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Collection and Dissemination of Exposure Data for Risk Screening of Formulated Consumer Products Presented By: Dr. Paul C. DeLeo Senior Director, Environmental Safety 21 st Annual Meeting of the International Society of Exposure Science

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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 1

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SLIDE 2

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

  • ver the last decade
  • ACI provided beyond-SIDS (screening information

data set) information including screening-level risk assessments of its ingredients

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SLIDE 5

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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SLIDE 6

Human Health Screening-Level Risk Characterization Algorithm

Margin in of E Exp xposure e (MOE OE) = = 𝑬𝑬𝑬𝑬 βˆ’ 𝑺𝑬𝑬𝑺𝑬𝑺𝑬𝑬 𝑼𝑼𝑼𝑬𝑬𝑼𝑬𝑼𝑼 𝑸𝑼𝑬𝑼𝑸𝑸𝑸 𝑭𝑭𝑺𝑬𝑬𝑸𝑼𝑬 𝑸𝑭 Γ— 𝑱𝑺𝑱𝑼𝑬𝑼𝑱𝑬𝑺𝑸 𝑫𝑬𝑺𝑸𝑬𝑺𝑸𝑼𝑫𝑸𝑱𝑬𝑺 (𝑱𝑫)

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Product Exposure Scenarios

  • Dermal:

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

  • Oral:

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

  • Inhalation:

– Direct (use) οƒ  Aerosols/Volatiles οƒ  Laundry Powders οƒ  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)

𝐺𝐺 Γ— 𝐡 Γ— 𝑄𝑄 Γ— 𝐷𝐺 Γ— 𝐸𝐡 𝐢𝐢

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Dermal-Indirect Exposure Scenario

(North American Approach for Laundered Clothing) 𝐡 Γ— 𝑄𝑄 Γ— 𝑄𝑄 Γ— 𝐷𝐺 Γ— 𝐸𝐡 𝐢𝐢

  • 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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SLIDE 11

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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SLIDE 14

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 β€œWhat’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%) 17

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SLIDE 18

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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SLIDE 19

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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SLIDE 20

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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SLIDE 22

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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SLIDE 23
  • 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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