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The Danger of Parabens
Five Types of Parabens Detected Intact in Human Breast Tumors
By Suzanne M. Snedeker, Ph.D.
Background
Parabens have been used as preservatives since the 1920s. Chemically,
parabens have a simple structure. They consist of a 6-member carbon ring
with a hydroxyl group on one side (-OH) of the ring and a side chain
called an alkyl ester on the opposite side of the ring. The side chains
can be of varying lengths. Parabens are used to prevent the growth of
bacteria in a wide range of consumer products, including a variety of
foods and pharmaceutical drugs. The most prevalent use has been as a
preservative in cosmetics, including facial and body cosmetics, skin
care products, shampoos and conditioners, sunscreens, underarm products
(antiperspirants and deodorants), colognes and perfumes, and soaps,
including liquid hand soap. One of the most widely quoted sources of
information on use, exposure and safety of the four most commonly used
parabens was published in 1984 in a report authored by Elder (1). This
report estimated that parabens were used in over 13,200 different
cosmetic products.
Parabens have been widely accepted and used because of past reports
of their effectiveness as preservatives, low cost, and rapid excretion
from the body (both human and animal testing). However, recently some
scientists have raised concerns that further assessment of parabens may
be needed. This is based on recent evidence from over a dozen scientific
studies indicating that several types of parabens can bind to the
estrogen receptor and can cause estrogen-like responses when tested in
laboratory animals or in a variety of tissue culture assays (see http://envirocancer.cornell.edu/Bibliography/Bibliography.cfm
under Endocrine Disruption Bibliographies). In whole-animal studies, the
estrogenic effects of parabens were not seen when fed to the animals,
but only when applied to or injected under the skin. But, these were
short-term, high-dose studies. Little to no information exists on
whether use of products with low levels of parabens over many years
results in accumulation of parabens in body tissues and whether there
are or are not any health effects associated with use of paraben-containing
consumer products.
Overview
The study by P. Darbre and colleagues (2) was conducted to assess
whether any of the six parabens commonly used in consumer products in
Europe could be detected in human breast tumors. The names of the
parabens studied were: methylparaben, ethylparaben, propylparaben,
isobutylparaben, butylparaben and benzylparaben. The prefix (e.g.
“methyl”) indicates the name of the side-chain structure of each paraben.
In this study, 20 samples of human breast tissue were obtained from
patients undergoing surgery at the Edinburgh Breast Unit in Scotland,
UK. The samples were frozen, and then tumors were minced and homogenized
to help break up the tissue. Solvents were used to extract the parabens
from the tumor sample, followed by the use of thin-layer chromotography
to isolate any of the parabens present in the samples. Another method
called high-pressure liquid chromatography with mass spectrometry was
used to identify the type and the concentration of each paraben. For
each batch of samples, a blank was included that had no tumor tissue,
which was run through the same extraction and detection procedure. The
authors were surprised that the blank was not zero, but had some
parabens. The authors thought parabens in the hand soap used by
technicians or in the detergent used to clean the glassware may have
contaminated the laboratory equipment. Blank values were subtracted from
sample paraben values to correct for this problem. At least one type of
paraben was detected in 19 out of 20 tumors. Methylparaben was the most
commonly observed paraben (18/20) and was detected at the highest
average level.
Commentary
This study is the first report of the detection of parabens in human
breast tumors. The authors are careful to point out that the results of
this study do not show that any of the parabens caused breast cancer in
these women. This study is not evidence of cause and effect. The study
did show that five of the six parabens widely used in consumer products
can be detected intact (not changed or metabolized) in human tissues.
This is an important initial finding, but more research is needed to see
if exposure to parabens does or does not affect breast cancer risk.
For instance, this study did not show if levels of the parabens in
breast tumors were any different from nearby normal breast tissue in
these women. Also, this study did not include any women without breast
cancer. To evaluate breast cancer risk, a study would need to compare
levels of parabens in women with breast cancer (cases) to women of
similar age without breast cancer (controls). This study was very small,
with only 20 tumor samples. A larger, case-controlled study would be
needed to more fully evaluate whether parabens do or do not affect
breast cancer risk. This study did have some other problems, such as the
contamination of the blank samples mentioned above. Another problem
reported was in the analytical method. An important way to measure the
ability to accurately detect the chemical includes adding (spiking) a
known amount of paraben to a sample to see how much of the known amount
can be recovered from the sample. For instance, if you add 100 units,
you would like to have a high recovery of over 90%. In this study, the
recoveries of added paraben averaged just under 50%. Hence, the method
used to extract the parabens from the sample needs to be improved.
This study has received attention in the popular press because the
authors are interested in exploring the hypothesis of whether estrogenic
parabens used in underarm products (like deodorants and antiperspirants)
increase breast cancer risk. This study did not test this hypothesis.
The results did show that intact parabens can be detected in human
tissue. It did not however, make any attempt to find out the source of
the parabens. The women who donated the tumor samples were not
interviewed. In fact, no reports of their age or tumor status were
included in this study. No information on other factors that may have
influenced their breast cancer risk, or information on past use or
patterns of use of products with parabens was obtained. It is not known
if the major exposure was due to the parabens from food or via topical
application of a certain type or a variety of personal care products.
Better studies are needed of whether or not long term use of paraben-containing
consumer products affect human tissue levels. Given the ubiquitous
nature of paraben use in consumer products and recent evidence of the
estrogenicity of parabens, I would agree with other scientists who have
called for a reassessment of the safety of parabens. Most of the risk
assessments conducted on the safety of parabens were done before it was
known that parabens can act as an environmental estrogen and before it
was known that levels are detectable in human tissue. A recent study on
the safety of propylparaben does acknowledge the estrogenicity of this
chemical, but does not fully explore possible human health risks (3).
More recent data is needed to update the 1984 study by Elder, which is
one of the few reports estimating exposure to parabens from food, drug
and cosmetic products. While use of parabens is widespread,
product-to-product use is variable. In a survey of products in my own
bathroom and kitchen, I found a type of paraben listed as an ingredient
in liquid hand soap, two hand lotions, one out of three shampoos (the
“natural” brand was the one with the paraben), one out of two hair
conditioners, and three out of five sunscreens (including two made for
use by children), but in none of the three antiperspirants that my
family uses.
At this point in time we do not have information on whether or not
paraben-containing products are used at a level that affects human
health. But, research indicating that several parabens can act as weak
environmental estrogens and the preliminary results of this study do
support the need for more vigorous research in this area. Unlike other
environmental contaminants, use of personal care products represents a
choice made by the consumer and a choice by the manufacturer who
determine the ingredients of the product.
1) Elder, RL. Final report on the safety assessment of methylparaben,
ethylparaben, propylparaben and butylparaben, Journal of the American
College of Toxicology, vol. 3, pp. 147-209, 1984.
2) Darbre, PD, A Aljarrah, WR Miller, NG Coldham, MJ Sauer and GS
Pope, Concentrations of parabens in human breast tumors, Journal of
Applied Toxicology, vol. 24, pp. 5-13, 2004.
3) Soni, MG, GA Burdock, SL Taylor, NA Greenberg, Safety assessment
of propyl paraben: a review of the published literature (Review), Food
and Chemical Toxicology, vol. 39, pp. 513-532, 2001.
Other Resources on the Danger of Parabens
Beckley-Kartey SA, Hotchkiss SA, and Capel M, "Comparative in vitro
skin absorption and metabolism of coumarin (1,2-benzopyrone) in human,
rat and mouse," Toxicology and Applied Pharmacology, Jul 1997: 145(1):
34-42.
Byford, J. R., Shaw, L. E., Drew, M. G., Pope, G. S., Sauer, M. J.,
and Darbre, P. D. “Oestrognic activity of parabens in MCF7 human breast
cancer cells,” Journal of Steroid Biochemistry and Molecular Biology,
2002: 80, 49-60.
Darbre, P. D., Aljarrah, A., Miller, W. R., Coldham, N. G., Sauer, M.
J., and Pope, G. S., “Concentrations of parabens in human breast
tumors,” Journal of Applied Toxicology, Jan 2004: (24): 5-13.
Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, and Sauer MJ, "Oestrogenic
activity of isobutylparaben in vitro and in vivo," Journal of Applied
Toxicology, Jul-Aug 2002; 22(4): 219-26.
Darbre PD, Byford JR, Shaw LE, Hall S, Coldham NG, Pope GS, and Sauer
MJ, "Oestrogenic activity of benzylparaben," Journal of Applied
Toxicology, Jan-Feb 2003; 23(1): 43-51.
Ema M, Kurosaka R, Amano H, Ogawa Y. “Comparative developmental
toxicity of n-butyl benzyl phthalate and di-n-butyl phthalate in rats.”
Arch Environ Contam Toxicol 1995; 28:223-228.
Ema M, Miyawaki E, Kawashima K. “Further evaluation of developmental
toxicity of di-n-butyl phthalate following administration during late
pregnancy in rats.” Toxicol Lett, 1998; 87-93.
Harvey, PW, Darbre PD, Endocrine disruptors and human health: Could
oestrogenic chemicals in body care cosmetics adversely affect breast
cancer incidence in women? A review of evidence and call for further
research. Journal of Applied Toxicology, Jan 2004: (24): 167-176.
Kang, “Decreased sperm number and motile activity on the F1 offspring
maternally exposed to butyl p-hydroxybenzoic acid (butyl parabens),”
Journal of Veterinary Medical Science, March 2002; 64(3): 227-35.
National Research Council, “Hormonally Active Agents in the
Environment,” NRC Report, Washington DC, National Academy Press (1999).
Oishi, S. “Effects of butyl paraben on the male reproductive system
in mice.” Archives of Toxicology 2002: 76, 423-429.
Oishi, S. “Effects of propyl paraben on the male reproductive
system.” Food and Chemical Toxicology 2002: 40, 1807-1813.
Okubo T, Yokoyama Y, Kano K, and Kano I, "ER-dependent estrogenic
activity of parabens assessed by proliferation of human breast cancer
MCF-7 cells and expression of ER alpha and PR," Food Chemistry
Toxicology, Dec 2001; 39(12): 1225-32.
Pedersen KL et al., "The preservatives ethyl-, propyl- and
butylparaben are Oestrogenic in an in Vivo Fish Assay," Pharmacology
Toxicology, March 2000.
Routledge EJ et al., "Some alkyl hydroxy benzoate preservatives (parabens)
are estrogenic," Toxicology and Applied Pharmacology, 1998; 153: 12-19.
U.S. Department of Health and Human Services, National Toxicology
Program, 10th Report on Carcinogens, 2002; pp. 116-19.
Yourick JJ and Bronaugh RL, "Percutaneous absorption and metabolism
of courmarin in human and rat skin," Journal of Applied Toxicology,
May-Jun 1997; 17(3): 153-8.
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