*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : UX9277000
CHEMICAL NAME           : 1H-Pyrrole-2-acetic acid,
                          5-(4-chlorobenzoyl)-1,4-dimethyl-, sodium salt,
                          dihydrate
CAS REGISTRY NUMBER     : 64092-48-4
LAST UPDATED            : 199706
DATA ITEMS CITED        : 8
MOLECULAR FORMULA       : C15-H13-Cl-N-O3.Na.2H2-O
MOLECULAR WEIGHT        : 349.77
WISWESSER LINE NOTATION : T5NJ A1 BVR DG& C1 E1VO &-NA- &QH 2
COMPOUND DESCRIPTOR     : Drug
                          Human
SYNONYMS/TRADE NAMES :
   * 5-(4-Chlorobenzoyl)-1,4-dimethyl-1H-pyrrole-2-acetic acid sodium salt  
   dihydrate
   * MCN 2783-21-98
   * Sodium 5-(4-chlorobenzoyl)-1,4-dimethyl-1H-pyrrole-2-acetate dihydrate
   * Sodium zomepirac
   * Zomax
   * Zomepirac
   * Zomepirac sodium
   * Zomepirac sodium salt
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 117 mg/kg
TOXIC EFFECTS :
   Behavioral - coma
   Cardiac - pulse rate increase, without fall in BP
   Vascular - BP lowering not characterized in autonomic section
REFERENCE :
   JATOD3 Journal of Analytical Toxicology.  (Preston Pub. Inc., POB 48312,
   Niles, IL 60648) V.1-    1977-  Volume(issue)/page/year: 7,223,1983
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 70 mg/kg/10D-I
TOXIC EFFECTS :
   Gastrointestinal - nausea or vomiting
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Immunological Including Allergic - anaphylaxis
REFERENCE :
   AJMEAZ American Journal of Medicine.  (Technical Pub., 875 Third Ave., New
   York, NY 10022) V.1-    1946-  Volume(issue)/page/year: 76,1113,1984
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 1429 ug/kg
TOXIC EFFECTS :
   Lungs, Thorax, or Respiration - cyanosis
REFERENCE :
   ANAEA3 Annals of Allergy.  (American College of Allergists, POB 20671,
   Bloomington, MN 55420) V.1-    1943-  Volume(issue)/page/year: 48,233,1982
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 16 mg/kg/2D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
REFERENCE :
   AIMDAP Archives of Internal Medicine.  (AMA, 535 N. Dearborn St., Chicago,
   IL 60610)  V.1-    1908-  Volume(issue)/page/year: 143,1171,1983
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 27 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   DRUGAY Drugs. International Journal of Current Therapeutics and Applied
   Pharmacology Reviews.  (ADIS Press International Inc., Suite B-30, Oxford
   Ct. Business Center, 582 Middletown Blvd., Langhorne, PA 19047)  V.1- 1971- 
   Volume(issue)/page/year: 23,250,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 63 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   DRUGAY Drugs. International Journal of Current Therapeutics and Applied
   Pharmacology Reviews.  (ADIS Press International Inc., Suite B-30, Oxford
   Ct. Business Center, 582 Middletown Blvd., Langhorne, PA 19047)  V.1- 1971- 
   Volume(issue)/page/year: 23,250,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : >100 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   DRUGAY Drugs. International Journal of Current Therapeutics and Applied
   Pharmacology Reviews.  (ADIS Press International Inc., Suite B-30, Oxford
   Ct. Business Center, 582 Middletown Blvd., Langhorne, PA 19047)  V.1- 1971- 
   Volume(issue)/page/year: 23,250,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - hamster
DOSE/DURATION           : 743 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   DRUGAY Drugs. International Journal of Current Therapeutics and Applied
   Pharmacology Reviews.  (ADIS Press International Inc., Suite B-30, Oxford
   Ct. Business Center, 582 Middletown Blvd., Langhorne, PA 19047)  V.1- 1971- 
   Volume(issue)/page/year: 23,250,1982
 
                            *** END OF RECORD ***