*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : RF5950000
CHEMICAL NAME           : Nystatin
CAS REGISTRY NUMBER     : 1400-61-9
LAST UPDATED            : 199512
DATA ITEMS CITED        : 13
MOLECULAR FORMULA       : C46-H83-N-O18
MOLECULAR WEIGHT        : 938.30
WISWESSER LINE NOTATION : T-38-VO D&V GU IU MU OU QU SUTJ C1 D1 EQ F1 WQ A&VQ
                          B&Q F&Q G&Q J&Q L&Q N&Q UO- BT6OTJ CQ DZ
COMPOUND DESCRIPTOR     : Drug
                          Mutagen
                          Reproductive Effector
                          Natural Product
SYNONYMS/TRADE NAMES :
   * Biofanal
   * Candio-hermal
   * Diastatin
   * Fungicidin
   * Moronal
   * Mycostatin
   * Mycostatin 20
   * Nilstat
   * Nystan
   * Nystatine
   * Nystatyna
   * Nystavescent
   * O-V Statin
   * Stamycin
 
                       *** 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           : 10 gm/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   APPHAX Acta Poloniae Pharmaceutica.  For English translation, see APPFAR.
   (Ars Polona, POB 1001, 00-680 Warsaw 1, Poland)  V.1-    1937-
   Volume(issue)/page/year: 30,81,1973
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 24305 ug/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   ABANAE Antibiotics Annual.  (New York, NY)  1953-60.  For publisher
   information, see AMACCQ.  Volume(issue)/page/year: 3,697,1955/1956
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 8 gm/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   PMDCAY Progress in Medical Chemistry.  (Elsevier Science Pub. Co., Inc., 52
   Vanderbilt Ave., New York, NY 10017)  V.1-    1961- Volume(issue)/page/year:
   14,105,1977
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 4400 ug/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JPMSAE Journal of Pharmaceutical Sciences.  (American Pharmaceutical Assoc.,
   2215 Constitution Ave., NW, Washington, DC 20037)  V.50-    1961-
   Volume(issue)/page/year: 65,905,1976
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 120 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   NYKZAU Nippon Yakurigaku Zasshi.  Japanese Journal of Pharmacology. (Nippon
   Yakuri Gakkai, c/o Kyoto Daigaku Igakubu Yakurigaku Kyoshitsu, Konoe-cho,
   Yoshida, Sakyo-ku, Kyoto 606, Japan) V.40-    1944- Volume(issue)/page/year:
   53,228S,1957
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 3 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JANTAJ Journal of Antibiotics.  (Japan Antibiotics Research Assoc., 2-20-8
   Kamiosaki, Shinagawa-ku, Tokyo, 141, Japan)  V.2-5, 1948-52;  V.21- 1968-
   Volume(issue)/page/year: 32,1230,1979
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 180 mg/kg/90D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
   TOXID9 Toxicologist.  (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
   Akron, OH 44311) V.1-    1981-  Volume(issue)/page/year: 15,69,1995
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 100 mg/kg
SEX/DURATION            : female 9 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
   ANTBAL Antibiotiki.  (Moscow, USSR)  V.1-29, 1956-84.  For publisher
   information, see AMBIEH.  Volume(issue)/page/year: 20,45,1975
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : Cytogenetic analysis
ROUTE OF EXPOSURE       : Parenteral
TEST SYSTEM             : Rodent - mouse
DOSE/DURATION           : 50 mg/kg
REFERENCE :
   EXPEAM Experientia.  (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
   Switzerland)  V.1-    1945-  Volume(issue)/page/year: 33,306,1977

         *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOHS - National Occupational Hazard Survey (1974)
     NOHS Hazard Code - M1053
       No. of Facilities: 28 (estimated)
       No. of Industries: 1
       No. of Occupations: 3
       No. of Employees: 8736 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - M1053
       No. of Facilities: 372 (estimated)
       No. of Industries: 1
       No. of Occupations: 10
       No. of Employees: 25202 (estimated)
       No. of Female Employees: 22859 (estimated)
   
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - X9349
       No. of Facilities: 3 (estimated)
       No. of Industries: 1
       No. of Occupations: 2
       No. of Employees: 2199 (estimated)
       No. of Female Employees: 2176 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA GENETOX PROGRAM 1988, Negative: N crassa-aneuploidy

 
                            *** END OF RECORD ***