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EC number: 930-993-4
CAS number: -
Long term exposure - systemic effects: Dermal DNEL in
mg/kg bw/day: 2.5 -3.0
In principle, if there is no dose descriptor for
the dermal exposure route available, the available dose descriptor (oral
route, systemic effect) can be converted into a correct starting point
by route-to route extrapolation according to the ECHA guidance document
"Guidance on information requirements and chemical safety assessment.
Chapter R.8: Characterisation of dose [concentration]-response for human
health", May 2008.
convert an oral N(L)OAEL (in mg/kg bw/d) into a dermal N(L)OAEL, the
differences in absorption between routes as well as differences in
dermal absorption between rats and humans have to be accounted for.
Since the oral bioavailablility of zeolites in beagle dogs is less than
3.5 % (Cefali et al. 1996, see chapter 7.1), the bioavailability can be
neglected. On the assumption that, in general, dermal absorption will
not be higher than oral absorption, no default factor (i.e. factor 1)
should be introduced when performing oral to dermal extrapolation.
Furthermore the same bioavailability for experimental animals and humans
is assumed (no default factor, i.e.factor 1). This assumptions results
in the identical N(L)OAEL for the oral and dermal exposure route.
the synthetic zeolites exposure at the workplace is neither regulated on
the EU level nor in any of the member states, the limits for the
exposure at the workplace are derived from the generic dust limits. The
generic dust limits for inorganic dust is defined in Germany in TRGS 900
chapter 2.6, taking into account particle size, solubility and density
of the substance. The AGW (workplace exposure limits) are defined as 10
mg/m3for inhalable and 3 mg/m3for respirable dust.
It is proposed to adopt the more critical value of 3 mg/m3 as
DNEL. This approach is in compliance with the ECHA "Guidance on
information requirements and chemical safety assessment. Chapter R.8:
Characterisation of dose [concentration]-response for human health", May
Oral, Dermal and Inhalation exposure is not a
relevant toxicological issue for general population, based on substance
properties, identified uses and experimental evidence. Therefore, a DNEL
for Oral, Dermal and Inhalation is not derived for the general
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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