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Cadmium Oxide (CAS No National Toxicology Program Toxicity Report Series Number 39 NTP Technical Report on Toxicity Studies of Cadmium Oxide (CAS No. 1306-19-0) Administered by Inhalation to F344/N Rats and B6C3F1 Mice June K. Dunnick, Ph.D., Study Scientist National Institute of Environmental Health Sciences Post Office Box 12233 Research Triangle Park, NC 27709 NIH Publication 95-3388 March 1995 United States Department of Health and Human Services Public Health Service National Institutes of Health Note to the Reader The National Toxicology Program (NTP) is made up of four charter agencies of the United States Department of Health and Human Services (DHHS): the National Cancer Institute (NCI) of the National Institutes of Health; the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health; the National Center for Toxicological Research (NCTR) of the Food and Drug Administration; and the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control. In July 1981, the Carcinogenesis Bioassay Testing Program was transferred from NCI to NIEHS. NTP coordinates the relevant Public Health Service programs, staff, and resources that are concerned with basic and applied research and with biological assay development and validation. 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. To carry out its mission, NTP designs and conducts studies 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. The studies described in this toxicity study report were performed under the direction of NIEHS and were conducted in compliance with NTP laboratory health and safety requirements. These studies met or exceeded all applicable federal, state, and local health and safety regulations. Animal care and use were in accord and compliance with the Public Health Service Policy on Humane Care and Use of Animals. Single copies of this report are available without charge, while supplies last, from the NTP Public Information Office (telephone number 919/541-3419). NTP Public Information Office NIEHS Post Office Box 12233 Research Triangle Park, NC 27709 National Toxicology Program Toxicity Report Series Number 39 NTP Technical Report on Toxicity Studies of Cadmium Oxide (CAS No. 1306-19-0) Administered by Inhalation to F344/N Rats and B6C3F1 Mice June K. Dunnick, Ph.D., Study Scientist National Institute of Environmental Health Sciences Post Office Box 12233 Research Triangle Park, NC 27709 NIH Publication 95-3388 March 1995 United States Department of Health and Human Services Public Health Service National Institutes of Health 2 CADMIUM OXIDE, NTP TOXICITY REPORT NUMBER 39 CONTRIBUTORS This NTP report on the toxicity studies of cadmium oxide is based primarily on 2-week studies conducted in November and December 1988 and on 13-week studies that began in August 1989 and ended in November 1989 at Battelle Pacific Northwest Laboratories, Richland, WA. National Toxicology Program NTP Pathology Working Group Evaluated experiment, interpreted results, and reported findings Evaluated slides and prepared pathology report June K. Dunnick, Ph.D., Study Scientist John C. Seely, D.V.M., Chair John R. Bucher, Ph.D. PATHCO, Inc. Robert E. Chapin, Ph.D. Michael R. Elwell, D.V.M., Ph.D. Rajendra S. Chhabra, Ph.D. National Toxicology Program Michael R. Elwell, D.V.M., Ph.D. Jeffery Everitt, D.V.M. Chemical Industry Institute of Toxicology Thomas J. Goehl, Ph.D. Joel Mahler, D.V.M. Joel Mahler, D.V.M. National Toxicology Program Ghanta N. Rao, D.V.M., Ph.D. Robert C. Sills, D.V.M., Ph.D. Joseph H. Roycroft, Ph.D. National Toxicology Program Gregory S. Travlos, D.V.M. Kristine L. Witt, M.S. Analytical Sciences, Inc. Oak Ridge Associated Universities Provided statistical analyses Steven Seilkop, M.S. Battelle Pacific Northwest Laboratories Janet L. Teague, M.S. Principal contributors for 13-week studies Billy J. Chou, D.V.M., Ph.D., Environmental Health Research and Testing, Principal Investigator Inc. Jeffrey A. Dill, Ph.D. Provided sperm motility and vaginal cytology evaluation Bernard J. Greenspan, Ph.D. Teresa Cocanougher, B.A. Chester L. Leach, Ph.D. Dushyant K. Gulati, Ph.D. Paul W. Mellick, D.V.M., Ph.D. Susan Russell, B.A. Roger A. Miller, D.V.M., Ph.D. Harvey A. Ragan, D.V.M. Biotechnical Services, Inc. Provided toxicity report preparation Principal contributors for developmental toxicity studies Daphne D. Lambright, Principal Investigator Terryl J. Mast, Ph.D., Director C. Michael Bailey, B.S. Pharm. Billy J. Chou, D.V.M., Ph.D. Sophonia A. Roe, B.S. Jeffrey A. Dill, Ph.D. Bernard J. Greenspan, Ph.D. Experimental Pathology Laboratories, Inc. Provided pathology quality assessment Deborah A. Banas, D.V.M., M.S. CADMIUM OXIDE, NTP TOXICITY REPORT NUMBER 39 3 PEER REVIEW The draft report on the toxicity studies of cadmium oxide was evaluated by the reviewers listed below. These reviewers serve as independent scientists, not as representatives of any institution, company, or governmental agency. In this capacity, reviewers determine if the design and conditions of these NTP studies are appropriate and ensure that the toxicity study report presents the experimental results and conclusions fully and clearly. The comments of the reviewers were received and reviewed prior to the finalization of this document. Changes have been made such that the concerns of the reviewers have been addressed to the extent possible. Charles H. Hobbs, D.V.M., Associate Director Curtis D. Klaassen, Ph.D., Chair Inhalation Toxicology Research Institute Department of Pharmacology and Toxicology Lovelace Biomedical and University of Kansas Medical Center Environmental Research Institute, Inc. Kansas City, KS Albuquerque, NM 4 CADMIUM OXIDE, NTP TOXICITY REPORT NUMBER 39 TABLE OF CONTENTS ABSTRACT ................................................................................. 5 INTRODUCTION ............................................................................ 13 Physical and Chemical Properties, Production, Use, and Exposure ............................... 13 Absorption, Disposition, Metabolism, and Excretion .......................................... 15 Toxicity ............................................................................... 17 Study Rationale and Design ............................................................... 27 MATERIALS AND METHODS .................................................................. 29 Procurement and Characterization of Cadmium Oxide ........................................ 29 Aerosol Generation System ............................................................... 29 Concentration Monitoring ................................................................ 33 Chamber Characterization ................................................................ 36 Toxicity Study Designs ................................................................... 38 Genetic Toxicity Studies .................................................................. 46 Statistical Methods ...................................................................... 47 Quality Assurance ....................................................................... 49 RESULTS .................................................................................. 51 2-Week Inhalation Study in F344/N Rats ................................................... 51 13-Week Inhalation Study in F344/N Rats .................................................. 55 Developmental Toxicity Study in Sprague-Dawley Rats ........................................ 66 2-Week Inhalation Study in B6C3F1 Mice .................................................... 67 13-Week Inhalation Study in B6C3F1 Mice ................................................... 70 Developmental Toxicity Study in CD® -1 Swiss Mice ........................................... 77 Genetic Toxicity ........................................................................ 78 DISCUSSION ............................................................................... 79 Respiratory Toxicity ..................................................................... 79 Kidney Toxicity ......................................................................... 81 Cardiovascular Toxicity .................................................................. 81 Reproductive Toxicity ................................................................... 82 Developmental Toxicity .................................................................. 85 Summary .............................................................................. 86 REFERENCES .............................................................................. 87 APPENDIXES Appendix A Organ Weights and Organ-Weight-to-Body-Weight Ratios ...................... A-1 Appendix B Hematology, Clinical Chemistry, and Urinalysis Results ........................ B-1 Appendix C Reproductive Tissue Evaluations, Estrous Cycle Characterization, and Developmental Toxicity Studies ......................... C-1 Appendix D Genetic Toxicology ...................................................... D-1 CADMIUM
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