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EC number: 200-867-7
CAS number: 75-38-7
The acute inhalation toxicity of vinylidene fluoride is low. The LC50 in rats is established to be >130000 mg/m3.
In accordance with
section 2 of REACH Annex XI, studies via the oral and dermal route do
not need to be conducted as the substance is a gas.
inhalation toxicity tests have been performed, which are more or less
comparable to LC50 studies.
In a series of acute
inhalation experiments, the lethal concentration for rats and mice after
1-hour exposure was greater than 200000 ppm. Animals were observed for 7
days post exposure. Only the mice showed some minor behavioral changes
(Pennwalt, 1974; 1982). In another test, rats were exposed to levels up
to 80% (+20% oxygen) for up to 19 hours. No mortality was observed. At
exposures to a concentration of 80%, some minor CNS effects were noted.
No pathological changes were reported (Lester et al. 1950). Other test
reports mentioned mortality of mice at 128000 ppm after a four-hour
exposure but results are difficult to interpret because of variable
exposure periods and the possibility of inadequate oxygen supply
(Carpenter et al, 1949).
In an acute
hepatotoxicity test with Holtzman rats, animals were exposed to
concentrations of 0, 500, 15000 and 25000 ppm for 4 to 6 hrs. No
mortality was observed. Only animals pretreated with polychlorinated
biphenyls showed increased liver weights, increased serum sorbital
dehydrogenase activity and hepatocellular damage at VF2 concentrations
of 500 ppm VF2 and above (Conolly et al, 1979).
Although none of the
mentioned studies were performed according to currently prescribed
standard protocols, the Pennwalt data indicate clearly that the
substance has a low acute toxicity. The other acute studies corroborate
the weight of evidence for low acute toxicity.
As the classification
and labelling according to EU Directive 67/548/EEC should be based on 4
hours exposure, a time extrapolation is required in this case. According
to Chapter R.8 of REACH Technical Guidance Document, if time
extrapolation is considered valid, then the most appropriate approach is
to make use of the modified Haber’s law (Cnx t = k,
where ‘C’ is the concentration, ‘n’ is a regression coefficient, ‘t’ is
the exposure time and ‘k’ is a constant) according to which the
relationship between exposure concentration and exposure duration for a
specific effect is exponential. A default value of n=1 is suggested for
extrapolating from shorter to longer exposure durations. Therefore the
recalculated LC50 for 4 hours exposure based on the Pennwalt studies
with rats is established to be > 50000 ppm.
Dogs and cats survived
exposure to 50% in air without cardiac sensitizing effects (Burgison,
Based on the 4 hours LC50of
> 50000 ppm (130000 mg/m3) in rats and the absence of
other major significant effects, vinylidene fluoride does not need to be
classified for acute toxicity according to EU Directive 67/548/EEC and
EU Classification, Labelling and Packaging of Substances and Mixtures
(CLP) Regulation (EC) No. 1272/2008.
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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