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EC number: 204-694-8
CAS number: 124-28-7
Worker DNEL: Long-term/short term for inhalation route, local
The German VCI ("Verband der chemischen Industrie") established an
inhalation DNEL for local effects for corrosive substances of 1 mg/m3
that should be applied for long- and short-term exposure equally. The
derivation of this value is fully described in Messinger (2013).
Briefly, the DNEL is a generic cut-off value based on an extensive
analysis of the German occupational exposure limit (OEL) values as
published in TRGS 900 (“Technnische Regeln für Gefahrstoffe”) for
substances that are legally classified as corrosive. Substances
identified as corrosive in self-classifications only were not
considered, since they lack a peer review of the classification
assigned. After exclusion of some (groups of) substances, such as CMR
substances, the evaluation retrieved 40 corrosive substances with OEL
values effective in Germany. In addition to the dermal effects,
corrosive substances often display pronounced acute toxicity when
administered by other pathways, especially via inhalation. When all very
toxic (R26 or R27 or R28) and all sensitising (R42 or R43) substances
were removed from the set of 40 corrosive substances, only 2/24 (8%)
substances had an OEL below 1 mg/m3. The
two substances are 1) sulfuric acid, a very strong acid vigorously
reacting with water and b) barium hydroxide, for which the low OEL was
derived on the basis of systemic effects (Messinger, 2013).
Overall, the applicability domain of the DNEL of 1 mg/m3
for corrosive substances is defined as follows (Messinger, 2013):
- The substance is not a CMR substance, a heavy metal derivative,
a sensitiser and does not hydrolyse to strong acids/bases
- The substance is not very toxic by ingestion, dermal contact or
The submission substance fulfils these criteria and the DNEL of 1
mg/m3 can be applied.
With this DNEL for local effects, any potential systemic effects
are covered as well.
Messinger, H.: An approach for the delineation of a generic cut-off
value for local respiratory tract irritation by irritating or corrosive
substances, 2013 (manuscript submitted for publication).
General population DNEL: Long-term for oral route, systemic effects
The DNEL long-term, oral exposure, systemic effects is derived from a
toxicity study with oral exposure. The most sensitive NOAEL for this
category was the NOAEL of 50 mg/kg bw/day identified in a chronic
toxicity study with rats.
Basis NOAEL: 50 mg/kg bw/day from a 2 -year oral toxicity study in rats
No specific values on oral absorption available, therefore default
assumption for oral absorption: 100 %
· Interspecies differences: 4 (allometric scaling), 2.5
· Intraspecies differences: 10
· Differences in duration of exposure: 1 (chronic study available)
· Issues related to dose-response: 1 (none)
· Quality of whole database: 1 (no deficiencies)
--> Overall assessment factor: 100
DNEL = 50 mg/kg bw/day / 100
DNEL = 0.5 mg/kg bw/day
An existing European evaluation is available. The European Food Safety
Authority (EFSA), using the same experimental study in rats as the
basis, derived a TDI for C12-20 -DMA (described by EFSA as "Alkyl,
linear with even number of carbon atoms (C12 -C20) dimethylamines") that
is identical to the DNEL derived here (0.5 mg/kg bw/d).
EFSA, European Food Safety Authority (2007): Scientific Opinion of the
Panel on food additives, flavourings, processing aids and materials in
contact with food (AFC) on a request related to a 16th list of
substances for food contact materials, The EFSA Journal, 555-563, 1-31
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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