Registration Dossier
Registration Dossier
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EC number: 231-829-8 | CAS number: 7758-01-2
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Provided information shows that potassium bromate has the potential to be a human carcinogen. This summary reveals background information on the legal classification for
Carcinogenicity Category 1B
according to the REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures.
Additional information
No data on bromate-induced carcinogenicity in humans have been identified.
Animal data
There are several published reports on bromate induced carcinogenicity in experimental animals available, with most significant evidence from studies performed in F344 rats.
In summary, bromate produces tumors at multiple sites in male rats, including the kidney (adenomas and carcinomas), the thyroid gland (follicular cell adenomas and carcinomas) and the peritoneum (mesotheliomas) [1-4].
In the female rat, only kidney tumors are observed [2]. Further, a clear dose–response relationship exists in tumor incidence and the severity/progression of tumors [3].
The weight of evidence from the rat bioassays clearly indicates that bromate has the potential to be a human carcinogen.
References
1. Kurokawa, Y., et al., Carcinogenicity of potassium bromate administered orally to F344 rats. J Natl Cancer Inst, 1983. 71(5): p. 965-72.
2. Kurokawa, Y., et al., Long-term in vivo carcinogenicity tests of potassium bromate, sodium hypochlorite, and sodium chlorite conducted in Japan. Environ Health Perspect, 1986. 69: p. 221-35.
3. Kurokawa, Y., et al., Dose-response studies on the carcinogenicity of potassium bromate in F344 rats after long-term oral administration. J Natl Cancer Inst, 1986. 77(4): p. 977-82.
4. DeAngelo, A.B., et al., Carcinogenicity of potassium bromate administered in the drinking water to male B6C3F1 mice and F344/N rats. Toxicol Pathol, 1998. 26(5): p. 587-94.
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