Miconazole nitrate NEW

• MOLECULAR FORMULA :

• C18-H14-Cl4-N2-O.H-N-O3

• MOLECULAR WEIGHT :

• 479.16

• WISWESSER LINE NOTATION :

• T5N CNJ A1YR CG DG&O1R BG DG &..H..N-O3

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 920 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: 6,809,1982

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 1060 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: 6,809,1982

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Subcutaneous

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• >5 gm/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - lacrimation Behavioral - ataxia Gastrointestinal - ulceration or bleeding from stomach

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,353,1976

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 14700 ug/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 11,181,1980

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 578 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - lacrimation Behavioral - ataxia Gastrointestinal - ulceration or bleeding from stomach

• REFERENCE :

• CHTHBK Chemotherapy (Basel). (S. Karger Pub., Inc., 79 Fifth Ave., New York, NY 10003) V.13- 1968- Volume(issue)/page/year: 17(6),392,1972

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 480 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: 6,809,1982

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Subcutaneous

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• >5 gm/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - lacrimation Behavioral - ataxia Gastrointestinal - ulceration or bleeding from stomach

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,353,1976

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 28 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 11,181,1980

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Mammal - dog

• DOSE/DURATION :

• >160 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• CHTHBK Chemotherapy (Basel). (S. Karger Pub., Inc., 79 Fifth Ave., New York, NY 10003) V.13- 1968- Volume(issue)/page/year: 17(6),392,1972

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - guinea pig

• DOSE/DURATION :

• 276 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• CHTHBK Chemotherapy (Basel). (S. Karger Pub., Inc., 79 Fifth Ave., New York, NY 10003) V.13- 1968- Volume(issue)/page/year: 17(6),392,1972 ** OTHER MULTIPLE DOSE TOXICITY DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 3360 mg/kg/4W-I

• TOXIC EFFECTS :

• Liver - other changes Blood - changes in erythrocyte (RBC) count Related to Chronic Data - changes in ovarian weight

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,353,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 15600 mg/kg/26W-I

• TOXIC EFFECTS :

• Liver - changes in liver weight Blood - changes in other cell count (unspecified) Related to Chronic Data - changes in ovarian weight

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,504,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 600 mg/kg/6D-I

• TOXIC EFFECTS :

• Liver - other changes Liver - changes in liver weight Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - other hydrolases

• REFERENCE :

• TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- Volume(issue)/page/year: 50,269,1988 ** REPRODUCTIVE DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 1100 mg/kg

• SEX/DURATION :

• female 7-17 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Specific Developmental Abnormalities - urogenital system Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - physical

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,367,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 330 mg/kg

• SEX/DURATION :

• female 7-17 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Maternal Effects - parturition

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,367,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 810 mg/kg

• SEX/DURATION :

• female 17-22 day(s) after conception lactating female 21 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - stillbirth Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,535,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 270 mg/kg

• SEX/DURATION :

• female 17-22 day(s) after conception lactating female 21 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - behavioral

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,535,1976

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 1300 mg/kg

• SEX/DURATION :

• female 6-18 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants)

• REFERENCE :

• IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 7,377,1976 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X6162 No. of Facilities: 393 (estimated) No. of Industries: 2 No. of Occupations: 2 No. of Employees: 1489 (estimated) No. of Female Employees: 180 (estimated)