*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : UV9100000
CHEMICAL NAME : 4,6(1H,5H)-Pyrimidinedione, 5-ethyldihydro-5-phenyl-
CAS REGISTRY NUMBER : 125-33-7
BEILSTEIN REFERENCE NO. : 0218034
REFERENCE : 5-24-08-00102 (Beilstein Handbook Reference)
LAST UPDATED : 199712
DATA ITEMS CITED : 33
MOLECULAR FORMULA : C12-H14-N2-O2
MOLECULAR WEIGHT : 218.28
WISWESSER LINE NOTATION : T6MV DVMTJ C2 CR
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* 5-Aethyl-5-phenyl-hexahydropyrimidin-4,6-dion
* Cyral
* 2-Deoxyphenobarbital
* 2-Desoxyphenobarbital
* Desoxyphenobarbitone
* 5-Ethyldihydro-5-phenyl-4,6(1H,5H)-pyrimidinedione
* 5-Ethylhexahydro-4,6-dioxo-5-phenylphrimidine
* 5-Ethylhexahydro-5-phenylpyrimidine-4,6-dione
* 5-Ethyl-5-phenylhexahydropyrimidine-4,6-dione
* Hexadiona
* Hexamidine
* Hexamidine (the antispasmodic)
* Lepimidin
* Lepsiral
* Majsolin
* Midone
* Milepsin
* Misodine
* Misolyne
* Mizodin
* Mizolin
* Mylepsin
* Mylepsinum
* Mysedon
* Mysoline
* NCI-C56360
* 5-Phenyl-5-aethylhexahydropyrimidindion-(4,6)
* 5-Phenyl-5-ethyl-hexahydropyrimidine-4,6-dione
* Prilepsin
* Primacione
* Primaclone
* Primacone
* Primakton
* Primidon
* Primidone
* Prysoline
* Pyrimidone medi-pets
* ROE 101
* Sertan
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 38 gm/kg/7Y-I
TOXIC EFFECTS :
Behavioral - hallucinations, distorted perceptions
Behavioral - toxic psychosis
REFERENCE :
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 17,551,1983
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1500 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,691,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 240 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
PCJOAU Pharmaceutical Chemistry Journal (English Translation). Translation
of KHFZAN. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) No.1-
1967- Volume(issue)/page/year: 25,305,1991
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >2 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK)
V.1-33, 1946-68. For publisher information, see BJPCBM.
Volume(issue)/page/year: 8,230,1953
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 280 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
34,271,1975
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 332 mg/kg
TOXIC EFFECTS :
Behavioral - anticonvulsant
REFERENCE :
PCJOAU Pharmaceutical Chemistry Journal (English Translation). Translation
of KHFZAN. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) No.1-
1967- Volume(issue)/page/year: 15,403,1981
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 340 mg/kg
TOXIC EFFECTS :
Behavioral - anticonvulsant
REFERENCE :
RPTOAN Russian Pharmacology and Toxicology (English Translation).
Translation of FATOAO. (Euromed Pub., 33, Woodlands Rd., Surbiton, Surrey,
UK) V.30- 1967- Volume(issue)/page/year: 43,73,1980
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 10500 mg/kg/14D-C
TOXIC EFFECTS :
Behavioral - ataxia
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Related to Chronic Data - death
REFERENCE :
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
Akron, OH 44311) V.1- 1981- Volume(issue)/page/year: 12,151,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 17062 mg/kg/13W-C
TOXIC EFFECTS :
Liver - other changes
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
Akron, OH 44311) V.1- 1981- Volume(issue)/page/year: 12,151,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 27440 mg/kg/14D-C
TOXIC EFFECTS :
Behavioral - ataxia
Related to Chronic Data - death
REFERENCE :
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
Akron, OH 44311) V.1- 1981- Volume(issue)/page/year: 12,151,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 89 gm/kg/13W-C
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Behavioral - ataxia
Related to Chronic Data - death
REFERENCE :
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
Akron, OH 44311) V.1- 1981- Volume(issue)/page/year: 12,151,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE/DURATION : 2 gm/kg/4D-I
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - ataxia
REFERENCE :
BJPCAL British Journal of Pharmacology and Chemotherapy. (London, UK)
V.1-33, 1946-68. For publisher information, see BJPCBM.
Volume(issue)/page/year: 8,230,1953
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 10350 mg/kg
SEX/DURATION : female 1-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - skin and skin
appendages
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
94,835,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 10350 mg/kg
SEX/DURATION : female 1-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - other neonatal measures or effects
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
JOPDAB Journal of Pediatrics. (C.V. Mosby Co., 11830 Westline Industrial
Dr., St. Louis, MO 63141) V.1- 1932- Volume(issue)/page/year:
94,835,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 2025 mg/kg
SEX/DURATION : female 1-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
Reproductive - Effects on Newborn - Apgar score (human only)
REFERENCE :
TJADAB Teratology, The International Journal of Abnormal Development. (Alan
R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
Volume(issue)/page/year: 32,13,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE : 10640 mg/kg
SEX/DURATION : female 1-38 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - drug dependence
Reproductive - Effects on Newborn - physical
REFERENCE :
TJADAB Teratology, The International Journal of Abnormal Development. (Alan
R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
Volume(issue)/page/year: 26(1),36A,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 330 mg/kg
SEX/DURATION : female 6-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
40,365,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 990 mg/kg
SEX/DURATION : female 6-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
40,365,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 875 mg/kg
SEX/DURATION : male 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 34,149,1986
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 275 mg/kg
SEX/DURATION : female 6-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
REFERENCE :
EPILAK Epilepsia (New York). (Raven Press, 1185 Ave. of the Americas, New
York, NY 10036) Ser.1-3: 1909-55; Ser.4: V.1- 1959-
Volume(issue)/page/year: 18,1,1977
** MUTATION DATA **
TYPE OF TEST : Mutation in microorganisms
TEST SYSTEM : Bacteria - Salmonella typhimurium
DOSE/DURATION : 6666 ug/plate
REFERENCE :
ENMUDM Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For
publisher information, see EMMUEG. Volume(issue)/page/year: 8(Suppl
7),1,1986
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Human Leukocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co.,
11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-
Volume(issue)/page/year: 116,867,1973
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 375 mg/L
REFERENCE :
AGMGAK Acta Geneticae Medicae et Gemellologiae. (Alan R. Liss, Inc., 41 E.
11th St., New York, NY 10003) V.1- 1952- Volume(issue)/page/year:
21,305,1972
TYPE OF TEST : Sperm Morphology
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 875 mg/kg
REFERENCE :
TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 34,149,1986
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Rodent - hamster Embryo
DOSE/DURATION : 250 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 392,61,1997
*** REVIEWS ***
TOXICOLOGY REVIEW
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 8,690,1974
TOXICOLOGY REVIEW
AUHPAI Australian Journal of Hospital Pharmacy. (B.R. Miller, POB 125,
Heidelberg, Vic., Australia) V.1- 1971- Volume(issue)/page/year:
4(1),5,1974
TOXICOLOGY REVIEW
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: 8,354,1974
TOXICOLOGY REVIEW
PRSMA4 Proceedings of the Royal Society of Medicine. (New York, NY) V.1-70,
1907-77. For publisher information, see JRSMD9. Volume(issue)/page/year:
63,48,1970
TOXICOLOGY RIVIEW
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
2,442,1973
TOXICOLOGY REVIEW
AJDCAI American Journal of Diseases of Children. (AMA, 535 N. Dearborn St.,
Chicago, IL 60610) V.1-80(3), 1911-50; V.100- 1960-
Volume(issue)/page/year: 131,1337,1977
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X4105
No. of Facilities: 416 (estimated)
No. of Industries: 3
No. of Occupations: 6
No. of Employees: 11085 (estimated)
No. of Female Employees: 6869 (estimated)
*** STATUS IN U.S. ***
NTP Carcinogenesis studies; test completed (post peer review), October 1997
*** END OF RECORD ***