*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : UK7894500
CHEMICAL NAME : Prosta-2,13-dien-1-oic acid,
11,15-dihydroxy-16,16-dimethyl-9-oxo-, methyl ester,
(2E,11-alpha,13E,15R)-
CAS REGISTRY NUMBER : 64318-79-2
OTHER CAS REGISTRY NOS. : 65135-28-6
LAST UPDATED : 199709
DATA ITEMS CITED : 25
MOLECULAR FORMULA : C23-H38-O5
MOLECULAR WEIGHT : 394.61
COMPOUND DESCRIPTOR : Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Cervagem
* trans-2,3-Didehydro-16,16-dimethyl PGE1 methyl ester
* 16,16-Dimethyl-trans-delta-2-PGE methyl ester
* 16,16-Dimethyl-trans-delta-2-PGE1 methyl ester
* 16,16-Dimethyl-trans-delta(sup 2)-prostaglandin E1 methyl ester
* Gemeprost
* Methyl 16,16-dimethyl-trans-delta-2-PGE1
* ONO 802
* Preglandin
*** 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 : 56500 ug/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Lungs, Thorax, or Respiration - respiratory depression
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 22600 ug/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 28600 ug/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - ataxia
Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 32500 ug/kg
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 59 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Lungs, Thorax, or Respiration - respiratory depression
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 32500 ug/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 29500 ug/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Behavioral - ataxia
Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 36 mg/kg
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 187500 ug/kg/30D-C
TOXIC EFFECTS :
Gastrointestinal - other changes
Liver - changes in liver weight
Blood - changes in leukocyte (WBC) count
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 7500 ug/kg/30D-C
TOXIC EFFECTS :
Kidney, Ureter, Bladder - other changes in urine composition
Endocrine - changes in spleen weight
Blood - normocytic anemia
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,188,1982
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Human - woman
DOSE : 86 ug/kg
SEX/DURATION : female 14 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
BJOGAS British Journal of Obstetrics and Gynaecology. (Blackwell Scientific
Pub. Ltd., POB 88, Oxford, UK) V.82- 1975- Volume(issue)/page/year:
91,1136,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Human - woman
DOSE : 20 ug/kg
SEX/DURATION : female 31 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
BJOGAS British Journal of Obstetrics and Gynaecology. (Blackwell Scientific
Pub. Ltd., POB 88, Oxford, UK) V.82- 1975- Volume(issue)/page/year:
96,745,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Human - woman
DOSE : 20 ug/kg
SEX/DURATION : female 10 week(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 27,51,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Human - woman
DOSE : 20 ug/kg
SEX/DURATION : female 10 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 27,339,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 4 mg/kg
SEX/DURATION : female 2 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)
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:
79,15,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 4 mg/kg
SEX/DURATION : female 17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
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:
79,15,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 2 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
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:
79,15,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 80 ug/kg
SEX/DURATION : female 17-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
Reproductive - Effects on Newborn - weaning or lactation index (e.g., #
alive at weaning per # alive at day 4)
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,593,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 438 ug/kg
SEX/DURATION : female 1-7 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)
Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,809,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 438 ug/kg
SEX/DURATION : female 1-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
(e.g., placenta, umbilical cord)
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,809,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 5 mg/kg
SEX/DURATION : female 6-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
4,233,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 2 mg/kg
SEX/DURATION : female 17-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
Reproductive - Effects on Newborn - stillbirth
Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
GEIRDK Gendai Iryo. Modern Medical Care. (Towa Bldg., 2-7 Nishiki-cho,
Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1969- Volume(issue)/page/year:
14,593,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rabbit
DOSE : 4 mg/kg
SEX/DURATION : female 6-7 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)
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:
79,15,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rabbit
DOSE : 200 ug/kg
SEX/DURATION : female 24-25 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
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:
79,15,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rabbit
DOSE : 162 ug/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)
Reproductive - Fertility - abortion
REFERENCE :
TCMUD8 Teratogenesis, Carcinogenesis, and Mutagenesis. (Alan R. Liss, Inc.,
41 E. 11th St., New York, NY 10003) V.1- 1980- Volume(issue)/page/year:
4,225,1984
*** END OF RECORD ***