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