*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : UK8390000
CHEMICAL NAME : Prost-13-en-1-oic acid,
11,16-dihydroxy-16-methyl-9-oxo-, methyl ester,
(11-alpha,13E)-(+-)-
CAS REGISTRY NUMBER : 59122-46-2
OTHER CAS REGISTRY NOS. : 62015-39-8
BEILSTEIN REFERENCE NO. : 4155643
LAST UPDATED : 199709
DATA ITEMS CITED : 20
MOLECULAR FORMULA : C22-H38-O5
MOLECULAR WEIGHT : 382.60
COMPOUND DESCRIPTOR : Drug
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Cytotec
* (11-alpha,13E)-(+-)-11,16-Dihydroxy-16-methyl-9-oxoprost-13-en-1-oic acid
methyl ester
* Methyl (+-)-11-alpha,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oate
* Misoprostol
* SC-29333
*** 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 : 81 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Lungs, Thorax, or Respiration - cyanosis
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,33,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 40 mg/kg
TOXIC EFFECTS :
Behavioral - changes in motor activity (specific assay)
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
DDSCDJ Digestive Diseases and Sciences. (Plenum Pub. Corp., 233 Spring St.,
New York, NY 10013) V.24- 1979- Volume(issue)/page/year: 30,142S,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 19 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Lungs, Thorax, or Respiration - cyanosis
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,33,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 27 mg/kg
TOXIC EFFECTS :
Behavioral - changes in motor activity (specific assay)
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
DDSCDJ Digestive Diseases and Sciences. (Plenum Pub. Corp., 233 Spring St.,
New York, NY 10013) V.24- 1979- Volume(issue)/page/year: 30,142S,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 70 mg/kg
TOXIC EFFECTS :
Behavioral - changes in motor activity (specific assay)
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
DDSCDJ Digestive Diseases and Sciences. (Plenum Pub. Corp., 233 Spring St.,
New York, NY 10013) V.24- 1979- Volume(issue)/page/year: 30,142S,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 16 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Lungs, Thorax, or Respiration - cyanosis
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,33,1985
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 3285 mg/kg/1Y-I
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Nutritional and Gross Metabolic - changes in iron
REFERENCE :
DDSCDJ Digestive Diseases and Sciences. (Plenum Pub. Corp., 233 Spring St.,
New York, NY 10013) V.24- 1979- Volume(issue)/page/year: 30,142S,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 56 mg/kg/5W-I
TOXIC EFFECTS :
Endocrine - changes in pituitary weight
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - true cholinesterase
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,39,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 140 mg/kg/28D-I
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Blood - changes in erythrocyte (RBC) count
Blood - changes in leukocyte (WBC) count
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,157,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 109 ug/kg/1Y-I
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Nutritional and Gross Metabolic - body temperature increase
Related to Chronic Data - death
REFERENCE :
DDSCDJ Digestive Diseases and Sciences. (Plenum Pub. Corp., 233 Spring St.,
New York, NY 10013) V.24- 1979- Volume(issue)/page/year: 30,142S,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 140 mg/kg/2W-I
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Related to Chronic Data - death
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,229,1985
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 12 ug/kg
SEX/DURATION : female 5-8 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - other developmental
abnormalities
REFERENCE :
AJMGDA American Journal of Medical Genetics. (John Wiley & Sons Ltd., 605
Third Ave., New York, NY 10158) V.1- 1977- Volume(issue)/page/year:
47,59,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Multiple routes
SPECIES OBSERVED : Human - woman
DOSE : 16 ug/kg
SEX/DURATION : female 5-8 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - body wall
REFERENCE :
AJMGDA American Journal of Medical Genetics. (John Wiley & Sons Ltd., 605
Third Ave., New York, NY 10158) V.1- 1977- Volume(issue)/page/year:
47,59,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 16 gm/kg
SEX/DURATION : male 10 week(s) pre-mating
female 3 week(s) pre-mating - 7 day(s) after
conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,167,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 320 mg/kg
SEX/DURATION : female 17-22 day(s) after conception
lactating female 26 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,213,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 440 mg/kg
SEX/DURATION : female 7-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,189,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 15 mg/kg
SEX/DURATION : female 7-9 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
REFERENCE :
SCYYDZ Shengzhi Yu Biyun. Reproduction and Contraception. (China
International Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) 1980-
Volume(issue)/page/year: 15,47,1995
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 3 mg/kg
SEX/DURATION : female 7-9 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant
per # sperm positive females; # females pregnant per # females mated)
REFERENCE :
SCYYDZ Shengzhi Yu Biyun. Reproduction and Contraception. (China
International Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) 1980-
Volume(issue)/page/year: 15,47,1995
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 1320 mg/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
11,237,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 4 mg/kg
SEX/DURATION : female 11-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
SCYYDZ Shengzhi Yu Biyun. Reproduction and Contraception. (China
International Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) 1980-
Volume(issue)/page/year: 15,47,1995
*** END OF RECORD ***