*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : US5653000
CHEMICAL NAME           : 3,5-Pyridinedicarboxylic acid,
                          1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, ethyl
                          methyl ester
CAS REGISTRY NUMBER     : 39562-70-4
BEILSTEIN REFERENCE NO. : 0498823
LAST UPDATED            : 199612
DATA ITEMS CITED        : 17
MOLECULAR FORMULA       : C18-H20-N2-O6
MOLECULAR WEIGHT        : 360.40
COMPOUND DESCRIPTOR     : Drug
                          Reproductive Effector
SYNONYMS/TRADE NAMES :
   * BAY e 5009
   * Bayotensin
   * Baypress
   * 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid  
   ethyl methyl ester
   * Ethyl methyl  
   1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate
   * Nidrel
   * Nitrendipine
 
                       *** 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           : 15370 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Lungs, Thorax, or Respiration - other changes
   Blood - changes in spleen
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,121,1988
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 205 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Lungs, Thorax, or Respiration - other changes
   Blood - changes in spleen
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,121,1988
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 5166 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - other changes
   Blood - changes in spleen
   Skin and Appendages - hair
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,121,1988
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 12600 ug/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 2540 mg/kg
TOXIC EFFECTS :
   Behavioral - somnolence (general depressed activity)
   Behavioral - rigidity (including catalepsy)
   Lungs, Thorax, or Respiration - cyanosis
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 303 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Lungs, Thorax, or Respiration - other changes
   Blood - changes in spleen
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,121,1988
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 7613 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - other changes
   Blood - changes in spleen
   Skin and Appendages - hair
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,121,1988
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 34500 ug/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   FRPSAX Farmaco, Edizione Scientifica. (Casella Postale 227, 27100 Pavia,
   Italy)  V.8-43 1953-88 For publisher information, see FRMCE8
   Volume(issue)/page/year: 42,697,1987
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : >100 mg/kg
TOXIC EFFECTS :
   Gastrointestinal - nausea or vomiting
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : >2500 ug/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 2500 mg/kg
TOXIC EFFECTS :
   Behavioral - somnolence (general depressed activity)
   Behavioral - rigidity (including catalepsy)
   Lungs, Thorax, or Respiration - cyanosis
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 2500 ug/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 107 gm/kg/2Y-C
TOXIC EFFECTS :
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   52EDA6 "Nitrendipine, Based on Presentations at International Workshop on
   Nitrendipine, 1st, New York, 1982," Scriabine, A., et al., eds., Baltimore,
   Urban & Schwarzenberg, 1984  Volume(issue)/page/year: -,25,1984
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 1720 mg/kg
SEX/DURATION            : female 17-22 day(s) after conception
                          lactating female 21 day(s) post-birth
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
   e.g., stunted fetus)
   Reproductive - Effects on Newborn - behavioral
   Reproductive - Effects on Newborn - physical
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,133,1988
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 11000 mg/kg
SEX/DURATION            : female 7-17 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
   resorbed implants per total number of implants)
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,145,1988
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 1100 mg/kg
SEX/DURATION            : female 7-17 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,145,1988
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 330 mg/kg
SEX/DURATION            : female 7-17 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
   OYYAA2 Oyo Yakuri.  Pharmacometrics.  (Oyo Yakuri Kenkyukai, CPO Box 180,
   Sendai 980-91, Japan) V.1-    1967-  Volume(issue)/page/year: 36,145,1988
 
                            *** END OF RECORD ***