Novel databases for exposure to cosmetics and
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GLOBAL Expert Models for Decision Makers TM Novel databases for exposure to cosmetics and personal care products Damien Comiskey, Mathematical Models and Statistics Creme Global 13th October 2014 Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ π΄ππ πΈπ₯π = ππ’πππππ π΄πππ Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ × πππππ‘πππ‘πππ π΄ππ πΈπ₯π = π΅πππ¦π€πππβπ‘ Daily Aggregate Exposure Population Exposure Modelling Databases Required ο§ ο§ ο§ ο§ ο§ ο§ ο§ Frequency of use Amount per use Concentration of fragrance Surface areas Body weights Retention Penetration Frequency of Use Survey Demographics Age groups EU US Male Female Male Female 18-24 1490 2557 412 1228 25-34 2980 3078 603 1954 35-49 4230 4763 838 2200 50-64 3210 2966 748 1541 65+ 560 375 289 424 Total 12470 13739 2890 7347 Online Consumption Diaries Personal Care Products Body Lotion Deodorant Oral Care • Mass Market • Prestige • Other • Deodorant/Anti-Perspirant Spray • Deodorant/Anti-Perspirant NonSpray • Body Spray • Toothpaste • Mouthwash Cosmetic Styling • Lipstick • Liquid/Makeup Foundation • Hair Styling Products (excl. Spray) Hydroalcholics • Eau de Toilette • Eau de Parfum • After Shave / Cologne (Splash-on) Shower Products Moisturizers • Showergel / Body Wash • Shampoo • Rinse-off Conditioner • Face Moisturizer • Hand Cream Application Sites Face+Eyes+Lips Mouth Chest Moisturizers Scalp Neck Back Underarms Stomach Arms+Wrists Intimate Parts Hands+Palms Bottom Legs Feet Bodyweight and Height US ο§ 2007-2008 NHANES survey Bodyweight and height data for 8,861 US subjects EU ο§ NHANES data scaled based on EU country average weights and heights Surface Area Calculations Dubois Formula ππ΄ = π × π π × π» π → head, trunk, arms, hands, legs and feet Surface Area Calculations Relative Body Part Scalp Neck Chest Stomach Back Arms Wrists Palms Intimate parts Surface Area 1/2 Head 1/10 Trunk 1/4 Trunk 1/5 Trunk 3/10 Trunk Arms – (1/4 Hands) 1/4 Hands 1/2 Hands 1/100 Total Body Absolute Body Part Surface Area Reference Face Eyes Lips Mouth Behind ears Underarms 1/2 Head – 28.8cm2 24cm2 4.8cm2 212cm2 36cm2 200cm2 Api et al. (2008); 28.8 cm2 refers to combined surface areas of eyes and lips Bremme et al. (2003) Ferrario et al. (2000) Collins and Dawes, (1987), Ferrario et al. (2000) Estimated based on expert judgement Bremme et al. (2003) Amount used ο§ Europe → COLIPA (Hall et al., 2007; 2011) ο§ USA → CTFA (Loretz et al., 2005; 2006; 2008) ο§ Hydro alcoholics → Tozer et al. (2004) Fragrances and Mixtures Fragrances and Mixtures Concentration in Product = Level 1 x Level 2 Retention Product Body lotion (mass, prestige, or other) Deodorant spray Deodorant roll-on Body spray Toothpaste Mouthwash Lipstick Liquid makeup foundation Hair styling Eau de toilette Eau de parfum Aftershave Shower gel Shampoo Rinse-off conditioner Face moisturiser Hand cream Dermal Retention Factor (%) 100 23.5 100 100 10 1 100 100 10 100 100 100 1 1 1 100 100 Ingestion Factor (%) 5* 10* - Aggregate Exposure Modelling πΉππππ’ππππ¦ × π΄πππ’ππ‘ × π ππ‘πππ‘πππ × πΆππππππ‘πππ‘πππ × πππππ‘πππ‘πππ π΄ππ πΈπ₯π = π΅πππ¦π€πππβπ‘ Aggregate Exposure Modelling Exposure = π΄πππ’ππ‘ ×π ππ‘πππ‘πππ ×πΆππππππ‘πππ‘πππ×πππππ‘πππ‘πππ π΅πππ¦ ππππβπ‘ Combining Databases ο§ Pick a subject in the diary Combining Databases ο§ Pick a subject in the diary ο§ Find their age, gender and country Combining Databases ο§ Pick a subject in the diary ο§ Find their age, gender and country ο§ Select their height and weight – calculate their body surface areas Combining Databases ο§ Pick a subject in the diary ο§ Find their age, gender and country ο§ Select their height and weight – calculate their body surface areas ο§ Determine which products they use in a day and how often Combining Databases ο§ Pick a subject in the diary ο§ Find their age, gender and country ο§ Select their height and weight – calculate their body surface areas ο§ Determine which products they use in a day and how often ο§ For each product randomly select: – Amount based on demographic – Fragrance concentration Calculating Exposure ο§ Calculate their daily aggregate exposure ο§ Repeat for all subjects in survey Lower-end consumer Higher-end consumer Lower-end consumer Higher-end consumer Maximum Consumer Exposure Lower-end consumer Higher-end consumer 95th Percentile Consumer Exposure Lower-end consumer Higher-end consumer Median Consumer Exposure Lower-end consumer Higher-end consumer Average Consumer Exposure Analysing the Databases ο§ Product Use, Co-Use and Non-use statistics – per subject – Per occasion ο§ Frequency of use Per subject Product Combination % of Subjects DeoRollOn, Toothpaste, Shampoo 6.19% DeoRollOn, Toothpaste, Shampoo, Showergel 2.53% DeoRollOn, Toothpaste, AfterShave, Shampoo 2.31% DeoRollOn, Toothpaste 1.53% Toothpaste, Shampoo 1.24% DeoSpray, Toothpaste, Shampoo 1.21% DeoRollOn, Toothpaste, Mouthwash, Shampoo 1.18% Per occasion Product Combination Toothpaste Toothpaste, Mouthwash DeoRollOn, Toothpaste DeoRollOn Shampoo Showergel Toothpaste, FaceMoisturizer DeoRollOn, Toothpaste, Shampoo % of Occasions 25.60% 4.38% 3.99% 3.75% 2.84% 2.28% 2.01% 1.96% Body Lotion Mass vs. Prestige (EU+US) Consumer Type Non-Consumers Consumers: Mass Only Consumers: Prestige Only Consumers: Mass and Prestige Consumers: Other Total Population Gender: Male Only Gender: Female Only Age: 18-34 Only Age: 35-49 Only Age: 50+ Only 80.91% 92.26% 70.08% 81.96% 81.02% 79.93% 10.87% 5.19% 16.28% 10.00% 10.63% 11.79% 2.99% 0.47% 5.40% 2.94% 3.12% 2.93% 0.67% 0.03% 1.28% 0.71% 0.89% 0.44% 4.57% 2.05% 6.96% 4.39% 4.34% 4.91% Co-use statistics on Per Subject basis, for Deodorants, and for the Total Population Product Combination DeoRollOn DeoSpray (no product) DeoRollOn, BodySpray DeoSpray, BodySpray DeoSpray, DeoRollOn BodySpray DeoSpray, DeoRollOn, BodySpray % of Subjects % (Cumulative) 59.39% 17.21% 10.04% 5.55% 4.25% 2.07% 1.05% 0.45% 59.39% 76.60% 86.65% 92.19% 96.44% 98.50% 99.55% 100.00% Frequency of Use Interestingly, the usage frequency of Face Moisturizer is very similar to that of Mouthwash. Again, distinct modes are seen at ~1, ~7 and ~14 uses per week. Frequency of Use In the 18-34 Age Group (below), the mean usage frequency for males is 4.53 times per week, and for females it is 3.85 times per week. GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Damien Comiskey, CEO 13th October 2014 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Damien Comiskey, CEO 13th October 2014 Product category Co-use Product Combination Deodorant, Oral Care, Shower Products Deodorant, Oral Care, Hydro-alcoholics, Shower Products Deodorant, Oral Care, Cosmetic Styling, Hydro-alcoholics, Shower Products, Moisturizers Deodorant, Oral Care, Cosmetic Styling, Shower Products Deodorant, Oral Care, Cosmetic Styling, Hydro-alcoholics, Shower Products Deodorant, Oral Care, Cosmetic Styling, Shower Products, Moisturizers % of Subjects 19.22% 11.78% 8.07% 6.77% 5.36% 4.20% Product Category Body lotion Deodorant Oral care Product Combination (no product) Body lotion (mass) Body lotion (other) Body lotion (prestige) Body lotion (mass), body lotion (prestige) Deodorant roll-on Deodorant spray (no product) Deodorant roll-on, body spray Deodorant spray, body spray Deodorant spray, deodorant roll-on Body spray Deodorant spray, deodorant roll-on, body spray Toothpaste Toothpaste, mouthwash (no product) Mouthwash % of Subjects 81% 11% 5% 3% 1% 59% 17% 10% 6% 4% 2% 1% <1% 66% 27% 5% 2% Benzaldehyde Cinnamaldehyde Limonene Revolution in Safety Assessment Big DATA Aggregate Exposure Expert Models Cloud Computing Statistical Analyses Intuitive Software New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde New Assessment Benzaldehyde Example - Vanillin Vanillin – Approximate relative contribution to P95 aggregate exposure Example - PEA Example - PEA PEA – Approximate relative contribution to P95 aggregate exposure Inhalation Exposure – Limonene Ingestion Exposure - Limonene Dermal Exposure per Surface Area (BarSoap) - Limonene Total Exposure (per unit BW) - Limonene Total Exposure (per unit BW) - Limonene Revolution in Safety Assessment Big DATA Aggregate Exposure Expert Models Cloud Computing Statistical Analyses Intuitive Software Revolution in Safety Assessment Big DATA Aggregate Exposure Expert Models Cloud Computing Statistical Analyses Intuitive Software GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Damien Comiskey, Project Manager, Modelling and Statistics 13th October 2014 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Cronan McNamara, CEO 20th November 2013 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Cronan McNamara, CEO 20th November 2013 Creme RIFM Model Options RIFM Members Only RIFM Model - Options Level 0 User – Read Only Level 1 User – Summary Statistics Graphs Level 2 User – Create Tables Level 3 User – Upload Large Data Tables; Advanced Features Pricing Structure – Per Annum # of Users 1 2 3 4 5 6 7 8 9 10 11 to 14 15 to 20 21+ Level 0 Level 1 Level 2 Level 3 Per User Per User Per User Per User €1,500 €5,000 €16,000 €32,000 €1,150 €4,500 €15,250 €26,500 €900 €4,000 €14,750 €19,200 €730 €3,600 €14,000 €16,800 €675 €3,450 €13,000 €15,600 €620 €3,300 €12,000 €14,400 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Cronan McNamara, CEO 20th November 2013 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Cronan McNamara, CEO 20th November 2013 GG LL OO BB AA LL Expert Models for Decision Makers TM Thank you Cronan McNamara, CEO 20th November 2013 EU amounts data Hall et al. (2007) ο§ 496 subjects: EU, M/F, aged 17-74 ο§ Empirical data: each subject’s average amount per use ο Body Lotion ο Deodorant Spray & Roll-on ο Toothpaste ο Lipstick ο Shampoo ο Face moisturizer EU amounts data Hall et al. (2011) ο§ 501 subjects: EU, M/F, aged 17-74 ο§ Empirical data: each subject’s average amount per use Mouthwash οLiquid makeup foundation οHair styling οShower gel οHand cream US amounts data Loretz et al. (2005) ο§ Summary statistics and distribution fit: average amount per use 360 subjects: US, F, aged 19-65
