnia and algae test results
for the chronic classification. N, C12 -14 -1,3 -diamine is
readily biodegradable and the lowest NOEC is 32 µg/L (21d daphnia test
in riverwater). Correcting this value for mitigation with the realistic
worst-case correction factor of 10 leads to NOEC/EC10 for classification
of 3.2 µg/L. The substance should be classified with:
Chronic(Long-term) aquatic hazard
Chronic Category 1
The corresponding M-factor is 1 based
on the NOEC of 3.2 ug/L (21d NOEC daphnia riverwater test of 32 ug/L
corrected with factor of 10)
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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