ESTIMATED EXPOSURE TO
PHTHALATES IN
COSMETICS AND RISK
ASSESSMENT
Hyun Jung Koo, Byung Mu Lee
Journal of Toxicology and Environmental Health
EOH 2504- Fall 2010
Leah Cambal
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
Why are they used?
• 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)
You may be surprised to learn…
YOU ARE ALREADY
FAMILIAR WITH
PHTHALATES
Phthalates are
found
everywhere.
arcarpetbarn.com
Not just in the
products in which
they are
potentially used,
but also as
contaminants in
just about
anything.
achooallergy.com
supereco.com
hk.sgs.com
enviroblog.org
cleanandhealthyme.org
nutritionwonderland.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
Objective
Estimate individual exposures to phthalates in cosmetics
Overview
Measure 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, 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
DEHP
DEP
DBP
BBP
Products
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 Perfume
Hair
Nail
Deodorant
Products
Product Polish
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
3/1.5
2/18
1/0.5
1/1
Percentile
The Paper…
ANALYSIS
• Daily human exposure levels to phthalates were estimated from
cosmetics using the following formula:
• 𝐃𝐚𝐢𝐥𝐲 𝐇𝐮𝐦𝐚𝐧 𝐄𝐱𝐩𝐨𝐬𝐮𝐫𝐞
•
•
•
•
μg
kg
bw
d
μg
=
ml
times
C g V time F d
Body Weight (kg)
X Abs
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
• In vivo human abs. = In vivo animal
In vitro human abs
abs
In vitro animal 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)
DEHP
DEP
DBP
BBP
Dermal
Inhalation
Absorption
0.0006
0.026
0.6
81.471
0.103
22.917
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