Appendix of the Screening Assessment for the Challenge
This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Archived
Octamethylcyclotetrasiloxane
(D4)
Chemical Abstracts Service Registry Number
556-67-2
Environment Canada
Health Canada
November 2008
Appendix
- Appendix 1: Upper-bounding Estimates of Daily Intake of D4 by the General Population in Canada (µg/kg-bw per Day by Various Age Groups)
- Appendix 2: Consumer Exposure Modelling
- Appendix 3: Summary of Health Effects Information for Octamethylcyclotetrasiloxane
- Appendix 4: Review of D5 Probabilistic Exposure Assessment
- Figure 1. Contribution of scenarios to children's mean and 90th percentile dermal exposures
- Figure 2. Contribution of scenarios to children's mean and 90th percentile inhalation exposures
- Figure 3. Contribution of scenarios to children's (breastfed vs. non-breastfed) mean and 90th percentile ingestion exposures
- Figure 4. Contribution of scenarios to children's (2-4 and 4-11 years) mean and 90th percentile ingestion exposures
- Figure 5. Contribution of exposure route to children's mean and 90th percentile total exposure (general population)
- Figure 6. Contribution of exposure route to children's mean and 90th percentile total exposure (subsistence population)
- Figure 7. Contribution of scenarios to adults' mean and 90th percentile dermal exposures
- Figure 8. Contribution of scenarios to adults' mean and 90th percentile inhalation exposures
- Figure 9. Contribution of scenarios to adults' mean and 90th percentile ingestion exposures
- Figure 10. Contribution of exposure route to adults' mean and 90th percentile total exposure (general population)
- Figure 11. Contribution of exposure route to adults' mean and 90th percentile total exposure (subsistence population)
- Appendix 5: Multimedia modelling input parameters for D4 in the ecological screening assessment
Appendix 1: Upper-bounding Estimates of Daily Intake of D4 by the General Population in Canada (µg/kg-bw per Day by Various Age Groups)
| Route of exposure | 0-6 months[1] | 0.5-4 years[5] | 5-11 years[6] | 12-19 years[7] | 20-59 years[8] | 60+ years[9] | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Breast fed[2] | Formula fed[3] | Fed solid food[4] | ||||||||
| Ambient air[10] | 0.08 | 0.18 | 0.14 | 0.08 | 0.07 | 0.06 | ||||
| Indoor air[11] | 61.01 | 130.73 | 101.91 | 57.95 | 49.78 | 43.27 | ||||
| Drinking water[12] | 0.99 | .01 | .004 | .004 | .003 | .002 | .002 | .002 | ||
| Food and beverages[13] | 2.97 | 1.62 | 0.91 | 0.49 | 0.32 | 0.29 | ||||
| Soil[14] | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | ||||
| Total intake | 62.08 | 61.1 | 64.06 | 132.53 | 102.96 | 58.53 | 50.17 | 43.62 | ||
[2] The highest concentration of D4 detected in human breast milk was10 µg/L in Sweden (Kaj et al. 2005). Breast-fed children 0-6 months of age are assumed to have an intake rate of 0.75 kg of breast milk per day (Health Canada 1998).
[3] For exclusively formula-fed infants, intake of water is only that required to reconstitute formula. No data on detectable concentrations of D4 in drinking water were located. No data on concentrations of D4 in formula or baby food were identified for Canada. Approximately 50% of infants are introduced to solid foods by 4 months of age and 90% by 6 months of age (NHW 1990,).
[4] The dietary intake is based on consumption of 0.3 litres of water and up to 1.18 kg of food daily. This intake pattern is presented as a hypothetical extreme case and does not reflect recommended infant feeding practice.
[5] Assumed to weigh 15.5 kg, to breathe 9.3 m3of air per day, to drink 0.7 L of water per day and to ingest 100 mg of soil per day (Health Canada 1998).
[6] Assumed to weigh 31.0 kg, to breathe 14.5 m3 of air per day, to drink 1.1 L of water per day and to ingest 65 mg of soil per day (Health Canada 1998).
[7] Assumed to weigh 59.4 kg, to breathe 15.8 m3 of air per day, to drink 1.2 L of water per day and to ingest 30 mg of soil per day (Health Canada 1998).
[8] Assumed to weigh 70.9 kg, to breathe 16.2 m3 of air per day, to drink 1.5 L of water per day and to ingest 30 mg of soil per day (Health Canada 1998).
[9] Assumed to weigh 72.0 kg, to breathe 14.3 m3 of air per day, to drink 1.6 L of water per day and to ingest 30 mg of soil per day (Health Canada 1998).
[10] D4 has been measured in ambient air near point sources in Canada, the United States, Europe and Asia. The highest measured concentration not near a point source, 2.4 µg/m3 in Sepstrup Sande, Denmark, was used for the level of D4 in ambient air (Norden 2005). Canadians are assumed to spend 3 h per day outside (Health Canada 1998).
[11] D4 was detected in 15% of about 130 homes in Syracuse, New York between 2002 and 2004. The maximum concentration of D4 measured was 20.56 ppb, or 249 µg/m3 (NYIEQ 2005). The data set considered includes a survey of bedrooms in homes in Sweden in which D4 was detected in 18% of samples and at a maximum concentration of 51.2 µg/m3 (Kaj et al. 2005). Canadians are assumed to spend 21 h per day inside (Health Canada 1998).
[12] No data on levels of D4 in Canadian drinking water were identified. D4 was not detected in two samples of surface water away from point sources in Norway. The higher limit of detection of 0.09 µg/L was used (Norden 2005).
[13] No data were identified for the concentration of D4 in foods in Canada. The concentration of D4 in flounder filets from Norwegian waters was reported to be 1.9 ng/g on a wet-weight basis (NILU 2007). The maximum concentration of DMPS (CAS RN 9006-65-9, dimethylpolysiloxane) in certain processed food is limited by regulation to 10 ppm.[*] A value of 1% D4 in DMPS, or 0.1 ppm in certain processed foods was assumed and it was further assumed that half of processed food and one quarter of dairy products are treated with antifoaming agents containing D4. The probable daily intake of D4 from food packaging for an adult was estimated to be less than 0.2µg/kg-bw/day (as per email from Food Packaging and Incidental Additives Section, Health Products and Food Branch of Health Canada, dated Feb. 27, 2008 unreferenced). Amounts of foods consumed on a daily basis by each age group are described by Health Canada (Health Canada 1998).
[14] No Canadian data were available for D4 levels in soil. No D4 was detected in two soil samples from the Faroe Islands taken at an abandoned and an operating landfill. The higher limit of detection of 10 µg/kg was used (Norden 2005).
[*] Food and Drug Regulations, Division 16. C.R.C., c. 870.
Sample ConsExpo 4.1 Report
Product
Body lotion - women - partitioning 90/10
Compound
Compound name: Octamethylcyclotetrasiloxane
CAS RN: 556-67-2
molecular weight: 297 g/mol
vapour pressure: 140 Pascal
KOW: 6.5 10Log
General exposure data
exposure frequency: 1.5 1/day
body weight: 69 kilogram
Inhalation model: exposure to vapour - constant rate
weight fraction compound: 0.185 fraction
exposure duration: 12 hour
room volume: 80 m3
ventilation rate: 1 1/hr
applied amount: 7.2 gram
release duration: 12 hour
Uptake model: fraction
uptake fraction: 0.12 fraction
inhalation rate: 22 m3/day
Dermal model: direct dermal contact with product - instant application
weight fraction compound: 0.185 fraction
exposed area: 1.57E3 cm2
applied amount: 0.8 gram
Uptake model: fraction
uptake fraction: 0.0094 fraction
Output
Inhalation (point estimates)
inhalation mean event concentration: 1.27 mg/m3
inhalation mean concentration on day of exposure: 0.953 mg/m3
inhalation air concentration year average: 0.953 mg/m3/day
inhalation acute (internal) dose: 0.0243 mg/kg
inhalation chronic (internal) dose: 0.0365 mg/kg/day
Dermal: point estimates
dermal load: 0.0943 mg/cm2
dermal external dose: 2.14 mg/kg
dermal acute (internal) dose: 0.0202 mg/kg
dermal chronic (internal) dose: 0.0302 mg/kg/day
Integrated (point estimates)
total external dose: 2.35 mg/kg
total acute dose (internal): 0.0445 mg/kg
total chronic dose (internal): 0.0667 mg/kg/day
Table 1. D4 - Systemic Dose by Exposure to Personal Care Products - 69-kg Woman
| Product | Amount per appli-cation grams | Autho-rity | Fre- quency per day |
Autho-rity | Weight fraction D4 | Autho-rity | Reten- tion factor |
Inha- lation mg/kg-bw/day at 12% abs |
Dermal mg/kg-bw/day at 0.94%abs | Oral mg/kg-bw/day at 52%abs | Total mg/kg-bw/day |
|---|---|---|---|---|---|---|---|---|---|---|---|
| antiperspirant solid | 0.8 | RIVM | 1 | Maxim | 0.049 | NMI | 1 | 0.00064 | 0.00053 | ||
| body lotion | 8 | RIVM | 1.5 | RIVM | 0.185 | Section 71 | 1 | 0.0365 | 0.0302 | ||
| sunscreen | 6.1 | RIVM | 0.2 | RIVM | 0.01 | NMI | 1 | 0 | 0.00016 | ||
| face moisturizer | 2.5 | RIVM | 2 | RIVM | 0.185 | Section 71 | 1 | 0.0405 | 0.0126 | ||
| face makeup | 0.8 | RIVM | 1 | RIVM | 0.185 | Section 71 | 1 | 0.00243 | 0.00202 | ||
| lipstick | 0.01 | Maxim | 4 | RIVM | 0.25 | Maxim | 1 | 0 | 0.00027 | 0.0603 | |
| hair spray | 6.8 | RIVM | 1.2 | RIVM | 0.3 | CNS | 0.1 | 0.0384 | 0.00333 | ||
| hair shampoo | 20 | RIVM | 0.7 | RIVM | 0.03 | CNS | 0.01 | 0 | 0.00006 | ||
| hair conditioner | 20 | RIVM | 0.3 | RIVM | 0.185 | Section 71 | 0.01 | 0 | 0.00015 | ||
| hair styling | 4.7 | Maxim | 0.6 | Maxim | 0.3 | CNS | 0.1 | 0.014 | 0.00123 | ||
| Totals | 0.132 | 0.0506 | 0.0603 | 0.243 |
Consumer exposure modelling based on ConsExpo (RIVM 2006)
Basic assumptions:
- Body weight 69 kg
- Absorption by inhalation 12% (Utell et al. 1998, SCCP 2005); dermal absorption 0.94% (SCCP 2005); absorption by ingestion 52% (Dow Corning 1998b).
- For products left on skin except lipstick, 10% of applied amount is available to be dermally absorbed, 90% evaporates
- For lipstick, 20% is available for dermal absorption and 80% is available for absorption by ingestion.
Authorities:
- NMI: see in references NMI 2007
- RIVM: see in references RIVM 2006
- CNS: see in references CNS 2007
- Section 71: see in references Environment Canada 2007
- Maxim: see in references Maxim 1998
Table 2. D4 - Systemic Dose by Exposure to Personal Care Products - 82.3-kg Man
| Product | Amount per appli- cation grams |
Autho- rity |
Fre- quency per day |
Autho- rity |
Weight fraction D4 | Autho- rity |
Reten- tion factor |
Inha- lation mg/kg-bw/day at 12% abs |
Dermal mg/kg-bw/day at 0.94%abs | Oral mg/kg-bw/day | Total mg/kg-bw/day | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| antiperspirant solid | 1.22 | Maxim | 1 | Estimate | 0.049 | NMI | 1 | 0.000825 | 0.000672 | |||
| body lotion | 3.5 | Maxim | 0.7 | RIVM | 0.185 | Section 71 | 1 | 0.0062 | 0.0052 | |||
| sunscreen | 6.1 | RIVM | 0.2 | RIVM | 0.01 | NMI | 1 | 0 | 0.000114 | |||
| shaving preparation | 2 | RIVM | 1 | RIVM | 0.1 | CNS | 0.01 | 0 | 0.000228 | |||
| after shave lotion | 1.2 | RIVM | 1 | RIVM | 0.1 | CNS | 1 | 0.00168 | 0.00228 | |||
| hair shampoo | 20 | RIVM | 0.7 | RIVM | 0.03 | CNS | 0.01 | 0 | 0.00048 | |||
| hair conditioner | 20 | RIVM | 0.3 | RIVM | 0.185 | Section 71 | 0.01 | 0.00144 | 0.00013 | |||
| hair pomade | 4.7 | Maxim | 0.6 | Maxim | 0.3 | CNS | 0.1 | 0.0116 | 0.0103 | |||
| Totals | 0.0217 | 0.0194 | 0.0411 | |||||||||
Consumer exposure modelling based on ConsExpo (RIVM 2006)
Basic assumptions:
- Body weight 82.3 kg
- Absorption by inhalation 12% (Utell et al. 1998, SCCP 2005); Dermal absorption 0.94% (SCCP 2005)
- For products left on skin 10% of applied amount is available to be dermally absorbed, 90% evaporates
Authorities:
- NMI: see in references NMI 2007
- RIVM: see in references RIVM 2006
- CNS: see in references CNS 2007
- Section 71: see in references Canada 2007
- Maxim: see in references Maxim 1998
| Endpoint | Lowest effect levels1/Results |
|---|---|
| Acute toxicity | Lowest oral LD50 (rat) = 1540 mg/kg-bw in rat (strain not stated) (Union Carbide Co. 1993). Lowest dermal LD50 (rabbit) = 759 mg/kg-bw [converted from 794 µL/kg] in rabbit (strain not stated) (Union Carbide Co. 1993)[2]. Lowest inhalation LC50: 36 000 mg/m3 =2975 ppm in Fischer rats for single 4-hour nose-only inhalation exposure (Dow Corning 1994). Other studies: Several cited in IUCLID 2000 and SEHSC 2007d. |
| Short-term repeated-dose toxicity | Lowest-observed-effect level (LOEL) - oral: 5 mg/kg-bw/day based on increased liver enzymes CYP2B1/2 and PROD in Sprague Dawley (SD) rats treated by oral gavage with 0, 5, 20 or 100 mg/kg-bw/day for 4 days. At 20 mg/kg-bw/day, effects observed were increased induction of liver enzyme, CYP3A1/2 and increased relative liver weights in females only and increased ethoxyresorufin-O-deethylase (EROD) activity in both sexes (but CYP1A1/2 level did not increase) (significant CYP3A1/2 induction and non-significant increase in relative liver weights in males only at 100 mg/kg-bw/day) (Zhang et al. 2000). Other inhalation studies: Dow Corning 1988a, 1998b, 1989a, 1995a; Klykken et al. 1999. Highest no-observed-effect level (NOEL) - dermal: No effects observed at 960 mg/kg-bw/day in a 3-week dermal study in New Zealand White rabbits exposed to unoccluded conditions (5 days/week) at 96, 190/288[3] or 960 mg/kg-bw/day. (Body weights, clinical signs, skin changes and clinical chemistry parameters measured during the study. At post-mortem, major organs were weighed and histology of the control and high-dose group was conducted.) (Bayer 1988). No other dermal studies identified. |
| Subchronic toxicity | Highest oral NOEL: No effects in rats (strain not stated) or rabbits (strain not stated) treated at 500 mg/kg-bw/day (1% in diet) for 8 (rabbits) or 12 months (rats) (Dow Corning 1986). Lowest inhalation LOEC: 360 mg/m3 = 30 ppm based on increased absolute liver weight (percentage increase not stated) in males in F344 rats exposed by whole-body inhalation to 0, 120, 360, 1800 or 8500 mg/m3 (0, 10, 30, 150 or 700 ppm) for 6 h/day, 5 days/wk for 6 months (Dow Corning 2004). Other LOEC: 420 mg/m3 based on alveolar macrophage foci and chronic interstitial inflammation of lung at this dose and higher in both sexes and in females, increased absolute (20%) and relative (22%) liver weights, increased absolute and relative (17% increase) adrenal weights and decreased absolute and relative (17% decrease) thymus weights in F344 rats exposed by nose-only inhalation for 6 h/day, 5 days/wk for 3 months to 0, 35, 122, 488 or 898 ppm (equal to 0, 420, 1480, 5910 or 10900 mg/m3). Reversible increased liver weight in rats (percentage increase not stated) at 488 ppm and higher (Burns-Naas et al 2002, Dow Corning 1995b) No dermal studies identified. |
| Chronic toxicity / carcinogenicity | Inhalation carcinogenicity bioassay in rats: Increased endometrial adenomas at 8500 mg/m3 (700 ppm) only, in F344 rats exposed by whole-body inhalation for 6 h/day, 5 days/wk for 2 years to 0, 120, 360, 1800 or 8500 mg/m3 (0, 10, 30, 150 or 700 ppm ). Mononuclear cell leukemia (MCL) incidence higher than historical values in control and high-dose (8500 mg/m3) males (Dow Corning 2004). Lowest inhalation non-neoplastic LOEC: 1800 mg/m3 = 150 ppm based on increased absolute and relative liver weight (percentage increase not stated) and increased absolute and relative kidney weight in female rats in the same 2-year rat study (Dow Corning 2004, Lee et al. 2005). No oral or dermal studies identified. |
| Developmental toxicity | Lowest oral LOEC for embryofetal toxicity: 500 mg/kg-bw/day based on increased spontaneous abortions at this dose and above in pregnant New Zealand White (NZW) rabbits treated by oral gavage during gestation days 7-19 to 0, 50, 100, 500 or 1000 mg/kg-bw/day. There were also increased post-implantation losses and decreased number of live fetuses at 1000 mg/kg-bw/day. Maternal toxicity (decreased food intake and body weight gain) was observed at doses of 50 mg/kg-bw/day and higher in this study, and the developmental effects were likely secondary rather than direct effects. No teratogenicity was observed in this study (IRDC 1993a). Inhalation: No teratogenicity or embryofetal toxicity was observed in inhalation studies at exposures of up to at 8500 mg/m3 (700 ppm) in SD rats exposed to 0, 1200, 3600 or 8500 mg/m3 (0, 100, 300 or 700 ppm) or up to 6100 mg/m3 (500 ppm) in NZW rabbits exposed to 0, 1200, 3600 or 6100 mg/m3 (0, 100, 300 or 500 ppm) by whole-body inhalation for 6 h/day during gestation days 6-15 (rats) or 6-18 (rabbits) (IRDC 1993b, 1993c). No dermal studies identified. |
| Reproductive toxicity | Inhalation LOEC for reproductive toxicity:3600mg/m3 (300 ppm) based on decreased number of corpora lutea in a single-generation study (Meeks et al.2007). Meeks et al. (2007) also conducted pre- and post-mating phase studies in which female SD rats were exposed to D4 by whole-body inhalation for 6 h/day for (i) 4th, 3rd, 2nd or 1st days prior to mating, 3-1 days prior to mating or 3 days prior to mating to gestation day 3 = premating phase or (ii) gestation days 0, 1 or 2 or gestation day 0-2 = post-mating phase. Main effects during the pre-mating phase were decreased food consumption and "effects on mean body weight gain," decreased number of corpora lutea and implantation sites, increased number of small implantation sites, and decreased mean uterine weight. During the post-mating phase the effects observed were decreased food consumption and mean body weight gain. No effects on reproductive parameters were observed when male rats were exposed by inhalation at concentrations up to 8500 mg/m3 (700 ppm) and mated with untreated females (Dow Corning 1997a, 1997b). Positive in estrogenic activity: D4 increased uterine weight in rats and mice and uterine epithelial cell height (up to 30 µm) in rats at oral doses of 250 to 1000 mg/kg-bw/day in immature SD and F344 rats and in B6C3F1 mice exposed for 3 or 4 days (McKim et al. 2001a, He et al. 2003). A dose-related reduction in serum estradiol from 100 to 1000 mg/kg-bw/day was observed in female B6C3F1 mice dosed for 7 days (He et al. 2003). |
| Endocrine disruption in vitro | D4 showed binding potential to human estrogen receptor (ER) but not to estrogen receptor (ER), and was positive in ERa reporter gene assay in a human epithelial cell line MCF-7. D4 showed no binding affinity to progesterone receptors (PRs), but was positive in PRß reporter gene assay (Quinn et al. 2007a). |
| Genotoxicity and related endpoints: in vivo | Chromosome aberrations: Dominant lethal assay: |
| Genotoxicity and related endpoints: in vitro | Mutagenicity: Chromosome aberrations: Sister chromatid exchange: DNA damage: |
| Human studies | Lowest effect levels1/Results |
| Acute toxicity | Human volunteers (8 males + 4 females) exposed to 10 ppm of D4 vapour (120 mg/m3) for one hour via the mouth in a double-blind, randomized study showed no changes in lung function. The blood clearance was non-linear with an elimination half-life of 330 min. The deposition of D4 was also measured with nasal and mouth breathing at resting ventilations in another 8 subjects. The overall average D4 absorption was 12% (Utell et al.1998). |
| Short-term repeated-dose toxicity | Human volunteers (number and sex not stated) exposed orally to 12 mg/day of D4 for 14 days in a double-blind, placebo-controlled crossover study did not show any immunotoxic or pro-inflammatory adjuvant effect (Dow Corning 1998c). |
LC50 = median lethal concentration
LOEL = lowest-observed-effect level
LOEC = lowest-observed-effect concentration
NOEL = no-observed-effect level
[2] This value was checked and appears to be correct. However, we note the apparent inconsistency between an oral LD50 value of 759 mg/kg-bw in rabbits and the dermal NOEL of 960 mg/kg-bw/day in the 3-week dermal rabbit study.
[3] IUCLID (2000) and SCCP (2005) state the mid-dose to be 190 mg/kg-bw/day whereas SEHSC (2007d) states the mid-dose to be 280 mg/kg-bw/day.
Project: D5 Probabilistic Exposure Assessment
Task: Review D5 Probabilistic Exposure Assessment conducted by Silicones Environmental, Health and Safety Council (SEHSC)
For: Health Canada (Healthy Environments and Consumer Safety Branch)
By: infoscientific, Henderson, Nevada, USA
Period: August-September, 2008
Executive Summary
A review of the D5 probabilistic exposure assessment submitted by SEHSC was done and comments to assist in preparing the screening assessment report for D5 is provided in this report.
"User Only" daily exposures were estimated based on a Monte Carlo analysis using Crystal Ball. Mean exposure and 90th percentile exposure summaries were generated for different subpopulations (children and adults).
For dermal and inhalation exposure routes, the current assessment resulted in higher exposures than the assessment done by SEHSC. The primary reason was the consideration of "user only" subpopulation in the current assessment compared to the "user" and "non-user" subpopulations considered in the SEHSC assessment. The dermal exposure route had higher exposures for both children and adults. Diaper cream, body lotion and sunscreen contributed to higher exposures in the dermal route; soothing vapour in the inhalation route and antifoam and fish in the ingestion route.
Introduction
As a part of Canada's Chemicals Management Program, Decamethylcyclopentasiloxane (D5) has been identified by Health Canada as a material to be reviewed and considered in a screening level assessment.
SEHSC submitted information on D5 to assist Health Canada in preparing the screening assessment report for D5. The information provided included toxicity information not readily available in the literature and a comprehensive exposure assessment utilizing Monte Carlo analysis. The exposure assessment included information on the levels of D5 in different environmental media and on consumer product use patterns.
Health Canada contracted with infoscientific, USA to review the D5 probabilistic exposure assessment submitted by SEHSC and to provide comments to assist in preparing the screening assessment report for D5.
Description
SEHSC's Monte Carlo-based probabilistic assessment for D5 included the following age-dependent and exposure-route-dependent scenarios:
- Children - dermal route: body lotion, conditioner (leave in), conditioner (rinse off), diaper cream, shampoo (2-in-1) soothing vapour, spray detangler, sunscreen
- Children - ingestion route: antifoam, baby bottle nipple, fish (general population), fish (subsistence population), human milk, leafy vegetables (greens), meat, milk, pacifier, root vegetables, sipper tube, soil, straws, water
- Children - ingestion route: OTC (over-the-counter) drugs
- Children - inhalation route: indoor air, outdoor air, soothing vapour
- Adults - dermal route: after shave, body lotion, conditioner (leave in), conditioner (rinse off), foundation, hair spray, mascara, moisturizer, nail care, roll-on antiperspirant, shampoo, solid antiperspirant, soothing vapour, sunscreen, under-eye cream
- Adults - ingestion route: antifoam, fish (general population), fish (subsistence population), leafy vegetables (greens), lipstick, meat, milk, root crops, soil, water
- Adults - ingestion route: OTC (over-the-counter) drugs
- Adults: inhalation route: indoor air, outdoor air, soothing vapour
Separate route-specific and total exposure estimates were made for the following subpopulations:
- Children: ages 0 to 6 months, breastfed
- Children: ages 0 to 6 months, non-breastfed
- Children: ages 0 to 6 months, males
- Children: ages 0 to 6 months, females
- Children: ages 7 to 11 months, breastfed
- Children: ages 7 to 11 months, non-breastfed
- Children: ages 1 to 2 years, breastfed
- Children: ages 1 to 2 years, non-breastfed
- Children: ages 2 to 4
- Children: ages 6 months to 4 years, males
- Children: ages 6 months to 4 years, females
- Children: ages 4 to 11 years, males
- Children: ages 4 to 11 years, females
- Adults: ages 12 to 19 years, males
- Adults: ages 12 to 19 years, females
- Adults: ages 20 to 59 years, males
- Adults: ages 20 to 59 years, females
- Adults: ages 60+ years, Males
- Adults: ages 60+ years, Females.
The following documents and data files were provided to assist with the review process:
- D5_Kids, an Excel file, compatible with Crystal Ball, that contained all the exposure calculations for children
- D5_Adults, an Excel file, compatible with Crystal Ball, that contained all the exposure calculations for adults
- UPDATED Final Submission for Health Canada - D5, a Word file that contains information related to toxicity and exposure for D5
- Attachment 1 - Exposure Assessment for D5, a Word file that is a report explaining the probabilistic exposure assessment, including inputs used and outputs generated
The following steps were taken during the process of reviewing the D5 probabilistic assessment submitted by SEHSC:
- reviewed documents provided by Health Canada
- identified product-based exposure scenarios, exposure pathways and exposure subpopulations
- used the Excel files provided by Health Canada (D5_Kids.xls and D5_Adults.xls; files created by SEHSC) as starting points
- assured the quality of Crystal Ball-based probabilistic calculations
- generated Crystal Ball-based probabilistic Monte Carlo outputs and compared them with those listed in documents submitted by SEHSC
- commented on the robustness of industry's (SEHSC) probabilistic assessment and recommended whether it should be considered further in the screening assessment for D5
It must be mentioned that the review process did not
- validate the list of scenarios that cover all D5 exposures to children and adults
- validate the input values used in the SEHSC assessment
- validate the sources of the input values
However, the review process did
- check cells designated as Crystal Ball Assumptions (check the assignment of distributional parameters for inputs)
- check cells designated as Crystal Ball Forecasts (check the assignment of results)
- check formulas for the different calculations
A few errors were detected in the calculations. All these errors, which appeared in the formula cells, were incorrect references to formula inputs (incorrect cell references were provided).
Each exposure scenario-dermal, ingestion, or inhalation-has two use-related parameters associated with it: frequency of use/occurrence (number of times per day) and percentage of population engaged in scenario. For the parameter " frequency of use/occurrence", the values used in the SEHSC assessment were also used in the current assessment, except when the value was less than 1.0; in this case, a value of 1.0 was assigned.
The SEHSC assessment relies heavily on the parameter "percentage of population engaged in scenario" to estimate exposures for the general population which includes users and non-users. The current assessment ignores this parameter completely. For example, in the case of a scenario where 20% of the population is engaged, in a probabilistic Crystal Ball run with 200 000 simulations, the SEHSC assessment will have 160 000 estimates with zero values and 40 000 estimates with values greater than zero. On the other hand, the current assessment will have 200 000 estimates with values greater than zero. As a result, both mean exposure estimates and 90th percentile exposure estimates generated by the current assessment will be greater than those generated by the SEHSC assessment. Conclusion: "user-only" exposures make a significant difference when comparing results generated by SEHSC and by infoscientific.
Exposure summary results were generated for 1) individual scenarios by specific exposure routes, 2) multiple scenarios by specific exposure routes (total exposure by specific exposure route) and 3) multiple scenarios aggregated over multiple routes (total exposure).
Total exposure within an exposure route is estimated by summing exposures for each scenario. Then total exposure across multiple exposure routes is estimated by summing exposures for each exposure route. Let us consider single Monte Carlo simulations within two separate probabilistic assessments: (1) a "user only" assessment (similar to the current assessment) and (2) a "user/non-user" assessment (similar to the SEHSC assessment).
In case (1), for each scenario, there is a finite probability that the individual represented in the simulation engages in that scenario. Thus, for multiple scenarios, the individual is involved only in a fraction of the scenarios and not all the scenarios considered. For those scenarios in which the individual engages, exposure estimates are generated. Total exposure is the sum of individual scenario exposures. This case can be extended to represent individuals in a general population.
By contrast, in case (2), for all scenarios, the probabilities for the individual represented in the simulation engaging in each equal 1.0 (100%). And, in this case, for multiple scenarios, the individual is involved in all the scenarios. Total exposure, which is the sum of individual scenario exposures, represents all the scenarios. The probability of an individual in a general population engaging in all the scenarios is unlikely.
Based on the above explanations for the two cases, in the current assessment, the "user only" summaries generated for individual scenarios are valid results. However, the summaries generated for total exposures, either within individual exposure routes or across exposure routes, are improbable and should be interpreted with caution. For total exposures, the estimates generated by SEHSC would be more applicable than the ones generated by the current assessment.
Adding exposures across exposure routes should be done after consideration of route-specific toxicological endpoints. If the route-specific toxicological endpoints are unequal, route-specific total exposures cannot be added without applying appropriate absorption/penetration factors and/or potency factors.
Exposure results and discussion: Children
Table 1. Children's mean exposures (based on 200 000 Crystal Ball simulations)
| Mean exposures | Ages 0-6 months | 6 m - 4 yrs | 4 yrs - 11 yrs | ||||
|---|---|---|---|---|---|---|---|
| M | F | M | F | M | F | ||
| Dermal | 2-in-1 shampoo | 3.636E-07 | 2.178E-07 | 1.760E-07 | 1.038E-07 | 2.358E-07 | 1.417E-07 |
| Body lotion | 3.625E-03 | 3.517E-03 | |||||
| Conditioner leave in | 2.498E-04 | 1.492E-04 | |||||
| Conditioner rinse off | 7.513E-06 | 4.497E-06 | |||||
| Soothing vapour | 1.447E-05 | 1.495E-05 | 6.662E-06 | 6.464E-06 | |||
| Diaper cream | 5.665E-03 | 5.944E-03 | 2.742E-03 | 2.832E-03 | |||
| Spray detangler | 1.654E-07 | 9.776E-08 | 7.617E-08 | 4.228E-08 | |||
| Sunscreen | 2.409E-03 | 2.529E-03 | 2.915E-03 | 3.011E-03 | 2.684E-03 | 2.605E-03 | |
| Total Dermal | 8.075E-03 | 8.473E-03 | 5.672E-03 | 5.858E-03 | 6.573E-03 | 6.282E-03 | |
| Inhalation | Indoor air | 2.403E-04 | 2.523E-04 | 2.251E-04 | 2.326E-04 | 1.515E-04 | 1.362E-04 |
| Outdoor air | 4.775E-06 | 5.006E-06 | 4.472E-06 | 4.619E-06 | 3.012E-06 | 2.707E-06 | |
| Soothing vapor | 2.921E-03 | 3.017E-03 | 1.965E-03 | 1.767E-03 | |||
| Total Inhalation | 2.451E-04 | 2.573E-04 | 3.151E-03 | 3.255E-03 | 2.119E-03 | 1.905E-03 | |
| Ingestion | Antifoam | 9.252E-04 | 8.539E-04 | ||||
| Baby bottle nipple | |||||||
| Fish, general | 4.499E-04 | 3.883E-04 | |||||
| Greens | 2.069E-08 | 2.126E-08 | |||||
| Human milk | |||||||
| Meat | 7.121E-08 | 6.347E-08 | |||||
| Milk | 1.027E-07 | 8.833E-08 | |||||
| Pacifier | |||||||
| Root vegetable | 1.129E-05 | 1.051E-05 | |||||
| Sipper tube | 5.176E-05 | 5.176E-05 | |||||
| Soil | 2.181E-06 | 2.116E-06 | |||||
| Straws | 2.133E-05 | 2.069E-05 | |||||
| Fish, subsistence | 3.770E-04 | 3.657E-04 | |||||
| Water | 1.461E-07 | 1.418E-07 | |||||
| OTC drugs | 5.434E-03 | 5.701E-03 | 1.316E-03 | 1.359E-03 | 2.213E-06 | 2.146E-06 | |
| Total Ingestion, Subsistence | 4.372E-03 | 4.372E-03 | 2.794E-03 | 2.794E-03 | 1.389E-03 | 1.305E-03 | |
| Total Ingestion, General | 2.654E-03 | 2.654E-03 | 2.428E-03 | 2.428E-03 | 1.462E-03 | 1.328E-03 | |
| Total | Total, Subsistence Population | 1.813E-02 | 1.880E-02 | 1.293E-02 | 1.327E-02 | 1.008E-02 | 9.494E-03 |
| Total, General Population | 1.641E-02 | 1.709E-02 | 1.257E-02 | 1.290e-02 | 1.016E-02 | 9.517E-03 | |
Table 1 summarizes all the exposure results for children as mean values. When compared with similar results generated by the SEHSC assessment, all the values are higher in the current assessment. Compared to the SEHSC assessment, the current assessment results in a difference of 1.79 to 2.32 times for total dermal exposures, in a difference of 1.00 to 13.56 times for total inhalation exposures, and in a difference of 0.97 to 1.56 times for total ingestion (general population) exposures. The primary reason for the differences is that the SEHSC assessed users and non-users whereas the current assessment considered users only.
Wherever exposures are estimated for multiple age groups, the estimates for lower age groups are usually greater than the estimates for higher age groups. Within dermal exposure scenarios, diaper cream, sunscreen and body lotion are the highest contributions; within inhalation, soothing vapour is the highest contributor; and within ingestion, the highest contributor is over-the-counter drugs for lower age groups and fish (subsistence) for higher age groups.
Table 2. Mean ingestion exposures for breastfed (BF) and non-breastfed (nBF) infants
| Mean exposures | Ages 0-6 months | 7-11 months | 1-2 years | 2-4 years | ||||
|---|---|---|---|---|---|---|---|---|
| BF | nBF | BF | nBF | BF | nBF | all | ||
| Ingestion | Antifoam | 1.060E-03 | 2.904E-03 | 1.145E-03 | 2.260E-03 | 1.259E-03 | 1.821E-03 | 1.390e-03 |
| Baby bottle nipple | 4.871E-04 | 3.484E-04 | 2.900E-04 | 2.092E-04 | ||||
| Fish, general | 3.341E-06 | 3.980E-04 | 1.700E-04 | 4.794E-04 | 4.800E-04 | 4.828E-04 | 5.023E-04 | |
| Greens | 4.889E-08 | 3.968E-08 | 1.749E-08 | 3.329E-08 | 6.773E-08 | 2.030E-08 | 2.718E-08 | |
| Human milk | 3.425E-04 | 2.009E-04 | 1.124E-04 | |||||
| Meat | 5.972E-08 | 4.442E-08 | 5.182E-08 | 7.268E-08 | 5.008E-08 | 9.237E-08 | 9.152E-08 | |
| Milk | 1.355E-07 | 1.343E-07 | 6.381E-08 | 1.957E-07 | 1.778E-07 | 2.985E-07 | 1.639E-07 | |
| Pacifier | 4.873E-04 | 4.873E-04 | 3.485E-04 | 3.485E-04 | 2.902E-04 | 2.902E-04 | 2.093E-04 | |
| Root vegetable | 1.961E-05 | 2.103E-05 | 2.126E-05 | 2.799E-05 | 1.702E-05 | 1.998E-05 | 1.571E-05 | |
| Sipper tube | 2.436E-04 | 2.436E-04 | 1.743E-04 | 1.743E-04 | 1.451E-04 | 1.451E-04 | 1.046E-04 | |
| Soil | 9.959E-06 | 9.959E-06 | 7.123E-06 | 7.123E-06 | 5.929E-06 | 5.929E-06 | 4.277E-06 | |
| Straws | 4.873E-04 | 9.740E-05 | 6.967E-05 | 6.967E-05 | 5.799E-05 | 5.799E-05 | 4.184E-05 | |
| Fish, subsistence | 1.721E-03 | 1.721E-03 | 1.231E-03 | 1.231E-03 | 1.025E-03 | 1.025E-03 | 7.393E-04 | |
| Water | 6.673E-07 | 6.673E-07 | 4.773E-07 | 4.773E-07 | 3.973E-07 | 3.973E-07 | 2.866E-07 | |
Table 2 summarizes all ingestion-related mean exposures specific to breastfed and non-breastfed infants. There are no significant differences in the results generated by the current assessment (shown above) and the SEHSC assessment. The two highest contributors to ingestion exposure for this subpopulation are antifoam and fish (subsistence).
Table 3. Children's 90th percentile exposures (based on 200 000 Crystal Ball simulations)
| 90thpercentile exposures | Ages 0-6 months | 6 m - 4 yrs | 4 yrs - 11 yrs | ||||
|---|---|---|---|---|---|---|---|
| M | F | M | F | M | F | ||
| Dermal | 2-in-1 shampoo | 7.952E-07 | 4.747E-07 | 3.847E-07 | 2.260E-07 | 5.177E-07 | 3.132E-07 |
| Body lotion | 7.894E-03 | 7.662E-03 | |||||
| Conditioner leave in | 5.265E-04 | 3.203E-04 | |||||
| Conditioner rinse off | 1.608E-05 | 9.733E-06 | |||||
| Soothing vapour | 2.019E-05 | 2.085E-05 | 9.294E-06 | 9.019E-06 | |||
| Diaper cream | 1.463E-02 | 1.535E-02 | 7.073E-03 | 7.312E-03 | |||
| Spray detangler | 3.192E-07 | 1.882E-07 | 1.468E-07 | 8.138E-08 | |||
| Sunscreen | 7.264E-03 | 7.613E-03 | 8.766E-03 | 9.062E-03 | 8.081E-03 | 7.860E-03 | |
| Total Dermal | 1.849E-02 | 1.942E-02 | 1.244E-02 | 1.286E-02 | 1.391E-02 | 1.338E-02 | |
| Inhalation | Indoor air | 5.001E-04 | 5.262E-04 | 4.700E-04 | 4.859E-04 | 3.185E-04 | 2.853E-04 |
| Outdoor air | 1.137E-05 | 1.200E-05 | 1.071E-05 | 1.100E-05 | 7.186E-06 | 6.495E-06 | |
| Soothing vapour | 4.379E-03 | 4.522E-03 | 2.964E-03 | 2.640E-03 | |||
| Total Inhalation | 5.038E-04 | 5.298E-04 | 4.663E-03 | 4.813E-03 | 3.155E-03 | 2.808E-03 | |
| Ingestion | Antifoam | 1.680E-03 | 1.567E-03 | ||||
| Baby bottle nipple | |||||||
| Fish, general | 1.008E-03 | 8.716E-04 | |||||
| Greens | 3.873E-09 | 4.007E-09 | |||||
| Human milk | |||||||
| Meat | 1.425E-07 | 1.276E-07 | |||||
| Milk | 1.991E-07 | 1.747E-07 | |||||
| Pacifier | |||||||
| Root vegetable | 2.966E-05 | 2.903E-05 | |||||
| Sipper tube | 6.587E-05 | 6.587E-05 | |||||
| Soil | 4.180E-06 | 4.056E-06 | |||||
| Straws | 2.715E-05 | 2.634E-05 | |||||
| Fish, subsistence | 8.404E-04 | 8.146E-04 | |||||
| Water | 2.901E-07 | 2.813E-07 | |||||
| OTC drugs | 1.304E-02 | 1.366E-02 | 3.627E-03 | 3.746E-03 | 5.306E-06 | 5.150E-06 | |
| Total Ingestion, Subsistence | 7.195E-03 | 7.195E-03 | 4.406E-03 | 4.406E-03 | 2.333E-03 | 2.203E-03 | |
| Total Ingestion, General | 4.326E-03 | 4.326E-03 | 3.804E-03 | 3.804E-03 | 2.488E-03 | 2.266E-03 | |
| Total | Total, Subsistence Population | 3.317E-02 | 3.456E-02 | 2.201E-02 | 2.260E-02 | 1.756E-02 | 1.673E-02 |
| Total, General Population | 3.102E-02 | 3.242E-02 | 2.155E-02 | 2.215E-02 | 1.773E-02 | 1.677E-02 | |
Table 3 summarizes all the exposure results for children as 90th percentile values. When compared with similar results generated by the SEHSC assessment, all the values are higher in the current assessment. Compared to the SEHSC assessment, the current assessment results in a difference of 1.33 to 1.69 times for total dermal exposures, in a difference of 1.00 to 9.83 times for total inhalation exposures, and in a difference of 0.97 to 1.36 times for total ingestion (general population) exposures. The primary reason for the differences is that the SEHSC assessed users and non-users whereas the current assessment considered users only.
Table 4. 90th percentile ingestion exposures for breastfed (BF) and non-breastfed (nBF) infants
| 90thpercentile exposures | Ages 0-6 months | 7-11 months | 1-2 years | 2-4 years | ||||
|---|---|---|---|---|---|---|---|---|
| BF | nBF | BF | nBF | BF | nBF | all | ||
| Ingestion | Antifoam | 2.706E-03 | 5.188E-03 | 2.490e-03 | 3.981E-03 | 2.423E-03 | 3.240E-03 | 2.487E-03 |
| Baby bottle nipple | 6.202E-04 | 4.434E-04 | 3.901E-04 | 2.663E-04 | ||||
| Fish, general | 6.719E-06 | 9.746E-04 | 3.701E-04 | 1.082E-03 | 1.146E-03 | 1.063E-03 | 1.126E-03 | |
| Greens | 1.028E-08 | 1.011E-08 | 2.465E-09 | 6.328E-09 | 1.852E-08 | 3.972E-09 | 4.953E-09 | |
| Human milk | 4.587E-04 | 3.428E-04 | 1.952E-04 | |||||
| Meat | 1.471E-07 | 9.750E-08 | 1.133E-07 | 1.476E-07 | 9.887E-08 | 1.841E-07 | 1.825E-07 | |
| Milk | 3.244E-07 | 3.045E-07 | 1.349E-07 | 4.601E-07 | 3.777E-07 | 5.904E-07 | 3.267E-07 | |
| Pacifier | 6.201E-04 | 6.201E-04 | 4.432E-04 | 4.432E-04 | 3.907E-04 | 3.907E-04 | 2.662E-04 | |
| Root vegetable | 5.571E-05 | 6.142E-05 | 5.768E-05 | 7.632E-05 | 4.353E-05 | 5.262E-05 | 4.168E-05 | |
| Sipper tube | 3.100E-04 | 3.100E-04 | 2.216E-04 | 2.216E-04 | 1.953E-04 | 1.953E-04 | 1.331E-04 | |
| Soil | 1.909E-05 | 1.909E-05 | 1.365E-05 | 1.365E-05 | 1.146E-05 | 1.146E-05 | 8.200E-06 | |
| Straws | 6.201E-04 | 1.240E-04 | 8.864E-05 | 8.864E-05 | 7.805E-05 | 7.805E-05 | 5.323E-05 | |
| Fish, subsistence | 3.837E-03 | 3.837E-03 | 2.744E-03 | 2.744E-03 | 2.284E-03 | 2.284E-03 | 1.648E-03 | |
| Water | 1.325E-06 | 1.325E-06 | 9.479E-07 | 9.479E-07 | 7.950E-07 | 7.950E-07 | 5.691E-07 | |
Table 4 summarizes all ingestion-related 90thpercentile exposures specific to breastfed and non-breastfed infants. There are no significant differences in the results generated by the current assessment (shown above) and the SEHSC assessment. The two highest contributors to ingestion exposure for this subpopulation are antifoam and fish (subsistence).
D5: Dermal exposures, males 0-6 months
D5: Dermal exposures, females 0-6 months

D5: Dermal exposures, males 6 months - 4 years

D5: Dermal exposures, females 6 months - 4 years

D5: Dermal exposures, males 4-11 years

D5: Dermal exposures, females 4-11 years

Figure 1 shows the contribution of scenarios to dermal exposures for children's mean and 90th percentile exposures. As seen in the bar charts, diaper cream, sunscreen, and body lotion are the highest contributors to dermal exposures.
D5: Inhalation exposures, males 6 months - 4 years

D5: Inhalation exposures, females 6 months - 4 years

D5: Inhalation exposures, males 4-11 years

D5: Inhalation exposures, females 4-11 years

Figure 2 shows the contribution of scenarios to inhalation exposures for children's mean and 90th percentile exposures. As seen in the bar charts, soothing vapour is the highest contributor to inhalation exposures.
Figure 3. Contribution of scenarios to children's (breastfed vs. non-breastfed) mean and 90th percentile ingestion exposures
D5: Ingestion exposures, 0-6 months, breastfed

D5: Ingestion exposures, 0-6 months, non-breastfed

D5: Ingestion exposures, 7-11 months, breastfed

D5: Ingestion exposures, 7-11 months, non-breastfed

D5: Ingestion exposures, 1-2 years, breastfed

D5: Ingestion exposures, 1-2 years, non-breastfed

Figure 3 shows the contribution of scenarios to ingestion exposures for children's (breastfed and non-breastfed) mean and 90th percentile exposures. As seen in the bar charts, the highest contributors to ingestion exposures for this subpopulation are antifoam and fish (for the general and subsistence population).
Figure 4. Contribution of scenarios to children's (2-4 and 4-11 years) mean and 90th percentile ingestion exposures
D5: Ingestion exposures, 2-4 years

D5: Ingestion exposures, males, 4-11 years

D5: Ingestion exposures, females, 4-11 years

Figure 4 shows the contribution of scenarios to ingestion exposures for children's (2-4 and 4-11 years) mean and 90th percentile exposures. Exposure estimates are based on 200 000 Crystal Ball simulations. As seen in the bar charts, the highest contributors to ingestion exposures for this subpopulation are antifoam and fish (for general and subsistence population).
Figure 5. Contribution of exposure route to children's mean and 90th percentile total exposure (general population)
D5: Exposures, males, 0-6 months (general population)

D5: Exposures, females, 0-6 months (general population)

D5: Exposures, males, 6 mth - 4 yr (general population)

D5: Exposures, females, 6 mth - 4 yr (general population)

D5: Exposures, males, 4-11 years (general population)

D5: Exposures, females, 4-11 years (general population)

Figure 5 shows the contribution of exposure route to children's mean and 90th percentile total exposures for the general population. The highest exposure route is dermal. In the case of children 0-6 months old, dermal exposure is followed by over-the-counter drugs and then by ingestion; however, in the case of children 6 months - 4 years old and children 4-11 years old, dermal exposure is followed by inhalation and then by ingestion.
Figure 6. Contribution of exposure route to children's mean and 90th percentile total exposure (subsistence population)
D5: Exposures, males, 0-6 months (subsistence population)

D5: Exposures, females, 0-6 months (subsistence population)

D5: Exposures, males, 6 mth - 4 yr (subsistence population)

D5: Exposures, females, 6 mth - 4 yr (subsistence population)

D5: Exposures, males, 4-11 years (subsistence population)

D5: Exposures, females, 4-11 years (subsistence population)

Figure 6 shows the contribution of exposure route to children's mean and 90th percentile total exposures for the subsistence population. The highest exposure route is dermal. In the case of children 0-6 months old, dermal exposure is followed by over-the-counter drugs and then by ingestion; however, in the case of children 6 months - 4 years old and children 4-11 years old, dermal exposure is followed by inhalation and then by ingestion.
Exposure results and discussion: Adults
Table 5. Adults' mean exposures (based on 200 000 Crystal Ball simulations)
| Mean exposures | 12-19 years | 20-59 years | 60+ years | ||||
|---|---|---|---|---|---|---|---|
| Males | Females | Males | Females | Males | Females | ||
| Dermal | After shave | 1.07E-04 | 8.25E-05 | 8.45E-05 | |||
| Body lotion | 3.11E-03 | 3.46E-03 | 2.40E-03 | 2.83E-03 | 2.45E-03 | 2.93E-03 | |
| Soothing vapour | 3.07E-06 | 3.41E-06 | 2.37E-06 | 2.80E-06 | 2.42E-06 | 2.90e-06 | |
| Foundation | 1.47E-04 | 1.21E-04 | 1.25E-04 | ||||
| Hair spray | 1.09E-04 | 6.44E-05 | 8.36E-05 | 5.28E-05 | 8.56E-05 | 5.46E-05 | |
| Leave-in condition | 6.21E-05 | 3.70E-05 | 4.78E-05 | 3.04E-05 | 4.89E-05 | 3.14E-05 | |
| Rinse-off conditioner | 1.86E-06 | 1.11E-06 | 1.43E-06 | 9.08E-07 | 1.47E-06 | 9.40E-07 | |
| Mascara | 3.45E-05 | 2.83E-05 | 2.93E-05 | ||||
| Moisturizer | 1.18E-03 | 9.70E-04 | 1.00E-03 | ||||
| Nail care | 1.14E-04 | 9.31E-05 | 9.65E-05 | ||||
| Roll-on antiperspirant | 5.58E-04 | 4.13E-04 | 4.29E-04 | 3.38E-04 | 4.40E-04 | 3.51E-04 | |
| Shampoo | 1.17E-07 | 6.95E-08 | 9.04E-08 | 5.70E-08 | 9.26E-08 | 5.90e-08 | |
| Solid antiperspiramt | 6.54E-04 | 4.47E-04 | 5.03E-04 | 3.66E-04 | 5.15E-04 | 3.79E-04 | |
| Sunscreen | 1.88E-03 | 2.09E-03 | 1.45E-03 | 1.71E-03 | 1.48E-03 | 1.77E-03 | |
| Under-eye cream | 4.24E-05 | 4.39E-05 | |||||
| Total Dermal | 6.49E-03 | 7.99E-03 | 5.00E-03 | 6.59E-03 | 5.11E-03 | 6.83E-03 | |
| Inhalation | Indoor air | 8.48E-05 | 6.94E-05 | 6.13E-05 | 5.28E-05 | 5.36E-05 | 4.91E-05 |
| Outdoor air | 1.69E-06 | 1.38E-06 | 1.22E-06 | 1.05E-06 | 1.07E-06 | 9.77E-07 | |
| Soothing vapour | 1.10E-03 | 9.01E-04 | 7.96E-04 | 6.86E-04 | 6.95E-04 | 6.37E-04 | |
| Total inhalation | 1.19E-03 | 9.72E-04 | 8.59E-04 | 7.40E-04 | 7.50E-04 | 6.87E-04 | |
| Ingestion | Fish, general population | 3.08E-04 | 2.24E-04 | 2.39E-04 | 2.36E-04 | 2.35E-04 | 2.68E-04 |
| Leafy vegetables | 1.90e-08 | 1.75E-08 | 2.21E-08 | 2.51E-08 | 2.45E-08 | 2.71E-08 | |
| Root crops | 8.39E-06 | 6.83E-06 | 7.49E-06 | 6.30E-06 | 7.33E-06 | 6.59E-06 | |
| Lipstick | 1.26E-05 | 1.03E-05 | 1.07E-05 | ||||
| Meat | 5.47E-08 | 3.76E-08 | 4.68E-08 | 3.32E-08 | 3.28E-08 | 2.86E-08 | |
| Milk | 4.63E-08 | 3.20E-08 | 1.97E-08 | 1.89E-08 | 2.05E-08 | 1.97E-08 | |
| Soil | 5.90e-07 | 6.55E-07 | 4.54E-07 | 5.37E-07 | 4.65E-07 | 5.56E-07 | |
| Fish, subsistence population | 4.07E-04 | 4.51E-04 | 3.13E-04 | 3.70E-04 | 3.20E-04 | 3.83E-04 | |
| Water | 1.01E-07 | 1.13E-07 | 1.02E-07 | 1.20E-07 | 1.04E-07 | 1.24E-07 | |
| Antifoam | 8.09E-04 | 7.98E-04 | 7.07E-04 | 6.38E-04 | 5.89E-04 | 5.63E-04 | |
| OTC drugs | 1.02E-06 | 1.13E-06 | 7.84E-07 | 9.26E-07 | 8.02E-07 | 9.59E-07 | |
| Total Ingestion, General | 1.13E-03 | 1.04E-03 | 9.55E-04 | 8.92E-04 | 8.32E-04 | 8.49E-04 | |
| Total Ingestion, Subsistence | 1.23E-03 | 1.27E-03 | 1.03E-03 | 1.03E-03 | 9.17E-04 | 9.65E-04 | |
| Total | General Population | 8.80E-03 | 1.00E-02 | 6.81E-03 | 8.22E-03 | 6.70E-03 | 8.36E-03 |
| Subsistence Population | 8.90e-03 | 1.02E-02 | 6.88E-03 | 8.36E-03 | 6.78E-03 | 8.48E-03 | |
Table 5 summarizes all the exposure results for adults as mean values. When compared with similar results generated by the SEHSC assessment, almost all the values are higher in the current assessment. Compared to the SEHSC assessment, the current assessment results in a difference of about 2.16 times for total dermal exposures, in a difference of about 13.55 times for total inhalation exposures, and in a difference of about 1.24 times for total ingestion (general population) exposures. The primary reason for the differences is that the SEHSC assessed users and non-users whereas the current assessment considered users only.
Table 6. Adults' 90th percentile exposures (based on 200 000 Crystal Ball simulations)
| 90thpercentile exposures | 12-19 years | 20-59 years | 60+ years | ||||
|---|---|---|---|---|---|---|---|
| Males | Females | Males | Females | Males | Females | ||
| Dermal | After shave | 1.62E-04 | 1.24E-04 | 1.27E-04 | |||
| Body lotion | 6.77E-03 | 7.51E-03 | 5.21E-03 | 6.16E-03 | 5.33E-03 | 6.38E-03 | |
| Soothing vapour rub | 4.29E-06 | 4.76E-06 | 3.30E-06 | 3.90e-06 | 3.38E-06 | 4.04E-06 | |
| Foundation | 3.69E-04 | 3.02E-04 | 3.13E-04 | ||||
| Hair spray | 2.70E-04 | 1.54E-04 | 2.08E-04 | 1.26E-04 | 2.13E-04 | 1.31E-04 | |
| Leave-in condition | 1.92E-04 | 1.07E-04 | 1.48E-04 | 8.79E-05 | 1.51E-04 | 9.10E-05 | |
| Rinse-off conditioner | 5.74E-06 | 3.18E-06 | 4.42E-06 | 2.61E-06 | 4.52E-06 | 2.70E-06 | |
| Mascara | 6.19E-05 | 5.08E-05 | 5.26E-05 | ||||
| Moisturizer | 2.79E-03 | 2.29E-03 | 2.37E-03 | ||||
| Nail care | 1.16E-04 | 9.44E-05 | 9.75E-05 | ||||
| Roll-on antiperspirant | 1.07E-03 | 7.92E-04 | 8.26E-04 | 6.48E-04 | 8.45E-04 | 6.72E-04 | |
| Shampoo | 2.50E-07 | 1.59E-07 | 1.92E-07 | 1.30E-07 | 1.97E-07 | 1.35E-07 | |
| Solid antiperspirant | 8.73E-04 | 9.63E-04 | 6.72E-04 | 7.90e-04 | 6.87E-04 | 8.18E-04 | |
| Sunscreen | 3.38E-03 | 3.75E-03 | 2.60E-03 | 3.07E-03 | 2.66E-03 | 3.18E-03 | |
| Under-eye cream | 7.33E-05 | 7.59E-05 | |||||
| Total Dermal | 1.04E-02 | 1.29E-02 | 8.01E-03 | 1.06E-02 | 8.20E-03 | 1.10E-02 | |
| Inhalation | Indoor air | 1.76E-04 | 1.43E-04 | 1.27E-04 | 1.09E-04 | 1.11E-04 | 1.01E-04 |
| Outdoor air | 4.02E-06 | 3.31E-06 | 2.93E-06 | 2.52E-06 | 2.56E-06 | 2.33E-06 | |
| Soothing vapour | 1.62E-03 | 1.29E-03 | 1.13E-03 | 9.69E-04 | 9.93E-04 | 9.03E-04 | |
| Total inhalation | 1.72E-03 | 1.37E-03 | 1.20E-03 | 1.03E-03 | 1.05E-03 | 9.58E-04 | |
| Ingestion | Fish, general population | 6.91E-04 | 5.20E-04 | 5.39E-04 | 5.25E-04 | 5.20E-04 | 5.92E-04 |
| Leafy vegetables | 3.75E-09 | 3.39E-09 | 4.00E-09 | 4.47E-09 | 4.60E-09 | 4.78E-09 | |
| Root crops | 2.24E-05 | 1.81E-05 | 2.04E-05 | 1.75E-05 | 2.03E-05 | 1.85E-05 | |
| Lipstick | 3.13E-05 | 2.57E-05 | 2.66E-05 | ||||
| Meat | 1.08E-07 | 7.57E-08 | 9.41E-08 | 6.64E-08 | 6.51E-08 | 5.70E-08 | |
| Milk | 9.47E-08 | 6.81E-08 | 4.11E-08 | 4.00E-08 | 4.14E-08 | 4.14E-08 | |
| Soil | 7.96E-07 | 8.83E-07 | 6.12E-07 | 7.23E-07 | 6.27E-07 | 7.49E-07 | |
| Fish, subsistence population | 9.09E-04 | 1.01E-03 | 6.99E-04 | 8.27E-04 | 7.17E-04 | 8.56E-04 | |
| Water | 1.91E-07 | 2.12E-07 | 1.74E-07 | 2.06E-07 | 1.78E-07 | 2.13E-07 | |
| Antifoam | 1.46E-03 | 1.24E-03 | 1.26E-03 | 1.15E-03 | 1.03E-03 | 1.00E-03 | |
| OTC drugs | 2.45E-06 | 2.72E-06 | 1.88E-06 | 2.23E-06 | 1.93E-06 | 2.31E-06 | |
| Total Ingestion, General | 1.94E-03 | 1.56E-03 | 1.65E-03 | 1.54E-03 | 1.40E-03 | 1.44E-03 | |
| Total Ingestion, Subsistence | 2.09E-03 | 1.95E-03 | 1.76E-03 | 1.76E-03 | 1.54E-03 | 1.64E-03 | |
| Total | General Population | 1.28E-02 | 1.50E-02 | 9.95E-03 | 1.23E-02 | 9.87E-03 | 1.26E-02 |
| Subsistence Population | 1.30E-02 | 1.52E-02 | 1.00E-02 | 1.25E-02 | 9.96E-03 | 1.27E-02 | |
Table 6 summarizes all the exposure results for adults as 90th percentile values. When compared with similar results generated by the SEHSC assessment, almost all the values are higher in the current assessment. Compared to the SEHSC assessment, the current assessment results in a difference of about 1.55 times for total dermal exposures, in a difference of about 9.44 times for total inhalation exposures, and in a difference of about 1.17 times for total ingestion (general population) exposures. The primary reason for the differences is that the SEHSC assessed users and non-users whereas the current assessment considered users only.
Figure 7. Contribution of scenarios to adults' mean and 90th percentile dermal exposures
D5: Dermal exposures, males 12-19 years

D5: Dermal exposures, females 12-19 years

D5: Dermal exposures, males 20-59 years

D5: Dermal exposures, females 20-59 years

D5: Dermal exposures, males 60+ years

D5: Dermal exposures, females 60+ years

Figure 7 (above) shows the contribution of scenarios to dermal exposures for adults' mean and 90th percentile exposures. As seen in the bar charts, body lotion, sunscreen, and moisturizer are the highest contributors to dermal exposures.
D5: Inhalation exposures, males 12-19 years

D5: Inhalation exposures, females 12-19 years

D5: Inhalation exposures, males 20-59 years

D5: Inhalation exposures, females 20-59 years

D5: Inhalation exposures, males 60+ years

D5: Inhalation exposures, females 60+ years

Figure 8 shows the contribution of scenarios to inhalation exposures for adults' mean and 90th percentile exposures. As seen in the bar charts, soothing vapour is the highest contributor to inhalation exposures.
D5: Ingestion exposures, males 12-19 years

D5: Ingestion exposures, females 12-19 years

D5: Ingestion exposures, males 20-59 years

D5: Ingestion exposures, females 20-59 years

D5: Ingestion exposures, males 60+ years

D5: Ingestion exposures, females 60+ years

Figure 9 shows the contribution of scenarios to ingestion exposures (general population) for adults' mean and 90thpercentile exposures. As seen in the bar charts, antifoam and fish are the highest contributors to ingestion exposures.
Figure 10. Contribution of exposure route to adults' mean and 90th percentile total exposure (general population)
D5: Exposures, males 12-19 years (general population)

D5: Exposures, females 12-19 years (general population)

D5: Exposures, males 20-59 years (general population)

D5: Exposures, females 20-59 years (general population)

D5: Exposures, males 60+ years (general population)

D5: Exposures, females 60+ years (general population)

Figure 10 shows the contribution of exposure route to adults' mean and 90th percentile total exposures for the general population. The highest exposure route is dermal. Dermal is followed by ingestion and inhalation.
Figure 11. Contribution of exposure route to adults' mean and 90th percentile total exposure (subsistence population)
D5: Exposures, males 12-19 years (subsistence population)

D5: Exposures, females 12-19 years (subsistence population)

D5: Exposures, males 20-59 years (subsistence population)

D5: Exposures, females 20-59 years (subsistence population)

D5: Exposures, males 60+ years (subsistence population)

D5: Exposures, females 60+ years (subsistence population)

Figure 11 shows the contribution of exposure route to adults' mean and 90th percentile total exposures for the subsistence population. The highest exposure route is dermal. Dermal is followed by ingestion and inhalation.
| Model input parameter | Value |
|---|---|
| Molecular weight (g/mol) | 297 |
| Melting point (°C) | 17.5 |
| Boiling point (°C) | 175.8 |
| Data temperature (°C) | 25 |
| Density (kg/m3) | 950 |
| Vapour pressure (Pa) | 140 (1.05 mm Hg) |
| Henry's Law constant (Pa·m3/mol) | 1 220 000 (12.0 atm·m3/mol) |
| Log Kaw (Air-water partition coefficient; dimensionless) |
2.69 |
| Log Kow (Octanol-water partition coefficient; dimensionless) |
6.49 |
| Log Koc (Organic carbon-water partition coefficient - L/kg) |
4.22 |
| Water solubility (mg/L) | 0.056 |
| Log Koa (Octanol-air partition coefficient; dimensionless) |
4.34 |
| Soil-water partition coefficient (L/kg) | 332 |
| Sediment-water partition coefficient (L/kg) | 664 |
| Suspended particles-water partition coefficient (L/kg) | 3320 |
| Fish-water partition coefficient (L/kg) | 13 400 |
| Aerosol-water partition coefficient; dimensionless | 100 |
| Vegetation-water partition coefficient; dimensionless | 166 |
| Half-life in air (days) | 10.6 |
| Half-life in water (days) | 3.7 |
| Half-life in sediment (days) | 49 |
| Half-life in soil (days) | 5.25 |
| Half-life in vegetation (days) | 3.7 |



























































