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EC number: 246-807-3
CAS number: 25307-17-9
All endpoints are based on measured data
applying assessment factors.
The PNECaquatic bulk is calculated
using the assessment factor proposed by the TGD. As
long-term NOECs from species representing two trophic levels are
available (algae and daphnia) an assessment factor of 50 may be used.
Based on the observed comparable or lower toxicity to fish for primary
fatty amine ethoxylates it is considered unlikely that fish toxicity
will be critical for primary fatty amine ethoxylates. Hence any
additional toxicity testing with fish will not add scientific value to
the ecotoxicity profile of the primary fatty amine ethoxylates 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.
This means that it is proposed to waive the long term fish unless a
further refinement of the effect assessment is considered necessary
based on the outcome of the chemical safety assessment. For
primary fatty amine ethoxylates a safety factor of 50 is applied for the
derivation of the PNECaquatic, bulk
The PNECsed and soil values calculated using
the EPM method were till recently considered of lower reliability for
ionic substances. Chen et al., 2014 have shown that for a quaternary
ammonium compound the concentration of the unbound chemical (i.e., the
freely dissolved concentration) is the relevant dose parameter and that
thus effects for sediment and soil organisms can be predicted using the
EPM without additional correction factor of 10 for additional exposure
via ingestion as long as the pore water concentration is correctly
predicted. Because of the availability of a measured equilibrium
distribution coefficient between water and soil the use of the EPM
without the additional correction factor of 10 is considered to be
Due to intrinsic properties of amine
containing cationic surfactants river water ecotoxicity tests deliver
more 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, is data obtained under standard test
conditions prefered for classification and labeling purposes. If no data
obtained under standard conditions is available the results of tests
performed in natural river water can be corrected for the mitigation
using a worst-case factor of 10 to the L(E)C50 .
algae, daphnia and fish test results.
Primary fatty amines ethoxylates
72 h algae
ERC10/ NOEC (µg/L)
48 h daphnia
21 d daphnia
EC50 (µg/L) used for Classification
EC10 (µg/L) used for classification
Figures given in italic and underlined
are performed in reconstituted lab water. The other endpoints were
obtained by performing tests in natural river water.
primary fatty amine ethoxylates are readily biodegradable.
No measured BCF fish is available for
the primary fatty amine ethoxylates. Standard OECD 305 tests are
technically very complicated with these strongly sorbing easily
biodegradable substances. Three valid measured log Kow values are
however available as presented in the table below.
primary fatty amines ethoxylates
Measured Log Kow
2,2'-(C12-18 evennumbered alkyl imino) diethanol
2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
The highest log Kow is observed for 2,2'-(C16-18
(evennumbered) alkyl imino) diethanol (CAS no 1218787-30-4). For this
product has also the lowest CMC of 3.5 mg/L was observed. The measuredlog
Kow value of 3.6 indicates a moderate bioaccumulation potential for
narcotic substances. For polar narcotics like the primary fatty amine
ethoxylates however there is only limited information on the
relationship between log Kow and BCF.
The observed rapid biotransformation of the C12
to C18 alkyldiethanol amines demonstrates that
it will be very unlikely that these substances will accumulate in fish.
This was confirmed by the calculated BCF values which were all below the
CLP threshold value of 500 L/kg.
according(Classification, Labeling & Packaging Directive 1272/2008/EC)
As all acute ecotoxicity values
(corrected and uncorrected) as given in the first table are below 1 mg/L
the substances should be classified as acute aquatic hazard category 1.
Primary fatty amine ethoxylates are all ‘readily biodegradable’ and have
a measured log Kow < 4. Based on long-term studies a classification for
chronic aquatic toxicity is warranted according to 2nd ATP to CLP. This
leads to the following environmental classification accordingfor
n-Primary alkyl amines ethoxylates
Acute (short-term) aquatic
hazard category 1
M factor 10
Chronic aquatic hazard category
M factor 1
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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