For definition of Groups, see Preamble Evaluation.
VOL.: 77 (2000) (p. 469)
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5. Summary of Data Reported and Evaluation
5.1 Exposure data
Glycidol is an epoxide used as a chemical intermediate in the production of functional epoxides, glycidyl urethanes, pharmaceuticals and other products. It is also used as a reactive diluent in epoxy resin systems and as a sterilant. Occupational exposure may occur during its production and use. No data were available on environmental exposure to glycidol.
5.2 Human carcinogenicity data
No data were available to the Working Group.
5.3 Animal carcinogenicity data
Glycidol has been tested by oral administration in one study in mice, in one study in rats and in one study in hamsters. It was also tested by skin application in one study in mice. After oral administration to mice, it produced increases in tumours of the Harderian gland in both males and females, of the forestomach, lung, liver and skin in males, and of the mammary gland and subcutaneous tissue in females. In rats, it produced increases in the incidence of gliomas of the brain and forestomach tumours in both males and females. Mesotheliomas of the tunica vaginalis/peritoneum, as well as tumours of the intestine, skin, thyroid gland and Zymbal gland were increased in males. Tumours of the clitoral gland, mammary gland and oral mucosa as well as leukaemia were increased in females.
In hamsters, there was a marginal increase in the incidence of splenic haemangiosarcomas after oral administration.
No skin tumours were observed in mice after skin application.
5.4 Other relevant data
Glycidol is an alkylating agent which reacts readily with glutathione. It causes a decrease in glutathione content in rat liver, probably reflecting its binding to glutathione. In rats, it is metabolized to oxidative and glutathione-derived products. No toxicokinetic data on humans were available.
No data on developmental and reproductive effects in humans were available to the Working Group.
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. Intra-amniotic injection of glycidol on day 13 of gestation in rats increased the frequency of resorptions and, at high doses, limb malformations.
Glycidol has been shown to be genotoxic using assays covering a wide range of end-points. In vitro, it did not require metabolic activation to elicit positive responses.
5.5 Evaluation
No epidemiological data relevant to the carcinogenicity of glycidol were available.
There is sufficient evidence in experimental animals for the carcinogenicity of glycidol.
Overall evaluation
Glycidol is probably carcinogenic to humans (Group 2A).
For definition of Groups, see Preamble Evaluation.
In making the overall evaluation, the Working Group took into consideration that glycidol is a direct-acting alkylating agent that is mutagenic in a wide range of in-vivo and in-vitro test systems.
Synonyms
See Also:
Toxicological Abbreviations
Glycidol (ICSC)