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EC number: 413-110-2
CAS number: 135861-56-2
The Pow value is not sufficiently high to indicate potential for bioaccumulation and there is no experimental evidence of this.
The substance is a sorbitol acetal derivative of molecular
weight which does not preclude absorption. Some limited
predictions relating to toxicokinetic behaviour can be made
based on the chemical structure. In principle, hydrolysis
might occur so there may be oral exposure to the aldehyde
and sorbitol degradants. The substance is a powder and,
although it contains a relatively high proportion of
particles of respirable size, its clumping properties are
such that significant inhalation exposure is considered to be unlikely.
Acute oral and dermal toxicity studies showed no toxicity
and, therefore, provide no evidence of absorption.
Nevertheless, a treatment-related increase in liver weight
was observed in a repeated dose oral toxicity study (28 -day)
which probably indicates at least some absorption by this route. The
substance has a relatively low log Pow value, but, in view
of the low water solubility, it may be sufficiently
lipophilic for absorption to occur. The substance is not
ionisable so pH will not affect absorption but the low water
solubility might result in deposition at the dosage site
which would reduce availability. Hydrolysis could occur
within the gastro-intestinal (GI) tract producing aldehydes
which could be absorbed and sorbitol which is poorly
absorbed from the GI tract.
There is no experimental evidence to indicate distribution.
The only effect seen in the toxicity studies involved the
liver so distribution beyond this has not been demonstrated.
The Pow value is not sufficiently high to indicate potential
for bioaccumulation and there is certainly no experimental
evidence of this. The substance is not a skin sensitiser so
it may not become bound to proteins.
The chemical structure indicates that biotransformation
would be expected, most probably by hydrolase enzymes
producing sorbitol and aldehydes. The sorbitol would be
metabolised via sorbitol dehydrogenase to fructose, whilst
the aldehydes would be expected to be oxidised by one of the
oxidative enzyme systems and the resulting acid conjugated
with glucuronic acid or amino acids. There are, however, no
experimental data to substantiate this biotransformation.
The in vitro mutagenicity studies showed no differences in
toxicity or mutagenicity in the presence or absence of S9 (a
rat hepatic microsomal enzyme broth). The increased liver
weight in the repeated dose oral toxicity study could be
associated with enzyme induction but, in the absence of any
histopathological changes such as hepatocyte enlargement,
this is by no means certain.
There is no experimental evidence to indicate the route of
excretion but the low water solubility of the parent
substance is such that it could not be eliminated, unchanged
in urine or bile. The biotransformation products would be
expected to either enter the normal energy yielding
metabolic processes, in the case of fructose or, in the case
of the conjugation products, be eliminated in bile or urine.
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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