1-chloro-1,1-difluoroethane

Endpoint summary

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

The substance is concluded not to exhibit developmental toxicity as no effects were observed in two developmental toxicity studies up to 10000 ppm (41000 mg/m3).

Effect on developmental toxicity: via inhalation route

Dose descriptor:

NOAEC

41 000 mg/m³

Additional information

Two developmental toxicity studies with rats were available for assessment. Pregnant female rats were exposed 6 hours/day, from day 3 to 15 or 6 to 15 of pregnancy, to airborne concentrations of 1-chloro 1,1-difluoroethane at concentrations ranging from 1000 (4100 mg/m³) to 10000 ppm (41000 mg/m³). No treatment related effects were reported on the pregnant females at all test levels. In one study (Damske et al, 1978), an increased incidence of delayed ossification of supraoccipital bone in both exposure levels was seen. These findings were considered to be usual in the strain of rats used in testing laboratory and not compound-induced. Furthermore such findings were not observed in the second study (Cullik and Kelly, 1976). In both studies there was no evidence of teratogenesis or embryotoxicity or inhibition of fetal growth and development. Consequently NOAEC for developmental toxicity and maternal toxicity is established to be higher than 10000 ppm (41000 mg/m³).

Justification for classification or non-classification

As no developmental toxicity was observed in two developmental toxicity studies with rats up to 10000 ppm (41000 mg/m³), classification is 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.