Collection and Dissemination of Exposure Data for Risk Screening of

Formulated Consumer Products

Presented By:

Dr. Paul C. DeLeo Senior Director, Environmental Safety

21st Annual Meeting of the International Society of Exposure Science Baltimore, Maryland

October 24, 2011

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Co-Authors Dr. Hans Sanderson Danish National Environmental Research Institute/ Aarhus University, Roskilde, DENMARK

Dr. Christina Cowan-Ellsberry CE2 Consulting LLC, Cincinnati, Ohio

Mr. William J. Greggs Sanibel, Florida

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Who are we? The 117-member trade association of the $30 billion US cleaning products industry

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What do we do? • ACI has conducted ingredient safety research for over

50 years • ACI sponsored nearly 300 of 2,700 high production

volume chemicals under EPA and OECD programs over the last decade

• ACI provided beyond-SIDS (screening information data set) information including screening-level risk assessments of its ingredients

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How did we do it?

• Formed ten chemical-specific consortia • Leveraged the expertise of 62 chemical

suppliers and product formulators • Prepared >6,100 robust study summaries • Identified relevant product exposure models • Conducted screening-level risk assessments

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Human Health Screening-Level Risk Characterization Algorithm

Margin of Exposure (MOE) =

𝑫𝑫𝑫𝑫 − 𝑹𝑫𝑫𝑹𝑫𝑹𝑫𝑫 𝑻𝑻𝑻𝑫𝑫𝑻𝑫𝑻𝑻𝑷𝑻𝑫𝑻𝑷𝑷𝑷 𝑬𝑬𝑹𝑫𝑫𝑷𝑻𝑫 𝑷𝑬 × 𝑰𝑹𝑰𝑻𝑫𝑻𝑰𝑫𝑹𝑷 𝑪𝑫𝑹𝑷𝑫𝑹𝑷𝑻𝑪𝑷𝑰𝑫𝑹 (𝑰𝑪)

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Product Exposure Scenarios • Dermal:

– Direct (use) Cleaning (rinse-off) Personal Care (leave-on & rinse off) – Indirect Cleaning-Laundry: clothes wearing

• Oral: – Direct (use) Personal Care/OTC drug – Indirect Cleaning: dishwashing

• Inhalation: – Direct (use) Aerosols/Volatiles Laundry Powders

Trigger Sprays

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Dermal-Direct Exposure Scenario (North American & EU Personal Care Approach)

• FQ: frequency of product use (use/day) • A: amount of product used (g/use) • PR: percent retained (%) • CF: conversion factor (1,000 mg/g) • DA: dermal absorption (100%) • BW: body weight (70 kg male/60 kg female/15 kg child)

𝐹𝐹 × 𝐴 × 𝑃𝑃 × 𝐶𝐹 × 𝐷𝐴𝐵𝐵

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Dermal-Indirect Exposure Scenario (North American Approach for Laundered Clothing)

𝐴 × 𝑃𝑃 × 𝑃𝑃 × 𝐶𝐹 × 𝐷𝐴𝐵𝐵

• A: amount product used (g/day) • PR: percent retained on clothing • PT: percent transferred from clothing to skin • CF: conversion factor (1,000 mg/g) • DA: dermal absorption (100%) • BW: female body weight (60 kg)

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How are products used by consumers?

Exposure factors for formulated consumer products: • Frequency of product use • Amount of product per use (dosing) • Duration of use (time to rinse-off)

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Assemble Habits & Practices Data

• Survey government reports • Survey the open literature • Survey our members • Survey other industries

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Data Sources • Regulatory authorities (e.g., EPA Exposure Factors

Handbook, EU Technical Guidance Document) • Submissions to regulatory authorities (e.g., AISE-

CEFIC HERA, AIHC exposure initiative assessments) • Published literature • Survey data collected by industry associations (i.e.,

CTFA/PCPC, COLIPA, AISE, SDA/ACI) • Member company data

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Data Sources, cont. • Cleaning product habits and practices

– For laundry, dishwashing & hard surface cleaners • North America: SDA (Sanderson et al., 2006) • Europe: AISE/CEFIC HERA Guidance Document (2005)

(http://www.heraproject.com)

• Personal care product habits and practices – For 12 product types covering 95% of exposures

• U.S.: CTFA/PCPC (Loretz et al., 2005, 2006, 2008) • Europe: (Hall et al., 2007, 2011)

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What is the concentration of an ingredient in a products?

• What ingredients are in products?

• SDA 2001 member survey

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What ingredients are in products? • Mandatory ingredient reporting

– Cosmetic labeling (except fragrances, dyes, preservatives) • Fragrance Industry published a list of fragrance ingredients used in

consumer goods by their customers worldwide in 2010

– Cleaning product labeling in Europe

• Voluntary ingredient reporting for cleaning products – N. American Ingredient Communication (ACI/CSPA/CCSPA) (http://www.cleaninginstitute.org/ingredientcentral/) – Australia “What’s In It?” campaign (ACCORD)

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SDA 2001 Member Survey (Concentration of ingredients in products)

• Manufacturers, importers, processors and formulators

• Consumer, commercial & industrial products • Ten families of chemicals • Regional use: N. America, Europe, Asia/Pacific

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SDA 2001 Member Survey, cont. • Chemical production/importation volume • Chemical use by product category (e.g., liquid

laundry detergent) • Chemical releases to the environment • Conditions under which potential worker

exposures are mitigated • Concentration range in formulated products

(<0.1%, 0.1<0.5%, 0.5<1%, 1<5%, 5<10%, 10<25%, 25<50%, 50<75%, 75<100%)

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Reported Use & Concentration Data • Minimum/maximum ingredient concentration • Product categories

– Laundry: 9 product types – Dishwashing: 3 product types – General Cleaning: 7 product types – Personal Care: 15 product types – Cosmetics: 4 product types

• North America, Europe and Japan

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Reported Use & Concentration Data, cont. • Concentration data across the five product

categories for seven chemical categories – Aliphatic Acids – Aliphatic Alcohols – Alkyl Sulfates – Amine Oxides – Hydrotropes – LAS – Triclocarban

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One-stop Shopping

• Risk screening methodology • Exposure factors for

formulated consumer products

• Case studies: peer-reviewed journal articles

• Ingredient concentration data • Available on ACI Science

website (aciscience.org)

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Conclusions • Extensive information about the safety of ingredients

in formulated consumer products is now publicly available, especially for high volume chemicals

• Product exposure information is widely available • While generally proprietary, some ingredient

concentration info is publicly (freely) available • Release of chemical use and exposure information

will continue and likely accelerate

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References • Hall, B., S. Tozer, B. Safford, M. Coroama, W. Steiling, M.C. Leneveu-Duchemin, C. McNamara, M. Gibney. 2007. European

consumer exposure to cosmetic products, a framework for conducting population exposure assessments. Food Chem. Tox. 45: 2097-2108.

• Hall, B., W. Steiling, B. Safford, M. Coroama, S. Tozer, C. Firmani, C. McNamara, M. Gibney. 2011. European consumer exposure to cosmetic products, a framework for conducting population exposure assessments Part 2. Food Chem. Tox. 49: 408-422.

• Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products (HERA). 2005. Guidance Document Methodology. Available at: http://www.heraproject.com/files/HERA TGD February 2005.pdf

• Loretz, L.J., A.M. Api, L.M. Barraj, J. Burdick, W.E. Dressler, S.D. Gettings, H. Han Hsu, Y.H.L. Pan, T.A. Re, K.J. Renskers, A. Rothenstein, C.G. Scrafford, C. Sewall. 2005. Exposure data for cosmetic products: lipstick, body lotion, and face cream. Food Chem. Tox. 43:279-291.

• Loretz, L., A.M. Api, L. Barraj, J. Burdick, D. Davis, W. Dressler, E. Gilberti, G. Jarrett, S. Mann, Y.H.L. Pan, T. Re, K. Renskers, C. Scrafford, S. Vater. 2006. Exposure data for personal care products: Hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. Food Chem. Tox. 44: 2008-2018.

• Loretz, L.J., A.M. Api, L. Babcock, L.M. Barraj, J. Burdick, K.C. Cater, G. Jarrett, S. Mann, Y.H.L. Pan, T.A. Re, K.J. Renskers, C.G. Scrafford. 2008. Exposure data for cosmetic products: Facial cleanser, hair conditioner, and eye shadow. Food Chem. Tox. 46: 1516-1524.

• Sanderson, H. J.L. Counts, K.L. Stanton and R.I. Sedlak. 2006. Exposure and prioritization – human screening data and methods for high production volume chemicals in consumer products: Amine oxides, a case study. Risk Analysis 26(6): 1637-1657.

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Dr. Paul C. DeLeo Senior Director, Environmental Safety

American Cleaning Institute 1331 L Street, N.W., Suite 650

Washington, D.C. 20005 202-662-2516

pdeleo@cleaninginstitute.org

http://www.aciscience.org

Thank You

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