Appendix of the Screening Assessment for The Challenge
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Archived
Decamethylcyclopentasiloxane
(D5)
Chemical Abstracts Service Registry Number
541-02-6
Environment Canada
Health Canada
November 2008
Appendix
- Appendix 1: Upper-bounding Estimates of Daily Intake of D5 by the General Population in Canada (µg/kg-bw/day by Various Age Groups)
- Appendix 2: Consumer Exposure Modelling
- Appendix 3: Summary of Health Effects Information for Decamethylcyclopentasiloxane (D5)
- 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 D5 in the Ecological Screening Assessment
Appendix 1: Upper-bounding Estimates of Daily Intake of D5 by the General Population in Canada (µg/kg-bw/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] | 0.09 | 0.19 | 0.15 | 0.08 | 0.07 | 0.07 | ||||
Indoor air[11] | 96.3 | 206.3 | 161 | 91.5 | 78.6 | 68.3 | ||||
Drinking water[12] | 0.45 | .01 | .004 | .004 | .003 | .002 | .002 | .002 | ||
Food and beverages[13] | 2.97 | 1.62 | 0.92 | 0.50 | 0.32 | 0.29 | ||||
Soil[14] | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | ||||
Total intake | 96.9 | 96.4 | 99.3 | 208 | 162 | 92.0 | 79.0 | 68.7 |
[2] The highest concentration of D5 detected in human breast milk was 4.5 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 D5 in drinking water were located. No data on concentrations of D5 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 m3 of 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] D5 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, 2.5 µg/m3 in Manglerud, Norway, was used for the level of D5 in ambient air (Norden 2005). Canadians are assumed to spend 3 h per day outside (Health Canada 1998).
[11] D5 was detected in 85% of 130 air samples taken in homes in Syracuse, New York. The maximum value of D5 in indoor air was1560 µg/m3 (NYIEQ 2005). The 90 th percentile of the air concentrations (393 µg/m3) for D5 in this indoor air survey is considered appropriate to derive upper-bounding exposure estimates. The data set considered includes a survey of bedrooms in homes in Sweden in which D5 was detected in 63% of samples and at a maximum concentration of 79.4 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 D5 in Canadian drinking water were identified. D5 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 D5 in foods in Canada. The concentration of D5 in flounder filets from Norwegian waters was reported to be 3.4 ng/g on a wet-weight basis (NILU 2007). A value of 0.1 ppm D5 was used for dairy and two groups of processed foods. 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% D5 in DMPS was assumed and it was further assumed that one quarter of dairy and one half of processed food had been treated with antifoaming agents containing D5. The amounts of foods consumed on a daily basis by each age group are described by Health Canada (1998). The probable daily intake of D5 from food packaging for an adult was estimated to be 0.01µg/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).
[14] No Canadian data were available for D5 levels in soil. No D5 was detected in two soil samples from the Faroe Islands taken at an abandoned and an operating landfill. The higher limit of detection of 5µg/kg was used (Norden 2005).
[*] Food and Drug Regulations,Division 16. C.R.C., c. 870.
Sample ConsExpo 4.1 Report
Product
D5 hair spray - women - partitioning 80/20
Compound
Compound name: Decamethylcyclopentasiloxane
CAS RN: 541-02-6
molecular weight: 371 g/mol
vapour pressure: 33.2 Pascal
Kow: 8.03 10Log
General exposure data
exposure frequency: 1.2 1/day
body weight: 69 kilogram
Inhalation model: exposure to vapour - constant rate
weight fraction compound: 0.3 fraction
exposure duration: 8 hour
room volume: 80 m3
ventilation rate: 1 1/hr
applied amount: 5.4 gram
release duration: 8 hour
Uptake model: fraction
uptake fraction: 0.02 fraction
inhalation rate: 22 m3/day
Dermal model: direct dermal contact with product - instant application
weight fraction compound: 0.3 fraction
exposed area: 1.44E3 cm2
applied amount: 1.4 gram
Uptake model: fraction
uptake fraction: 0.0017 fraction
Output
Inhalation (point estimates)
inhalation mean event concentration: 2.21 mg/m3
inhalation mean concentration on day of exposure: 0.885 mg/m3
inhalation air concentration year average: 0.885 mg/m3/day
inhalation acute (internal) dose: 0.0047 mg/kg
inhalation chronic (internal) dose: 0.00564 mg/kg/day
Dermal: point estimates
dermal load: 0.292 mg/cm2
dermal external dose: 6.09 mg/kg
dermal acute (internal) dose: 0.0103 mg/kg
dermal chronic (internal) dose: 0.0124 mg/kg/day
Integrated (point estimates)
total external dose: 6.32 mg/kg
total acute dose (internal): 0.0151 mg/kg
total chronic dose (internal): 0.0181 mg/kg/day
Table 1. D5 - 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 VMS | Autho- rity |
Reten- tion factor |
Inha- lation mg/kg-bw/day at 2.0% abs |
Dermal mg/kg-bw/day at 0.17% abs | Oral mg/kg-bw/day at 52% abs | Total mg/kg-bw/day |
---|---|---|---|---|---|---|---|---|---|---|---|
antipers- pirant solid |
0.8 | RIVM | 1 | Maxim | 0.58 | NMI | 1 | 0.00113 | 0.00229 | ||
body lotion | 8 | RIVM | 1.5 | RIVM | 0.63 | Section 71 | 1 | 0.00184 | 0.0373 | ||
sun- screen |
6.1 | RIVM | 0.2 | RIVM | 0.347 | NMI | 1 | 0.00003 | 0.00205 | ||
face mois- turizer |
2.5 | RIVM | 2 | RIVM | 0.63 | Section 71 | 1 | 0.0204 | 0.0155 | ||
face makeup | 0.8 | RIVM | 1 | RIVM | 0.63 | Section 71 | 1 | 0.00123 | 0.00248 | ||
lipstick | 0.01 | Maxim | 4 | RIVM | 0.25 | Maxim | 1 | 0 | 0.00005 | 0.0603 | |
hair spray | 6.8 | RIVM | 1.2 | RIVM | 0.3 | CNS | 0.1 | 0.00564 | 0.00124 | ||
hair sham- poo |
20 | RIVM | 0.7 | RIVM | 0.03 | CNS | 0.01 | 0 | 0.00002 | ||
hair condi- tioner |
20 | RIVM | 0.3 | RIVM | 0.63 | Section 71 | 0.01 | 0 | 0.000186 | ||
hair styling | 4.7 | Maxim | 0.6 | Maxim | 0.63 | Section 71 | 0.1 | 0.00437 | 0.00084 | ||
Totals | 0.035 | 0.062 | 0.0603 | 0.16 |
Consumer exposure modelling based on ConsExpo (RIVM 2006)
Basic assumptions
- Body weight 69 kg
- Absorption by inhalation 2.0% (Tobin et al. 2008); dermal absorption 0.17% (Jovanovic et al. 2008); absorption by ingestion 52% (Dow Corning 1998).
- For products left on skin except lipstick, 20% of applied amount is available to be dermally absorbed, 80% 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
Endpoint | Lowest effect levels[1] / Results |
---|---|
Acute toxicity | Lowest oral LD50: > 4800 mg/kg-bw in Wistar rats (Löser 1984). Other studies: Pauluhn (1984). No dermal studies identified. |
Short-term repeated-dose toxicity | Lowest-observed-effect level (LOEL) - oral: 5 mg/kg based on significant increases in liver enzyme activities of CYP2B1/2 and EROD in male and female Sprague-Dawley (SD) rats treated by gavage with 1, 5, 20 or 100 mg/kg-bw/day D5 in corn oil daily for 4 days. At 20 mg/kg-bw/day and higher, significant increases in relative liver weight (33% increase at 100 mg/kg-bw/day) was observed in female rats (Zhang et al.2000). Lowest-observed-effect concentration (LOEC) - inhalation 150 mg/m3 (10 ppm) based on increased incidence and severity of goblet cell proliferation in level 1 of the nasal cavity in both sexes. Male and female Fischer 344 rats were exposed by whole-body inhalation to 0, 150, 380, 1100 or 2400 mg/m3 (0, 10, 25, 75 or 160 ppm) D5 for 6 h/day for 28 days. At 380 mg/m3 (25 ppm), relative spleen weight was increased in both sexes only after the 14-day recovery period. At 1100 mg/m3 (75 ppm), incidence and severity of submucosal inflammation was increased in the nasal cavity in male rats, and at 2400 mg/m3 (160 ppm), there was increased lung weight and focal alveolar macrophage accumulation in the lung in both sexes, relative liver weight was significantly increased in both sexes (13% in females, 5% in males), relative thymus weight was increased in males (14%) and serum alkaline phosphatase was decreased in females (even after a 14-day recovery period) (Burns-Naas et al. 1998a). Highest no-observed-adverse-effect level (NOAEL) - dermal: 1600 mg/kg-bw/day based on no systemic adverse effects in SD rats exposed dermally under occlusive conditions for 6 h/day, 7 days/wk for 28 days (no LOEL at 1600 mg/kg-bw/day). Evidence of dermal absorption and metabolism based on urinalysis (Dow Corning 1990c). |
Subchronic toxicity | Lowest oral LOEL: 100 mg/kg-bw/day for significant increases in liver weight (percent increase not stated) in both sexes of Wistar rats, administered 100, 330 or 1000 mg/kg-bw/day for 13 weeks by oral gavage (Jager and Hartmann 1991). Lowest inhalation LOEC: 700 mg/m3(46 ppm) based on a dose-related increase in absolute and relative lung weights in both sexes (still increased in females after a 1-month recovery period), significant increases in liver weight / brain weight ratios in females (13, 9 and 16% increases at 700, 1300 and 3700 mg/m3, respectively) and in gamma glutamyl transferase (γ-GT) in female rats (Fischer 344 rats exposed to D5 6 hours/day 5 days/week for 3 months (nose-only exposure) at concentrations of 0, 400, 700, 1300 or 3700 mg/m3 (0, 26, 46, 86 or 244 ppm)). At 1300 mg/m3 (86 ppm), serum lactate dehydrogenase was decreased in females (even after a 1-month recovery period). At 3700 mg/m3 (224 ppm), there was increased focal macrophage accumulation and interstitial inflammation in the lungs of both sexes (Burns-Naas et al.1998b). No dermal studies identified. |
Chronic toxicity / Carcinogenicity | Groups of Fischer 344 rats were exposed to vapour concentrations of 0, 150, 600 or 2400 mg/m3 (0, 10, 40 or 160 ppm) D5 for 6 hours/day, 5 days/week for 6 (6 males and 6 females per group), 12 (10 males and 10 females per group), 12 plus 12 months recovery (20 males and 20 females per group) and 24 months (60 male and 60 females per group). Female rats exposed to the highest concentration of D5 exhibited a significant increase of uterine tumours, specifically endometrial adenocarcinomas (Dow Corning 2005, US EPA 2005, Lassen et al. 2005). Lowest inhalation non-neoplastic LOEC: 600 mg/m3 (40 ppm) for increased incidence of hyaline inclusions in the nasal respiratory/olfactory epithelium of both sexes (Dow Corning 2005). In the 6-month subgroup, there was an increased incidence of hyaline inclusions in the nasal respiratory/olfactory epithelium of both sexes, relative liver weights were increased in females, serum calcium concentration was increased in both sexes and mean corpuscular volume (MCV) was increased in females at 2400 mg/m3 (160 ppm). In the 12-month subgroup, urea concentration was decreased and cholesterol concentration was increased in females at 600 and 2400 mg/m3; and at 2400 mg/m3, absolute liver weight, liver weight / body weight ratio and liver weight / brain weight ratio in females were increased (11, 10 and 10%, respectively), serum gamma glutamyl-transferase (γ-GT), triglycerides, calcium and MCV were increased in females, and aspartate aminotransferase (AST) was decreased in males. In the 12-month exposure plus 12-month recovery subgroup, there was an increased incidence of hyaline inclusions in the nasal respiratory/olfactory epithelium of both sexes at 600 and 2400 mg/m3, the brain weight / body weight ratio in females was decreased (8%) at 2400 mg/m3, and the combined incidence of endometrial adenomatous polyps and adenocarcinomas was 1, 1, 0 and 3, in the 0, 150, 600 and 2400 mg/m3 groups respectively, but the trend or difference was not statistically significant. In the 24-month group, there was an increased incidence of hyaline inclusions in the nasal respiratory/olfactory epithelium of both sexes and the liver weight / brain weight ratio in males was increased (9%) at 2400 mg/m3 (160 ppm). In this same subgroup the incidence of endometrial adenocarcinomas was 0, 1, 0 and 5 in the 0, 150, 600 and 2400 mg/m3 groups respectively, which was statistically significant, and the incidence of endometrial adenomatous polyps was 1, 0, 1 and 0, respectively, which was not statistically significant. |
Developmental toxicity | No developmental toxicity studies were identified. |
Reproductive toxicity | Inhalation NOAEC for reproductive toxicity:2400 mg/m3 (160 ppm) based on a 2-generation study in which SD rats were exposed by whole-body inhalation to 0, 450, 1050 or 2400 mg/m3 (0, 30, 70, or 160 ppm) D5 for 6 h/day from 70 days prior to mating, throughout mating and to gestation day 20, and again on lactation days 5 to sacrifice of F1 animals (Siddiqui et al. 2007). Inhalation LOEC for systemic toxicity: 450 mg/m3 (30 ppm) based on a significant increased incidence of pulmonary vascular mineralization in all F0 and F1 animals (Siddiqui et al. 2007). Negative in estrogenic activity: D5 showed no increase in uterine wet or blotted weights or in uterine epithelial cell height following 16 hours/day inhalation exposure for 3 days in SD and F344 rats at 2400 mg/m3 (160 ppm) (Quinn et al. 2007). Negative in androgenic activity: In a Hershberger assay, D5 did not result in any increase in reproductive organ weights following 16 hours/day inhalation exposure for 10 days in male F344 rats at 2400 mg/m3(160 ppm) (Quinn et al. 2007). |
Endocrine disruption in vitro | D5 did not bind to human estrogen receptor a (ERa) or estrogen receptor ß (ERß), and was negative in ERa reporter gene assay in a human epithelial cell line MCF-7. D5 showed no binding affinity to progesterone receptors (PRs) and was negative in PRß reporter gene assay (Quinn et al. 2007). |
Genotoxicity and related endpoints: in vivo | DNA damage: Micronuclei formation: |
Genotoxicity and related endpoints: in vitro | Mutagenicity: Chromosome aberrations: Sister chromatid exchange: DNA damage: |
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 years
- 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.
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) | 371 |
Melting point (°C) | -38 |
Boiling point (°C) | 210 |
Data temperature (°C) | 25 |
Density (kg/m3) | 954 |
Vapour pressure (Pa) | 33.2 (0.249 mm Hg) |
Henry's Law constant (Pa·m3/mol) | 3 350 000 (33.1 atm·m3/mol) |
Log Kaw (Air-water partition coefficient; dimensionless) |
3.13 |
Log Kow (Octanol-water partition coefficient; dimensionless) |
8.03 |
Log Koc (Organic carbon-water partition coefficient - L/kg) |
5.17 |
Water solubility (mg/L) | 0.017 |
Log Koa (Octanol-air partition coefficient; dimensionless) |
5.06 |
Soil-water partition coefficient (L/kg) | 2958 |
Sediment-water partition coefficient (L/kg) | 5916 |
Suspended particles-water partition coefficient (L/kg) | 29 580 |
Fish-water partition coefficient (L/kg) | 13 300 |
Aerosol-water partition coefficient; dimensionless | 100 |
Vegetation-water partition coefficient; dimensionless | 1479 |
Half-life in air (days) | 6.9 |
Half-life in water (days) | 74 |
Half-life in sediment (days) | 49 |
Half-life in soil (days) | 5.25 |
Half-life in vegetation (days) | 74 |
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