Journal of Toxicology and Environmental Health EOH 2504 Fall 2010 Leah Cambal Estimated exposure to phthalates in cosmetics and risk assessment Background on Phthalates Widely used multifunctional group of compounds ID: 726710
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Hyun Jung Koo, Byung Mu LeeJournal of Toxicology and Environmental HealthEOH 2504- Fall 2010Leah Cambal
Estimated exposure to phthalates in cosmetics and risk assessmentSlide2
Background onPhthalatesSlide3
Widely used, multifunctional group of compoundsUsed in industry and in a variety of consumer productsApproximately one billion tons produced per year worldwideDialkyl 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?Slide4
You may be surprised to learn…YOU ARE ALREADY FAMILIAR WITH PHTHALATESSlide5
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.comSlide6
What are the..Health Concerns?Slide7
Existing literature focusHigh level exposure for cancer endpointsOccupational exposure leading to adult infertilityRecent studies, t
urning 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 useAssociation between pregnant women’s exposure to phthalates and adverse effects on genital development in their male childrenSlide8
Focusing on..The PaperSlide9
ObjectiveEstimate individual exposures to phthalates in cosmeticsOverviewMeasure the level of 4 phthalate diesters
in 102 cosmetic products using high-performance liquid chromatography (HPLC). Use this quantified data to estimate individual exposure.
Cosmetics
31 hair products, 42 perfumes, 8 deodorants
, and 21 nail polishes
Participants
150 women (aged 20-73
yrs
) living in Suwon, KoreaSlide10
The Paper…4 Phthalates of interestSlide11
Di(2-ethylhexyl) phthalate (DEHP)Butyl benzyl phthalate (BBP)Dibutyl
phthalate (DBP
B
anned
in all toys and childcare articles in EuropeLimited to toys and childcare articles which can be placed in the mouth by childrenBanned in cosmetics including nail polishConsidered 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*Slide12
HPLC Analysis…ResultsSlide13
Phthalates with 0% levels were <LOD. For analysis purposes <LOD was considered to be halfway between 0 and the LOD values of each phthalate Slide14
The Paper… Frequency and volume of cosmetics useSlide15
Cosmetics and hair products purchased at retail stores in Seoul, KoreaQuestionnaire was used to determine the frequency and volume of cosmetics usedTABLE 1.
Frequency and Volume of Cosmetics Use Based on Questionnaire for 150 Users (Women,
Aged 20-73
yrs
)Slide16
The Paper…AnalysisSlide17
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.
Slide18
Model 1 – Dermal AbsorptionWhen only rat in vivo dermal absorption data was available, assumed human absorption is similar to that of a rat in terms of in vivo absorptionModel 2 – Dermal AbsorptionRat 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
Slide19
Results…Exposure LevelsSlide20
Estimated Median Exposure Levels to Phthalates Resulting from the Concurrent use of Multiple Cosmetic Products (µg/kg bw/d)
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 equalSlide21
The Paper…ConclusionsSlide22
Study showed 4 individual phthalates present in cosmeticsNo human data available, results extrapolated from animal dataBBP not found in nail polish, hair products, or deodorantMedian exposure levels and health indices not givenHazard Indices suggest that estimated exposure to these 4 phthalates in the cosmetics studied are relatively smallSlide23
Assessment of the PaperEstimation 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 assessmentQuestionnaire used to assess volume – another way?Is this study generalizable?Age range?Slide24
References