*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : NL3500000
CHEMICAL NAME : Indole-3-acetic acid,
1-(p-chlorobenzoyl)-5-methoxy-2-methyl-
CAS REGISTRY NUMBER : 53-86-1
BEILSTEIN REFERENCE NO. : 0497341
REFERENCE : 5-22-05-00239 (Beilstein Handbook Reference)
LAST UPDATED : 199703
DATA ITEMS CITED : 125
MOLECULAR FORMULA : C19-H16-Cl-N-O4
MOLECULAR WEIGHT : 357.81
WISWESSER LINE NOTATION : T56 BNJ BVR CG& C1 D1VQ GO1
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Amuno
* Artracin
* Artrinovo
* Artrivia
* N-p-Chlorbenzoyl-5-methoxy-2-methylindole-3-acetic acid
* 1-(p-Chlorbenzoyl)-5-methoxy-2-methylindol-3-essigsaeure
* 1-(p-Chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid
* (1-p-Chlorobenzoyl-5-methoxy-2-methylindol-3-yl)acetic acid
* 1-(p-Chlorobenzoyl)-2-methyl-5-methoxyindole-3-acetic acid
* 1-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indole-acetic acid
* alpha-(1-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indolyl)acetic acid
* 1-p-Cloro-benzoil-5-metoxi-2-metilindol-3-acido acetico
* Confortid
* Dolovin
* Idomethine
* Imbrilon
* Inacid
* Indacin
* Indocid
* Indomecol
* Indomed
* Indomee
* Indometacin
* Indometacine
* Indometacyna
* Indomethacin
* Indomethacine
* Indometicina
* Indoptic
* Indo-rectolmin
* Indo-tablinen
* Inflazon
* Infrocin
* Inteban SP
* Kwas 1-(p-chlorobenzoilo)-2-metylo-5-metoksy-3-indolilooctowy
* Lausit
* Metacen
* Metartril
* Methazine
* Metindol
* Mezolin
* Mikametan
* Mobilan
* NCI-C56144
* Reumacide
* Sadoreum
* Tannex
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 4286 ug/kg/2D-I
TOXIC EFFECTS :
Skin and Appendages - dermatitis, other (after systemic exposure)
REFERENCE :
PGMJAO Postgraduate Medical Journal. (Blackwell Scientific Pub. Ltd., POB
88, Oxford, UK) V.1- 1925- Volume(issue)/page/year: 72,186,1996
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 15 mg/kg/2W-I
TOXIC EFFECTS :
Blood - aplastic anemia
REFERENCE :
IJMDAI Israel Journal of Medical Sciences. (POB 1435, Jerusalem 91013,
Israel) V.1- 1965- Volume(issue)/page/year: 17,433,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 400 ug/kg/2D-I
TOXIC EFFECTS :
Gastrointestinal - necrotic changes
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
107,484,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 2098 ug/kg/1D-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Kidney, Ureter, Bladder - urine volume decreased
REFERENCE :
SMJOAV Southern Medical Journal. (Southern Medical Assoc., POB 2446,
Birmingham, AL 35205) V.1- 1908- Volume(issue)/page/year: 78,1390,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 22500 ug/kg/3W-I
TOXIC EFFECTS :
Liver - hepatitis, fibrous (cirrhosis, post-necrotic scarring)
Liver - other changes
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
3,155,1967
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human
DOSE/DURATION : 113 mg/kg/8W-I
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Gastrointestinal - other changes
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 33,636,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 200 ug/kg
TOXIC EFFECTS :
Blood - hemorrhage
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
107,312,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - man
DOSE/DURATION : 499 mg/kg/87W-I
TOXIC EFFECTS :
Behavioral - stiffness
Kidney, Ureter, Bladder - hematuria
REFERENCE :
ARHEAW Arthritis and Rheumatism. (Arthritis Foundation, 1314 Spring St.,
NW, Atlanta, GA 30309) V.1- 1958- Volume(issue)/page/year: 20,917,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Human - man
DOSE/DURATION : 2586 mg/kg/3.5Y-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - retinal changes (pigmentary
depositions, retinitis, other)
REFERENCE :
AJOPAA American Journal of Ophthalmology. (Ophthalmic Pub. Co., 435 N.
Michigan Ave., Suite 1415, Chicago, IL 60611) Series 3: V.1- 1918-
Volume(issue)/page/year: 73,846,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Multiple routes
SPECIES OBSERVED : Human - man
DOSE/DURATION : 3557 mg/kg/5Y-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - retinal changes (pigmentary
depositions, retinitis, other)
REFERENCE :
AJOPAA American Journal of Ophthalmology. (Ophthalmic Pub. Co., 435 N.
Michigan Ave., Suite 1415, Chicago, IL 60611) Series 3: V.1- 1918-
Volume(issue)/page/year: 73,846,1972
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 2420 ug/kg
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 25,1526,1975
TYPE OF TEST : LD - Lethal dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >250 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 14,3185,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 13 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
38,127,1976
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 12 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 2,70,1968
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 21 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 31,655,1981
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 26300 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 31900 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 14,2259,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 11841 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
GWXXBX German Offenlegungsschrift Patent Document. (U.S. Patent and
Trademark Office, Foreign Patents, Washington, DC 20231)
Volume(issue)/page/year: #3005827
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 10 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
AFTOD7 Archivos de Farmacologia y Toxicologia. (Universidad Complutense,
Facultad de Medicina, Departamento Coordinado de Farmacologia, Ciudad
Universitaria, Madrid 3, Spain) V.1- 1975- Volume(issue)/page/year:
8,201,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 18300 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 30 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 19,1198,1969
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 18200 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
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 :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 2,70,1968
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 100 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 320 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 20200 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 33,726,1983
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 135 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: 6,90,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 100 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 2,70,1968
TYPE OF TEST : LD - Lethal dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : >100 mg/kg
TOXIC EFFECTS :
Behavioral - excitement
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 14,3185,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 143 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 30,1398,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 180 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
JNPHAG Journal de Pharmacologie. (SPPIF, B.P.22, F-41353 Vineuil, France)
V.1- 1970- Volume(issue)/page/year: 2,259,1971
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - hamster
DOSE/DURATION : 81 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ATSUDG Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc.,
Service Center, 44 Hartz Way, Secaucus, NJ 07094) No.1- 1978-
Volume(issue)/page/year: 7,365,1984
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - species unspecified
DOSE/DURATION : 8 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
IJMRAQ Indian Journal of Medical Research. (Indian Council of Medical
Research, Ansari Nagar, New Delhi 110 029, India) V.1- 1913-
Volume(issue)/page/year: 81,621,1985
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 33 mg/kg/11D-I
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
Gastrointestinal - ulceration or bleeding from duodenum
Gastrointestinal - other changes
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 44,1329,1994
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 168 mg/kg/4W-C
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - changes in lung weight
Endocrine - changes in spleen weight
Blood - normocytic anemia
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 16,2763,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 273 mg/kg/13W-I
TOXIC EFFECTS :
Blood - normocytic anemia
Biochemical - Metabolism (Intermediary) - other proteins
Related to Chronic Data - death
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 17,21,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1820 mg/kg/52W-C
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from small intestine
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Related to Chronic Data - death
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 7,333,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 210 mg/kg/35D-C
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
Endocrine - other changes
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 22,665,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 650 mg/kg/26W-I
TOXIC EFFECTS :
Behavioral - food intake (animal)
Gastrointestinal - ulceration or bleeding from small intestine
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 28,445,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 105 mg/kg/21D-I
TOXIC EFFECTS :
Liver - changes in liver weight
Kidney, Ureter, Bladder - changes in bladder weight
Related to Chronic Data - changes in ovarian weight
REFERENCE :
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag,
Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
Volume(issue)/page/year: 22,226,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 24 mg/kg/4D-I
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
52,454,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 150 mg/kg/5W-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - other changes
Blood - changes in spleen
Related to Chronic Data - death
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 13,1901,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 90 mg/kg/90D-C
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
Gastrointestinal - ulceration or bleeding from small intestine
Gastrointestinal - hypermotility, diarrhea
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 7,333,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 350 mg/kg/5W-I
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from large intestine
Kidney, Ureter, Bladder - other changes in urine composition
Related to Chronic Data - death
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 17,1433,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE/DURATION : 135 mg/kg/90D-C
TOXIC EFFECTS :
Gastrointestinal - ulceration or bleeding from stomach
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Blood - changes in leukocyte (WBC) count
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 7,333,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - species unspecified
DOSE/DURATION : 168 mg/kg/4W-I
TOXIC EFFECTS :
Gastrointestinal - necrotic changes
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Nutritional and Gross Metabolic - changes in chlorine
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
15,800,1990
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 644 mg/kg/92W-C
TOXIC EFFECTS :
Tumorigenic - neoplastic by RTECS criteria
Skin and Appendages - tumors
REFERENCE :
CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1980-
Volume(issue)/page/year: 16,1493,1995
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1500 ug/kg
SEX/DURATION : female 36 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - respiratory system
Reproductive - Effects on Newborn - other neonatal measures or effects
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
92,478,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 1500 mg/kg
SEX/DURATION : female 27 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
319,327,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 12 mg/kg
SEX/DURATION : female 33-34 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - stillbirth
REFERENCE :
JRPMAP Journal of Reproductive Medicine. (2 Jacklynn Ct., St. Louis, MO
63132) V.3- 1969- Volume(issue)/page/year: 24,137,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 525 mg/kg
SEX/DURATION : female 16-32 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Maternal Effects - other effects
Reproductive - Specific Developmental Abnormalities - urogenital system
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:
39,252,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE : 18 mg/kg
SEX/DURATION : female 33-34 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - homeostasis
REFERENCE :
AOGSAE Acta Obstetricia et Gynecologica Scandinavica. (Box 443, S-90109
Umeaa, Sweden) V.1- 1921- Volume(issue)/page/year: 61,183,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 6 mg/kg
SEX/DURATION : female 39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
JMFMEC Journal of Maternal - Fetal Medicine. (John Wiley & Sons, 605 Third
Ave., New York, NY 10158) V.1- 1992- Volume(issue)/page/year: 4,65,1995
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 4 mg/kg
SEX/DURATION : female 10 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
MIPEA5 Minerva Pediatrica. (Edizioni Minerva Medica, Casella Postale 491,
I-10126 Turin, Italy) V.1- 1949- Volume(issue)/page/year: 27,675,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 2 mg/kg
SEX/DURATION : female 28 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
Reproductive - Specific Developmental Abnormalities - homeostasis
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 24,644,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 12 mg/kg
SEX/DURATION : female 32 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - stillbirth
REFERENCE :
JRPMAP Journal of Reproductive Medicine. (2 Jacklynn Ct., St. Louis, MO
63132) V.3- 1969- Volume(issue)/page/year: 24,137,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 14 mg/kg
SEX/DURATION : female 34 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - other neonatal measures or effects
REFERENCE :
JRPMAP Journal of Reproductive Medicine. (2 Jacklynn Ct., St. Louis, MO
63132) V.3- 1969- Volume(issue)/page/year: 24,137,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Multiple routes
SPECIES OBSERVED : Human - woman
DOSE : 22 mg/kg
SEX/DURATION : female 33 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
Reproductive - Effects on Newborn - Apgar score (human only)
REFERENCE :
RFDEEH Reproduction, Fertility and Development. (Reproduction, Fertility
and Development, 314 Albert Street, East Melbourne, Victoria 3002 Australia)
V.2- 1990- Volume(issue)/page/year: 3,489,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Human - woman
DOSE : 12 mg/kg
SEX/DURATION : female 28 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - blood and lymphatic
systems (including spleen and marrow)
Reproductive - Specific Developmental Abnormalities - gastrointestinal
system
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
113,738,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1 mg/kg
SEX/DURATION : female 21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 27,117,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 300 ug/kg
SEX/DURATION : female 21-22 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Effects on Newborn - stillbirth
Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
NATUAS Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736)
V.1- 1869- Volume(issue)/page/year: 240,21,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 10 mg/kg
SEX/DURATION : female 17-22 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
Reproductive - Specific Developmental Abnormalities - respiratory system
REFERENCE :
PEREBL Pediatric Research. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1967- Volume(issue)/page/year: 15,147,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 12 mg/kg
SEX/DURATION : female 5-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD
Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970-
Volume(issue)/page/year: 7,701,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 20 mg/kg
SEX/DURATION : female 1-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Effects on Embryo or Fetus - fetal death
Reproductive - Specific Developmental Abnormalities - other developmental
abnormalities
REFERENCE :
IRLCDZ IRCS Medical Science: Library Compendium. (Lancaster, UK) V.3-11,
1975-83. For publisher information, see IMSCE2. Volume(issue)/page/year:
3,300,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 2500 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
PROMDL Prostaglandins and Medicine. (Edinburgh, Scotland, UK) V.1-7,
1978-81. For publisher information, see PLMEDD. Volume(issue)/page/year:
7,29,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 28 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - male fertility index (e.g. # males impregnating
females per # males exposed to fertile nonpregnant females)
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 76,65,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 4150 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 1,21,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 5 mg/kg
SEX/DURATION : female 5 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 :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
16,286,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 2500 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 1,3,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 12 mg/kg
SEX/DURATION : female 3-4 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 62,73,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 9 mg/kg
SEX/DURATION : female 9 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
REFERENCE :
ACENA7 Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E,
DK-2500 Valby, Denmark) V.1- 1948- Volume(issue)/page/year: 78,343,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE : 3 mg/kg
SEX/DURATION : female 19-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
Reproductive - Specific Developmental Abnormalities - respiratory system
REFERENCE :
ERJOEI European Respiratory Journal. (Munksgaard International Publishers,
238 Main St., Cambridge, MA 02142) V.1- 1988- Volume(issue)/page/year:
8,209,1995
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - rat
DOSE : 3 mg/kg
SEX/DURATION : female 20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
TJADAB Teratology, The International Journal of Abnormal Development. (Alan
R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
Volume(issue)/page/year: 30(1),20A,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intrauterine
SPECIES OBSERVED : Rodent - rat
DOSE : 500 ug/kg
SEX/DURATION : female 4 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 :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 24,283,1981
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravaginal
SPECIES OBSERVED : Rodent - rat
DOSE : 125 mg/kg
SEX/DURATION : female 7 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 - litter size (e.g. # fetuses per litter; measured
before birth)
Reproductive - Fertility - other measures of fertility
REFERENCE :
RDCNBM Reproduccion. (Madrid, Spain) V.1-7, 1974-83. Discontinued.
Volume(issue)/page/year: 1,177,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 10 mg/kg
SEX/DURATION : female 7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
Reproductive - Specific Developmental Abnormalities - Central Nervous System
Reproductive - Specific Developmental Abnormalities - eye/ear
REFERENCE :
SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o
Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho,
Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher
information, see CGANE7. Volume(issue)/page/year: 17,177,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 10 mg/kg
SEX/DURATION : female 7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o
Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho,
Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher
information, see CGANE7. Volume(issue)/page/year: 17,177,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 4 mg/kg
SEX/DURATION : female 13 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
JCGBDF Journal of Craniofacial Genetics and Developmental Biology. (Alan R.
Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1980-
Volume(issue)/page/year: 10,83,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 9 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 :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 4,795,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 40 mg/kg
SEX/DURATION : female 8-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Effects on Embryo or Fetus - fetal death
Reproductive - Specific Developmental Abnormalities - body wall
REFERENCE :
ANANAU Anatomischer Anzeiger. (VEB Gustav Fischer Verlag, Postfach 176,
Jena DDR-6900, Ger. Dem. Rep.) V.1- 1886- Volume(issue)/page/year:
136,349,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 40 mg/kg
SEX/DURATION : female 8-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
ANANAU Anatomischer Anzeiger. (VEB Gustav Fischer Verlag, Postfach 176,
Jena DDR-6900, Ger. Dem. Rep.) V.1- 1886- Volume(issue)/page/year:
136,349,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 8 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
Reproductive - Fertility - other measures of fertility
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 25,636,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - mouse
DOSE : 8 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 40,467,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 496 mg/kg
SEX/DURATION : female 21-26 week(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
Reproductive - Effects on Newborn - physical
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 27,588,1976
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE : 747 mg/kg
SEX/DURATION : female 21-26 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
(e.g., placenta, umbilical cord)
REFERENCE :
AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co.,
11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-
Volume(issue)/page/year: 118,412,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Primate - monkey
DOSE : 6 mg/kg
SEX/DURATION : female 2 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 27,505,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 96 mg/kg
SEX/DURATION : female 20-31 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
15,551,1976
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 10 mg/kg
SEX/DURATION : female 29 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 9,585,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 6 mg/kg
SEX/DURATION : female 2 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
JJPAAZ Japanese Journal of Pharmacology. (Japanese Pharmacological Soc.,
c/o Dept. of Pharmacology, Faculty of Medicine, Kyoto Univ., Sakyo-ku, Kyoto
606, Japan) V.1- 1951- Volume(issue)/page/year: 28,909,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 1590 ug/kg
SEX/DURATION : female 6 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - maternal-fetal exchange
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
29,833,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 48 mg/kg
SEX/DURATION : female 23-28 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
REFERENCE :
JOENAK Journal of Endocrinology. (Biochemical Soc. Book Depot, POB 32,
Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1939-
Volume(issue)/page/year: 64,363,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 32 mg/kg
SEX/DURATION : female 5-6 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 :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 20,587,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 24 mg/kg
SEX/DURATION : female 4-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
Reproductive - Effects on Embryo or Fetus - extra-embryonic structures
(e.g., placenta, umbilical cord)
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
18,148,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 64 mg/kg
SEX/DURATION : female 9-12 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
18,148,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 20 mg/kg
SEX/DURATION : female 26-29 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetal death
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
CJPPA3 Canadian Journal of Physiology and Pharmacology. (National Research
Council of Canada, Publication Sales and Distribution, Ottawa ON K1A OR6,
Canada) V.42- 1964- Volume(issue)/page/year: 58,212,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 148 mg/kg
SEX/DURATION : female 1-9 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 - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 46,375,1976
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 20 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S,
Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 39,85,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 20 mg/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
PRGLBA Prostaglandins. (Geron-X, Inc., P.O. Box 1108, Los Altos, CA 94022)
V.1- 1972- Volume(issue)/page/year: 1,89,1972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 7500 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
19,552,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 5500 ug/kg
SEX/DURATION : female 1-3 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 :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
14,451,1976
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rabbit
DOSE : 30 mg/kg
SEX/DURATION : female 24-26 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - respiratory system
Reproductive - Effects on Newborn - biochemical and metabolic
REFERENCE :
JPEMAO Journal of Perinatal Medicine. (Walter de Gruyter, Inc., 200 Saw
Mill River Rd., Hawthorne, NY 10532) V.1- 1973- Volume(issue)/page/year:
6,240,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rabbit
DOSE : 2500 ng/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
LIFSAK Life Sciences. (Pergamon Press Inc., Maxwell House, Fairview Park,
Elmsford, NY 10523) V.1-8, 1962-69; V.14- 1974- Volume(issue)/page/year:
14,129,1974
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - pig
DOSE : 160 mg/kg
SEX/DURATION : female 16 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
32,105,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - guinea pig
DOSE : 240 mg/kg
SEX/DURATION : female 12 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
REFERENCE :
BJPCBM British Journal of Pharmacology. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.34- 1968- Volume(issue)/page/year:
49,98,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intrauterine
SPECIES OBSERVED : Rodent - guinea pig
DOSE : 66640 ug/kg
SEX/DURATION : female 9 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
REFERENCE :
BJPCBM British Journal of Pharmacology. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.34- 1968- Volume(issue)/page/year:
49,98,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - hamster
DOSE : 144 mg/kg
SEX/DURATION : female 18 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects
REFERENCE :
ACENA7 Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E,
DK-2500 Valby, Denmark) V.1- 1948- Volume(issue)/page/year: 78,343,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Mammal - cattle
DOSE : 40 ug/kg
SEX/DURATION : female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 75,547,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - species unspecified
DOSE : 1 mg/kg
SEX/DURATION : female 21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
TJADAB Teratology, The International Journal of Abnormal Development. (Alan
R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
Volume(issue)/page/year: 30(1),15A,1984
** MUTATION DATA **
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Bacteria - Salmonella typhimurium
DOSE/DURATION : 100 ug/disc
REFERENCE :
JNUDAT Journal of Nihon University School of Dentistry. (Nihon University
School of Dentistry, 1-8-13 Surugadai, Kanda, Chiyoda-ku, Tokyo, 101, Japan)
V.1- 1958- Volume(issue)/page/year: 34,183,1992
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 10 mg/L
REFERENCE :
BOAEBM Berichte der Oesterreichischen Studiengesellschaft fuer Atomenergie.
(Vienna, Austria) SGAE 2001-SGAE 4032, 1972-80. Volume(issue)/page/year:
SGAE-2261,1974
TYPE OF TEST : Mutation test systems - not otherwise specified
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 12 mg/kg/3D (Continuous)
REFERENCE :
REXMAS Research in Experimental Medicine. (Springer-Verlag, Heidelberger
Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.157- 1972-
Volume(issue)/page/year: 189,173,1989
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Rodent - rat Cells - not otherwise specified
DOSE/DURATION : 10 mg/L
REFERENCE :
REXMAS Research in Experimental Medicine. (Springer-Verlag, Heidelberger
Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.157- 1972-
Volume(issue)/page/year: 189,173,1989
TYPE OF TEST : Dominant lethal test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 17 mg/kg/13W (Continuous)
REFERENCE :
BZARAZ Biologicheskii Zhurnal Armenii. Biological Journal of Armenia. (V/O
Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.19- 1966-
Volume(issue)/page/year: 32,1039,1979
TYPE OF TEST : Host-mediated assay
TEST SYSTEM : Rodent - rat Cells - not otherwise specified
DOSE/DURATION : 10 mg/kg
REFERENCE :
BCPCA6 Biochemical Pharmacology. (Pergamon Press Inc., Maxwell House,
Fairview Park, Elmsford, NY 10523) V.1- 1958- Volume(issue)/page/year:
24,219,1975
TYPE OF TEST : Micronucleus test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 72 mg/kg/24H
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 188,343,1987
TYPE OF TEST : Micronucleus test
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 72 mg/kg/24H
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 188,343,1987
TYPE OF TEST : DNA inhibition
ROUTE OF EXPOSURE : Administration onto the skin
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 44 umol/kg
REFERENCE :
RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD
Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970-
Volume(issue)/page/year: 24,533,1979
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - mouse Cells - not otherwise specified
DOSE/DURATION : 10 mg/L
REFERENCE :
BOAEBM Berichte der Oesterreichischen Studiengesellschaft fuer Atomenergie.
(Vienna, Austria) SGAE 2001-SGAE 4032, 1972-80. Volume(issue)/page/year:
SGAE-2261,1974
TYPE OF TEST : Cytogenetic analysis
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 84 mg/kg/1W (Continuous)
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 188,343,1987
TYPE OF TEST : Sperm Morphology
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 60 mg/kg/5D (Continuous)
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 188,343,1987
TYPE OF TEST : Sperm Morphology
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 60 mg/kg/5D (Continuous)
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 188,343,1987
*** REVIEWS ***
TOXICOLOGY REVIEW
CTOXAO Clinical Toxicology. (New York, NY) V.1-18, 1968-81. For publisher
information, see JTCTDW. Volume(issue)/page/year: 17,85,1980
TOXICOLOGY REVIEW
REPTED Reproductive Toxicology. (Pergamon Press Inc., Maxwell House,
Fairview Park, Elmsford, NY 10523) V.1- 1987- Volume(issue)/page/year:
9,7,1995
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X4091
No. of Facilities: 123 (estimated)
No. of Industries: 2
No. of Occupations: 10
No. of Employees: 5082 (estimated)
No. of Female Employees: 2130 (estimated)
*** STATUS IN U.S. ***
EPA TSCA Section 8(b) CHEMICAL INVENTORY
*** END OF RECORD ***