Registration Dossier
Registration Dossier
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EC number: 484-420-3 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The substance, an UVCB, is a reaction product of the esterification of
fatty acids (C14-18 and C16-18 unsaturated, octanoic acid,
decanoic acid, 2-ethylhexanoic acid) with pentaerythritol.
The toxicokinetic assessment is based on the
physical/chemical properties as determined for the test
substance and it is anticipated that these properties are
representative for all constituents in this substance.
The water solubility is very low (<1 mg/L). Since in general
a substance needs to be dissolved before it can be taken up
from the gastro-intestinal tract, it is unlikely that the
test substance will show a high systemic exposure after oral
administration. The absorption will furthermore be lowered
by the relatively high molecular weight (approx. 930) of
this substance limiting the passage through biological
membranes. Its highly lipophilic character (logPow > 5.1)
indicates that uptake by micellular solubilisation may be of
particular importance. For risk assessment purposes the
oral absorption of the test substance is set at 10%. The
results of the toxicity studies do not provide reasons to
deviate from this proposed oral absorption factor.
No significant cleavage of the ester bounds is to be
expected in the gastro-intestinal tract, due to the limited
water solubility. In the case absorption of the test
substance occurs, cleavage of the ester bonds and
conjugation is to be expected. The test substance, the
resulting metabolites and conjugation products will be
excreted via feces (high molecular substances) or via urine
(low molecular substances).
The low vapour pressure (< 8.40 x 10-7 Pa) indicates that
the availability of the substance for inhalation will be
limited. However, once present in the respiratory tract, the
low water solubility (<1 mg/L) indicates a potential for
accumulation, while its lipophilic character (logPow > 5.1)
indicates the potential for absorption directly across the
respiratory tract epithelium. For risk assessment purposes
the inhalation absorption of the test substance is set at
100% as a worst case assumption.
The low water solubility (<1 mg/L) and its highly lipophilic
character (logPow > 5.1) do not facilitate dermal
absorption. Following the relatively high molecular weight
of the substance (approx. 930), it can be concluded that the
criteria for 10% dermal absorption as given in the REACH guidance
(MW > 500 and logPow > 4) are met. Therefore, 10% dermal
absorption of the test substance is proposed for risk
assessment purposes. The results of the toxicity studies do
not provide reasons to deviate from this proposed dermal
absorption factor, although the slight skin irritating properties
might reduce the skin barrier and hence enhance dermal absorption.
Based on the present available data, no additional
conclusions can be drawn on the metabolism and excretion of
the test substance after dermal and inhalatory absorption.
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.
