RTECS:QI8650000 The Registry of Toxic Effects of Chemical Substances

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

RTECS #: QI8650000

CAS #: 564-25-0

UPDATE: May 2009 MW: 444.48 MF: C₂₂H₂₄N₂O₈

NOTE:

TOXICITY DATA HAVE NOT BEEN EVALUATED. OMISSION OF A SUBSTANCE OR NOTATION DOES NOT IMPLY ANY RELIEF FROM REGULATORY RESPONSIBILITY.

TABLE OF CONTENTS:

SYNONYMS:

MUTATION DATA:

REPRODUCTIVE EFFECTS DATA:

ACUTE TOXICITY DATA:

OTHER MULTIPLE DOSE DATA:

REVIEWS:

NIOSH DOCUMENTATION AND SURVEILLANCE:

STATUS IN FEDERAL AGENCIES:

REFERENCES:

SYNONYMS:

5 - Hydroxy - alpha - 6 - deoxytetracycline

6 - alpha - Deoxy - 5 - oxytetracycline

Doxiciclina (Italian)

Doxycycline

GS - 3065

Liviatin

Vibramycin

alpha - 6 - Deoxy - 5 - hydroxytetracycline

alpha - 6 - Deoxyoxytetracycline

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
DNA inhibition human lymphocyte 3,750 痢/L BCPHBM 16,127,1983
micronucleus test oral
human 60 mg/kg/20 day- intermittent MUREAV 608,43,2006

REPRODUCTIVE EFFECTS DATA AND REFERENCES:
ROUTE/
ORGANISM DOSE
EFFECT

REFERENCE
oral
mouse lowest published toxic dose: 750 mg/kg (2 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) ARZNAD 36,219,1986

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
intraperitoneal
mouse lethal dose (50 percent kill): 410 mg/kg N/R GICTAL 17,276,1970
intraperitoneal
rat lethal dose (50 percent kill): 378 mg/kg N/R THERAP 23,575,1968
intravenous
dog lethal dose (50 percent kill): >100 mg/kg N/R PBPSDY 2,305,1979
intravenous
mouse lethal dose (50 percent kill): 241 mg/kg N/R PBPSDY 2,305,1979
intravenous
rat lethal dose (50 percent kill): 228 mg/kg N/R PBPSDY 2,305,1979
oral
dog lethal dose (50 percent kill): >500 mg/kg N/R PBPSDY 2,305,1979
oral
mouse lethal dose (50 percent kill): 1,007 mg/kg N/R VCVPS* -,430,1998
oral
rat lethal dose (50 percent kill): >2 gm/kg N/R PBPSDY 2,305,1979
oral
woman lowest published toxic dose: 68 mg/kg/24 day- intermittent Musculoskeletal: Joints

Immunological Including Allergic: Other immediate (humoral): uticaria, allergic rhinitis, serum sickness (multiple organ involvement)

Nutritional and Gross Metabolic: Body temperature increase PGMJAO 67,313,1991

OTHER MULTIPLE DOSE DATA AND REFERENCES:
ROUTE/
ORGANISM DOSE
EFFECT

REFERENCE
intraperitoneal
mouse lowest published toxic dose: 20 mg/kg/4 day- intermittent Tumorigenic: Active as anti-cancer agent TXAPA9 202,268,2005
subcutaneous
rat lowest published toxic dose: 35 mg/kg/7 day- intermittent Musculoskeletal: Changes in teeth and supporting structures

Musculoskeletal: Other changes

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation BJMRDK 35,613,2002

REVIEWS:
ORGANIZATION STANDARD
REFERENCE

TOXICOLOGY REVIEW
PBPSDY 2,305,1979
TOXICOLOGY REVIEW
MUREAV 488,151,2001
TOXICOLOGY REVIEW
EMMUEG 43,143,2004
TOXICOLOGY REVIEW
APHRER 37,1675,2003
TOXICOLOGY REVIEW
CLTHE* 27,1329,2005
TOXICOLOGY REVIEW
CLTHE* 27,1329,2005
TOXICOLOGY REVIEW
APHRER 40,1939,2006
TOXICOLOGY REVIEW
HPCQA4 38,527,2007
TOXICOLOGY REVIEW
HUTOX* -,429,1996

STANDARDS AND REGULATIONS:
ORGANIZATION STANDARD
REFERENCE

N/R N/R N/R

NIOSH DOCUMENTATION AND SURVEILLANCE:
ORGANIZATION STANDARD or SURVEY
REFERENCE

National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 84744;
Number of Industries 1;
Total Number of Facilities 641;
Number of Occupations 1;
Total Number of Employees Exposed 1,281
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 84744;
Number of Industries 1;
Total Number of Facilities 450;
Number of Occupations 5;
Total Number of Employees Exposed 22,055;
Total Number of Female Employees Exposed 18,813

STATUS IN FEDERAL AGENCIES:
ORGANIZATION
REFERENCE

EPA GENETOX PROGRAM 1988, Inconclusive: Sperm morphology-human

REFERENCES:
CODEN
REFERENCE

APHRER Annals of Pharmacotherpy. (Harvey Whitney Books Co., POB 42696, Cincinnati, OH 45242) V. 26- 1992-
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
BCPHBM British Journal of Clinical Pharmacology. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1974-
BJMRDK Brazilian Journal of Medical and Biological Research. (Associacao Brasileira de Divulgacao Cientifica, Faculdade de Medicina de Ribeirao Preto, USP, 141000 Ribeirao Preto, SP, Brazil) V.14- 1981-
CLTHE* Clinical Therapeutics : The International Peer-Reviewed Journal of Drug Therapy (Elsevier, USA) V.17- 1995-
EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.10- 1987-
GICTAL Giornale Italiano di Chemioterapia. Italian Journal of Chemotherapy. (Edizioni Minerva Medica, Casella Postale 491, I-10126 Turin, Italy) V.1- 1954-
HPCQA4 Human Pathology. (W.B. Saunders Co., W. Washington Sq., Philadelphia, PA 19105) V.1- 1970-
HUTOX*

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
PBPSDY Pharmacological and Biochemical Properties of Drug Substances. (American Pharmaceutical Assoc., 2215 Constitution Ave., NW, Washington, DC 20037) V.1- 1977-
PGMJAO Postgraduate Medical Journal. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1925-
THERAP Therapie. (Doin, Editeurs, 8, Place de l'Odeon, F-75006 Paris, France) V.1- 1946-
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959-
VCVPS* "Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998.

FDA-proprietary drug

RTECS Compound Description:
   Drug
   Mutagen
   Reproductive Effector
   Human Data

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SYNONYMS:
5 - Hydroxy - alpha - 6 - deoxytetracycline 6 - alpha - Deoxy - 5 - oxytetracycline Doxiciclina (Italian) Doxycycline GS - 3065	Liviatin Vibramycin alpha - 6 - Deoxy - 5 - hydroxytetracycline alpha - 6 - Deoxyoxytetracycline

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
DNA inhibition	human lymphocyte	3,750 痢/L	BCPHBM 16,127,1983
micronucleus test	oral human	60 mg/kg/20 day- intermittent	MUREAV 608,43,2006

REPRODUCTIVE EFFECTS DATA AND REFERENCES:
ROUTE/ ORGANISM	DOSE	EFFECT	REFERENCE
oral mouse	lowest published toxic dose: 750 mg/kg (2 day pregnant)	Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)	ARZNAD 36,219,1986

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
intraperitoneal mouse	lethal dose (50 percent kill): 410 mg/kg	N/R	GICTAL 17,276,1970
intraperitoneal rat	lethal dose (50 percent kill): 378 mg/kg	N/R	THERAP 23,575,1968
intravenous dog	lethal dose (50 percent kill): >100 mg/kg	N/R	PBPSDY 2,305,1979
intravenous mouse	lethal dose (50 percent kill): 241 mg/kg	N/R	PBPSDY 2,305,1979
intravenous rat	lethal dose (50 percent kill): 228 mg/kg	N/R	PBPSDY 2,305,1979
oral dog	lethal dose (50 percent kill): >500 mg/kg	N/R	PBPSDY 2,305,1979
oral mouse	lethal dose (50 percent kill): 1,007 mg/kg	N/R	VCVPS* -,430,1998
oral rat	lethal dose (50 percent kill): >2 gm/kg	N/R	PBPSDY 2,305,1979
oral woman	lowest published toxic dose: 68 mg/kg/24 day- intermittent	Musculoskeletal: Joints Immunological Including Allergic: Other immediate (humoral): uticaria, allergic rhinitis, serum sickness (multiple organ involvement) Nutritional and Gross Metabolic: Body temperature increase	PGMJAO 67,313,1991

OTHER MULTIPLE DOSE DATA AND REFERENCES:
ROUTE/ ORGANISM	DOSE	EFFECT	REFERENCE
intraperitoneal mouse	lowest published toxic dose: 20 mg/kg/4 day- intermittent	Tumorigenic: Active as anti-cancer agent	TXAPA9 202,268,2005
subcutaneous rat	lowest published toxic dose: 35 mg/kg/7 day- intermittent	Musculoskeletal: Changes in teeth and supporting structures Musculoskeletal: Other changes Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation	BJMRDK 35,613,2002

REVIEWS:
ORGANIZATION	STANDARD	REFERENCE
TOXICOLOGY REVIEW		PBPSDY 2,305,1979
TOXICOLOGY REVIEW		MUREAV 488,151,2001
TOXICOLOGY REVIEW		EMMUEG 43,143,2004
TOXICOLOGY REVIEW		APHRER 37,1675,2003
TOXICOLOGY REVIEW		CLTHE* 27,1329,2005
TOXICOLOGY REVIEW		CLTHE* 27,1329,2005
TOXICOLOGY REVIEW		APHRER 40,1939,2006
TOXICOLOGY REVIEW		HPCQA4 38,527,2007
TOXICOLOGY REVIEW		HUTOX* -,429,1996

STANDARDS AND REGULATIONS:
ORGANIZATION	STANDARD	REFERENCE
N/R	N/R	N/R

NIOSH DOCUMENTATION AND SURVEILLANCE:
ORGANIZATION	STANDARD or SURVEY	REFERENCE
National Occupational Hazard Survey 1974	National Occupational Hazard Survey 1974: Hazard Code: 84744; Number of Industries 1; Total Number of Facilities 641; Number of Occupations 1; Total Number of Employees Exposed 1,281
National Occupational Exposure Survey 1983	National Occupational Exposure Survey 1983: Hazard Code: 84744; Number of Industries 1; Total Number of Facilities 450; Number of Occupations 5; Total Number of Employees Exposed 22,055; Total Number of Female Employees Exposed 18,813

STATUS IN FEDERAL AGENCIES:
ORGANIZATION	REFERENCE
EPA GENETOX PROGRAM 1988, Inconclusive: Sperm morphology-human

REFERENCES:
CODEN	REFERENCE
APHRER	Annals of Pharmacotherpy. (Harvey Whitney Books Co., POB 42696, Cincinnati, OH 45242) V. 26- 1992-
ARZNAD	Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
BCPHBM	British Journal of Clinical Pharmacology. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1974-
BJMRDK	Brazilian Journal of Medical and Biological Research. (Associacao Brasileira de Divulgacao Cientifica, Faculdade de Medicina de Ribeirao Preto, USP, 141000 Ribeirao Preto, SP, Brazil) V.14- 1981-
CLTHE*	Clinical Therapeutics : The International Peer-Reviewed Journal of Drug Therapy (Elsevier, USA) V.17- 1995-
EMMUEG	Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.10- 1987-
GICTAL	Giornale Italiano di Chemioterapia. Italian Journal of Chemotherapy. (Edizioni Minerva Medica, Casella Postale 491, I-10126 Turin, Italy) V.1- 1954-
HPCQA4	Human Pathology. (W.B. Saunders Co., W. Washington Sq., Philadelphia, PA 19105) V.1- 1970-
HUTOX*
MUREAV	Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
PBPSDY	Pharmacological and Biochemical Properties of Drug Substances. (American Pharmaceutical Assoc., 2215 Constitution Ave., NW, Washington, DC 20037) V.1- 1977-
PGMJAO	Postgraduate Medical Journal. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1925-
THERAP	Therapie. (Doin, Editeurs, 8, Place de l'Odeon, F-75006 Paris, France) V.1- 1946-
TXAPA9	Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959-
VCVPS*	"Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998.