*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : UU8815550
CHEMICAL NAME           : 7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic
                          acid, 2,3-dihydro-9-fluoro-3-methyl-
                          10-(4-methyl-1-piperazinyl)-7-oxo-, hemihydrate, (S)-
CAS REGISTRY NUMBER     : 100986-85-4
LAST UPDATED            : 199403
DATA ITEMS CITED        : 8
MOLECULAR FORMULA       : C18-H20-F-N3-O4.1/2H2-O
MOLECULAR WEIGHT        : 342.41
COMPOUND DESCRIPTOR     : Drug
                          Reproductive Effector
SYNONYMS/TRADE NAMES :
   * DR3355
   * Levofloxacin
   * (-)-Ofloxacin
   * (S)-Ofloxacin
   * RWJ-25213
 
                       *** 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           : 1478 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - ptosis
   Behavioral - somnolence (general depressed activity)
   Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,365,1992
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 1803 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - ptosis
   Behavioral - somnolence (general depressed activity)
   Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,365,1992
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Primate - monkey
DOSE/DURATION           : >250 mg/kg
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - ptosis
   Behavioral - somnolence (general depressed activity)
   Lungs, Thorax, or Respiration - respiratory depression
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,365,1992
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 14560 mg/kg/26W-I
TOXIC EFFECTS :
   Gastrointestinal - other changes
   Kidney, Ureter, Bladder - other changes in urine composition
   Blood - changes in leukocyte (WBC) count
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,367,1992
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 22400 mg/kg/28D-I
TOXIC EFFECTS :
   Gastrointestinal - other changes
   Blood - changes in leukocyte (WBC) count
   Nutritional and Gross Metabolic - changes in phosphorus
REFERENCE :
   JTSCDR Journal of Toxicological Sciences.  (Japanese Soc. of Toxicological
   Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku,
   Tokyo 113, Japan)  V.1-    1976-  Volume(issue)/page/year: 16,29,1991
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Primate - monkey
DOSE/DURATION           : 2800 mg/kg/28D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - urine volume decreased
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   JTSCDR Journal of Toxicological Sciences.  (Japanese Soc. of Toxicological
   Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku,
   Tokyo 113, Japan)  V.1-    1976-  Volume(issue)/page/year: 16,29,1991
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 8910 mg/kg
SEX/DURATION            : female 7-17 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
   Reproductive - Effects on Embryo or Fetus - fetal death
   Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,374,1992
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 8910 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 :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 42,374,1992
 
                            *** END OF RECORD ***