Registration Dossier
Registration Dossier
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EC number: 231-157-5 | CAS number: 7440-47-3
Carcinogenicity
Administrative data
Description of key information
Long term in vivo studies with stainless steel, chromium(III) oxide and chromium picolinate do not show any evidence that chromium III would be a potential carcinogen.
Human exposure observations and international carcinogenicity evaluations (IARC) also concluded that trivalent chromium compounds are not classifiable for carcinogenicity.
Key value for chemical safety assessment
Justification for classification or non-classification
No classification is suggested for chromium.
According to available data on in vivo studies with stainless steel, chromium(III) oxide and chromium picolinate, as well as human exposure data, there are no indications that chromium metal / trivalent chromium would be a carcinogen. Several extensive evaluations also conclude that chromium(III) compounds are not classifiable as carcinogens.
Additional information
Following oral route of exposure, chromium(III) picolinate was not carcinogenic in rats and mice (Stout et al., 2010). Indeed, under the conditions of the NTP 2-year feed studies there was only equivocal evidence of carcinogenic activity of chromium picolinate monohydrate in male F344/N rats based on an increase in the incidence of preputial gland adenoma (showing a marginal increase of neoplasms that may be chemical related).
This increase appeared to be treatment-related; however, because of the lack of an exposure concentration response, the lack of progression to carcinoma, the lack of preneoplastic lesions, including hyperplasia, and the lack of a neoplastic response in the clitoral gland in females, this increase was considered to be equivocal evidence of carcinogenic activity in male rats. In female rats exposed to chromium picolinate monohydrate, there was no evidence of carcinogenic activity.
The assumption that the increase in preputial gland adenomas in male rats is considered to be equivocal is supported by the fact that a 2-year feeding study in mice, conducted at the same time and by the same laboratory, did not show any increase in adenomas or carcinomas in any tissue or organ.
The study concluded there was no evidence of carcinogenic activity of chromium picolinate monohydrate in female F344/N rats or in male or female B6C3F1 mice exposed to 2,000, 10,000, or 50,000 ppm.
The same conclusion was obtained for Chromium(III) oxide which had also no carcinogenic potential in a 2-year oral study in BD rats (Ivankovic and Preusmann, 1974).
The available data on the carcinogenicity of insoluble chromium do not show any clear carcinogenic effects. Trivalent chromium has been evaluated for carcinogenicity by IARC, WHO, ACGIH and US EPA, and none of these evaluations have found any evidence for chromium metal or Cr(III) being a potential carcinogen.
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