estimated exposure to phthalates in cosmetics and risk assessment
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Hyun Jung Koo, Byung Mu LeeJournal of Toxicology and Environmental Health
EOH 2504- Fall 2010Leah Cambal
ESTIMATED EXPOSURE TO PHTHALATES IN
COSMETICS AND RISK ASSESSMENT
Background on
PHTHALATES
•Widely used, multifunctional group of compounds• Used in industry and in a variety of consumer products• Approximately one billion tons produced per year worldwide•Dialkyl or alkyl aryl esters of 1,2-benzenedicarboxylic acid
•Many beneficial chemical properties make them useful in a variety of applications• Excellent plasticizing properties -- increase flexibility,
transparency, durability and longevity (original use - PVC)• Skin moisturizers (humectants) and skin softeners (emollients)• Agents to prevent brittleness and cracking (nail polishes and
sealants)• Antifoaming agents (aerosols)• Solvents (wide range of applications)
Why are they used?
You may be surprised to learn…
YOU ARE ALREADY FAMILIAR WITH
PHTHALATES
Phthalates are found
everywhere.
Not just in the products in which
they are potentially used,
but also as contaminants in
just about anything.
achooallergy.com
supereco.com
enviroblog.org
hk.sgs.com
nutritionwonderland.com
cleanandhealthyme.org
arcarpetbarn.com
What are the..
HEALTH CONCERNS?
• Existing literature focus• High level exposure for cancer endpoints• Occupational exposure leading to adult infertility• Recent studies, turning to low-dose toxicity of phthalates• Male reproductive development sensitive to some phthalates• In rats, suppression of the activity of aromatase , an important
enzyme for masculinization of the male brain• Increase allergic reactions in mice to a dust mite allergen, may
explain increased incidence of allergic reactions in countries with widespread phthalate use
• Association between pregnant women’s exposure to phthalates and adverse effects on genital development in their male children
Focusing on..
THE PAPER
ObjectiveEstimate individual exposures to phthalates in cosmetics
OverviewMeasure the level of 4 phthalate diesters in 102 cosmetic
products using high-performance liquid chromatography (HPLC). Use this quantified data to estimate individual exposure.
Cosmetics31 hair products, 42 perfumes, 8 deodorants, and 21 nail polishes
Participants150 women (aged 20-73 yrs) living in Suwon, Korea
The Paper…
4 PHTHALATES OF INTEREST
• Di(2-ethylhexyl) phthalate (DEHP)• Butyl benzyl phthalate (BBP)• Dibutyl phthalate (DBP• Banned in all toys and childcare articles in Europe• Limited to toys and childcare articles which can be placed in the mouth by
children• Banned in cosmetics including nail polish• Considered to be carcinogenic, mutagenic, toxic to reproduction
• Diethyl phthalate (DEP)• In 1995, DEP reported to be present in 67 cosmetic formulations,
concentrations ranging from 0.1 to 50%
• *In spite of their common occurrence in cosmetics and consumer products, little was known about human exposure to phthalates at this time*
HPLC Analysis…
RESULTS
Levels of Phthalates in Cosmetic Products Types of Products
DEHP DEP DBP BBP
Perfume (42) 4.8% 57.1% 26.2% 4.8% Nail Polish (21) 9.5% 9.5% 90.5% 0% Hair Product (31) 0% 3.2% 0% 0% Deodorant (8) 0% 25% 0% 0%
Phthalates with 0% levels were <LOD. For analysis purposes <LOD was considered to be halfway between 0 and the LOD values
of each phthalate
The Paper…
FREQUENCY AND VOLUME OF
COSMETICS USE
• Cosmetics and hair products purchased at retail stores in Seoul, Korea
• Questionnaire was used to determine the frequency and volume of cosmetics used
TABLE 1. Frequency and Volume of Cosmetics Use Based on Questionnaire for 150 Users (Women, Aged 20-73 yrs)
Frequency (times/day) / Volume (ml/time) Types of Products
Perfume Hair Product
Nail Polish
Deodorant
Mean ± SD 0.62/0.5 0.59/5 0.16/0.3 0.59/0.5 Maximum 5/5 3/20 2/2 2/3 Minimum 0/0 0/0 0/0 0/0
Median 1/1 1/10 1/0.5 1/1 90th
Percentile 3/1.5 2/18 1/0.5 1/1
The Paper…
ANALYSIS
• Daily human exposure levels to phthalates were estimated from cosmetics using the following formula:
•
• C is the concentration of phthalates in the products (µg/ml)• V is the volume of cosmetics consumed per time (ml/time)• F is the frequency of use (times/day)• Abs is the absorption rate – Must Determine*
*No human data was available on actual dermal absorption or inhalation at the given exposure scenarios. Absorption rates were extrapolated using animal data – with the help of 3 models.
•Model 1 – Dermal Absorption•When only rat in vivo dermal absorption data was available,
assumed human absorption is similar to that of a rat in terms of in vivo absorption
•Model 2 – Dermal Absorption• Rat in vivo and human skin in vitro known find in vivo human abs
•Model 3 – Inhalation• Fragrance chemicals can enter the body by inhalation as well as
dermally• Radiolabeled DEHP found to be absorbed in rats when exposed
by inhalation
Results…
EXPOSURE LEVELS
Estimated Median Exposure Levels to Phthalates Resulting from the Concurrent use of Multiple Cosmetic Products
(µg/kg bw/d) Dermal
Absorption Inhalation
DEHP 0.0006 0.026 DEP 0.6 81.471 DBP 0.103 22.917 BBP N/A N/A
Risk Assessment• Hazard Indices (daily exposure level/regulation level) determined
for median inhalation exposure levels• 0.0007 DEHP, 0.012 DEP, 0.347 DBP• HI’s all far below 1, which implies daily exposure levels and
regulation levels are equal
The Paper…
CONCLUSIONS
•Study showed 4 individual phthalates present in cosmetics•No human data available, results extrapolated from animal data•BBP not found in nail polish, hair products, or deodorant•Median exposure levels and health indices not
given•Hazard Indices suggest that estimated exposure to these 4 phthalates in the cosmetics studied are relatively small
Assessment of the Paper• Estimation of daily human exposure and risk assessment based on the
assumption that either dermal absorption or inhalation occurred • Does not reflect actual exposure scenarios• Many exposures from all different sources may be additive and a
greater cause of concern than found in this study• Variation in method of using cosmetics• Perfume application to skin or clothes• Seemed to focus more on analytical work rather than exposure
assessment• Questionnaire used to assess volume – another way?• Is this study generalizable?• Age range?
References
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