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EC number: 701-388-0
CAS number: -
There are no specific studies available on the ADME of Dantocol DHE.
However, data is available from the physico-chemical parameters, in
vitro and in vivo toxicology studies and these have been employed to
predict the ADME for this substance.
The physico-chemical characteristics of Dantocol DHE suggest that the
UVCB may be absorbed via the gastro-intestinal tract. The UVCB contains
mono, di, tri and tetra ethoxylated isomers and the MW covers a range
(not more than 500) with approximately 77% of Dantocol DHE comprising of
the diethoxylated isomers (MW of 216). The low MW taken together with a
Log P of 1.32 and high water solubility are indicative of high
absorption following oral exposure. A pKa (dissociation constant) in
water has not been determined.
The low toxicity in the oral toxicity studies may be a function of
innate low toxicity associated with the structural and functional
characteristics of the molecules in the UVCB given that appreciable oral
absorption is likely to occur.
Dantocol DHE is a waxy solid with a range of MW (with approximately 77%
of the composition being the diethoxylated isomers with a MW of 216) and
a Log P value of 1.32. It is miscible in water at any proportion. These
parameters suggest that the substance may be capable of significant
systemic absorption through the dermal route. This is because the
substance must be sufficiently soluble in water to partition from the
stratum corneum into the epidermis.
The low acute dermal toxicity (as indicated by an LD50 of over 2000
mg/kg bw) taken together with the lack of skin sensitisation and
irritation suggests that this UCVB has low toxicological activity to the
skin given that absorption is likely.
Dantocol DHE is not expected to be highly volatile given that vapour
pressure is 0.0021 Pa at 25°C and boiling temperature is 657K ± 0.5K at
98.7kPa. Therefore, significant exposure as a vapour is unlikely. The
substance is a waxy solid and therefore it is not technically possible
to determine a particle size. However, in the absence of further
information any absorption via this route should be assumed to be 100%
given that Dantocol DHE is water soluble.
Dantocol DHE is moderately irritating to the eyes as evidenced by
effects observed following ocular exposure of New Zealand White rabbits.
The substance caused redness and swelling of the conjunctiva in all
animals and ocular discharge was seen in 5 of the 6 animals. Moreover,
reversible adverse ocular effects were reported in an acute inhalation
toxicity study in rats. This may be indicative of some ocular
absorption. Equally, this could also be as a result of the toxicological
activity of Dantocol DHE via this route of exposure.
There are no studies available to evaluate the systemic distribution of
Dantocol DHE. The low acute toxicity findings from the oral, dermal and
oral repeated dose studies provide no evidence regarding the systemic
distribution of Dantocol DHE. Given that the UVCB is soluble in water it
is likely that Dantocol DHE would be distributed in the organs within
the body at appreciable levels. In the absence of other information it
is not possible to make conclusions on the distribution of Dantocol DHE
in the body.
There are no studies available to evaluate the metabolism of Dantocol
DHE. However, Dantocol DHE did not induce mutagenicity or genotoxicity
in in vitro studies both in the presence and absence of a metabolic
activation system. This could be indicative of a lack of metabolism of
the parent compounds, however this could also be taken to mean that both
the parent compounds and any metabolites that are formed are not
mutagenic or genotoxic. Indeed, the substance was also negative in an in
vivo genotoxicity assay.
There are no studies available to evaluate the excretion of Dantocol
DHE. The MW of Dantocol DHE is a range because it is a UCVB. Small
organic compounds are more likely to be excreted in the urine. Biliary
excretion is more likely for high MW compounds either because of
biotransformation by phase 2 conjugation or because the parent is
innately large (>500 MW). Therefore it is possible that the smaller
molecules in Dantocol DHE may be excreted via the urine. This is
expected for the majority of Dantocol DHE given that approximately 77%
of the UVCB is in the form of the diethoxylated isomers with a MW of
216. The UVCB contains mono, di, tri and tetra ethoxylated isomers and
none of these will have a MW >500 so it is likely that urinary excretion
will predominate. However, there is no conclusive evidence for this and
it will depend on the extent of metabolism.
Summary and conclusions
Dantocol DHE is a UCVB and is comprised of a range of MW with the major
constituents (diethoxylated species) being approximately 216, it is
water soluble and has a Log P of 1.32. The MW range and physico-chemical
properties of Dantocol DHE indicate that it is likely to be absorbed via
the oral and dermal routes of exposure. The available toxicology studies
show that there are no adverse effects associated with acute (oral and
dermal) and repeated dose (oral) exposure to Dantocol DHE and it is not
a skin sensitiser nor is it a skin irritant. This is suggestive of a
function of innate low toxicity as opposed to low bioavailability by the
oral and dermal routes of exposure. Exposure via the inhalation route to
Dantocol DHE is unlikely given that the substance has a very low vapour
pressure. However, in the absence of further information any absorption
via this route should be assumed to be 100%. There is no evidence
regarding the distribution, metabolism, metabolite fate or excretion of
Dantocol DHE. Excretion via the kidneys is considered likely based on
the Log P and relatively low MW of the constituents of the UVCB. There
was no information on bioaccumulation but based on the Log P of 1.32
significant bioaccumulation is unlikely.
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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