Registration Dossier
Registration Dossier
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EC number: 201-164-8 | CAS number: 78-98-8
Carcinogenicity
Administrative data
Description of key information
No guideline compatible carcinogenicity study is available. Based on the life-spanning administration in drinking water, the study of Fujita (1991), found no indication for carcinogenic potential of pyruvaldehyde. All remaining studies listed were negligible for the assessment of carcinogenicity of pyruvaldehyde and were therefore disregarded.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on the available carcinogenicity data, the classification criteria of Directive 67/548 EEC and CLP Regulation (1272/2008) are not met.
Additional information
The study by Fujita et al. (1991) was available as secondary literature only (Abstract quoted in an IARC Monograph, for details see Reference list below) and therefore the reliability could not be assessed. The test substance was administered as a 0.5% watery solution, corresponding to approximately 7.7 mg/kg bw/d, to a total of 40 male Fischer F344 rats by drinking water; 40 male rats received the concurrent vehicle via the same route. The maximum duration of application was 854 days. Compared to the control animals, the mean body weight of rats receiving pyruvaldehyde was reduced by 15%. No test substance related development of tumours was observed. Results from further studies, listed under "References" below, did not provide additional information to assess carcinogenicity under REACH.
References
Hasegawa, R. und Ito, N.: Liver Medium-term Bioassay in Rats for Screening of Carcinogens and Modifying Factors in Hepatocarcinogenesis. Fd. Chem. Toxic. 30 (11), 979-992 (1992)
Hasegawa R. et al.: Analysis of the Potential Carcinogenicity of Coffee and its Related compounds in a Medium-term Liver Bioassay of Rats. Fd Chem. Toxic. 33(1), 15-20, 1995
Martelli, A. et al.: Induction and Promotion of gamma-Glutamyltranspeptidase-Positive Foci in the Rat Liver by Methylglyoxal. Jpn. J. Cancer Res.(Gann) 79, 666-669 (1988)
Miyakawa, Y. et al.: Initiating activity of eight pyrolysates of carbohydrates in a two-stage mouse skin tumorigenesis model. Carcinogenesis 12 (7), 1169-1173 (1991)
Nagao M. et al.: Methylglyoxal in Beverages and Foods: Its Mutagenicity and Carcinogenicity. IARC Sci. Publ. 70, 283-291 (1986)
Sano, M. et al.: The Effects of Coffee on Liver Carcinogenesis using a Medium-term Bioassay System. J. Toxicol.Sci. 18 (4), 419 (1993), Abstract Nr. P-224
Takahashi, M. et al.: Effects of Glyoxal and Methylglyoxal Administration on Gastric Carcinogenesis in Wistar rats after Initiation with N-methyl-N'-nitro-N-nitrosoguanidine. Carcinogenesis 10 (10), 1925-1927 (1989)
Takayama, S. et al.: Long-term Carcinogenicity Studies on Caffeine, Instant Coffee, and Methylglyoxal in Rats. Banbury Report, Vol. 17, 99-104 (1984)
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