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2 - Naphthacenecarboxamide, 4 - (dimethylamino) - 1,4,4a,5,5a,6,11,12a - octahydro - 3,6,10,12,12a - pentahydroxy - 6 - methyl - 1,11 - dioxo - , monohydrochloride

RTECS #: QI9100000

CAS #: 64-75-5


UPDATE: May 2008 MW: 480.94 MF: C22H24N2O8•ClH


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. MUTATION DATA:
  3. REPRODUCTIVE EFFECTS DATA:
  4. ACUTE TOXICITY DATA:
  5. OTHER MULTIPLE DOSE DATA:
  6. REVIEWS:
  7. STANDARDS AND REGULATIONS:
  8. NIOSH DOCUMENTATION AND SURVEILLANCE:
  9. STATUS IN FEDERAL AGENCIES:
  10. REFERENCES:

SYNONYMS:

  1. ALA TET
  2. Achromycin hydrochloride
  3. Amycin, hydrochloride
  4. Artomycin
  5. Bristacycline
  6. Cancycline - 250
  7. Cefracycline tablets
  8. Chlorhydrate de tetracycline (French)
  9. Chlorowodorku tetracykliny (Polish)
  10. Cyclopar
  11. Diacycine
  12. Dumocyclin
  13. Hostacycline
  14. Medamycin
  15. Mephacyclin
  16. NCI - C55561
  17. Neocycline B
  18. Paltet
  19. Panmycin hydrochloride
  20. Partrex
  21. Piracaps
  22. Polycycline hydrochloride
  23. Polyotic ointment
  24. Qidtet
  25. Quadracycline
  26. Quatrex
  27. Remicyclin
  28. Ricycline
  29. Ro - Cycline
  30. Sanclomycine
  1. Steclin
  2. Stilciclina
  3. Subamycin
  4. Sumycin
  5. Supramycin
  6. Tefilin
  7. Teline
  8. Telotrex
  9. Tet - Cy
  10. Tetra - D
  11. Tetra - wedel
  12. Tetrabakat
  13. Tetrabid
  14. Tetrablet
  15. Tetracaps
  16. Tetrachel
  17. Tetraciclina cloridrato (Italian)
  18. Tetracompren
  19. Tetracycline chlorohydrate
  20. Tetracycline hydrochloride
  21. Tetrakap
  22. Tetralution
  23. Tetramavan
  24. Tetrosol
  25. Topicycline
  26. Triphacyclin
  27. U - 5965
  28. Unicin
  29. Unimycin
  30. Vetquamycin - 324


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
cytogenetic analysis mouse mammary gland 31,600 µg/L/24 hour MUREAV 40,261,1976
DNA adduct Escherichia coli 50 µmol/L MUREAV 89,95,1981
DNA damage human fibroblast 500 µmol/L MUREAV 315,33,1994
DNA damage other microorganisms 1 mmol/L MUREAV 315,33,1994
DNA damage rat liver 200 µmol/L EMMUEG 24,181,1994
DNA inhibition human fibroblast 1,250 µmol/L MUREAV 348,7,1995
DNA inhibition mouse mammary gland 31,600 µg/L MUREAV 40,261,1976
unscheduled DNA synthesis human fibroblast 750 µmol/L MUREAV 315,33,1994
gene conversion and mitotic recombination Saccharomyes cerevisiae 3 gm/L MUREAV 12,357,1971
mutation in mammalian somatic cells mouse lymphocyte 120 mg/L NTPTR* NTP-TR-344,1989
mutation in mammalian somatic cells mouse mammary gland 100 mg/L MUREAV 40,261,1976
other mutation test systems mouse mammary gland 31,600 µg/L MUREAV 40,261,1976
sister chromatid exchange hamster embryo 3 mg/L SHIGAZ 74,1385,1987


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
intramuscular
rat
lowest published toxic dose: 240 mg/kg (10-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) BINEAA 4,365,1962
intramuscular
rat
lowest published toxic dose: 150 mg/kg (1-6 day pregnant) Reproductive: Specific developmental abnormalities: Endocrine system FATOAO 47,66,1984
intramuscular
rat
lowest published toxic dose: 150 mg/kg (8-13 day pregnant) Reproductive: Specific developmental abnormalities: Endocrine system FATOAO 47,66,1984
intramuscular
rat
lowest published toxic dose: 150 mg/kg (14-19 day pregnant) Reproductive: Specific developmental abnormalities: Endocrine system FATOAO 47,66,1984
intramuscular
rat
lowest published toxic dose: 150 mg/kg (1-6 day pregnant) Reproductive: Specific developmental abnormalities: Blood and lymphatic systems (including spleen and marrow)

Reproductive: Specific developmental abnormalities: Immune and reticuloendothelial system
FATOAO 47,70,1984
intramuscular
rat
lowest published toxic dose: 150 mg/kg (8-13 day pregnant) Reproductive: Specific developmental abnormalities: Blood and lymphatic systems (including spleen and marrow) FATOAO 47,70,1984
intramuscular
rat
lowest published toxic dose: 150 mg/kg (14-19 day pregnant) Reproductive: Specific developmental abnormalities: Blood and lymphatic systems (including spleen and marrow) FATOAO 47,70,1984
intraperitoneal
mouse
lowest published toxic dose: 900 mg/kg (8-13 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetal death

Reproductive: Specific developmental abnormalities: Musculoskeletal system
IYKEDH 3,75,1972
intraperitoneal
mouse
lowest published toxic dose: 600 mg/kg (8-13 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) IYKEDH 3,75,1972
intraperitoneal
mouse
lowest published toxic dose: 150 mg/kg (10 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system IYKEDH 3,82,1972
intraperitoneal
rat
lowest published toxic dose: 425 mg/kg (14-18 day pregnant) Reproductive: Effects on fertility: Abortion

Reproductive: Effects on embryo or fetus: Extra embryonic structures (e.g., placenta, umbilical cord)
LAINAW 14,1456,1965
intrauterine
rat
lowest published toxic dose: 100 mg/kg (1 day prior to copulation) Reproductive: Maternal effects: Uterus, cervix, vagina CCPTAY 29,553,1984
oral
rat
lowest published toxic dose: 14 gm/kg (3 day male/3 day prior to copulation-22 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system

Reproductive: Specific developmental abnormalities: Urogenital system
TXAPA9 7,409,1965
oral
rat
lowest published toxic dose: 6 gm/kg (9-14 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) KSRNAM 4,516,1970
oral
rabbit
lowest published toxic dose: 9 gm/kg (8-16 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants) KSRNAM 4,516,1970
parenteral
mouse
lowest published toxic dose: 2,250 mg/kg (10-18 day pregnant) Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) JOPHAN 57,567,1965
subcutaneous
mouse
lowest published toxic dose: 2,250 mg/kg (10-18 day pregnant) Reproductive: Specific developmental abnormalities: Urogenital system

Reproductive: Effects on newborn: Viability index (e.g., # alive at day 4 per # born alive)

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain)
CRSBAW 161,300,1967
subcutaneous
mouse
lowest published toxic dose: 750 mg/kg (1-6 day pregnant) Reproductive: Effects on fertility: Abortion ASPHAK 23,481,1969
subcutaneous
rat
lowest published toxic dose: 240 mg/kg (16-20 day pregnant) Reproductive: Other effects to embryo or fetus BCPCA6 17,1479,1968
unreported route
rat
lowest published toxic dose: 450 mg/kg (7-15 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)
ANTBAL 16,923,1971
unreported route
rat
lowest published toxic dose: 765 mg/kg (7-15 day pregnant) Reproductive: Effects on fertility: Abortion ANTBAL 16,923,1971


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
intrapleural
rabbit
lowest published lethal dose: 35 mg/kg Lung, Thorax, or Respiration: Fibrosis (interstitial)

Lung, Thorax, or Respiration: Other changes
LUNGD9 174,373,1996
intraperitoneal
mouse
lethal dose (50 percent kill): 368 mg/kg N/R JPPMAB 16,33,1964
intraperitoneal
rat
lethal dose (50 percent kill): 318 mg/kg N/R GNRIDX 2,26,1968
intravenous
mouse
lethal dose (50 percent kill): 157 mg/kg N/R FRPSAX 10,197,1955
intravenous
rat
lethal dose (50 percent kill): 128 mg/kg N/R FRPSAX 10,197,1955
oral
man
lowest published toxic dose: 200 mg/kg/7 day- intermittent Taste: Change in function CPHADV 4,455,1985
oral
mouse
lethal dose (50 percent kill): 2,759 mg/kg N/R JPPMAB 16,33,1964
oral
mouse
lowest published toxic dose: 2,000 mg/kg Liver: Fatty liver degeneration

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Phosphatases
JTSCDR 31,23,2006
oral
mouse
lowest published toxic dose: 600 mg/kg Liver: Other changes

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Transaminases
JTSCDR 31,23,2006
oral
rat
lethal dose (50 percent kill): 6,443 mg/kg N/R TXAPA9 18,185,1971
oral
rat
lowest published toxic dose: 2,000 mg/kg Liver: Fatty liver degeneration

Liver: Other changes

Blood: Changes in serum composition (e.g. TP, bilirubin, cholesterol)
JTSCDR 31,49,2006
subcutaneous
rat
lethal dose (50 percent kill): 700 mg/kg Gastrointestinal: Hypermotility, diarrhea TXAPA9 9,445,1966
unreported route
mouse
lethal dose (50 percent kill): 105 mg/kg N/R 40YJAX -,55,1979


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
intramuscular
rat
lowest published toxic dose: 210 mg/kg/7 day- intermittent Kidney, Ureter, and Bladder: Changes in bladder weight

Blood: Changes in serum composition (e.g. TP, bilirubin, cholesterol)

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Phosphatases
INJPD2 18,110,1986
intramuscular
rabbit
lowest published toxic dose: 500 mg/kg/20 day- intermittent Blood: Changes in serum composition (e.g. TP, bilirubin, cholesterol)

Blood: Other changes

Biochemical: Metabolism (intermediary): Other proteins
ANTBAL 26,374,1981
intravenous
dog
lowest published toxic dose: 1,287 mg/kg/30 day- intermittent Blood: Pigmented or nucleated red blood cells

Blood: Changes in erythrocyte (RBC) count

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
TXAPA9 11,128,1967
oral
mouse
lowest published toxic dose: 772,500 mg/kg/103 week- intermittent Liver: Tumors

Tumorigenic: Active as anti-cancer agent
NTIS** PB90-198540/AS
oral
rat
lowest published toxic dose: 432 mg/kg/90 day- intermittent Related to Chronic Data: Changes in uterine weight

Musculoskeletal: Other changes
ACPSI* 24,599,2003


REVIEWS:

ORGANIZATION STANDARD
REFERENCE

TOXICOLOGY REVIEW
MUREAV 584,1,2005


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE

Occupational Exposure Limit - RUSSIA short term exposure limit 0.1 mg/m3, Skin, JUN2003


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE

National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 83550;
Number of Industries 2;
Total Number of Facilities 474;
Number of Occupations 2;
Total Number of Employees Exposed 1,795
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 83550;
Number of Industries 4;
Total Number of Facilities 680;
Number of Occupations 15;
Total Number of Employees Exposed 22,901;
Total Number of Female Employees Exposed 17,276


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE

EPA TSCA Section 8(b) CHEMICAL INVENTORY
Used as a pharmaceutical and veterinary drug
NCI Carcinogenesis Studies (feed);no evidence:mouse,rat


REFERENCES:

CODEN
REFERENCE

40YJAX "Evaluation of Embryotoxicity, Mutagenicity and Carcinogenicity Risks In New Drugs, Proceedings of the Symposium on Toxicological Testing for Safety of New Drugs, 3rd, Prague, 1976," Benesova, O., et al., eds., Prague, Czechoslovakia, Univerzita Karlova, 1979
ACPSI* Acta pharmacologica Sinica (Shanghai : Shanghai Institute of Materia Medica : Chinese Academy of Science ; Carlton, VIC, Australia : Blackwell Publishing Asia, 2005) V.21- 2000-
ANTBAL Antibiotiki. (Moscow, USSR) V.1-29, 1956-84. For publisher information, see AMBIEH.
ASPHAK Archives des Sciences Physiologique. (Paris, France) V.1-28, 1947-74. Discontinued.
BCPCA6 Biochemical Pharmacology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1- 1958-
BINEAA Biologia Neonatorum. (Basel, Switzerland) V.1-14, 1956-69. For publisher information, see BNEOBV.
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970-
CPHADV Clinical Pharmacy. (American Soc. of Hospital Pharmacists, 4630 Montgomery Ave., Bethesda, MD 20814) V.1- 1982-
CRSBAW Comptes Rendus des Seances de la Societe de Biologie et de Ses Filiales. (SPPIF, B.P.22, F-41353 Vineuil, France) V.1- 1849-
EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.10- 1987-
FATOAO Farmakologiya i Toksikologiya (Moscow). For English translation, see PHTXA6 and RPTOAN. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.2- 1939-
FRPSAX Farmaco, Edizione Scientifica. (Casella Postale 227, 27100 Pavia, Italy) V.8-43 1953-88 For publisher information, see FRMCE8
GNRIDX Gendai no Rinsho. (Tokyo, Japan) V.1-10, 1967-76(?).
INJPD2 Indian Journal of Pharmacology. (Dept. of Pharmacology, Baranas Hindu Univ., Varanasi 221 005, India) V.1- 1968(?)-
IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970-
JOPHAN Journal de Physiologie (Paris). (SPPIF, B.P.22, F-41353 Vineuil, France) V.39- 1946-
JPPMAB Journal of Pharmacy and Pharmacology. (Pharmaceutical Soc. of Great Britain, 1 Lambeth High St., London SEI 7JN, UK) V.1- 1949-
JTSCDR Journal of Toxicological Sciences. (Japanese Soc. of Toxicological Sciences, 4th Floor, Gakkai Center Bldg., 4-16, Yayoi 2-chome, Bunkyo-ku, Tokyo 113, Japan) V.1- 1976-
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
LAINAW Laboratory Investigation. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1952-
LUNGD9 Lung. (Springer-Verlag New York, POB 2485, Secaucus, NJ 07096) V.154- 1976-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
NTIS** National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information.
NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206-
SHIGAZ Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20 Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 1949-
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959-

Used as a pharmaceutical and veterinary drug

FDA-proprietary drug

RTECS Compound Description:
   Tumorigen
   Drug
   Mutagen
   Reproductive Effector
   Human Data
   Natural Product

ALT CAS #: 8017-77-4
ALT CAS #: 8026-72-0
ALT CAS #: 90438-83-8
ALT CAS #: 102030-19-3
Click Here for Additional Information about RTECS

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