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Exposure and Prioritization—Human Screening Data and Methods for High Production Volume Chemicals in Consumer Products: Amine Oxides a Case Study

2006; Wiley; Volume: 26; Issue: 6 Linguagem: Inglês

10.1111/j.1539-6924.2006.00829.x

1539-6924

Hans Sanderson, Jennifer L. Counts, Kathleen Stanton, Richard Sedlak,

Risk and Safety Analysis

Risk AnalysisVolume 26, Issue 6 p. 1637-1657 Open Access Exposure and Prioritization—Human Screening Data and Methods for High Production Volume Chemicals in Consumer Products: Amine Oxides a Case Study† Hans Sanderson, Hans SandersonSearch for more papers by this authorJennifer L. Counts, Jennifer L. CountsSearch for more papers by this authorKathleen L. Stanton, Kathleen L. StantonSearch for more papers by this authorRichard I. Sedlak, Corresponding Author Richard I. Sedlak*Address correspondence to Rick I. Sedlak, The Soap and Detergent Association, Technical and International Affairs, Washington, DC, USA.Search for more papers by this author Hans Sanderson, Hans SandersonSearch for more papers by this authorJennifer L. Counts, Jennifer L. CountsSearch for more papers by this authorKathleen L. Stanton, Kathleen L. StantonSearch for more papers by this authorRichard I. Sedlak, Corresponding Author Richard I. Sedlak*Address correspondence to Rick I. Sedlak, The Soap and Detergent Association, Technical and International Affairs, Washington, DC, USA.Search for more papers by this author First published: 08 December 2006 https://doi.org/10.1111/j.1539-6924.2006.00829.xCitations: 24 † Re-use of this article is permitted in accordance with the Terms and Conditions set out at: http://olabout.wiley.com/WileyCDA/Section/id-828080.html. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat 1. INTRODUCTION Consumer and personal care products may have multiple forms, uses, and exposure scenarios. Their uses are often associated with a range of intended and unintended exposure routes (e.g., oral, dermal, and inhalation), frequencies and durations. Given the large number of products and possible associated consumer exposure scenarios to chemical ingredients, a priority setting process is needed to identify consumer product ingredients and use scenarios for which more detailed exposure and risk assessment may be needed to adequately characterize consumers' exposures and risks to product ingredients. This is especially important for the compounds with widespread use in industry, including in consumer and personal products. These compounds can be referred to as High Production Volume (HPV) chemicals. HPVs are receiving increasing regulatory attention due to lack of information and the chemical right-to-know initiative in the United States (http://www.epa.gov/chemrtk/) (Hansson & Ruden, 2006). Screening-level exposure and risk assessments provide the basis for that process. Recommendations and/or requirements for further work due to concerns based on the hazard profile should also consider the findings of screening level exposure and/or risk assessments. While several regulatory bodies have programs to assess "new chemicals," some are also focusing attention to existing chemicals, i.e., those recognized as being in commerce prior to a particular date. The Canadian Domestic Substances Lists (DSL) (http://www.ec.gc.ca/substances/ese/eng/dsl/pilpro.cfm) process relies heavily on exposure assessment of categorization and prioritization of compounds registered before 1986 (∼23,000 compounds), and the European Registration Evaluation Authorization of Chemicals (REACH) (http://europa.eu.int/comm/environment/chemicals/reach.htm) program also will rely on exposure assessments for registration of compounds marketed before 1981 (∼100,000 compounds). The Organization for Economic Co-operation and Development (OECD) already has indicated approaches in relation to HPVs that can be used as a globally recognized methodology by contributing to development of regional and national HPV screening and prioritization procedures and generating initial data sets to those programs such as the US EPA Challenge program, Canadian Domestic Substances List, OECD HPV program (OECD, 2003), and REACH. The OECD (2003) Screening Information Data Set (SIDS) program provides the following guidance with respect to characterization of potential human exposure to HPV chemicals (e.g., consumers exposure via consumer product ingredients): The human population for which there is a potential exposure to the chemical should be identified with specific consideration of occupational exposure, consumer exposure and indirect exposure via the environment. These considerations should be based on readily available general information on exposure, the use pattern, and physicochemical properties of the chemical. The concluding OECD recommendations based on the hazard information results in either a recommendation for further work (typically refined exposure assessment and/or risk assessment), or low priority for further work that member countries may consider (http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_1_1,00.html). Consistent with these guidelines, exposure can be estimated for priority-setting purposes without the need for either monitoring or sophisticated modeling data. Rather, for screening and priority-setting purposes, conservative estimates of exposures can be based on the following: simple, first principle exposure equations that are regularly used in the scientific and regulatory communities; conservative assumptions about exposure; and readily available information about the characteristics of the HPV chemical category, the consumer product type, and the nature of product use. Although the use of conservative assumptions would lead to over-estimation of exposure, the conservatism is appropriate for screening-level assessments that are purposely designed to avoid making false negative decisions (decisions that are based on exposure and risk estimates that are lower than their true levels; for example, decision not to conduct further tests because risk estimates were falsely estimated to be low). The most significant limiting factor to accurate exposure screening and subsequent prioritization for further risk screening has been the lack of readily available specific use and exposure data as these data are generally considered competitively sensitive information by companies. This article provides detailed use and exposure data that are based upon a consolidation of information shared by many consumer and personal product companies, and a proposed exposure screening methodology for evaluating potential chronic human exposures and risk from HPV chemicals due to their use in consumer products in North America (Canada and the United States) and the European Union (EU). The Alliance for Chemical Awareness (ACA) suggested a screening level assessment as part of a framework for a stepwise approach for risk characterization that provides the opportunity, on an as-needed basis, to replace conservative exposure assumptions with more realistic data prior to deciding whether additional toxicology information should be generated or risk management actions need to be taken. By design, one only advances to the next step in the process if there is reason to believe that the refinement will likely result in a different decision about the priority for further work (such as more detailed exposure assessment or risk assessment) on the HPV chemical. The following are the key steps in the screening level process for human health endpoints as described in the ACA framework (ACA, 2002): 1 Identify the product type(s) where the HPV chemical is used, the concentration (%) of the HPV chemical in the product(s), the physical and chemical properties of the HPV chemical. 2 Estimate, qualitatively or quantitatively, exposure to the HPV chemical for each product category, initially by using highly conservative assumptions about the circumstances of product(s) use. 3 Identify the relevant SIDS endpoint and a "no observed adverse effect level" (NOAEL) or a "lowest observed adverse effect level" (LOAEL) from animal toxicology or epidemiological studies. 4 Determine, for each product category, whether or not the margin of exposure (MOE) to the HPV chemical is adequate. In general, the risk screening methodology described in this article mirrors the key steps identified in the ACA framework mentioned above. The described methodology addresses chronic noncancer SIDS endpoints and is focused on a screening-level assessment (OECD, 2003). The scope of this risk screening methodology in this article is limited to the exposure scenarios that fall within the intended/labeled use of products. The HPV category Amine Oxides (AO) is used as a case study to illustrate the described stepwise methodology (AO SIDS Initial Assessment Report (SIAR), 2006). Commercial AO are either alkyl dimethyl amine oxides or alkyl dihydroxyethyl amine oxides which contain two methyl groups or two hydroxyethyl groups, respectively, attached to the tertiary nitrogen. Alkyl chain lengths range from 8 to 20 with 12 and 14 being predominant. For the AO Category as a whole, current production is approximately 26,000 metric tonnes in the United States, 16,000 tonnes in Europe and 6,800 tonnes in Japan (AO SIAR, 2006). Amine oxides are amphoteric surfactants used at active concentrations between 0.1 and 10% in consumer cleaning and personal care products, usually in conjunction with other surfactants. They function as foam stabilizers, thickeners and emollients, emulsifying and conditioning agents in liquid dishwashing and laundry detergents, liquid hard surface cleaners, shampoos, hair conditioners, creams, moisturizers, bar soaps, cleansing and other personal care products (AO SIAR, 2006). 2. METHODS 2.1. Exposure Screening To facilitate the implementation of this risk screening methodology, a product exposure data matrix has been constructed for many categories of consumer products. Several first principle equations (models) are used to estimate consumer exposure. Although most are generic equations based on general parameters and maximum or target values (maximum values refers to values in the upper percentile range of the distribution, i.e., above the 90th percentile; target refers to the value recommended on the product labels), some are based on chemical and scenario-specific parameters. Taken together, these equations provide for a conservative estimate of consumer exposure by a particular route. Appendix Table 1A provides an overview of the model equations and parameters included in the appropriate screening level exposure assessment. The equations are standard international equations and conservative default assumptions as described in Section 2.2 (SDA, 2005). Table Appendix Table 1.. Summary of Model Equations Used to Calculate Product Exposure (PE) Exposure Route Product Exposure Scenario Product Exposure Model Parameters Dermal: Exposure after activity/use of: A: amount used (g/day) Indirect Laundry detergents: wearing clothing NA approach: PR: percent retained on clothing (%) Fabric conditioners: wearing clothing PT: percent transferred from clothing to skin CF: conversion factor (1,000 mg/g) where: PR = 1% based on SDA data. BW: female body weight (60 kg) DA: dermal absorption (100%) EU approach: PD: percent deposition (%) FD: fabric density (mg/cm2) where: PR = (PD × FD)/W) × CA and PD = Sw/Tw W: total wash weight (mg) CA: body surface contact area (cm2) Sw: Mass of water after spin cycle (kg) Tw: Mass of water per spin cycle (kg) Dermal: Exposure during the activity×use of: product FQ: frequency of use (use/day) Direct Laundry detergent: hand-washing clothes NA and EU approach: CA: body surface contact area (cm2) Laundry detergent: laundry pretreatment PC: product concentration (g/cm3) Dish detergent: hand washing dishes FT: film thickness on skin (cm) Dish detergent: washing hands CF: conversion factor (1,000 mg/g) Dilutable hard surface cleaners TF: time scaling factor (unitless) Nondilutable hard surface cleaners BW: female bodyweight (60 kg) Dilutable all-purpose cleaners DA: dermal absorption (100%) Dermal: Exposure after the activity×use (residual): NA and EU approach: FQ: frequency of use (use/day) Direct Adult rinsed-off products: A: amount used (g/use) Body washes PR: percent retained (%) Bath foam/bubble baths CF: conversion factor (1,000 mg/g) Hair conditioners DA: dermal absorption (100%) Hair rinses BW: female bodyweight (60 kg) Hand/body/face soaps male bodyweight (70 kg) (shaving products) child bodyweight Shaving cream (15 kg) (baby care products) Shampoos Adult leave-on products: Antiperspirants Aftershave Face/eye cosmetics Fragrances Facial cream Hand/body moisturizer Hair Spray Styling/tonic gel Styling mouse Sun cream/lotions Baby care rinsed-off products: Baby bath liquids Kid Shampoos Baby care leave-on products: Baby lotion and cream Oral: Exposure after activity/use: NA and EU approach: C′: product concentration (mg/cm3) Indirect Dish detergents (hand washed) T′: amount of water on dish after rinse (mL/cm2) Sa: area of dish contacting food (cm2/day) CF: conversion factor (1 cm3 water/1 mL water) BW: female bodyweight (60 kg) Oral: Exposure during activity/use: NA and EU approach (except additives and OTC medicine): FQ: frequency (use/day) Direct Mouthwash A: amount used (g/day) Lipstick NA and EU approach (additives and OTC pharmaceuticals only): FI: fraction ingested (%) Toothpaste CF: conversion factor (1,000 mg/g) Food additives BW: female bodyweight (60 kg) child bodyweight (15 kg) (toothpaste) Over the counter (OTC) pharmaceuticals C: food consumption of pharmacological dose Note: FI and C will vary by food types. Default screening values have not been established. Exposure Route Product Exposure Scenario Product Exposure Model Parameters Inhalation: Exposure during activity/use: NA and EU approach: FQ: frequency (use/day) Direct Hairspray A: amount used (g/use) Antiperspirants – aerosols IR: inhalation rate (m3/hr) Fragrances ED: exposure duration (hr/day) Paints F: respirable fraction (%) CF: conversion factor (1,000 mg/g) V: effective breathing air space (2 m3); (Note: this value is not appropriate for paints) BW: female body weight (60 kg) Exposure during activity/use: NA and EU approach: FQ: frequency (use/day) Laundry Detergent – powders A: amount used (g/use); (Note: A is the amount of dust/scoop × 1 scoop/use) F: respirable fraction (%) BW: female body weight (60 kg) Exposure during activity/use: NA and EU approach: FQ: frequency (use/day) Trigger Spray Cleaners RPC: respirable product concentration in breathing zone (mg/m3) IR: inhalation rate (m3/hr) ED: exposure duration (hr/day) BA: bioavailability fraction (100%) BW: female body weight (60 kg) For a screening-level assessment, maximum exposure factors (e.g., maximum frequency of product use, longer duration of product use/contact, largest amount of product use per occasion) would be used. For transparency and comprehensiveness, the readily available ranges (minimum-maximum) of values for North America and the EU and associated references/documentation are also summarized in Appendix Tables 2A–4AB. Tables 2A, 3A, and 4A contain factors for North America (NA), and Tables 2B, 3B, and 4B contain factors for the EU. The data matrix provides use factors (e.g., frequency of use, duration of use, amount use per occasion) and equations used to estimate oral, inhalation, and dermal exposures directly resulting from use of the product for the key scenarios of each consumer product category. It is possible and appropriate to further refine the screening assessment based upon more relevant exposure parameters. The average or median values from the data range could be utilized in a refined analysis, when exposure conditions and hazard information are available to support such refinement. It should be noted that the exposure estimates are provided in terms of product types—not specific chemical substances. To estimate exposures to the ingredient, these exposures would be combined with formulation data. The presented data matrix does not account for indirect exposures (e.g., environmental, dietary, or drinking water). Estimated exposures from all exposure routes are developed and integrated into the overall assessment. Table Appendix Table 2:. Data Ranges (Min-Max) of Dermal Exposure Parameters to Estimate Screening Exposures to Consumer Products—North America(References, abbreviations and special notes are indicated in grey columns and described in footnotes at end of table) Product Use Frequency [FQ] (use/day) Product Amount Used per Use [A] (g/use) Product Amount Used per Day [A'] (g/day) Product Use Conc. (%) Product Use Conc. [PC] (g/cm3) Contact Area [CA] (cm2) Product Retained [R] (mg/cm2) Film Thickness [FT] (cm) (E) Product Retained [PR] (%) Percent Transfer [PT] (%) Dermal Absorption [DA] (%) Body Weight [BW] (kg) Scaling: Duration of Exposure [TF] Soaps and Detergents Laundry detergent—Wearing clothes 76–121 A 0.1–1% A 1% A 100% 60 F Laundry detergent (tablets)—Wearing clothes 45–135 G 0.1–1% A 1% A 100% 60 F Fabric conditioners, rinse added—wearing clothes 56–112 A 0.1–1% A 1% A 100% 60 F Fabric conditioners, dryer sheets—wearing clothes 3 A 10.00% A 1% A 100% 60 F Laundry detergent/fabric conditioner handwash 1 A 0.1–1% A 0.001–0.01 A′ 1,680 C 0.0024 100% 60 F 0.007 G Laundry detergent pretreatment (powder paste) 1 A 50–60% G 0.5–0.6 A′ 360 H 0.0024 100% 60 F 0.007 G Laundry detergent pretreatment (liquid neat/nondilutable) 1 A 100% Q 1.0 A′ 360 H 0.0024 100% 60 F 0.003–0.007 G Dishwashing liquids-handwash (hands) 0.1–0.14 E 0.9 E 1,680 C 0.0024 100% 60 F 0.00035 A Dishwashing liquids-handwash (dishes) 1.0–3.0 A–E 0.03–0.15% A 0.0003–0.0015 A′ 1,680 C 0.0024 100% 60 F 0.007–0.03 G Hard surface cleaner-powder 0.14–1 A 20–51 A 0.4–1% P 0.004–0.01 A′ 1,680 C 0.0024 100% N 100% 60 F 0.007–0.014 G APC liquid 0.14–1 A 41–76 A 0.8–1.5% P 0.008–0.015 A′ 1,680 C 0.0024 100% N 100% 60 F 0.007–0.014 G APC gel (neat/nondilutable) 0.14–1 G 100% Q 1.0 A′ 180 D 0.0024 100% N 100% 60 F 0.007–0.014 G APC spray (neat/nondilutable) 0.14–1 G 100% Q 1.0 A′ 180 D 0.0024 100% N 100% 60 F 0.0014–0.014 G, A Personal Care and Cosmetics Shampoos 0.48–1 B 5–16.4 E, B 0.5–1% A, K 100% 60 F Hair rinses 0.064–1 B 7–12.7 A, B 0.5–1% A, K 100% 60 F Styling tonic/gel 0.5–1 A 1.5–5.6 A, K 0.5–5% A, K 100% 60 F Hair sprays – aerosol 1–5.36 *, J, 1 0.05–14.08 *, J, 1 0.5–5% A, K 100% 60 F Hair spray (pump) 1–4.22 *, J, 1 0–21.4 *, J, 1 0.5–5% A, K 100% 60 F F&H liquid soap – hand 5.0–8.0 A 1.6–1.7 A 0.5–1% A, N 100% 60 F F&H Bar Soap –Hand 1.0–6.0 A 0.36 A 0.5–1% A, N 100% 60 F Liquid Soap-Body 0.088–0.57 B 11.8 B*, 2 0.5–1% A, N 100% 60 F F&H Bar Soap –Body 0.95–3 B 2.6–8.6 B, A 0.5–1% A, N 100% 60 F Cleansing products 0.54–2 B 1.7 B*, 2 0.5–1% A, N 100% 60 F Body Wash 1 A 8.0–12.0 A 0.5–1% A, N 100% 60 F Bath Foam/Bubble Bath 0.14–0.29 M 14–17 A 0.5–1% A, N 100% 60 F F &H Bar Soap – Face 1.00 A 0.27 A 0.5–1% A, N 100% 60 F Shave Cream 0.3–1 A 1.0–9.0 *, N, 3 1% A 100% 70 F Body moisturizer 0.05–36.3 *, J, 1 100% L 100% 60 F Antiperspirants – roll-ons 0.8–2.0 B*, 6 0.52–1.22 B, K 100% L 100% 70 F Antiperspirant aerosols 0.8–2.0 B*, 6 0.52–2.2 B, A, 75% N 100% 60 F Antiperspirant solid/bar 0.8–2.0 B*, 6 0.5–1.2 A 100% L 100% 60 F Lipstick 1.0–4.0 B, 5 0–0.2 *, J, 1 100% L 100% 60 F Face/eye cosmetics foundation liquid 1.0–2.0 J 0–2.65 *, J, 1 100% L 100% 60 F Other – Makeup remover 1.0–2.0 M 2.5 M 5% I 100% 60 F Baby Care Products Baby/Bath liquid 1 A 0.873 O 9,000 A 0.097 A 100% 100% 15 F Baby Lotions and creams 0.38–2 B 1.4–2 B, N 100% L 100% 15 F Kids shampoos 0.11–0.43 B 0.5–10 B, A 0.5–1% A. K 100% 15 F Fragrances Fine fragrances 1.0–11.6 B, J *, 4 0.1–5.08 *, J, 1 100% L 100% 60 F Aftershave 0.66–1 A 0.65–1 A 100% L 100% 70 F Abbreviations: AIHC American Industrial Health Council. AISE International Association for Soaps, Detergents and Maintenance Products. APC All purpose cleaners. CTFA Cosmetic, Toiletry and Fragrance Association (Loretz et al., 2005, 2006). D4 Octamethylcyclotetrasiloxane Exposure Assessment, K.S. Crump Group (1999). EFH US EPA's Exposure Factors Handbook, 1997. F&H Face and Hand. HERA Human & Environmental Risk Assessments (subcommittee within AISE). SRTC CTFA-Safety Regulatory Toxicology Subcommittee (Loretz et al., 2005, 2006). TGD EU Technical Guidance Document, 2003. References: A SDA internal data. A′ PC (%) was converted to PC (g/cm3); where (X g product/100 g water) × (1 g water/1 cm3 water). B US EPA (1997) (EFH). C AIHC alkyldimethylamine oxide assessment: hands and forearms D EFH&SDA 2/03 and 4/03 resolutions—one palm average females. E AIHC alkyldimethylamine oxide assessment: internal data. F US EPA (1997) and 2001 (OPP Residential SOPs). G AISE/HERA (2002a) (Table of Habit and Practices for consumer products in Western Europe) (No NA-specific data identified). H EFH: both palms (average female)—SDA 2/03 resolution. I No available data. J CTFA (2002). K AIHC/K.S. Crump Group, 1999(D4 assessment). L Leave-on product; assumed 100%. M EU TGD, 2003 (No NA specific data identified). N Based on CTFA-SRTC comments on SDA Exposure Assessment Methodology April 2003. O Derived based on CA × R/1000. P PC (%) was calculated by assuming product will be diluted in 5 L of water; PC (%) = (X g/use)/(5 L/use) × (1,000 g/L). Q Nondiluted products use 100% product concentration. *Value other than maximum selected; see additional numbered notes below: 1. Selected 90th percentile from data range. 2. Full data range not provided; only averages were available. 3. Selected reasonable average value as recommended by CTFA-SRTC. 4. Selected average value from CTFA 2002, which is in the upper range of data provided in EFH. 5. Selected value based on CTFA-STRC comment and at the 90th percentile of the CTFA 2002 survey data range (Loretz et al., 2005, 2006). 6. Selected reasonable value based on outcome of discussions among SDA member companies. Table Appendix Table 2B:. Data Ranges (Min-Max) of Dermal Exposure Parameters to Estimate Screening Exposures to Consumer Products – Europe (References, abbreviations and special notes are indicated in grey columns and described in footnotes at end of table) Product Use Frequency [FQ] (use/day) Product Amount Used per Use [A] (g/use) Product Amount Used per Day [A'] (g/day) Product Use Conc. (%) Product Use Conc. [PC] (g/cm3) Contact Area [CA] (cm2) Product Retained [R] (mg/cm2) Product Retained [PR] (%) Film Thickness [FT] (cm) (E) Transfer to Skin [PT] (%) Dermal Absorption [DA] (%) Body Weight [BW] (kg) Scaling: Duration of Exposure [TF] Soaps and Detergents Laundry detergents-indirect: powder 55–290 B 0.95% A′ 10% A 100% 60 H Laundry detergents-indirect: liquid 78–230 B 0.95% A′ 10% A 100% 60 H Laundry detergent-indirect: tablet 45–135 B 0.95% A′ 10% A 100% 60 H Fabric conditioners indirect: liquid regular 50–140 B 0.95% A′ 10% A 100% 60 H Fabric conditioners indirect: liquid concentrate 11.0–90 B 0.95% A′ 10% A 100% 60 H Hand-washing: powder 0.14–2.57 B 0.1–1% B D 1,980 C 0.01 A 100% 60 H 0.007 B Hand-washing: liquid laundry and fabric conditioners 0.26–1.43 B 0.1–1% B D 1,980 C 0.01 A 100% 60 H 0.007 B Pretreatment (powder paste) 1.00 E 50–60% B D 840 H 0.01 A 100% 60 H 0.007 B Pretreatment (liquid neat) 1.00 E 100% M D 840 H 0.01 A 100% 60 H 0.007 B Dishwashing liquids-hand wash (hands) 0.14 G 0.9 G 1,680 G 0.01 A 100% 60 H 0.00035 E Dishwashing liquids-hand wash (dishes) 0.43–3.0 B 3.0–28 B, H 0.1–0.9% I 0.001–0.009 D 1,980 C 0.01 A 100% 60 H 0.007 -0.03 B APC liquid 0.14–1 B 30–110 B B′ D 1,980 C 0.01 A 100% 60 H 0.007–0.014 B APC powder 0.14–1 B 20–40 B B′ D 1,980 C 0.01 A 100% 60 H 0.007–0.014 B APC spray (neat) diluted 0.14–1 B 5.0–30 B B′ D 1,980 C 0.01 A 100% 60 H 0.0014–0.007 B APC gel (neat) diluted 0.14–1 B 20–40 B B′ D 1,980 C 0.01 A 100% 60 H 0.007–0.014 B APC spray (neat) undiluted 0.14–1 B 100% M 1 D 1,980 C 0.01 A 100% 60 H 0.0014–0.007 B APC gel (neat) undiluted 0.14–1 B 100% M 1 D 1,980 C 0.01 A 100% 60 H 0.007–0.014 B Personal Care and Cosmetics Shampoos 0.29–1 H, O 8.0–12 O, H, *, 1 0.5–1% E, G 100% 60 H Hair conditioners 0.14–0.29 H 14 H 0.5–1% E, G 100% 60 H Styling mousse 1.0–2.0 H 4.0–5.0 E, H 0.5–5% E, G 100% 60 H Hair sprays – aerosol 2 O 5 O 0.5–10% E, O 100% 60 H F&H liquid soap – hand 5.0–7.0 E 1.6 E 0.5% E 100% 60 H F&H bar soap -hand (toilet soap) 6 O 0.8 O 10.0% O 100% 60 H Liquid soap-body (shower gel) 1.07 O 5 O 10.0% O 100% 60 H F&H bar soap –body 1 E 5.0–10 E 0.5% E 100% 60 H F &H bar soap – face 1 E 0.27 E 0.5% E 100% 60 H Body wash 1 E 9.2 E 0.5% E 100% 60 H Bath foam/bubble bath 0.14–0.29 H 14–17 E 0.5% E 100% 60 H Shaving lubricant 1 H 2 H 1% E 100% 70 H Skin lotions and creams (body lotion) 0.71–2 O, H, *, 1 7.5–8 H, O 100% O 100% 60 H Hand moisturizer 1.0–7.0 E 0.5–0.8 E 100% K 100% 60 H Fragrance cream (including makeup and foundation) 0.29 O 5 O 100% O 100% 60 H Facial moisturizer 1.0–2.0 E, O 0.8 O 100% O 100% 60 H Antiperspirants – aerosols 1.0–3.0 H 0.5–3.0 E, H 100% K 100% 60 H Antiperspirant—roll-ons 1 O 0.5–1.0 O, E, *, 1 100% O 100% 60 H Antiperspirant—solid/bar 1 O 0.5–1.0 O, E, *, 1 100% O 100% 60 H Lipstick 2.0–6.0 H 0.01 H 100% K 100% 60 H Face/Eye Cosmetics 0.5–3 H 0.005–0.025 H 100% K 100% 60 H Other – Makeup remover 1.0–2.0 H 0.5–2.5 H 5% L 100% 60 H Baby Care Products Baby shampoo 5 E 1% G 100% 15 H Baby/Bath liquid 1 E 0.873 J 9,000 E 0.097 E 100% 15 H Baby Lotions and creams 0.38–2 N 1.4–2 N, F 100% K 100% 15 H Skin wipes Fragrances Fine fragrances -pour form 0.66–5 E 0.1–1.2 E 100% K 100% 60 H Aftershave 0.66–1 E 0.65–1 E 100% K 100% 70 H Eau de toilette (including perfume and aftershave) 1 O 0.75 O 100% O 100% 60 H Abbreviations: AIHC American Industrial Health Council. AISE International Association for Soaps, Detergents and Maintenance Products. APC All purpose cleaners. COLIPA European Cosmetic, Toiletry, and Perfumery Association. CTFA Cosmetic, Toiletry and Fragrance Association (Loretz et al., 2005, 2006). D4 Octamethylcyclotetrasiloxane Exposure Assessment, K.S. Crump Group (1999). EFH US EPA's Exposure Factors Handbook, 1997. F&H Face and Hand. HERA Human & Environmental Risk Assessments (subcommittee within AISE). TGD EU Technical Gu