Registration Dossier
Registration Dossier
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EC number: 200-579-1 | CAS number: 64-18-6
Carcinogenicity
Administrative data
Description of key information
Potassium diformate did not show potential for carcinogenicity in two valid long-term rodent feed studies at 2000 mg/kg bw/day. This can be extrapolated to formic acid.
Key value for chemical safety assessment
Justification for classification or non-classification
Potassium diformate (1:2) did not show potential for carcinogenicity in two long-term rodent feed studies. This can be extrapolated to formic acid and other formate salts.
Additional information
There are two combined oral feed chronic toxicity and oncogenicity studies on potassium diformate (1:2) known to exist. These tests include the combined 104-week chronic toxicity and oncogenicity rat study (50 Crl:HanWist(Glx:BRL)BR rats/sex/concentration at concentrations of 0, 50, 400, and 2000 mg/kg bw/day) and the combined oral feed 80-week chronic toxicity and oncogenicity mouse study (51 Crl:CD-1 (ICR)BR mice/sex/concentration at concentrations of 0, 50, 400, and 2000 mg/kg bw per day). The pattern of mortality did not indicate any treatment-related effect in either the rat or mouse. The spectrum of tumours was generally consistent with that expected in rats or mice of these strains. There were no tumours of unusual nature or incidence indicative of specific target organ carcinogenicity in the stomach or any other tissue at any concentration level in any species or sex.The NOAEL for carcinogenicity was 2000 mg potassium diformate/kg bw/day in both sexes. This dose is equivalent to 708 mg formic acid/kg bw/day, or 1415 mg formate anion/kg bw/day.
Potassium diformate (1:2) did not show potential for carcinogenicity in two long-term rodent feed studies. This result can be extrapolated to formic acid and the other formate salts.
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