Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
2 816 mg/m³
Additional information

Based on the classification and labelling of vinyl chloride as genotoxic carcinogen and appropriate risk management measures are implemented, no studies are required. Nevertheless data is available and summarised below.

In a recent well conducted combined two-generation reproductive/developmental study in rats the NOAEC for reproductive effects was 1,100 ppm (2816 mg/m3), the highest dose tested (Thornton, 2002). No effect of exposure of parental animals to vinyl chloride was noted on mating indices, pregnancy rate, male fertility, gestation length, parturition data, or litter size. However, a parental NOAEC was determined to be 10 ppm (increased liver weight, liver changes in dams).


Short description of key information:
Based on the available animal studies, a NOAEC of 2816 mg/m3 (the highest dose tested) was established for vinyl chloride for effects on fertility.

Effects on developmental toxicity

Description of key information
Based on the available animal studies, a NOAEC of 2816 mg/m3 (the highest dose tested) was established for vinyl chloride for developmental effects. 
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
2 816 mg/m³
Additional information

Based on the classification and labelling of vinyl chloride as genotoxic carcinogen and appropriate risk management measures are implemented, no studies are required. Nevertheless data is available and summarised below.

Human studies have not linked vinyl chloride exposure with developmental toxicity.

In a recent well conducted combined two-generation reproductive/developmental study in rats the NOAEC for developmental effects was 1,100 ppm (2816 mg/m3), the highest dose tested (Thornton, 2002). There was no effect of treatment on sex ratio, foetal body weight or number or type of malformations.

However, a parental NOAEC was determined to be 10 ppm (increased kidney:body weight ratio).

The weight of evidence of older developmental studies indicates that vinyl chloride produces foetal toxicity only at exposures that produce maternal toxicity (John et al, 1977 and 1981).

Justification for classification or non-classification

Based the absence of effects on fertility and developmental effects at the highest tested concentration of 2816 mg/m3, classification is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.