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EC number: -
CAS number: -
710 is a reddish-brown viscous liquid, although it may sometimes appear
yellowish. It has a boiling point of 177°C. It
is poorly soluble in water with a solubility of 2.807 mg/L at 21°C. Due
to its chemical nature it is not possible to experimentally determine a
Log Pow; however, a calculated Log Pow of 5.51 is
available which indicates that it is likely to be very lipid soluble.
hydrolysis information is available as the test was waivered because
KOMAD 710 is classified as readily biodegradable having attained 100%
biodegradability after 28-days in a ready biodegradability test.
710 a viscous liquid at room temperature (18°C). No
vapour pressure is available as the test was not technically possible as
when a determination was made a true boil could not be achieved. However,
given its viscous nature it is anticipated that KOMAD 710 will not be
able volatise easily and therefore exposure and absorption via the
inhalation route is considered unlikely.
710 has a low water solubility but a high calculated Log Pow of
5.51 and it can therefore be expected to be very lipid soluble and that absorption
across the gastrointestinal mucosa will occur as it passes through the
gut. Cell membranes walls contain a family of fatty acid active
transport proteins (SLC27); however, given that KOMAD 710 lacks direct
similarity with endogenous molecules, it is not possible to confirm if
these transport proteins will be able to transport KOMAD 710.
is no information with which to assess the dermal absorption of KOMAD
its high Log
Pow and likely lipid solubility it is conceivable that dermal
absorption could occur.
that KOMAD 710 is a UVCB it is likely that different components may be
absorbed to different degrees, or not at all.
710 contains 2,2'-iminodiethanol as an identified component. It
is not free within the product, but believed to be bound by physical
forces to the fatty acid chains. What
its absorption profile will be and how it may be affected by being bound
to the KOMAD 710 fatty acids and /or other components is not known.
acute oral toxicity study on KOMAD 710 gave an LD50 values female rats
of > 2000 mg/kg bw. There
were no deaths, clinical signs or abnormalities at necropsy. Because
of the lack of observations it is not possible to draw any conclusions
as to whether the dose of KOMAD 710 was absorbed.
OECD 422 oral repeated dose reproductive developmental toxicity
screening study has been conducted on KOMAD 710 at doses of 100, 330 and
750 mg/kg bw/day. A
significant number of effects were noted on this study indicating that
KOMAD 710 was absorbed during the dosing period. Organs
affected included kidneys, lungs, stomach, mammary
gland and liver. Changes
were also seen in body and organ weights along with changes in liver
enzymes, haematological parameters and changes to some reproductive
study NOAEL for both general systemic toxicity and reproductive effects
was 100 mg/kg bw/day.
wide ranging effects demonstrate that KOMAD 710 or its components can be
absorbed following repeated oral exposure. It is not possible to assess
if all components are absorbed to an equal degree.
should be noted that the identified component of KOMAD 710,2,2'-iminodiethanol,
has shown significant toxicity in repeated dose studies and it is not
possible to excluded the scenario that it is wholly or in part
responsible for the toxicity observed. Hence the absorption profile for
KOMAD 710 fatty acid components may be different from that suggested by
the toxicological observations.
is not possible to determine the distribution of systemically absorbed
KOMAD 710 with available studies.
significant number of toxicological effects were observed in the OECD
422 repeated dose study; however, it is not possible to establish if
these were direct effects of KOMAD 710, individual components, or the
effects of metabolites.
is no data on the mammalian metabolism of KOMAD 710. Given
it is made up of fatty acid chains it could be expected that it will in
part be metabolised by bacteria in the gut and any absorbed material, be
it KOMAD 710, or products from its metabolism by gut bacteria will
subsequently undergo fatty acid catabolism in cell mitochondria
(excluding red blood cells which do not contain mitochondria and
possibly the central nervous system as long chain fatty acids cannot
cross the blood brain barrier).
the ready biodegradability test using sludge organisms, KOMAD 710
underwent 100% degradation indicating that all components are readily
metabolised by bacteria and other organisms found in the environment.
Ames, Chromosome Aberration and Mouse Lymphoma assays conducted on KOMAD
710 gave negative
responses in both the presence and absence of an S9 metabolising system. No
conclusions about the potential of KOMAD 710 to undergo metabolic change
can be drawn from these studies given that negative responses were
observed both in the presence and absence of S9.
route or details of excretion of KOMAD 710 can be deduced from the
studies available. Material that is not absorbed from the gut or
metabolised by gut bacteria can be expected to
be excreted in the faeces. Given its fatty acid composition it is likely
that after entering the fatty acid catabolism pathways component parts
will be incorporated into other molecules. Excretion
may therefore be limited, but where it does occur a proportion is likely
to be via the urine as this is a route of excretion for fatty acids.
An expert review of toxicokinetic data on
KOMAD 710 was undertaken to provide a basic toxicokinetic asessment as
required for REACH Annex VIII registration. The assessment was based on
available data from toxicological studies studies and some literature
references. No specific toxicokinetic studies were undertaken.
from repeated dose oral toxicity studies demonstrate that KOMAD 710 or
components of it can be absorbed from the gastrointestinal
system and exert systemic effects.
absorbed KOMAD 710 will probably enter fatty acid catabolism pathways
and be metabolised; however, it is not possible to determine if
metabolism will be similar for all components.
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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