Registration Dossier
Registration Dossier
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EC number: 209-128-3 | CAS number: 556-52-5
Carcinogenicity
Administrative data
Description of key information
One key study is available. The study used male and female Fischer 344 rats exposed to the test substance via oral gavage for a period of 103 weeks.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 37.5 mg/kg bw/day
Justification for classification or non-classification
Based on the information provided in this study, it is not possible to conclude a definitive classification for this substance,
but classification as at least a Category 3 carcinogen is required since there is evidence to regard the material as causing concern in respect of causing cancer in humans, but with insufficient evidence to warrant classification as Cat. 2.
However, the WHO IARC Volume 77 monograph on the evaluation of carcinogenic risks to humans for glycidol adds useful information and concludes that on the basis of overall carcinogenicity and mutagenicity data that glycidol is probably carcinogenic to humans and warrants classification as Group 2A.
The information provided in this IUCLID dossier leads to IARC classification (International Agency for Research on Cancer which help to classify and regulate chemical carcinogens) . Carc. 2A is the IARC classification equivalent to Carc 2 under Directive 67/548/EEC . Carc. 2 under Directive 67/548/EEC corresponds to Carc 1B under CLP. The GHS classification is therefore Carc. 1B. H350 GHS06
Additional information
In a study conducted by Tennant et al (1991), the test substance, Glycidol, was evaluated for its ability to induce a carcinogenic response when tested on male and female Fischer 344 rats. The test substance was administered via oral gavage at concentrations of 37.5 or 75 mg/kg 5 days a week for a total of 103 weeks. Glycidol showed an increase in the incidence of tumors. Tumour sites were tunica vaginalis, mammary gland, brain, oral cavity, stomach, skin, zymbal gland, clitoral gland, thyroid gland, hematopoietic system. Based on the results of this study, Glycidol showed a positive carcinogenic response under the conditions of this test. Based on the information provided in this study, it is not possible to conclude a definitive classification for this substance.
The WHO IARC Volume 77 monograph on the evaluation of carcinogenic risks to humans for glycidol summarises data collated from various animal and human data sources.
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 human carcinogenicity data were available to the WHO Working Group. 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.
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.
No epidemiological data relevant to the carcinogenicity of glycidol were available. There is sufficient evidence in experimental animals for the carcinogenicity of glycidol. Glycidol is probably carcinogenic to humans (IARC classification - Group 2A). The information provided in this IUCLID dossier leads to IARC classification (International Agency for Research on Cancer which help to classify and regulate chemical carcinogens) . Carc. 2A is the IARC classification equivalent to Carc 2 under Directive 67/548/EEC . Carc. 2 under Directive 67/548/EEC corresponds to Carc 1B under CLP. THe GHS classification is therefore Carc. 1B. H350 GHS06
Carcinogenicity: via oral route (target organ): digestive: stomach; glandular: mammary gland; glandular: thyroids; glandular: other; neurologic: brain (multiple sections); urogenital: vagina; urogenital: other; other: skin
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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