Toxicological Review

By Environmental Protection Agency

Book Id: WPLBN0000020698
Format Type: PDF eBook:
File Size: 0.2 MB
Reproduction Date: 2007

Title:	Toxicological Review
Author:	Environmental Protection Agency
Volume:
Language:	English
Subject:	Ecology, Natural resource issues, Environemtal protection
Collections:	Environmental Awareness Library Collection
Historic Publication Date:
Publisher:	United States Environmental Protection Agency


Citation APA MLA Chicago Protection Agency, B. E. (n.d.). Toxicological Review. Retrieved from http://www.gutenberg.cc/

Description
Excerpt: The purpose of this Toxicological Review is to provide scientific support and rationale for the hazard identification and dose-response information in IRIS pertaining to chronic exposure to tributyltin oxide. It is not intended to be a comprehensive treatise on the chemical or toxicological nature of tributyltin oxide. In Section 6, EPA has characterized its overall confidence in the quantitative and qualitative aspects of hazard and dose-response (U.S. EPA, 1995a). Matters considered in this characterization include knowledge gaps, uncertainties, quality of data, and scientific controversies. This characterization is presented in an effort to make apparent the limitations of the assessment and to aid and guide the risk assessor in the ensuing steps of the risk assessment process.

Table of Contents
TABLE OF CONTENTS Contributors and Reviewers Foreword 1.0 Introduction 1 2.0 Chemical and Physical Information Relevant to Assessments . . . . . . . . . . . . . . . . . . . . 2 3.0 Toxicokinetics Relevant to Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.0 Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.1 Studies in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.2 Prechronic and Chronic Studies and Cancer Bioassays in Animals . . . . . . . . . . . . . . . . 4 4.3 Reproductive/Developmental Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.4 Other Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.4.1 Immunotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 4.4.2 Neurotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.4.3 Genotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.5 Synthesis and Evaluation of Major Noncancer Effects and Mode of Action . . . . . . . . 24 4.6 Weight of Evidence Evaluation and Cancer Classification . . . . . . . . . . . . . . . . . . . . . 26 4.7 Other Hazard Identification Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 4.7.1 Possible Childhood Susceptibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 4.7.2 Possible Gender Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.0 Dose-Response Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.1 Oral Reference Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.1.1 Choice of Principal Study and Critical Effect . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.1.2 Methods of Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.1.3 Oral Reference Dose Derivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.2 Inhalation Reference Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.3 Cancer Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6.0 Major Conclusions in Characterization of Hazard and Dose-Response . . . . . . . . . . . 28 6.1 Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6.2 Dose-Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 7.0 References............................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 8.0 Appendices Appendix A. Benchmark Dose Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Appendix B. Summary of Comments from External Peer Reviewers . . . . . . . . . . . . . . . . 43