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EC number: 947-476-4
CAS number: -
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
PNECaquatic,bulk. Despite of that an assessment factor of 50
is used for the calculation of the PNEC
The PNECsediment and the
PNECsoil are derived on the basis of experimental data and the
application of the appropriate assessment factor according to REACH
purposes Ecotoxicity, Biodegradability and Bioconcentration have to be
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 is
applied to the L(E)Cxto correct for the lower ecotoxicity
observed for the alkyl-1,3 -diaminopropanes. 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 similar as for the alkyl-1,3 -diaminopropanes, the 21 day daphnia EC50(parental
mortality) is included in the table below at the acute EC50 for daphnia.
For classification purposes the acute daphnia result as observed for
R814M is used. The lowest chronic NOEC for (Z)-N-9 -octdecenyl-1,3
-diamopropane is 192 µg R814M/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 19.2
Available ecotoxicity data for R814M used for
72 h algae
96 h fish LC50 (µg/L)
Value used for classification (µg/L)
For chronic classification the long term
ecotoxicity data as read across from oleyl and tallow-1,3
-diaminopropanes are used. Because these studies were performed in
natural river water the value used for Classification is as a worst-case
devided by a factor 10 to compensate for possible mitigation by river
Available river water EC10/NOEC data algae and
chronic daphnia used for classification
R814M read across from Alkyl-1,3-diaminopropanes
21 d daphnia
EC10corr(µg/L) (corrected for Classification with Factor 10)
(Z)-N-9 -octdecenyl-1,3 -diaminopropane
7173 -62 -8
Based on the available
studies on biodegradation, R814M is considered 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 and also not needed
in the framework of PBT/vPvB assessment because the substance is readily
biodegradable and therefore not P. REACh guidance
chapter R.11 on PBT/vPvB assessment (v3.0, June 2017, p. 26).
Measured log Kow
values for Oleyl-1,3,diaminopropane and R814M.
* Considering the limited
solubility of the test substance an OECD 305 -I (water exposure) is
considered as not technically feasible. Because of the strong sorbing
properties of the several constituents of the substance, maintaining
steady concentrations of these constituents in water is technically not
feasible. OECD 305-I and OECD 305-II is therefore waived according to
annex XI, section 2 of REACh regulation EC 1907/2006.
In relation to OECD 305
-III (dietary) testing it should be noted that annex XIII of REACh
requires a fish BCF to be derived to allow comparison with B/vB
criteria. It is however known that OECD 305 -III only provides a fish
BMF and that BMF cannot be directly compared to B/vB criteria. In order
to be used in the framework of the PBT/vPvB assessment of REACh, BMF
must be converted into BCF. Several equations are available to do so.
However, all these equations use log Kow as a key parameter (i.e. they
are based on the lipophilicity of the substance). Since log Kow is not
considered to representatively predict the fate of surfactants, the
available equations cannot be used to convert a BMF into a BCF for the
registered substance. As a result, it is not feasible to derive a
reliable BCF from an OECD 305-III test with the registered substance.
This is due to the cationic surface-active property of the substance
(i.e. one of its intrinsic properties). Performance of an OECD 305 -III
study cannot reach its purpose (i.e. cannot be used to assess B/vB of
In conclusion OECD 305
-III testing is in general for cationic surfactants not technically
feasible and should be waived according to annex XI (section 2) of REACh
regulation EC 1907/2006.
available aquatic ecotoxicity data used for the dossier of "Reaction
mass of Amines, N-tallow alkyltrimethylenedi-, (2-ethylhexanoates),
Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3
-diaminopropane ditallate" (R814M) are presented in the table below
Aquatic ecotoxicity data used for R814M
Corrected value for C&L*
Value for R814M**
Value used for C&L
Fish acute (96h) LC50 (mg/L)
Daphnia acute (48h) EC50 (mg/L)
Daphnia Chronic (21d) EC10/NOEC (mg/L)
Algae acute (72h) ErC50 (mg/L)
Algae Chronic (72h) ErC10/NOEC (mg/L)
read across from alkyl-1,3-diaminopropanes and recalculated to R814M
in bold are Bulk approach data obtained in tests with river water.
Observed for R814M in acute daphnia and algae study.
results presented in the table show that all acute ecotoxicity values
(corrected and uncorrected) are below 1 mg/L. From the fate paragraph it
can be read that all alkyl-1,3 -diaminopropanes are ‘readily
biodegradable’ and have a low predicted bioaccumulation potential based
on the measured log Kow values and observed biotransformation in
in-vitro biotransformation tests.
on this information the environmental classification for R814M according
to CLP (Classification,
Labeling & Packaging Directive 1272/2008/EC) is:
(short-term) aquatic hazard Acute Category 1
corresponding M-factor is 10 based on the EC50 of 0.0482 mg/L.
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.
is readily biodegradable and the lowest EC10/NOEC is 0.0188 mg/L (72h
ErC10 algae test with R814M). This leads to a classification of:
(Long-term) aquatic hazard Chronic Category 1
M-factor is needed for chronic classification based on the EC10/NOEC of
0.0188 mg/L and R814M being readily biodegradable.
need to be assigned.
leads to the following environmental classification according DSD for
(Z)-N-9 -octadecenyl-1,3-diaminopropane and
N-C16-18-alkyl-(evennumbered) C18 unsaturated-1,3-diaminopropane is:
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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