Registration Dossier
Registration Dossier
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EC number: 200-831-0 | CAS number: 75-01-4
Endpoint summary
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
Additional information
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.
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