Novel databases for exposure to cosmetics and personal care products

Damien Comiskey, Mathematical Models and StatisticsCreme Global

13th October 2014

Expert Models for Decision Makers TM

G L O B A L

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

Aggregate Exposure Modelling

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛

𝑆𝑢𝑟𝑓𝑎𝑐𝑒 𝐴𝑟𝑒𝑎

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛×𝑃𝑒𝑛𝑒𝑡𝑟𝑎𝑡𝑖𝑜𝑛

h𝐵𝑜𝑑𝑦𝑤𝑒𝑖𝑔 𝑡

Aggregate Exposure Modelling

Daily Aggregate Exposure

Population Exposure Modelling

Databases Required

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• Mass Market

• Prestige• OtherBody Lotion

• Deodorant/Anti-Perspirant Spray• Deodorant/Anti-Perspirant NonSpray

• Body SprayDeodorant• Toothpaste• MouthwashOral Care

• Lipstick• Liquid/Makeup Foundation

• Hair Styling Products (excl. Spray)Cosmetic Styling

• Eau de Toilette• Eau de Parfum

• After Shave / Cologne (Splash-on)Hydroalcholics

• Showergel / Body Wash• Shampoo

• Rinse-off ConditionerShower Products

• Face Moisturizer• Hand CreamMoisturizers

Application Sites

Moisturizers

Face+Eyes+Lips

Mouth

Chest

Stomach

Intimate Parts

Neck

Arms+Wrists

Underarms

Hands+Palms

Legs

Feet

Scalp

Back

Bottom

Bodyweight and Height

US 2007-2008 NHANES survey

Bodyweight and height data for 8,861 US subjects

EU NHANES data scaled based on EU

country average weights and heights

Surface Area Calculations

Dubois Formula

head, trunk, arms, hands, legs and feet

Surface Area Calculations

Body Part Surface AreaScalp 1/2 HeadNeck 1/10 TrunkChest 1/4 TrunkStomach 1/5 TrunkBack 3/10 TrunkArms Arms – (1/4 Hands)Wrists 1/4 HandsPalms 1/2 HandsIntimate parts 1/100 Total Body

Body Part Surface Area Reference

Face 1/2 Head – 28.8cm2 Api et al. (2008); 28.8 cm2 refers to combined surface areas of eyes and lipsEyes 24cm2 Bremme et al. (2003)Lips 4.8cm2 Ferrario et al. (2000)Mouth 212cm2 Collins and Dawes, (1987), Ferrario et al. (2000)Behind ears 36cm2 Estimated based on expert judgementUnderarms 200cm2 Bremme et al. (2003)

Relative

Absolute

Amount used

Europe COLIPA (Hall et al., 2007; 2011) USA CTFA (Loretz et al., 2005; 2006; 2008) Hydro alcoholics Tozer et al. (2004)

Fragrances and Mixtures

Fragrances and Mixtures

Concentration in Product = Level 1 x Level 2

Retention

ProductDermal Retention

Factor (%)Ingestion Factor

(%)Body lotion (mass, prestige, or other) 100 -Deodorant spray 23.5 -Deodorant roll-on 100 -Body spray 100 -Toothpaste 10 5*Mouthwash 1 10*Lipstick 100 -Liquid makeup foundation 100 -Hair styling 10 -Eau de toilette 100 -Eau de parfum 100 -Aftershave 100 -Shower gel 1 -Shampoo 1 -Rinse-off conditioner 1 -Face moisturiser 100 -Hand cream 100 -

𝐴𝑔𝑔𝐸𝑥𝑝=𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦×𝐴𝑚𝑜𝑢𝑛𝑡×𝑅𝑒𝑡𝑒𝑛𝑡𝑖𝑜𝑛×𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛×𝑃𝑒𝑛𝑒𝑡𝑟𝑎𝑡𝑖𝑜𝑛

h𝐵𝑜𝑑𝑦𝑤𝑒𝑖𝑔 𝑡

Aggregate Exposure Modelling

Exposure

Aggregate Exposure Modelling

Combining Databases

Pick a subject in the diary

Combining Databases

Pick a subject in the diary Find their age, gender and country

Combining Databases

Pick a subject in the diary Find their age, gender and country Select their height and weight

– calculate their body surface areas

Combining Databases

Pick a subject in the diary Find their age, gender and country Select their height and weight

– calculate their body surface areas Determine which products they use in a day

and how often

Combining Databases

Pick a subject in the diary Find their age, gender and country Select their height and weight

– calculate their body surface areas Determine which products they use in a day

and how often For each product randomly select:

– Amount based on demographic– Fragrance concentration

Calculating Exposure

Calculate their daily aggregate exposure

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

Product Use, Co-Use and Non-use statistics– per subject– Per occasion

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 % of OccasionsToothpaste 25.60%Toothpaste, Mouthwash 4.38%DeoRollOn, Toothpaste 3.99%DeoRollOn 3.75%Shampoo 2.84%Showergel 2.28%Toothpaste, FaceMoisturizer 2.01%DeoRollOn, Toothpaste, Shampoo 1.96%

Body Lotion Mass vs. Prestige (EU+US)

Consumer Type Total Population

Gender: Male Only

Gender: Female Only

Age: 18-34 Only

Age: 35-49 Only

Age: 50+ Only

Non-Consumers80.91% 92.26% 70.08% 81.96% 81.02% 79.93%

Consumers: Mass Only10.87% 5.19% 16.28% 10.00% 10.63% 11.79%

Consumers: Prestige Only2.99% 0.47% 5.40% 2.94% 3.12% 2.93%

Consumers: Mass and Prestige0.67% 0.03% 1.28% 0.71% 0.89% 0.44%

Consumers: Other4.57% 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 % of Subjects % (Cumulative)

DeoRollOn 59.39% 59.39%DeoSpray 17.21% 76.60%(no product) 10.04% 86.65%DeoRollOn, BodySpray 5.55% 92.19%DeoSpray, BodySpray 4.25% 96.44%DeoSpray, DeoRollOn 2.07% 98.50%BodySpray 1.05% 99.55%DeoSpray, DeoRollOn, BodySpray 0.45% 100.00%

Frequency of UseInterestingly, 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.

Thank you

Damien Comiskey, CEO13th October 2014

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Thank you

Damien Comiskey, CEO13th October 2014

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Product category Co-use

Product Combination % of Subjects

Deodorant, Oral Care, Shower Products 19.22%Deodorant, Oral Care, Hydro-alcoholics, Shower Products 11.78%Deodorant, Oral Care, Cosmetic Styling, Hydro-alcoholics, Shower Products, Moisturizers

8.07%

Deodorant, Oral Care, Cosmetic Styling, Shower Products 6.77%Deodorant, Oral Care, Cosmetic Styling, Hydro-alcoholics, Shower Products

5.36%

Deodorant, Oral Care, Cosmetic Styling, Shower Products, Moisturizers

4.20%

Product Category

Product Combination % of Subjects

Body lotion

(no product) 81%Body lotion (mass) 11%Body lotion (other) 5%Body lotion (prestige) 3%Body lotion (mass), body lotion (prestige) 1%

Deodorant

Deodorant roll-on 59%Deodorant spray 17%(no product) 10%Deodorant roll-on, body spray 6%Deodorant spray, body spray 4%Deodorant spray, deodorant roll-on 2%Body spray 1%Deodorant spray, deodorant roll-on, body spray <1%

Oral care

Toothpaste 66%Toothpaste, mouthwash 27%(no product) 5%Mouthwash 2%

Benzaldehyde 

Cinnamaldehyde 

Limonene 

Revolution in Safety Assessment

Big DATA

Statistical Analyses

Intuitive Software

Cloud Computing

Aggregate Exposure

Expert Models

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

Expert Models

Statistical Analyses

Intuitive Software

Cloud Computing

Aggregate Exposure

Revolution in Safety Assessment

Big DATA

Expert Models

Statistical Analyses

Intuitive Software

Cloud Computing

Aggregate Exposure

Thank you

Damien Comiskey, Project Manager, Modelling and Statistics13th October 2014

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Thank you

Cronan McNamara, CEO20th November 2013

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Thank you

Cronan McNamara, CEO20th November 2013

Expert Models for Decision Makers TM

G L O B A LG L O B A L

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 Level 0 Per User

Level 1 Per User

Level 2 Per User

Level 3 Per User

1 €1,500 €5,000 €16,000 €32,00023 €1,150 €4,500 €15,250 €26,500456 €900 €4,000 €14,750 €19,2007891011 €730 €3,600 €14,000 €16,800to1415 €675 €3,450 €13,000 €15,600to20

21+ €620 €3,300 €12,000 €14,400

Thank you

Cronan McNamara, CEO20th November 2013

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Thank you

Cronan McNamara, CEO20th November 2013

Expert Models for Decision Makers TM

G L O B A LG L O B A L

Thank you

Cronan McNamara, CEO20th November 2013

Expert Models for Decision Makers TM

G L O B A LG L O B A L

EU amounts dataHall et al. (2007)

496 subjects: EU, M/F, aged 17-74 Empirical data: each subject’s average

amount per use Body Lotion Deodorant Spray & Roll-on Toothpaste Lipstick Shampoo Face moisturizer

EU amounts dataHall et al. (2011)

501 subjects: EU, M/F, aged 17-74 Empirical data: each subject’s average

amount per useMouthwash

Liquid makeup foundationHair stylingShower gelHand cream

US amounts dataLoretz et al. (2005)

Summary statistics and distribution fit: average amount per use360 subjects: US, F, aged 19-65