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DEEEEPPPPAAAARTTMMEENNTTT OOFFFF HHEEAAAALLLLTTTTHHH AANNNNDDDD HHHHUUUMMMMAAAANN SSSEEERVVIIIICCEESSS PPPuubbbblllliiiicc HHeeeeaaaalllltthhh Serrrrvvviiiicccceeee Naaatiiioonnnnaaaal IIIInnnnssttttiiiittttuuuutttteeees ooooffff HHHeeaaaalllltttthhhh FOREWARD The National Toxicology Program (NTP) is made up of four charter agencies of the U.S. Department of Health and Human Services (DHHS): the National Cancer Institute (NCI), National Institutes of Health; the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health; the National Center for Toxicological Research (NCTR), Food and Drug Administration; and the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control. In July, 1981, the Carcinogenesis Bioassay Testing Program, NCI, was transferred to the NIEHS. The NTP coordinates the relevant programs, staff, and resources from the Public Health Service agencies relating to basic and applied research and to biological assay development and validation. The NTP develops, evaluates, and disseminates scientific information about potentially toxic and hazardous chemicals. This knowledge is used for protecting the health of the American people and for the primary prevention of disease. The studies described in this toxicity study report were performed under the direction of the NIEHS and were conducted in compliance with NTP chemical health and safety requirements and must meet or exceed all applicable federal, state, and local health and safety regulations. Animal care and use were in accordance with the Public Health Service Policy on Humane Care and Use of Animals. Anyone who is aware of related ongoing or published studies not mentioned in this report, or of any errors in this report, is encouraged to make this information known to the NTP. Comments and questions should be directed to Dr. J.R. Bucher, NIEHS, P.O. Box 12233, Research Triangle Park NC 27709 (919) 541­4532). These studies are designed and conducted to characterize and evaluate the toxicologic potential of selected chemicals in laboratory animals (usually two species, rats and mice). Chemicals selected for NTP toxicology studies are chosen primarily on the bases of human exposure, level of production, and chemical structure. Selection per se is not an indicator of a chemical's toxic potential. Single copies of this Report are available without charge while supplies last from the NTP Public Information Office, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 (919­541­3991). TOX I CIT Y S TU D IE S O F A NTI MON Y P OT AS S IUM TA R TR A T E ( CA S NO. : 2 83 0 0­74 ­5) IN F34 4 /N RA T S AND B6 C3 F 1 MICE ( D R INK ING W AT E R A ND IN TRA PE RI TON EA L IN JE CTI ON S TU D IE S) M ic h a e l P. D ie t e r, Ph . D. ( St ud y Sci en ti s t) N A T ION AL TO X ICO LOG Y PRO GRA M P .O. Bo x 1 22 33 R e s e a r c h Tr i a n g l e P a rk , N C 27 7 09 Ma r c h 1 99 2 N T P TOX 11 NIH P ub li ca ti o n No . 9 2­3 13 0 U . S. D EP A R TM EN T O F H EA LT H A ND H UMA N SE RV ICE S Pu bl ic H e a lt h S erv ic e Na t io n a l I n s ti tu t e s of Hea l th 2 Antimony Potassium Tartrate, NTP TOX 11 C O N T R I B U T O R S The NTP report on the toxicity studies of antimony potassium tartrate is based on the 14­day drinking water studies that began in December, 1986, and ended in January, 1987; the 16­day intraperitoneal injection studies that began in March, 1987, and ended in April, 1987; and the 13­ week intraperitoneal injection studies that began in November, 1987, and ended in May, 1988. National Toxicology Program (Evaluated Experiment, Interpreted Results, and Reported Findings) Michael P. Dieter, Ph.D., Study Scientist John Bucher, Ph.D. Morrow Thompson, Ph.D. Michael Elwell, D.V.M., Ph.D. Errol Zeiger, Ph.D. H. B. Matthews, Ph.D. NTP Pathology Working Group (Evaluated Slides and Prepared Pathology Report) Dawn Goodman, D.V.M., Ph.D., Chairperson, Pathco John Cullen, D.V.M., Ph.D., NCSU William F. MacKenzie, D.V.M., M.S., EPL Michael Elwell, D.V.M., Ph.D., NTP Joel Mahler, D.V.M., NTP Principal Contributors at Battelle Memorial Institute, Columbus Division Arthur C. Peters, Ph.D., Study Director Ming J. W. Chang, Ph.D., Chemist Milton Hejtmancik, Ph.D., Study Peter Jepsen, D.V.M., Study Toxicologist Veterinarian Lawrence E. Mezza, D.V.M., Pathologist Michael J. Ryan, D.V.M., Pathologist Principal Contributor at Experimental Pathology Laboratories, Inc. (Pathology Quality Assurance) William F. MacKenzie, D.V.M., M.S. Principal Contributors at Experimental Health Research and Testing, Inc. (Sperm Morphology and Vaginal Cytology Evaluation) Dushant K. Gulati, Ph.D. Teresa Cocanougher, B.A. Susan Russell, B.A. Analytical Sciences, Inc. (Statistical Analysis) Steven Seilkop, M.S. Janet Teague, M.S. Principal Contributors at NTP for Report Preparation Jane Lambert, B.S. Diane Overstreet, B.S. Kristine Witt, M.S. (Oak Ridge Associated Universities) Antimony Potassium Tartrate, NTP TOX 11 3 CONTENTS CONTRIBUTORS .................................................................................................................................2 TABLE OF CONTENTS ........................................................................................................................3 ABSTRACT ..........................................................................................................................................5 PEER REVIEW PANEL .........................................................................................................................7 SUMMARY OF PEER REVIEW COMMENTS .........................................................................................8 I. INTRODUCTION .........................................................................................................................9 II. MATERIALS AND METHODS ................................................................................................... 11 Procurement and Characterization of Antimony Potassium Tartrate ........................................ 11 Animals ................................................................................................................................. 11 14­Day Drinking Water Studies .............................................................................................. 11 16­Day Intraperitoneal Injection Studies ................................................................................ 12 13­Week Intraperitoneal Injection Studies .............................................................................. 12 Clinical Examinations, Supplemental Studies, and Pathology ................................................. 12 Virology Screen ...................................................................................................................... 14 Reproductive Toxicity ............................................................................................................. 14 Statistical Methods ................................................................................................................ 15 Quality Assurance .................................................................................................................. 15 III. RESULTS ................................................................................................................................ 18 F344/N RATS .......................................................................................................................... 18 14­Day Drinking Water Studies ........................................................................................... 18 16­Day Intraperitoneal Injection Studies .............................................................................. 18 13­Week Intraperitoneal Injection Studies ........................................................................... 20 B6C3F1 MICE .......................................................................................................................... 31 14­Day Drinking Water Studies ........................................................................................... 31 16­Day Intraperitoneal Injection Studies ............................................................................. 32 13­Week Intraperitoneal Injection Studies ........................................................................... 33 GENETIC TOXICOLOGY .......................................................................................................... 35 IV. DISCUSSION ........................................................................................................................... 37 V. REFERENCES ........................................................................................................................
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