Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
3.3 mg/kg bw/day
Additional information

In a study conducted by Brown-Woodman et al(1979), the test substance was evaluated for its ability to induce reproductive toxicity when administered to male Wistar rats via intraperitoneal injection over a period of 14 days. The test substance was administered at a concentration of 3.3 mg/kg b.w. Following 7 days of treatment, the males were cohabited with 2 females and the presence of spermatozoa in vaginal smears was taken as evidence of mating. Pregnancy and litter sizes in females were determined 20 days after mating. Under the conditions of this study, no effects were observed on fertility. There was a reduction in the number of spermatozoa counted in vasa deferentia, mean litter size, mean embryo weight and sperm motility. No effect on body, testes and spleen weight, epididymal and thymus hypertrophy. Based on these results, the NOAEL was determined to be 3.3 mg/kg bw/day. Under the conditions of this study, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.

No data on developmental and reproductive effects in humans were available to the WHO Working Group (IARC Monograph Vol. 77) but the group evaluated available animal study results and concluded no effects on fertility or development were observed in mice given intraperitoneal injections of glycidol 24 h before mating or orally during organogenesis. In contrast, when a single dose of glycidol was administered to female mice within 25 h after mating, the numbers of fetal deaths and anomalies were increased. Intraamniotic injection of glycidol on day 13 of gestation in rats increased the frequency of resorptions and, at high doses, limb malformations.


Short description of key information:
A key study is available. The study was conducted in male Wistar rats administered the test substance via intraperitoneal injection.

Effects on developmental toxicity

Description of key information
One key study is available.  The study was conducted in female rats exposed to the test substance via inhalation exposure.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
14.5 mg/m³
Additional information

In a study conducted by Koeter and Appelman (1980) the test substance, Glycidol, was examined for its ability to cause reproductive toxicity when administered to female rats. The test animals were exposed via inhalation, at concentrations of 0, 50, 150 and 300ppm, although due to overt toxicity observed at the highest dose level, this was reduced to 250ppm after 11 days exposure. The female rats were mated and pregnancy was confirmed by the presence of sperm in a vaginal smear (day 0 of pregnancy). The females were exposed to the test substance for 6 hours, from days 6 to 16 of pregnancy.

Clinical observations and body weight were recorded from day 0 to day 21, at which point the animals were sacrificed. The uterus and ovaries were removed and examined and the number of corpura lutea, implantation sites and the number of early and late resorptions were recorded. Half the foetueses from each litter were examined for soft tissue abnormalities and half for skeletal malformations. Under the conditions of this study, the NOAEC for maternal rats was determined to be 53ppm while the NOAEC was determined to be 145ppm for embryo/foetotoxicity. Under the conditions of this study, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.

Justification for classification or non-classification

Effects on fertility:

Under the conditions of the key study, the test substance, Glycidol, does not require classification acording to Regulation EC No. 1272/2008 or Directive 67/548/EEC, although some effects were evident affecting

a reduction in the number of spermatozoa counted in vasa deferentia, reduced mean litter size, lower mean embryo weight and reduced sperm motility. Evidence from the supporting studies was equivocal, with no clearly identified effects on fertility or reproductive performance.

However, glycidol is classified in Annex VI of Regulation 1272/2008 as a Repr. Cat 1B and despite the lack of confirmatory evidence in the studies presented in the dossier, the harmonised classification was adopted. Glycidol is therefore classified as Repr. 1B, H360F according to GHS and Repr. Cat 2, R60 may impair fertility in accordance with Directive 67/548/EEC (as subsequently amended).

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Developmental Toxicity/Teratogenicity:

Under the conditions of this study, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.