Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
18 000 mg/m³
Additional information

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).

A male/female fertility study in the rat did not reveal any effect at up to 7000 ppm vinylidene fluoride (18000 mg/m3) (Civo, 1986).

Short description of key information:
A male/female fertility study in the rat did not reveal any effect at up to 7000 ppm vinylidene fluoride (18000 mg/m3).

Effects on developmental toxicity

Description of key information
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).
Effect on developmental toxicity: via inhalation route
Dose descriptor:
26 000 mg/m³
Additional information

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 mg/m3).

Justification for classification or non-classification

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) No. 1272/2008.