Aromatic Amines An Assessment of the Biological and Environmental Effects (1981) / Chapter Skim
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Furazolidone
Furazolidone
Pages 288-319
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From page 288... ...
S . producer of furazol idone is the Norwich Pharmaceutical Company in Norwich, N.Y.
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. Furazol idone is one of two 5-nitrofurans that have been approved in the United States as veterinary feed additives (Federal Register, 1976a,b)
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At that time, the agency ruled that data were not adequate to determine the total drug-related residues that can occur, that the analytic techniques for measuring the drug were not reliable for the lower concentrations found in food, that the drug was present in edible tissue following medication when no withdrawal period was observed, 290
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The 1976 proposal to ban the use of furazolidone in food-product ng an imals was withdrawn because of problems in obta in ing supportive data, but another proposal is being issued in 1980 (Moy, Food An ima 1 Add i t ive Bra nch, FDA, per sona 1 conm~un ice t ion, 1980 ~ . Although FDA requ ires that food products con ta in no res idue, compliance is handled by the U
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From page 292... ...
Table 11-1 Results of Testing for Furazol idone in Food Food Hype Dose Res idue Reference Chicken ~Excessive. None after 2 days Krieg and Loeliger, 1973 Eggs 100 mg/100 ml water 8 mg/g on 3rd day; Krieg, 1972 for 3 days, and none after 10 S mg/100 mg for 2 days days Eggs 40 mg/100 g water 23 micrograms/9 Krieg, 1972 for 15 days on 6th day; none after 19th day Vea 1 Unknown None found Nouws, 1973 292
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, W absorption spectrophoto~netry, or comb ina t ion s of the se techn ique s . A general procedure using TLC to identify 18 drugs, including furazolidone, in animal feed was reported by Williams (1978~.
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(1978) determined furazolidone levels in swine and poultry feed at levels as low as 5ppm, with a silica column and a mobile phase of water-saturated dichloromethone.
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Problems associated with the analysis of furazolidone in edible tissues of at levels of 0.5 to 4.0 ppb with methods ava liable prior to 1976 are well documented (Federal Register, 1976~. Various spectrophotometric and TLC procedures failed to yield satisfactory and reproducible recoveries at these levels.
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From page 296... ...
One biotransformation product, 3-~4-cyano-2-oxobutylideneamino) -2oxazolidone, was characterized by mass-, ultraviolet-, and nuclear-magnetic-resonance-spectroscopic methods following furazol idone incubation In vitro with milk xanthine oxidase or administration in viva to rabbits, when it was identif fed in urine.
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. Statistical comparisons of significant effects in rats and mice of both sexes exposed to varying dose levels of furazolidone administered orally for 18 or more months are presented in Tables 11-2 through 11-5.
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lo A o ~ us 3 O m1 , C a, ~ O .,~ · ~ O 3 ~ O O ~ · a.
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to ~1 ~ ~ o o O N ~ E4 · O o A 1 L m · ED · ~: U]
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Control groups of both sexes were fed a drug-f ree diet for the 52 weeks . The female rats fed furazol idone had a higher inc idence of mammary tumors than did the female controls.
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Malignant mammary tumors were diagnosed only in fema le ra ts fed the highest dosage of furazolidone. At all dosage levels, the proportion of female rats with mammary tumors was signif icantly higher (P |
From page 304... ...
was noted, with a significant (P ~ O .05 ~ linear dose-response relationship. Furazolidone resulted in signif icant and early onset and development of mammary tumors in female rats at the 375-ppm dose level as compared with that of controls.
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Male and female mice fed furazolidone both exhibited significant {P <0.05) early mortality which was linear in dose response (Federal Register, 1976a)
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including furazolidone. The most active compound was 2- (2-furyl)
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found that furazol idone produced dose-dependent mitotic suppression, chromosomal breakage, and sister-chromatic exchanges (SCE 's)
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Both agents induce interstrand cross-linking in DNA, inhibit DNA synthesis, and cause filamentation of the cells at the appropr late dose level by inhibiting cell division. Te ratogen ic ity No data were ava liable to evaluate the teratogenicity or embryotoxicity of furazolidone.
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Resolution of this matter awaits the development of a sufficiently sensitive and reliable analytic method. If risk to human health does exist, it most certainly would be associated with the use of furazolidone for veterinary purposes.
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1976a. E'urazolidone (NF-180~- Notice of opportunity for hearing on proposal to withdraw approval of certain new animal drug applications.
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Hawk ing, eds. Experimental Chemotherapy, Volume 2: Chemotherapy of Bacter ial Infections, Part I .
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1977. Synthetic Organic Chemicals.
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1978. Quantitative thin layer chromatographic determination of furazolidone and nitrofurazone in animal feeds .
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Report prepared by the Medicinal Additives in Animal Feeds Sub-comm i t tee n B
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1977. Cross linking of deoxyribonucleic acid in furazolidone treated Vibrio cholerae cell.
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1978. Characterization of glycogen in selected tissues of turkey poults with spontaneous round heart disease and furazolidone-induced cardio~yopa tiny.
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Lu, C., D.R. McCalla, and D.W.
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From page 319... ...
1973. Chromosomal aberrations and DNA reps ir synthes is in cultured human cells exposed to nitrofurans .
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