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EC number: 604-045-2
CAS number: 137862-53-4
Based on the available data, oral absorption of valsartan for risk
assessment purposes is set to
35% as a worst-case value.
No information on respiratory absorption of valsartan was recovered from
public literature. The
vapor pressure of the substance is very low (<0.0000001 hPa) which
indicates that its
availability for inhalation as a vapor is negligible. The test substance
is a powdery solid, with
a median particle size of 3 μm. In humans, particles with aerodynamic
diameters below 100
μm have the potential to be inhaled. Particles with aerodynamic diameter
below 50 μm can
reach the thoracic region, and those below 15 μm the alveolar region of
the respiratory tract.
The particles of the substance can therefore deposit in the alveolar
region where they may be
engulfed by alveolar macrophages. The macrophage could then either
translocate particles to
the ciliated airways or carry particles into the pulmonary interstitium
and lymphoid tissues.
For risk assessment purposes, the inhalation absorption of valsartan is
set at the default value
of 100%, taking into account its small particle size and its moderate
A study on the in vitro dermal penetration of valsartan through rat skin
was reported in public
literature. The passive diffusion of valsartan produced a flux of 39.3
μg/cm2/hour, and the
substance was thus able to penetrate the skin. According to the ECHA
guidance, a default
value of 100% skin absorption is generally used unless molecular weight
is above 500 and log
Pow is outside the range between -1 and 4. However, it is generally
accepted that dermal
absorption does not exceed oral absorption. Therefore, for risk
assessment purposes, it is
considered acceptable to set the dermal absorption of valsartan at 35%.
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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