UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C. 20460 EPA-SAB-EHC-89-029 OFFICE OF THE ADMINISTRATOR July 17, 1989 Honorable William K. Reilly Administrator U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Subject: Science Advisory Board's review of the ANTIMONY health criteria document Dear Mr. Reilly: The Metals Subcommittee of the science Advisory Board's Environmental Health Committee has completed its review of the Drinking Water Health Criteria Document for Antimony dated January, 1988. The review was conducted December 8-9, 1988 at the One Washington circle Hotel in Washington,D.C. Participants in the review are listed in Enclosure l. The Subcommittee review focused on two primary issues: Is antimony tartrate, for which the largest body of data exists, an acceptable compound upon which to base Drinking Water Equivalent Level (DWEL) calculations? Is the Schroeder et al (1970) study appropriate for deriving the Lowest Observable Effect Level (LOAEL)? The Office of Drinking Water has identified a LOAEL of 0-43 mg/kg/day based on the Schroeder study noted above—a life-time ingestion study (via drinking water) which reported decreased longevity and altered blood levels of glucose and cholesterol in rats dosed with potassium antimony tartrate. With an uncertainty factor of 1000 ("standard" for LOAEL in animal studies), this produced a Reference Dose of 0.00043 mg/kg/day, and with the usual assumptions about body weight, drinking water consumption, and routes of exposure, a DWEL of 0.015 mg/1 of antimony. The Subcommittee found that the antimony tartrate data are acceptable for determining the DWEL. The problem of comparing the toxicity of the tartrate form, rather than an oxide of antimony (which is presumed to be the form encountered in drinking water) A '% *SZ£J ------- is important, but without specific data on the oxide, the tartrate data is the sole alternative. The Subcommittee also found the Schroeder et al study acceptable for determining the LOAEL. Although these data are based on animals, rather than humans, it is the best body of information available. Consequently, the Committee accepts the proposed LOAEL of 0,43 rag/kg/day. Taking this information together, the Subcommittee found the proposed DWEL of 0.015 mg/1 resulting from the data to be a reasonable and conservative finding. Because of the absence of other acceptable studies, and given the questions and uncertainties surrounding the Prebyl (1927) data, the Subcommittee recommends that the DWEL value also be used for the ten day Health Advisory calculation. The Subcommittee found that, in general, the antimony criteria document was well prepared. A number of detailed comments and suggestions, on editorial and technical issues have been provided separately to the program office. The Subcommittee appreciates the opportunity to present our views on the antimony health criteria document. We looK forward to the Agency's response to our report. Enclosure Dr. Raymond Loehr, Chairman Science Advisory Board Dr. Arthur Upton, Chairman Environmental Health Committee Dr. Bernard Weiss, chairman Metals subcommittee ------- EFA-SABHEHC-89-029 ABSTRACT This report presents the conclusions and recommendations of the U.S. Environmental Protection Agency's science Advisory Board summarizing a review of the Drinking Water Health Criteria Document for Antimony. The Board's major conclusion is that the proposed Drinking Water Equivalent Level (DWEL) of 0.015 mg/1 of antimony, based on the 1970 Schroeder et al study for the Lowest Observable Adverse Effects Level (LOAEL), is appropriate. The Board also found that the use of antimony tartrate acceptable for determining the DWEL. Kev Words: Antimony,* DWEL; LOAEL; drinking water. ------- U.S Envi rontiental Protection Agency Science Advisory Board Environmental Health Committee Metals Subcommittee CHARIHAN Dr. Bernard Weiss Division of Toxicology P.O. Box RBB University of Rochester School of Medicine Rochester, NY 14642 VICE-CHAIRMAN Or. Ronald Wyzga Electric Power Research Institute 3412 Hi 11 view Avenue P.O. Box 1041 Palo Alto, California 94303 Dr» Thomas Clarkson Division of Toxicology University of Rochester School of Medicine Post Office Box RBB, Rochester, New York 14642 Dr. Gary Diamond Toxicology Center Director Syracuse Research Corporation Merrill Lane Syracuse, New York 13210 Dr. Phil Enterline Department of Biostatistics Graduate School of Public Health University of Pittsburg 130 Desoto Street Pittsburgh, PA 15261 Dr. Marvin Kuschner Professor of Pathology Dept. of Pathology School of Medicine Health Science Center Stony Brook, New York 11794 Enclosure (1) ------- Dr. Brooke T. Mossman Department of Pathology The University of Vermont Medical Alumni Building Burlington, Vermont 05405-0068 Dr. Guenter Oberdoerster Radiation Biology and Biophysics Division University of Rochester School of Medicine 400 Elmwood Avenue Rochester, N.Y. 14642 Dr. Kenneth Reuhl (Neurotoxicology) Dept. of Pharmacology and Toxicology Neurotoxicology Laboratory College of Pharmacy Rutgers University Busch Campus Piscataway, NJ 08855-0789 Or. F. William Sunderman Department of Laboratory Medicine University of Connecticut Health Center, Room C 2021 Farroirsgton, Connecticut 06032 Executive Secretary Mr. Samuel Rondberg Executive Secretary Metals Subcommittee Science Advisory Board (A-101F) U.S. Environmental Protection Agency Washington, D.C. 20460 Staff Secretary , Mary L. Winston Staff Secretary Environmental Health Committee Science Advisory Board (A-101F) U.S. Environmental Protection Agency Washington, D.C. 20460 SAB Staff Director Donald 8. Barnes Di rector Science Advisory Board U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 ------- |