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

RTECS #: QI8225000

CAS #: 2058-46-0


UPDATE: August 2008 MW: 496.94 MF: C22H24N2O9•ClH


NOTE:

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

SYNONYMS:

  1. 5 - Hydroxytetracycline hydrochloride
  2. Aquacycline
  3. Biosolvmycin
  4. Biosolvomycin
  5. Engemycin
  6. Hydrocyclin
  7. Liquamycin
  8. Liquamycin injectable
  9. Mepatar
  10. NSC 9169
  1. Otetryn
  2. Oxlopar
  3. Oxyject 100
  4. Oxytetracycline hydrochloride
  5. Oxytetrin
  6. TM 5
  7. Terramycin hydrochloride
  8. Tetramine
  9. Tetran hydrochloride


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 adduct Bacillus subtilis 10 µmol/L BIORAK 39,587,1974
DNA adduct mammal (species unspecified) lymphocyte 20 mg/L BIORAK 39,587,1974
DNA adduct other microorganisms 10 mg/L BIORAK 39,587,1974
DNA adduct other microorganisms 10 µmol/L BIORAK 39,587,1974
unscheduled DNA synthesis mammal (species unspecified) lymphocyte 20 mg/L BIORAK 39,587,1974
micronucleus test oral
mouse
100 mg/kg/24 hour- intermittent MUREAV 117,193,1983
specific locus test mouse lymphocyte 200 mg/L EMMUEG 17,196,1991
specific locus test inhalation
mouse
616 µmol/L MUREAV 608,29,2006


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
oral
mouse
lowest published toxic dose: 21 gm/kg (6-15 day pregnant) Reproductive: Maternal effects: Uterus, cervix, vagina NTIS** PB83-151027
oral
mouse
lowest published toxic dose: 21 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) NTIS** #PB83-151027
oral
mouse
lowest published toxic dose: 13.3 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetal death NTIS** #PB83-151027
oral
rat
lowest published toxic dose: 11,250 mg/kg (6-15 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)
NTIS** PB83-182469
oral
rat
lowest published toxic dose: 12 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) FAATDF 7,434,1986
oral
rat
lowest published toxic dose: 12 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) NTIS** #PB83-182469
parenteral
woman
lowest published toxic dose: 20 mg/kg (20 week pregnant) Reproductive: Effects on fertility: Abortion GOBIDS 26,177,1988
subcutaneous
mouse
lowest published toxic dose: 900 mg/kg (10-18 day pregnant) 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


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
oral
rat
lowest published toxic dose: 1,802 gm/kg/2 year Tumorigenic: Equivocal tumorigenic agent by RTECS criteria

Endocrine: Tumors
NTPTR* NTP-TR-315,1987
oral
rat
lowest published toxic dose: 2,163,000 mg/kg/103 week- continuous Tumorigenic: Neoplastic by RTECS criteria

Endocrine: Adrenal cortex tumors
NTIS** PB87-204103/AS
oral
rat
lowest published toxic dose: 1,802,500 mg/kg/103 week- continuous Tumorigenic: Equivocal tumorigenic agent by RTECS criteria

Brain and Coverings: Tumors
NTIS** PB87-204103/AS


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
intravenous
dog
lowest published lethal dose: 100 mg/kg Peripheral Nerve and Sensation: Flaccid paralysis without anesthesia (usually neuromuscular blockage)

Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Other changes
ANYAA9 53,238,1950
intravenous
mouse
lethal dose (50 percent kill): 100 mg/kg N/R 85FZAT -,490,1967
intravenous
rat
lethal dose (50 percent kill): 302 mg/kg N/R JPETAB 99,234,1950
intravenous
rabbit
lowest published lethal dose: 80 mg/kg Behavioral: Tremor

Behavioral: Convulsions or effect on seizure threshold

Behavioral: Excitement
JPETAB 99,234,1950
oral
mouse
lethal dose (50 percent kill): 6,696 mg/kg N/R ANYAA9 53,238,1950
subcutaneous
mouse
lethal dose (50 percent kill): 600 mg/kg N/R ANYAA9 53,245,1950
subcutaneous
rat
lethal dose (50 percent kill): 800 mg/kg N/R ARZNAD 9,711,1959


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT

REFERENCE
oral
mouse
lowest published toxic dose: 129 gm/kg/14 day- continuous Behavioral: Food intake (animal)

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
NTPTR* NTP-TR-315,1987
oral
mouse
lowest published toxic dose: 21,000 mg/kg/10 day- intermittent Lung, Thorax, or Respiration: Dyspnea

Liver: Changes in liver weight

Skin and Appendages: Other: Hair
NTIS** #PB83-151027
oral
mouse
lowest published toxic dose: 21,000 mg/kg/10 day- intermittent Peripheral Nerve and Sensation: Flaccid paralysis without anesthesia (usually neuromuscular blockage)

Behavioral: Sleep

Lung, Thorax, or Respiration: Dyspnea
NTIS** #PB83-151027
oral
mouse
lowest published toxic dose: 13,250 mg/kg/10 day- intermittent Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** #PB83-151027
oral
rat
lowest published toxic dose: 108 gm/kg/14 day- continuous Behavioral: Food intake (animal)

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
NTPTR* NTP-TR-315,1987
oral
rat
lowest published toxic dose: 7,200 mg/kg/6 day- intermittent Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** #PB83-182469
oral
rat
lowest published toxic dose: 12,000 mg/kg/10 day- intermittent Liver: Changes in liver weight NTIS** #PB83-182469


REVIEWS:

ORGANIZATION STANDARD
REFERENCE

TOXICOLOGY REVIEW
MUTAEX 14,5,1999
TOXICOLOGY REVIEW
MUREAV 584,1,2005
TOXICOLOGY REVIEW
REPTED 25,192,2008
TOXICOLOGY REVIEW
REPTED 25,192,2008


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE

Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1988 PESTICIDE SUBJECT TO REGISTRATION OR RE-REGISTRATION FEREAC 54,7740,1989
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1998 STATUS OF PESTICIDES: RED Completed RBREV* -,140,1998


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE

National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 83236;
Number of Industries 2;
Total Number of Facilities 49;
Number of Occupations 6;
Total Number of Employees Exposed 9,441
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 83236;
Number of Industries 2;
Total Number of Facilities 763;
Number of Occupations 10;
Total Number of Employees Exposed 20,845;
Total Number of Female Employees Exposed 16,524


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE

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


REFERENCES:

CODEN
REFERENCE

85FZAT "Index of Antibiotics from Actinomycetes," Umezawa, H. et al., eds., Tokyo, Univ. of Tokyo Press, 1967
ANYAA9 Annals of the New York Academy of Sciences. (New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877-
ARZNAD Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951-
BIORAK Biochemistry (English Translation). Translation of BIOHAO. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.21- 1956-
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-
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1-40, 1981-97. For publisher information, see TOSCF2
FEREAC Federal Register. (U.S. Government Printing Office, Supt. of Documents, Washington, DC 20402) V.1- 1936-
GOBIDS Gynecologic and Obstetric Investigation. (S. Karger Pub., Inc., 79 Fifth Ave., New York, NY 10003) V.9- 1978-
JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
MUTAEX Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1986-
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-
RBREV* Status of Pesticides in Registration, Reregistration, and Special Review (Rainbow Report), Special Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection Agency, 401 M. Street, S.W., Washington, D.C. 20460, Spring 1998
REPTED Reproductive Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1- 1987-

Used as a pharmaceutical and veterinary drug

FDA-over the counter and proprietary drug

RTECS Compound Description:
   Tumorigen
   Drug
   Mutagen
   Reproductive Effector
   Human Data

Click Here for Additional Information about RTECS

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