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. 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.

2 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. 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.

3 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. 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.

4 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. 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.

5 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. 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.

6 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. 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).

7 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 plant viii 1 Introduction Purpose and Audience The Consumer products industry has Exposure information and Screening Methods that can be of value in putting high production volume (HPV) chemical hazard data into an Exposure perspective and thereby facilitate prioritization of chemicals for further evaluation if appropriate.

8 The main purpose of this document is to present methodologies and specific Consumer Exposure information that can be used for Screening -level risk assessments of environmental and repeated human exposures to HPV chemicals through the manufacturing and use of Consumer products, mainly laundry, cleaning, and personal care products. However, the approach can be applied to other Consumer products when information on how consumers use the products is available. These methodologies allow hazard information to be put into context by using Exposure information to characterize risk. Screening -level risk assessments are useful for prioritizing the need for further work. The intended audience of this document is chemical risk assessors within governmental agencies, businesses, and stakeholder groups who have limited experience in the area of Consumer product Exposure and risk assessment, and have responsibility for prioritizing chemical safety reviews of numerous substances.

9 This document would also be useful for assessors involved in chemical risk management work as a tool to improve the efficiency of resource utilization. Background on SDA HPV Program In support of the HPV chemicals program, The Soap and Detergent Association (SDA) is coordinating preparation of the Organisation for Economic Co-operation and Development (OECD) Screening information data sets (SIDS) initial assessment reports (SIARs) for eight families of chemicals: Aliphatic acids Methyl esters Amine oxides Aliphatic alcohols Fatty acid distillation residues Alkyl sulfates Hydrotropes Glycerides These chemicals have a wide range of uses including, for example, soaps and detergents;. disinfectants, sanitizers, and household pest controls; cosmetics, fragrances, and personal care products; food and food additives; automotive care products; and polishes. The scope of the SIARs includes both human and environmental health Exposure and hazard evaluations as each relates to the production and use of 300+ chemicals grouped into eight families.

10 It is generally 1-1. recognized that during chemical manufacturing, product formulation, and the use and disposal of products, some human exposures and environmental releases can occur. Human Exposure can be both direct and indirect. There can be both occupational Exposure and Exposure resulting from Consumer products. Environmental releases to air, water, and land might occur during the manufacture, processing or formulating, and intended use of the chemical or product . Preparing a SIAR involves multiple steps. The initial step in the SIAR process involves assembling the available hazard data ( , physicochemical properties, environmental fate, ecotoxicity, and mammalian toxicity) and preparing a summary document, an Assessment Plan, for each chemical family as prescribed by the Environmental Protection Agency ( EPA) HPV Chemical Challenge Program ( ). The second step is a global effort to gather and summarize available production, use and Exposure information for these same families of chemicals.