Rtecs number : ww2710000 chemical name : Talc (powder), containing no asbestos fibers

TETRACYCLINE HYDROCHLORIDE

CHEMICAL NAME : 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

CAS REGISTRY NUMBER : 64-75-5

LAST UPDATED : 199904

DATA ITEMS CITED : 44

MOLECULAR FORMULA : C22-H24-N2-O8.Cl-H

MOLECULAR WEIGHT : 480.94

WISWESSER LINE NOTATION : L E6 C666 BV FV CU GUTTT&J DQ EQ GVZ HQ IN1&1 MQ

M1

RQ &GH

Drug

Reproductive Effector

Human

Natural Product

* Achromycin hydrochloride

* ALA TET

* Amycin, hydrochloride

* Artomycin

* Bristacycline

* Cefracycline tablets

* Chlorhydrate de tetracycline

* Chlorowodorku tetracykliny

* Cyclopar

* Diacycine

* Dumocyclin

* Hostacycline

* Medamycin

* Mephacyclin

* NCI-C55561

* Neocyclin B

* Paltet

* Partrex

* Piracaps

* Polycycline hydrochloride

* Qidtet

* Quadracycline

* Quatrex

* Remicyclin

* Ricycline

* Ro-Cycline

* Sanclomycine

* Steclin

* Stilciclina

* Subamycin

* Sumycin

* Supramycin

* Sustamycin

* T-250 capsules

* TC hydrochloride

* Tefilin

* Teline

* Telotrex

* Tet-Cy

* Tetrabakat

* Tetrabid

* Tetrablet

* Tetracaps

* Tetrachel

* Tetraciclina cloridrato

* Tetracompren

* Tetracycline chloride

* Tetracycline hydrochloride

* Tetra-D

* Tetrakap

* Tetralution

* Tetramavan

* Tetra-wedel

* Tetrosol

* Topicycline

* Triphacyclin

* U-5965

* Unicin

* Vetquamycin-324

*** HEALTH HAZARD DATA ***

** ACUTE TOXICITY DATA **

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Human - man

DOSE/DURATION : 200 mg/kg/7D-I

TOXIC EFFECTS :

Sense Organs and Special Senses (Taste) - change in function

REFERENCE :

CPHADV Clinical Pharmacy. (American Soc. of Hospital Pharmacists, 4630

Montgomery Ave., Bethesda, MD 20814) V.1- 1982-

Volume(issue)/page/year:

4,455,1985

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 6443 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:

18,185,1971

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 318 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

GNRIDX Gendai no Rinsho. (Tokyo, Japan) V.1-10, 1967-76(?).

Volume(issue)/page/year: 2,26,1968

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Subcutaneous

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 700 mg/kg

TOXIC EFFECTS :

Gastrointestinal - hypermotility, diarrhea

REFERENCE :

TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.

First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:

9,445,1966

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Intravenous

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 128 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

FRPSAX Farmaco, Edizione Scientifica. (Casella Postale 227, 27100 Pavia,

Italy) V.8-43 1953-88 For publisher information, see FRMCE8

Volume(issue)/page/year: 10,197,1955

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Rodent - mouse

DOSE/DURATION : 2759 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

JPPMAB Journal of Pharmacy and Pharmacology. (Pharmaceutical Soc. of

Great

Britain, 1 Lambeth High St., London SEI 7JN, UK) V.1- 1949-

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - mouse

DOSE/DURATION : 368 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

JPPMAB Journal of Pharmacy and Pharmacology. (Pharmaceutical Soc. of

Great

Volume(issue)/page/year: 16,33,1964

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Intravenous

SPECIES OBSERVED : Rodent - mouse

DOSE/DURATION : 157 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

FRPSAX Farmaco, Edizione Scientifica. (Casella Postale 227, 27100 Pavia,

Italy) V.8-43 1953-88 For publisher information, see FRMCE8

Volume(issue)/page/year: 10,197,1955

TYPE OF TEST : LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE : Unreported

SPECIES OBSERVED : Rodent - mouse

DOSE/DURATION : 105 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

40YJAX "Evaluation of Embryotoxicity, Mutagenicity and Carcinogenicity

Risks

In New Drugs, Proceedings of the Symposium on Toxicological Testing for

Prague,

-,55,1979

** OTHER MULTIPLE DOSE TOXICITY DATA **

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intramuscular

SPECIES OBSERVED : Rodent - rat

DOSE/DURATION : 210 mg/kg/7D-I

TOXIC EFFECTS :

Kidney, Ureter, 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

REFERENCE :

INJPD2 Indian Journal of Pharmacology. (Dept. of Pharmacology, Baranas

Hindu Univ., Varanasi 221 005, India) V.1- 1968(?)-

Volume(issue)/page/year: 18,110,1986

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intravenous

SPECIES OBSERVED : Mammal - dog

DOSE/DURATION : 1287 mg/kg/30D-I

TOXIC EFFECTS :

Blood - pigmented or nucleated red blood cells

Blood - changes in erythrocyte (RBC) count

Nutritional and Gross Metabolic - weight loss or decreased weight gain

REFERENCE :

TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.

First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:

11,128,1967

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intramuscular

SPECIES OBSERVED : Rodent - rabbit

DOSE/DURATION : 500 mg/kg/20D-I

TOXIC EFFECTS :

Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)

Blood - other changes

Biochemical - Metabolism (Intermediary) - other proteins

REFERENCE :

ANTBAL Antibiotiki. (Moscow, USSR) V.1-29, 1956-84. For publisher

information, see AMBIEH. Volume(issue)/page/year: 26,374,1981

** REPRODUCTIVE DATA **

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Rodent - rat

DOSE : 14 gm/kg

SEX/DURATION : male 3 day(s) pre-mating

female 3 day(s) pre-mating - 22 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:

7,409,1965

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Rodent - rat

DOSE : 6 gm/kg

SEX/DURATION : female 9-14 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - post-implantation mortality (e.g. dead and/or

resorbed implants per total number of implants)

REFERENCE :

KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda

Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-

Volume(issue)/page/year: 4,516,1970

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - rat

DOSE : 425 mg/kg

SEX/DURATION : female 14-18 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - abortion

Reproductive - Effects on Embryo or Fetus - extra-embryonic structures

(e.g., placenta, umbilical cord)

REFERENCE :

LAINAW Laboratory Investigation. (Williams & Wilkins Co., 428 E. Preston

St., Baltimore, MD 21202) V.1- 1952- Volume(issue)/page/year:

14,1456,1965

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Subcutaneous

SPECIES OBSERVED : Rodent - rat

DOSE : 240 mg/kg

SEX/DURATION : female 16-20 day(s) after conception

TOXIC EFFECTS :

Reproductive - Effects on Embryo or Fetus - other effects to embryo

REFERENCE :

BCPCA6 Biochemical Pharmacology. (Pergamon Press Inc., Maxwell House,

Fairview Park, Elmsford, NY 10523) V.1- 1958-

Volume(issue)/page/year:

17,1479,1968

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intramuscular

SPECIES OBSERVED : Rodent - rat

DOSE : 240 mg/kg

SEX/DURATION : female 10-15 day(s) after conception

TOXIC EFFECTS :

Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,

e.g., stunted fetus)

REFERENCE :

BINEAA Biologia Neonatorum. (Basel, Switzerland) V.1-14, 1956-69. For

publisher information, see BNEOBV. Volume(issue)/page/year: 4,365,1962

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Unreported

SPECIES OBSERVED : Rodent - rat

DOSE : 450 mg/kg

SEX/DURATION : female 7-15 day(s) after conception

TOXIC EFFECTS :

Reproductive - 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)

REFERENCE :

ANTBAL Antibiotiki. (Moscow, USSR) V.1-29, 1956-84. For publisher

information, see AMBIEH. Volume(issue)/page/year: 16,923,1971

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Unreported

SPECIES OBSERVED : Rodent - rat

DOSE : 765 mg/kg

SEX/DURATION : female 7-15 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - abortion

REFERENCE :

ANTBAL Antibiotiki. (Moscow, USSR) V.1-29, 1956-84. For publisher

information, see AMBIEH. Volume(issue)/page/year: 16,923,1971

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intrauterine

SPECIES OBSERVED : Rodent - rat

DOSE : 100 mg/kg

SEX/DURATION : female 1 day(s) pre-mating

TOXIC EFFECTS :

Reproductive - Maternal Effects - uterus, cervix, vagina

REFERENCE :

CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022)

V.1-

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - mouse

DOSE : 900 mg/kg

SEX/DURATION : female 8-13 day(s) after conception

TOXIC EFFECTS :

Reproductive - 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 Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho

Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1-

1970-

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - mouse

DOSE : 600 mg/kg

SEX/DURATION : female 8-13 day(s) after conception

TOXIC EFFECTS :

Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,

e.g., stunted fetus)

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho

Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1-

1970-

Volume(issue)/page/year: 3,75,1972

ROUTE OF EXPOSURE : Intraperitoneal

SPECIES OBSERVED : Rodent - mouse

DOSE : 150 mg/kg

SEX/DURATION : female 10 day(s) after conception

TOXIC EFFECTS :

Reproductive - Specific Developmental Abnormalities - musculoskeletal

system

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho

Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1-

1970-

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Subcutaneous

SPECIES OBSERVED : Rodent - mouse

DOSE : 2250 mg/kg

SEX/DURATION : female 10-18 day(s) after conception

TOXIC EFFECTS :

Reproductive - Specific Developmental Abnormalities - urogenital system

Reproductive - Effects on Newborn - viability index (e.g., # alive at day

4

per # born alive)

weight

REFERENCE :

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-

Volume(issue)/page/year: 161,300,1967

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Subcutaneous

SPECIES OBSERVED : Rodent - mouse

DOSE : 750 mg/kg

SEX/DURATION : female 1-6 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - abortion

REFERENCE :

ASPHAK Archives des Sciences Physiologique. (Paris, France) V.1-28,

1947-74. Discontinued. Volume(issue)/page/year: 23,481,1969

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Parenteral

SPECIES OBSERVED : Rodent - mouse

DOSE : 2250 mg/kg

SEX/DURATION : female 10-18 day(s) after conception

TOXIC EFFECTS :

Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced

weight

gain)

JOPHAN Journal de Physiologie (Paris). (SPPIF, B.P.22, F-41353 Vineuil,

France) V.39- 1946- Volume(issue)/page/year: 57,567,1965

TYPE OF TEST : TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE : Oral

SPECIES OBSERVED : Rodent - rabbit

DOSE : 9 gm/kg

SEX/DURATION : female 8-16 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - post-implantation mortality (e.g. dead and/or

resorbed implants per total number of implants)

REFERENCE :

KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda

Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-

Volume(issue)/page/year: 4,516,1970

** MUTATION DATA **

TYPE OF TEST : DNA adduct

TEST SYSTEM : Bacteria - Escherichia coli

DOSE/DURATION : 50 umol/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

89,95,1981

TYPE OF TEST : DNA damage

TEST SYSTEM : Microorganism - not otherwise specified

DOSE/DURATION : 1 mmol/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

315,33,1994

TYPE OF TEST : Gene conversion and mitotic recombination

TEST SYSTEM : Yeast - Saccharomyces cerevisiae

DOSE/DURATION : 3 gm/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

12,357,1971

TYPE OF TEST : DNA damage

TEST SYSTEM : Human Fibroblast

DOSE/DURATION : 500 umol/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

315,33,1994

TYPE OF TEST : Unscheduled DNA synthesis

TEST SYSTEM : Human Fibroblast

DOSE/DURATION : 750 umol/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

315,33,1994

TYPE OF TEST : DNA inhibition

TEST SYSTEM : Human Fibroblast

DOSE/DURATION : 1250 umol/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

348,7,1995

TYPE OF TEST : DNA damage

TEST SYSTEM : Rodent - rat Liver

DOSE/DURATION : 200 umol/L

REFERENCE :

EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41

E.

11th St., New York, NY 10003) V.10- 1987- Volume(issue)/page/year:

TYPE OF TEST : DNA inhibition

TEST SYSTEM : Rodent - mouse Mammary gland

DOSE/DURATION : 31600 ug/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

40,261,1976

TYPE OF TEST : Mutation test systems - not otherwise specified

TEST SYSTEM : Rodent - mouse Mammary gland

DOSE/DURATION : 31600 ug/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

40,261,1976

TYPE OF TEST : Cytogenetic analysis

TEST SYSTEM : Rodent - mouse Mammary gland

DOSE/DURATION : 31600 ug/L/24H

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

40,261,1976

TYPE OF TEST : Mutation in mammalian somatic cells

TEST SYSTEM : Rodent - mouse Lymphocyte

DOSE/DURATION : 120 mg/L

REFERENCE :

NTPTR* National Toxicology Program Technical Report Series. (Research

Triangle Park, NC 27709) No.206- Volume(issue)/page/year:

NTP-TR-344,1989

TYPE OF TEST : Mutation in mammalian somatic cells

TEST SYSTEM : Rodent - mouse Mammary gland

DOSE/DURATION : 100 mg/L

REFERENCE :

MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE

Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year:

40,261,1976

TYPE OF TEST : Sister chromatid exchange

TEST SYSTEM : Rodent - hamster Embryo

DOSE/DURATION : 3 mg/L

REFERENCE :

SHIGAZ Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20

Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 1949-

Volume(issue)/page/year: 74,1385,1987

*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :

NOHS - National Occupational Hazard Survey (1974)

NOHS Hazard Code - 83550

No. of Facilities: 474 (estimated)

No. of Industries: 2

No. of Occupations: 2

No. of Employees: 1795 (estimated)

NOES - National Occupational Exposure Survey (1983)

NOES Hazard Code - 83550

No. of Facilities: 680 (estimated)

No. of Industries: 4

No. of Occupations: 15

No. of Employees: 22901 (estimated)

No. of Female Employees: 17276 (estimated)

*** STATUS IN U.S. ***

EPA TSCA Section 8(b) CHEMICAL INVENTORY

NTP Carcinogenesis Studies (feed);no evidence:mouse,rat

NTPTR* National Toxicology Program Technical Report Series. (Research

Triangle Park, NC 27709) No.206- Volume(issue)/page/year:

NTP-TR-363,1989