Exposure and Risk Screening Methods for Consumer …

1 Exposure and Risk Screening Methods for Consumer product Ingredients The Soap and Detergent Association The Soap and Detergent Association Exposure and Risk Screening Methods for Consumer product Ingredients The Soap and Detergent Association Washington, DC. April 2005. Copyright 2005: The Soap and Detergent Association. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage retrieval system, without written permission from the publisher.

2 For information, contact: The Soap and Detergent Association, 1500 K Street, NW, Suite 300, Washington, DC 20005, USA. Telephone: +1-202-347-2900. Fax: + 1-202-347-4110. Email: Web: Acknowledgements The following contributed significantly to the development of this document: The SDA High Production Volume Chemicals Task Force; the Cosmetic, Toiletry, and Fragrance Association;. the Consumer Specialty Products Association; the European Cosmetic Toiletry and Perfumery Association; the Human and Environmental Risk Assessment project; and Exponent. A panel of international experts conducted a peer review which provided very helpful input in finalizing the document.

3 Ii Contents Page List of Figures vi List of Tables vii Acronyms and Abbreviations viii 1 Introduction 1-1. Purpose and Audience 1-1. Background on SDA HPV Program 1-1. Background on Screening -Level Assessments for Priority Setting 1-2. 2 Risk Screening Methodology for Exposure to High Production Volume Chemicals via Consumer Products 2-1. Background and Scope 2-1. Objectives 2-2. General Framework 2-3. Screening -Level Exposure Data 2-4. product Exposure Estimates and Data Sources 2-4. Screening -Level Ingredient Concentration Data 2-10. Selecting No-Observed-Adverse-Effect Levels for Screening -Level Risk Characterization 2-12.

4 Screening -Level Assessments 2-14. Screening Based on Exposures 2-15. Screening Risk Characterization 2-17. Consideration for Refinements 2-20. Refining Exposures 2-21. Identifying Relevant NOAELs 2-22. Minor Exposure Scenarios Not Considered in Screening Assessment 2-22. Summary 2-23. References 2-23. iii Page 3 Exposure , Effects, and Risk Screening Methodologies for High Production Volume Chemicals via Environmental Releases 3-1. Background and Scope 3-1. Assessment Tiers versus Levels 3-3. Exposure Assessment 3-3. Objectives 3-4. Chemical Use and Exposure Information 3-4.

5 General Framework 3-5. Basic Equations 3-6. Assessment Approach 3-6. Key Methodologies 3-8. Identifying Relevant Environmental Compartments and Fate Processes 3-8. Exposure Models Used in Assessments 3-9. Exposure Models Used in European Assessments 3-10. Exposure Models Used in Asia Pacific Assessments 3-11. Other International Exposure Modeling Resources 3-11. Use of Monitoring Data 3-12. Instructions for Generating PECs in the , EU, and Asia Pacific (Japan) 3-12. United States 3-12. European Union 3-16. Japan 3-21. Exposure Assessment Summary 3-22.

6 Effects Assessment 3-23. Objective 3-23. Data Evaluation 3-23. Assessment Factors Approach 3-24. Statistical Extrapolation Process 3-26. Comparison of PEC and PNEC 3-28. Related Compartments 3-30. Summary 3-30. References 3-30. 4 Glossary of Terms 4-1. iv List of Appendices Appendix I-A Sources of product Exposure (PE) Models and Model Input Parameters Appendix I-B Primary, Secondary, and Selected References for Exposure Models and Factors Appendix II-A Screening product Exposure Data Matrix: Default High-End Values Appendix II-B Screening product Exposure Data Matrix: Minimum-Maximum Values Appendix III Comparison of E-FAST and EUSES Exposure Assessments Appendix IV Case Studies v List of Figures Page Figure 1-1.

7 Generic Exposure framework 1-4. Figure 2-1. Screening -level assessment continual refinement process 2-21. Figure 3-1. Pathways of chemicals produced and used in Consumer products to the environment 3-5. Figure 3-2. Environmental Exposure assessment approach 3-7. Figure 3-3. environmental Exposure assessment process 3-12. Figure 3-4. EU environmental Exposure assessment process 3-17. Figure 3-5. Extrapolation from a species sensitivity distribution 3-27. vi List of Tables Page Table 2-1. Summary of model equations used to calculate product Exposure 2-5.

8 Table 2-2. An ingredient concentration data matrix for the HPV Chemical A Group 2-11. Table 2-3. Hypothetical hazard data matrix 2-13. Table 2-4. HPV Chemical A group hazard data matrix 2-14. Table 2-5. Chemical A Screening -level exposures by product Exposure scenarios 2-15. Table 2-6. Exposures to Chemical A by product category 2-16. Table 2-7. Percent contribution of total Exposure by product type 2-17. Table 2-8. Hypothetical outputs from a Screening risk characterization 2-17. Table 2-9. Screening -level MOEs from Chemical A exposures by product category 2-18.

9 Table 3-1. Assessment factors for the derivation of PNECs from aquatic toxicity data 3-25. vii Acronyms and Abbreviations ACA Alliance for Chemical Awareness AISE Association Internationale de la Savonnerie, de la D tergence et des Produits d' ntretien AP Asia Pacific APAG European Oleochemicals and Allied Products Group CESIO Comite Europeen des Agents de Surface et de Leurs Intermediaries Organiques CTFA Cosmetic, Toiletry, and Fragrance Association E-FAST Exposure & Fate Assessment Screening Tool EFH EPA's Exposure Factors Handbook EQC equilibrium criterion EU European Union EUSES European Union System for the Evaluation of Substances HERA Human & Environmental Risk Assessment project HPV high production volume IC ingredient concentration JSDA Japan Soap and Detergent Association Kow octanol-water partition coefficient LAS linear alkylbenzene sulfonate LOAEL lowest-observed-adverse-effect level MOE margin of Exposure NA North America ( and Canada).

10 NOAEL no-observed-adverse-effect level NOEC no-observed-effect concentration OECD Organisation for Economic Co-operation and Development OPPT Office of Pollution Prevention and Toxics PBT persistent, bioaccumulative, and toxic PDM probabilistic dilution model PE product Exposure PEC predicted environmental concentration PNEC predicted no-effect concentration POP persistent organic pollutant POTW publicly owned treatment works QSAR quantitative structure activity relationship SDA The Soap and Detergent Association SIAR SIDS initial assessment report SIC standard industrial classification SIDS Screening information data sets STP sewage treatment plant TCC triclocarban TGD technical guidance document EPA Environmental Protection Agency WWTP wastewater treatment