*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : UQ8400000
CHEMICAL NAME           : 3,5-Pyrazolidinedione,
                          4-butyl-1-(p-hydroxyphenyl)-2-phenyl-
CAS REGISTRY NUMBER     : 129-20-4
BEILSTEIN REFERENCE NO. : 0307474
REFERENCE               : 5-24-05-00404 (Beilstein Handbook Reference)
LAST UPDATED            : 199612
DATA ITEMS CITED        : 24
MOLECULAR FORMULA       : C19-H20-N2-O3
MOLECULAR WEIGHT        : 324.41
WISWESSER LINE NOTATION : T5VNNV EHJ BR DQ& CR& E4
COMPOUND DESCRIPTOR     : Tumorigen
                          Drug
                          Mutagen
                          Reproductive Effector
                          Human
SYNONYMS/TRADE NAMES :
   * Artroflog
   * BM 1
   * Butaflogin
   * Butanova
   * Butapirone
   * Butilene
   * 4-Butyl-1-(p-hydroxyphenyl)-2-phenyl-3,5-pyrazolidinedione
   * 4-Butyl-1-(4-hydroxyphenyl)-2-phenyl-3,5-pyrazolidinedione
   * 4-Butyl-2-(p-hydroxyphenyl)-1-phenyl-3,5-pyrazolidinedione
   * 4-Butyl-2-(4-hydroxyphenyl)-1-phenyl-3,5-dioxopyrazolidine
   * Crovaril
   * Deflogin
   * Etrozolidina
   * Flamaril
   * Flanaril
   * Flogal
   * Floghene
   * Flogistin
   * Flogitolo
   * Flogodin
   * Flogoril
   * Flogostop
   * Flopirina
   * Frabel
   * G 27202
   * p-Hydroxyphenylbutazone
   * 1-(p-Hydroxyphenyl)-2-phenyl-4-butyl-3,5-pyrazolidinedione
   * 1-p-Hydroxyphenyl-2-phenyl-3,5-dioxo-4-N-butylpyrazolidine
   * Idrobutazina
   * Infamil
   * Infammil
   * Ipabutona
   * Iridil
   * Isobutazina
   * Isobutil
   * Neo-farmadol
   * Neofen
   * Offitril
   * Oxalid
   * Oxazolidin-geigy
   * Oxibutol
   * Oxi-fenibutol
   * Oxifenylbutazon
   * Oxazolidin
   * Oxiphenbutazone
   * Oxyphenbutazone
   * Oxyphenobutazone
   * Oxyphenylbutazone
   * 1-Phenyl-2-(p-hydroxyphenyl)-3,5-dioxo-4-butylpyrazolidine
   * Pirabutina
   * Piraflogin
   * Poliflogil
   * Remazin
   * Reumox
   * Rumapax
   * Tandacote
   * Tandalgesic
   * Tandearil
   * Tanderal
   * Tanderil
   * Telidal
   * Tendearil
   * Valioil
   * Visubutina
   * USAF GE-14
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - child
DOSE/DURATION           : 420 mg/kg/4W-I
TOXIC EFFECTS :
   Liver - hepatitis (hepatocellular necrosis), diffuse
   Blood - agranulocytosis
   Blood - thrombocytopenia
REFERENCE :
   BMJOAE British Medical Journal.  (British Medical Assoc., BMA House,
   Tavistock Sq., London WC1H 9JR, UK)  V.1-    1857- Volume(issue)/page/year:
   2,1517,1962
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 27 mg/kg/14D
TOXIC EFFECTS :
   Gastrointestinal - hypermotility, diarrhea
   Gastrointestinal - nausea or vomiting
   Blood - hemorrhage
REFERENCE :
   LAKAA3 Laekartidningen.  Medical News.  (Sveriges Laekarfoerbund, POB 5610,
   S-11486 Stockholm, Sweden)  V.62-    1965-  Volume(issue)/page/year:
   63,53,1966
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 50 mg/kg/7D
TOXIC EFFECTS :
   Skin and Appendages - dermatitis, other (after systemic exposure)
   Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
   LAKAA3 Laekartidningen.  Medical News.  (Sveriges Laekarfoerbund, POB 5610,
   S-11486 Stockholm, Sweden)  V.62-    1965-  Volume(issue)/page/year:
   63,53,1966
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 24 mg/kg/4D
TOXIC EFFECTS :
   Gastrointestinal - changes in structure or function of salivary glands
   Endocrine - other changes
REFERENCE :
   JAMAAP JAMA, Journal of the American Medical Association.  (AMA, 535 N.
   Dearborn St., Chicago, IL 60610)  V.1-    1883-  Volume(issue)/page/year:
   238,1399,1977
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 329 mg/kg
TOXIC EFFECTS :
   Behavioral - altered sleep time (including change in righting reflex)
   Behavioral - convulsions or effect on seizure threshold
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:
   63,43,1967
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 145 mg/kg
TOXIC EFFECTS :
   Behavioral - altered sleep time (including change in righting reflex)
   Behavioral - convulsions or effect on seizure threshold
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:
   63,43,1967
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 68 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   MEXPAG Medicina Experimentalis.  (Basel, Switzerland)  V.1-11, 1959-64;
   V.18-19, 1968-69.  For publisher information, see JNMDBO.
   Volume(issue)/page/year: 6,88,1962
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 330 mg/kg
TOXIC EFFECTS :
   Behavioral - altered sleep time (including change in righting reflex)
   Behavioral - convulsions or effect on seizure threshold
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:
   63,43,1967
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 100 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   NTIS** National Technical Information Service.  (Springfield, VA 22161)
   Formerly U.S. Clearinghouse for Scientific & Technical Information.
   Volume(issue)/page/year: AD414-344
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 52 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 10,129,1960
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 178 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
REFERENCE :
   AIPTAK Archives Internationales de Pharmacodynamie et de Therapie. (Heymans
   Institute of Pharmacology, De Pintelaan 185, B-9000 Ghent, Belgium)  V.4-   
   1898-  Volume(issue)/page/year: 149,571,1964
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 104 mg/kg
TOXIC EFFECTS :
   Brain and Coverings - recordings from specific areas of CNS
   Behavioral - excitement
   Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
   ANYAA9 Annals of the New York Academy of Sciences.  (New York Academy of
   Sciences, 2 E. 63rd St., New York, NY 10021)  V.1-    1877-
   Volume(issue)/page/year: 86,263,1960
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 1165 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   PHMGBN Pharmacology: International Journal of Experimental and Clinical
   Pharmacology.  (S. Karger AG, Postfach CH-4009 Basel, Switzerland)  V.1-
   1968-  Volume(issue)/page/year: 11,220,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - hamster
DOSE/DURATION           : 1180 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
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 560 mg/kg
SEX/DURATION            : male 28 day(s) pre-mating
TOXIC EFFECTS :
   Reproductive - Fertility - male fertility index (e.g. # males impregnating
   females per # males exposed to fertile nonpregnant females)
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       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 100 mg/kg
SEX/DURATION            : female 10 day(s) pre-mating
TOXIC EFFECTS :
   Reproductive - Fertility - mating performance (e.g. # sperm positive females
   per # females mated; # copulations per # estrus cycles)
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       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 700 mg/kg
SEX/DURATION            : female 1-7 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
   before birth)
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       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 700 mg/kg
SEX/DURATION            : female 10-16 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Newborn - live birth index (measured after birth)
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
 
                            ** 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            : Sex chromosome loss and nondisjunction
TEST SYSTEM             : Mold - Aspergillus nidulans
DOSE/DURATION           : 1 gm/L
REFERENCE :
   MUREAV Mutation Research.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1964-  Volume(issue)/page/year: 26,159,1974

                              *** REVIEWS ***
 
   IARC Cancer Review:Human No Adequate Data
   IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
   to Man.  (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
   V.1-    1972-  Volume(issue)/page/year: 13,183,1977

   IARC Cancer Review:Animal No Adequate Data
   IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
   to Man.  (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
   V.1-    1972-  Volume(issue)/page/year: 13,183,1977

   IARC Cancer Review:Group 3
   IMSUDL IARC Monographs, Supplement.  (WHO Publications Centre USA, 49
   Sheridan Ave., Albany, NY 12210)  No.1-    1979-  Volume(issue)/page/year:
   7,56,1987

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

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - X5469
       No. of Facilities: 25 (estimated)
       No. of Industries: 1
       No. of Occupations: 2
       No. of Employees: 290 (estimated)
       No. of Female Employees: 121 (estimated)

 
                            *** END OF RECORD ***