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EC number: 431-620-3
CAS number: 162537-11-3
Based on two acute toxicity studies in rat (oral and dermal), 28 day
oral study in rats and oral (daily) Study of Fertility and Early
Embryonic Development (rat). Also consideration of the substances water
solubility, partition coefficient, molecular mass and particle size.
The substance is a substituted valine of molecular weight
that does not preclude absorption. The substance is stable to hydrolysis
so exposure to degradation products is not relevant.
Oral: evidence presented by the subacute oral toxicity study indicates
that the substance is slightly absorbed following at the high
dose. Additionally, no toxicologically significant effects were observed
on reproductive or developmental parameters in the exposed animals.
Inhalation: It is a non-volatile powder with a proportion of
particles in the respirable size range so inhalation
exposure is possible. Evidence presented by the acute inhalation study
indicate some systemic absorption but only at high doses: lethargy,
hunched posture, and piloerection were observed in the animals. Laboured
respiration and ptosis were seen for the males and watery discharge and
chromodacryorrhoea was seen for the females. However, these effects were
reversible after 6 days.
Dermal absorption: The low Log Kow (0.832) and the high water solubility
(26.4g/L) would indicate that absorption to the lipophilic stratum
corneum would be low. No effects were detected in an acute dermal study
up to a limit value of 2000mg/kg and no effects seen in in-vivo
Distribution: No specific distribution studies have been conducted
the low log Pow value indicates
that wide distribution and bioaccumulation would not be expected.
However it is conceivable based on limited evidence from the 28 Day
study at the higher dose concentrations (1000mg/kg) that some
distribution may occur.
Macroscopic findings including small spleen, gaseous distension of
the intestines and stomach and thinning/sloughing of the non-glandular
gastric epithelium and microscopic examination of tissues revealed an
increased incidence and severity of agglomeration of secretion and
goblet cell hyperplasia in the stomach indicates that some there is some
distribution throughout the body at high doses. The substance is
not a contact sensitiser and may, therefore, not become
bound to proteins.
Metabolism: there is no evidence to suggest metabolism; it is
possible, if possible, that the substance could be metabolised
as an amino acid by transamination, deamination or
Excretion: No specific excretion studies have been conducted
however the physical characteristics (MW, water solubility and partition
coefficient), would suggest that the substance is excreted by the
kidneys. Amino acid catabolism could occur resulting in
production of urea. The parent substance is non-volatile so
elimination via the lungs, in expired air, would not be expected.
Based upon the results of repeat dose toxicity testing and the physical
properties of the substance, it can be predicted that absorption and
distribution can be expected by the oral and inhalation routes. Uptake
is unlikely by the dermal route, a default value of 10% is assigned
based upon the physical properties of the substance.
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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