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Formic Acid (CAS No: 64-18-6) Administered by Inhalation to F344/N Rats and B6C3F1 Mice

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Formic Acid (CAS No: 64-18-6) Administered by Inhalation to F344/N Rats and B6C3F1 Mice National Toxicology Program Toxicity Report Series Number 19 NTP Technical Report on Toxicity Studies of Formic Acid (CAS No: 64-18-6) Administered by Inhalation to F344/N Rats and B6C3F1 Mice Morrow Thompson, DVM, PhD, Study Scientist National Toxicology Program Post Office Box 12233 Research Triangle Park, NC 27709 NIH Publication 92-3342 July 1992 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 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. 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 (919-541-3991). National Toxicology Program Toxicity Report Series Number 19 NTP Technical Report on Toxicity Studies of Formic Acid (CAS No: 64-18-6) Administered by Inhalation to F344/N Rats and B6C3F1 Mice Morrow Thompson, DVM, PhD, Study Scientist National Toxicology Program Post Office Box 12233 Research Triangle Park, NC 27709 NIH Publication 92-3342 July 1992 United States Department of Health and Human Services Public Health Service National Institutes of Health 2 FORMIC ACID, NTP TOXICITY REPORT NUMBER 19 CONTRIBUTORS The NTP report on the toxicity studies of formic acid is based primarily on the 2-week studies that began in August, 1987, and ended in September, 1987, and the 13-week studies that began in December, 1987, and ended in March, 1988, at Battelle Northwest Laboratories. National Toxicology Program NTP Pathology Working Group Evaluated experiment, interpreted results, Evaluated slides and prepared pathology report and reported findings John Seely, DVM Morrow Thompson, DVM, PhD Chairperson Study Scientist Pathco, Inc. John R. Bucher, PhD Michael R. Elwell, DVM, PhD Leo T. Burka, PhD National Toxicology Program Rajendra S. Chhabra, PhD Jerry Hardisty, DVM Experimental Pathology Laboratories, Inc. Michael P. Dieter, PhD Michael Jokinen, DVM Michael R. Elwell, DVM, PhD National Toxicology Program Joel F. Mahler, DVM Joel Leininger, DVM, PhD H.B. Matthews, PhD National Toxicology Program Errol Zeiger, PhD William MacKenzie, DVM, MS Experimental Pathology Laboratories, Inc. Coordinated report preparation Experimental Pathology Laboratories, Inc. Jane M. Lambert, BS Provided pathology quality assessment Kristine Witt, MS Oak Ridge Associated Universities Jerry Hardisty, DVM William MacKenzie, DVM, MS Battelle Northwest Laboratories, Richland, WA Environmental Health Research Principal contributors and Testing, Inc. Sperm morphology and vaginal cytology evaluation B.J. Chou, DVM, PhD Principal Investigator Dushant K. Gulati, PhD J.R. Decker, BS Teresa Cocanougher, BA Bioengineer Susan Russell, BA J.A. Dill, PhD Chemistry C.L. Leach, PhD Analytical Sciences, Inc. Statistical analysis Toxicologist P.W. Mellick, DVM, PhD Richard Morris, MS Pathology Steven Seilkop, MS R.A. Miller, DVM, PhD Pathology Janet Teague, MS H.A. Ragan, DVM Clinical Pathology S.E. Rowe, DVM, MS Study Veterinarian R.A. Renne, DVM Pathology R.B. Westerberg, PhD Chemistry FORMIC ACID, NTP TOXICITY REPORT NUMBER 19 3 TABLE OF CONTENTS CONTRIBUTORS......................................................................................................................... 2 TABLE OF CONTENTS ............................................................................................................... 3 ABSTRACT ................................................................................................................................. 5 PEER REVIEW PANEL ............................................................................................................... 7 SUMMARY OF PEER REVIEW COMMENTS ................................................................................ 8 INTRODUCTION ......................................................................................................................... 9 Physical Properties, Occurrence, Production, Uses, and Exposure ............................ 9 Human Toxicity ...................................................................................................... 10 Animal Studies....................................................................................................... 10 Disposition and Metabolism ................................................................................... 11 Chronic Toxicity/Carcinogenicity............................................................................ 12 Genetic Toxicity...................................................................................................... 12 Study Rationale and Design ................................................................................... 12 MATERIALS AND METHODS.................................................................................................... 13 Procurement and Characterization of Formic Acid .................................................. 13 Vapor Generation ................................................................................................... 13 Concentration Monitoring....................................................................................... 14 Toxicity Study Design............................................................................................. 14 Reproductive Toxicity ............................................................................................. 17 Genetic Toxicology.................................................................................................. 17 Statistical Methods................................................................................................. 18 Quality Assurance.................................................................................................. 18 RESULTS .................................................................................................................................. 20 2-Week Studies in Rats .......................................................................................... 20 13-Week Studies in Rats ........................................................................................ 22 2-Week Studies in Mice .......................................................................................... 29 13-Week Studies in Mice ........................................................................................ 31 Genetic Toxicology.................................................................................................. 32 DISCUSSION ............................................................................................................................ 34 REFERENCES ........................................................................................................................... 38 TABLES Table 1 Experimental Design and Materials and Methods in the 2-Week and 13-Week Inhalation Studies of Formic Acid.................................19 Table 2 Survival and Weight Gain of F344/N Rats in the 2-Week Inhalation Studies of Formic Acid......................................................20 Table 3 Histopathologic Lesions in F344/N Rats in the 2-Week Inhalation Studies of Formic Acid .....................................................21 Table 4 Survival and Weight Gain of F344/N Rats in the 13-Week Inhalation Studies of Formic Acid ...................................................22 4 FORMIC ACID, NTP TOXICITY REPORT NUMBER 19 Table 5 Histopathologic Lesions in F344/N Rats in the 13-Week Inhalation Studies of Formic Acid....................................................24 Table 6 Survival and Weight Gain of B6C3F1 Mice in the 2-Week Inhalation Studies of Formic Acid......................................................29 Table 7 Histopathologic Lesions in B6C3F1 Mice in the 2-Week Inhalation Studies of Formic
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