API 4743 : 2005

Table of Contents

Executive Summary
1.0 Introduction
2.0 Hazard Narrative
2.1 Overview
2.2 Carcinogenicity Studies
    2.2.1 Human Data
    2.2.2 Animal Data
2.3 Analysis of Other Key Data
    2.3.1 Pharmacokinetics
    2.3.2 Animal Toxicity Studies
          2.3.2.1 Acute and Subacute
          2.3.2.2 Subchronic
          2.3.2.3 Reproductive and Developmental Studies
    2.3.3 Mutagenicity and Genotoxicity Studies
2.4 Potential Modes of Action
    2.4.1 Mode of Action for Kidney Tumors in Rats
          2.4.1.1 Overview of [alpha]2u-globulin-induced Renal
                  Tumors
          2.4.1.2 Evidence that TBA is a CIGA chemical
    2.4.2 Mode of Action for Thyroid Tumors in Mice
2.5 Weight of Evidence
3.0 Dose-Response Assessment
3.1 Selection of Data for Dose-Response Modeling
3.2 Estimation of the Human Equivalent Dose
3.3 Estimation of Point of Departure
3.4 Evaluation of the Approach for Low-dose Extrapolation
3.5 Extrapolation to Low Doses
4.0 Discussions and Conclusions
5.0 References
Appendix A TOX_RISK Output
Appendix B Graphs of Time-to-Tumor Models
Tables
Figures

Abstract

Conducts a quantitative risk assessment according to USEPA guidelines (USEPA 2005) in which data on the mode of action by which TBA induced renal tumors in rats and thyroid tumors in mice was considered.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	American Petroleum Institute
Pages
ISBN