*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : UG5700000
CHEMICAL NAME : m-Propionotoluidide,
2-methyl-4'-nitro-alpha,alpha,alpha-triflouro-
CAS REGISTRY NUMBER : 13311-84-7
BEILSTEIN REFERENCE NO. : 2157663
LAST UPDATED : 199806
DATA ITEMS CITED : 27
MOLECULAR FORMULA : C11-H11-F3-N2-O3
MOLECULAR WEIGHT : 276.24
WISWESSER LINE NOTATION : FXFFR BNW EMVY1&1
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
Hormone
SYNONYMS/TRADE NAMES :
* Flutamide
* Niftholide
* Niftolide
* 4'-Nitro-3'-trifluoromethylisobutyranilide
* Propanamide, 2-methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
* Sch 13521
* alpha,alpha,alpha-Trifluoro-2-methyl-4'-nitro-m-propionotoluidide
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 310 mg/kg/31D-I
TOXIC EFFECTS :
Behavioral - euphoria
REFERENCE :
AJPSAO American Journal of Psychiatry. (American Psychiatric Assoc.,
Circulation Dept., 1400 K St., NW, Washington, DC 20005) V.78- 1921-
Volume(issue)/page/year: 143,1498,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 787 mg/kg
TOXIC EFFECTS :
Kidney, Ureter, Bladder - hematuria
Kidney, Ureter, Bladder - incontinence
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 45,135,1993
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 289 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Lungs, Thorax, or Respiration - cyanosis
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 45,135,1993
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : >2 gm/kg
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Gastrointestinal - other changes
Liver - other changes
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 45,135,1993
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 700 mg/kg/28D-I
TOXIC EFFECTS :
Endocrine - androgenic
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
BJCAAI British Journal of Cancer. (Macmillan Press Ltd., Houndmills,
Basingstoke, Hants. RG21 2XS, UK) V.1- 1947- Volume(issue)/page/year:
60,664,1989
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 27300 mg/kg/52W-I
TOXIC EFFECTS :
Blood - pigmented or nucleated red blood cells
Biochemical - Metabolism (Intermediary) - other proteins
Related to Chronic Data - changes in prostate weight
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 45,163,1993
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 2730 mg/kg/1Y-I
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria
Reproductive - Tumorigenic effects - testicular tumors
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 45,141,1993
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 1050 mg/kg
SEX/DURATION : female 14-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
AAMMAU Archives d'Anatomie Microscopique et de Morphologie Experimentale.
(SPPIF, B.P.22, F-41353 Vineuil, France) V.36-76, 1947-1987. For publisher
information, see BSTME2. Volume(issue)/page/year: 64,27,1975
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 150 mg/kg
SEX/DURATION : male 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 25,81,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 375 mg/kg
SEX/DURATION : male 15 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
EXCEDS Experimental and Clinical Edocrinology. (Johann Ambrosius Barth
Verlag, Postfach 109, Leipzig DDR-7010, Ger. Dem. Rep.) V.81- 1983-
Volume(issue)/page/year: 82,140,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 3840 mg/kg
SEX/DURATION : male 64 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - male fertility index (e.g. # males impregnating
females per # males exposed to fertile nonpregnant females)
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: 45,187,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 280 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 16,157,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 525 mg/kg
SEX/DURATION : female 14-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - skin and skin
appendages
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
BIRSB5 Biology of Reproduction, Supplement. (Champaign, IL) No.1-4,
1969-71(?). Discontinued. For publisher information, see BIREBV.
Volume(issue)/page/year: 20(Suppl 1),116A,1979
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 275 mg/kg
SEX/DURATION : female 11-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - Central Nervous System
REFERENCE :
BRREAP Brain Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1966- Volume(issue)/page/year: 578,69,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 70 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - other effects on male
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 15,788,1977
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 400 mg/kg
SEX/DURATION : female 16-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - endocrine system
Reproductive - Specific Developmental Abnormalities - other developmental
abnormalities
REFERENCE :
JPDSA3 Journal of Pediatric Surgery. (Grune and Stratton, Inc., Journal
Subscription Dept., POB 6280, Duluth, MN 55806) V.1- 1966-
Volume(issue)/page/year: 29,836,1994
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 65 mg/kg
SEX/DURATION : female 10-22 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - delayed effects
REFERENCE :
ENDOAO Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston
St., Baltimore, MD 21203) V.1- 1917- Volume(issue)/page/year:
103,1702,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE : 29040 ug/kg
SEX/DURATION : male 17 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
Reproductive - Paternal Effects - testes, epididymis, sperm duct
REFERENCE :
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information
Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
Volume(issue)/page/year: 18,1225,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE : 350 mg/kg
SEX/DURATION : male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
Reproductive - Paternal Effects - other effects on male
REFERENCE :
ANDRDQ Andrologia. (Grosse Verlag GmbH, Kurfuerstenstr. 112-113, D-1000
Berlin 30, Fed. Rep. Ger.) V.6- 1974- Volume(issue)/page/year:
24,113,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE : 200 mg/kg
SEX/DURATION : female 16-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Paternal Effects - other effects on male
Endocrine - androgenic
REFERENCE :
JOURAA Journal of Urology. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1917- Volume(issue)/page/year: 151,509,1994
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 80 mg/kg
SEX/DURATION : male 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
ENDKAC Endokrinologie. (Leipzig, Ger. Dem. Rep.) V.1-80, 1928-82. For
publisher information, see EXCEDS. Volume(issue)/page/year: 71,135,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 400 mg/kg
SEX/DURATION : male 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
ENDKAC Endokrinologie. (Leipzig, Ger. Dem. Rep.) V.1-80, 1928-82. For
publisher information, see EXCEDS. Volume(issue)/page/year: 71,135,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 1 gm/kg
SEX/DURATION : female 13-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - other postnatal measures or effects
REFERENCE :
BIREBV Biology of Reproduction. (Soc. for the Study of Reproduction, 309 W.
Clark St., Champaign, IL 61820) V.1- 1969- Volume(issue)/page/year:
44,707,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE : 300 mg/kg
SEX/DURATION : female 14-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
IJANDP International Journal of Andrology. (Scriptor Publisher ApS, 15
Gasvaerksvej, DK-1656 Copenhagen V, Denmark) V.1- 1978-
Volume(issue)/page/year: 19,263,1996
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - pig
DOSE : 1225 mg/kg
SEX/DURATION : female 6 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - other effects to embryo
REFERENCE :
JOURAA Journal of Urology. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1917- Volume(issue)/page/year: 156,767,1996
** MUTATION DATA **
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - rat Liver
DOSE/DURATION : 50 umol/L
REFERENCE :
CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1980-
Volume(issue)/page/year: 13,373,1992
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Negative: Rodent dominant lethal
*** END OF RECORD ***