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Isonicotinic acid hydrazide (INH) is widely used in the treatment and prophylaxis of tuberculosis. Hydrazine is its principal metabolite. INH administered in aqueous solution by stomach tube to CBA/Cb/Se mice caused liver tumors in 17% of the males and in 12% of the females and increased lung tumors to 61 and 76%. Oral administration of hydrazine sulfate in aqueous solution increased the liver tumors to 62 and 71% in male and female CBA/Cb/Se mice, respectively, and the number of lung tumors to 76 and 90%. Administration of INH in drinking water induced liver tumors in 2% and lung tumors in 4% of male Cb/Se rats, and breast tumors in 27% of female Cb/Se rats. Hydrazine sulfate administered by stomach tube induced liver tumors in 30% of male Cb/Se rats, and lung tumors in 21 and 27% of male and female Cb/Se rats, respectively. Histologically, the liver tumors in mice were hepatocarcinomas, the lung tumors adenomas and adenocarcinomas; in rats the liver tumors were hepatocarcinomas and spindle cell sarcomas, the lung tumors adenocarcinomas, and the breast tumors fibroadenomas.

RATS provide good material for the study of pulmonary carcinogens since spontaneous pulmonary tumours are very rare. They have never been observed in colonies maintained by Orr and Bielschowsky1 or by Mori2, and when Wilson et al.3 killed about 1,500 rats and carried out histological examinations on all the organs suspected of neoplasia, they did not observe pulmonary tumours.

EXPERIMENTAL study of the relation of isoniazid to carcinogenesis takes its origin from human pathology and this is an index of the timeliness of the research and of the seriousness of the problem, which was posed by the Hungarian school (Berencsi et al., 1952;Juhasz et al., 1957).The root of experimental research should always be this: experimental pathology not as an end in itself (as is often the case) but having a starting-point, which is the human disease, and an objective, which is the solution of the problems inherent in diseases in man (Severi, 1965).Berencsi et at.(1952) were the first to bring under consideration the enhancing effect of isonicotinic acid hydrazide or isoniazid (INH) on the growth of a neoplasm: because of a diagnostic error, they administered about 7-7 g. of INH to a 33-year- old man with a pulmonary tumour, and noted that the clinical course was extremely rapid owing to precocious, numerous and voluminous metastases.Pompe showed in 1956 that the cancerous development of Lupus vulgaris increased after the introduction of INH therapy from 0 5% to 4-6%.Randazzo (1959), who had already reported a case of cutaneous tuberculosis treated with INH which had developed into carcinoma (Randazzo, 1954), makes the point that these contributions do not permit a possible relationship between this chemical and cancer to be completely ruled out. INH and Hydrazine in MiceJuhasz et al., in 1957, used 95 albino mice about 2 months old; they injected 45 of them intraperitoneally with 1 mg. of INH per day for a period of about 3 months and they kept 50 as controls.In 310% of the treated mice which lived beyond 71 months, neoplasms of the lungs and the lymph nodes were present, while the incidence of neoplasms in the controls was almost insignificant (2 %).Mori and Yasuno (1959) and Mori et al. (1960) reported that this chemical was carcinogenic for another substrain of mice; they, in fact, obtained pulmonary tumours in " dd " mice which lived more than 71 months after the start of treat- ment of 3 to 4 months' duration, with INH added to the diet.The Japanese workers also observed a relationship between the amount of drug and the incidence of neoplasms, which dropped from 100% to 70%, to 60%, to 50% and to 8% when the INH dose was cut progressively from 0-25 to 0-125, to 0410, to 0-06 and to 0-001% of the diet.The subcutaneous administration of INH was equally effective.Schwan treated RIII mice with intraperitoneal INH in two experimental investigations; in the first (1961) he administered 2-50 mg. of INH per day for