*** 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 ***