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EC number: 200-867-7
CAS number: 75-38-7
The potential effect
of vinylidene fluoride on male and female fertility and reproduction has
been studied in rats. In a 13-week inhalation study there was an effect
on the testes (at 7000 and 40000 ppm), indicating impaired
spermatogenesis (Civo, 1986). However, a subsequent 13-week study
(concentrations tested up to 7000 ppm), with emphasis on male fertility,
failed to confirm this earlier finding (Civo, 1987) (for both studies:
see repeated dose toxicity).
fertility study in the rat did not reveal any effect at up to 7000 ppm
vinylidene fluoride (18000 mg/m3) (Civo, 1986).
A teratology study in the rat did not indicate any embryotoxic, foetotoxic or teratogenic effect at the highest concentration tested (10000 ppm; 26000 mg/m3).
In a teratology study
female pregnant rats were exposed to 0, 2000 and 10000 ppm vinylidene
fluoride during gestation days 6 to 15 (Litton Bionetics, 1978). Mothers
were sacrificed on day 20 of pregnancy. No effects were observed at any
concentration on maternal body weight, food consumption, nor on number
of implantation sites, corpora lutea live and dead fetuses resorption
sites. No treatment-related effects were seen at any concentration
tested on fetal soft tissues of head, thoracic and visceral organs, nor
on skeletal structures. The NOAEC for teratogenicity was considered to
be greater than or equal to 10000 ppm (26000 mg/m3).
Overall, this study
supports the starting point for DNEL derivation, i.e., 10000 ppm (26000
Based on the available
data, classification for effects on fertility and developmental toxicityis
not warranted according to EU Directive 67/548/EEC or EU Classification,
Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC)
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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