Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 445-790-1
CAS number: 404362-22-7
Relevant phys.-chem. substance properties
The submission item is a multiconstituent substance consisting of four
main components. One compound is soluble in water to ca. 2 g/L whereas
the three other main components have low water solubilities. All four
major components have a low vapour pressure. The substance (in its
non-ionised form) exhibits surface-active properties and has a high
octanol-water partition coefficient of log Kow >6.2.
Transport and distribution
The constituents of the submission item may occur in an ionised form
under environmental pH conditions. This is because the amine groups
present will be ionised at pH values found in the environment and the
cationic species tend to bind strongly to soil/particles due to
partitioning onto organic matter or interactions with clay minerals. In
conclusion, it can be expected that the submission item has the
potential to adsorb to soil and sediment particles under environmental
conditions. The low vapour pressure of the substance results in a low
Henry's Law constant, which makes it unlikely that the substance will be
released from water surfaces or the soil compartment to the atmosphere
in significant amounts.
Stability - abiotic and biotic degradation
The submission item is unlikely to undergo hydrolysis in significant
amounts under environmental conditions and the hydrolysis half-lives of
the four components are greater than 1 year at 25 °C. In addition, there
is no hint that the substance may be transformed by sunlight
irradiation. Considering the lack of biodegradation observed in the
ready biodegradation test, it is to be expected that the submission item
is unlikely to be degraded to a significant extent under the conditions
of an inherent biodegradability study, unless a toxic effect to the
microorganism community was the reason for the absence of degradation.
In the study of Clarke (2002) on the toxicity to microorganisms
according to OECD TG 209 the NOEC was found to be 10 times lower than
the initial concentration in the ready biodegradation test of 100 mg/L.
The EC 50 in this study was at 70 % of the concentration used in the
MITI test for ready biodegradability. It seems therefore possible, that
significant intoxication of the microorganism community prevented
biodegradation the MITI test. Nonetheless, as long as no data are
becoming available indication ultimate biodegradability of the substance
under real environmental conditions, the test item should be regarded as
non-biodegradable. Based on these grounds the screening assignment
"P/vP" shall be given.
The submission item shall not be considered to fulfil the B criterion of
PBT substances, based on the following:
1) BCFWIN computations lead to log BCF results of 1.37, 2.99, and 2.82,
respectively, for the three major substance components. These results
all below the cut-off value for the B criterion of log BFC 3.3 (BCF
These BCFWIN-computed data even are to be seen as worst case results
(i.e. tendency of overestimation of the BCF results as computed via
BCFWIN), as they include a number of worst case assumptions:
2) In the environmentally relevant pH range 5 - 9, the ionised species
of the three major components of the submission item are prevailing,
whereas the BCFWIN computation was based on log Kow estimates of the
non-ionised species (Kow estimates for non-ionised species are higher
than for the ionised species).
3) Computed pH-dependent log D values show clearly that these log D data
within the environmentally relevant pH range 5 - 9 are much lower than
the BCFWIN estimates for log Kow (and lower as the HPLC-based log Kow
results, which also were being obtained with non-ionised substance
4) BCF computations based on log D values reveal log BCF results of
0.36, 1.9, and 1.94, respectively, which all are well below the
regulatory cut-off value for the B criterion of 3.3.
With the evidence provided it safely can be assumed that the substance
is not fulfilling the B criterion, and that the submission item
therefore shall not be considered as a PBT or vPvB substance. Based on
these grounds, a study on bioaccumulation can be waived, what further
can be supported by the fact that (referring to the restricted
industrial uses of the substance, and based on the high adsorption
potential) a direct or indirect exposure to the aquatic environment 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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again