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Pregn - 4 - ene - 3,20 - dione, 17 - hydroxy - , hexanoate

RTECS #: TU5085000

CAS #: 630-56-8

UPDATE: February 2003 MW: 428.67 MF: C27H40O4


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. REPRODUCTIVE EFFECTS DATA:
  3. OTHER MULTIPLE DOSE DATA:
  4. REVIEWS:
  5. NIOSH DOCUMENTATION AND SURVEILLANCE:
  6. REFERENCES:

SYNONYMS:

  1. 17 - ( (1 - Oxohexyl) oxy) pregn - 4 - ene - 3,20 - dione
  2. 17 - Hydroxypregn - 4 - ene - 3,20 - dione hexanoate
  3. 17 - alpha - Hexanoyloxypregn - 4 - ene - 3,20 - dione
  4. 17 - alpha - Hydroxyprogesterone caproate
  5. 17 - alpha - Hydroxy progesterone n - caproate
  6. 17 - alpha - Hydroxyprogesterone hexanoate
  7. Corlutin L.A.
  8. Delalutin
  9. Depo - Proluton
  10. Duraluton
  11. Estralutin
  12. Gesterol L.A.
  13. HPC
  14. Hormofort
  15. Hydroxyprogesterone caproate
  16. Hylutin
  17. Hyproval - PA
  1. Hyroxon
  2. Idrogestene
  3. Lutate
  4. Luteocrin
  5. Luteocrin depot
  6. Lutopron
  7. NSC - 17592
  8. Neolutin
  9. Pregn - 4 - ene - 3,20 - dione, 17 - ( (1 - oxohexyl) oxy) -
  10. Primolut depot
  11. Progesterone caproate
  12. Progesterone retard pharlon
  13. Proluton depot
  14. Relutin
  15. Syngynon
  16. Teralutil


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
N/R N/R N/R N/R


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
implant
mouse 		lowest published toxic dose: 650 mg/kg (6-18 day pregnant) Reproductive: Other effects to embryo or fetus TJADAB 35,28A,1987
implant
rat 		lowest published toxic dose: 30 mg/kg (20 day male) Reproductive: Effects on fertility: Male fertility index (e.g., # males impregnating females per # males exposed to fertile nonpregnant females) IJEBA6 18,1225,1980
implant
rat 		lowest published toxic dose: 61,953 µg/kg (26 week male) Reproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count) IJEBA6 18,1225,1980
implant
rat 		lowest published toxic dose: 45,157 µg/kg (17 week male) Reproductive: Paternal effects: Testes, epididymis, sperm duct IJEBA6 18,1225,1980
intramuscular
human 		lowest published toxic dose: 100 mg/kg (8-77 day pregnant) Reproductive: Tumorigenic effects: Transplacental tumorigenesis LANCAO 2,P580,1983
intramuscular
human 		lowest published toxic dose: 100 mg/kg (8-78 day pregnant) Reproductive: Tumorigenic effects: Transplacental tumorigenesis LANCAO 2,580,1983
intramuscular
monkey 		lowest published toxic dose: 180 mg/kg (3-21 week pregnant) Reproductive: Effects on embryo or fetus: Fetal death TJADAB 35,129,1987
intramuscular
rat 		lowest published toxic dose: 700 mg/kg (18-24 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Effects on embryo or fetus: Fetal death 		TJADAB 31,48A,1985
parenteral
monkey 		lowest published toxic dose: 125 mg/kg (1-150 day pregnant) Endocrine: Androgenic

Endocrine: Estrogenic

Endocrine: Other changes 		AMJPR* 25,175,1991
subcutaneous
mouse 		lowest published toxic dose: 4,160 mg/kg (6-15 day pregnant) Reproductive: Effects on fertility: Pre- implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea)

Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) 		TJADAB 28,201,1983
unreported route
woman 		lowest published toxic dose: 12 mg/kg (6-20 week pregnant) Reproductive: Effects on newborn: Behavioral SCIEAS 211,1171,1981


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intramuscular
rabbit 		lowest published toxic dose: 123.5 mg/kg/38 week- intermittent Endocrine: Changes in endocrine weight (unspecified)

Endocrine: Other changes

Endocrine: Tumors 		IMEMDT 21,399,1979
intraperitoneal
mouse 		lowest published toxic dose: 380 mg/kg/5 day- intermittent Reproductive: Maternal effects: Ovaries, fallopian tubes TJADAB 34,29,1986
intraperitoneal
mouse 		lowest published toxic dose: 13,500 mg/kg/9 day- intermittent Skin and Appendages: Tumors

Tumorigenic: Protects against induction of experimental tumors

Tumorigenic: Active as anti-cancer agent 		VOONC* 43,317,1997
parenteral
mouse 		lowest published toxic dose: 342,500 µg/kg/5 day- intermittent Reproductive: Maternal effects: Oogenesis

Reproductive: Maternal effects: Ovaries, fallopian tubes 		TJADAB 34,29,1986
subcutaneous
rat 		lowest published toxic dose: 800 mg/kg/40 week- intermittent Tumorigenic: Protects against induction of experimental tumors IMEMDT 21,399,1979


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
International Agency for Research on Cancer (IARC) Cancer Review Animal Inadequate Evidence IMEMDT 21,399,1979
TOXICOLOGY REVIEW
TJADAB 21,225,1980


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
N/R N/R N/R


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: X6069;
Number of Industries 1;
Total Number of Facilities 7;
Number of Occupations 2;
Total Number of Employees Exposed 628;
Total Number of Female Employees Exposed 314


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
N/R


REFERENCES:

CODEN
REFERENCE
AMJPR* American Journal of Primatology (The Official Journal of the American Society of Primatologists, Wiley-Liss, Inc., a division of John Wiley & Sons, Inc.)-
IJEBA6 Indian Journal of Experimental Biology. (Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963-
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) V.1- 1972-
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
SCIEAS Science. (American Assoc. for the Advancement of Science, 1333 H St., NW, Washington, DC 20005) V.1- 1895-
TJADAB Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
VOONC* Voprosi oncologii (Questions of oncology. Journal of Petrov's Institute of Oncology, B. Zelenina str, 43a, Spb 197110, Russia) V.1- 1955-

Used as a drug for the treatment of menstrual disorders, threatened abortion, sterility

FDA-proprietary drug

RTECS Compound Description:
   Tumorigen
   Drug
   Reproductive Effector
   Human Data
   Hormone

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