Questions & Answers
Is it true that I
could be endangering my health by using cosmetics or perfume
DEP has been the
subject of numerous toxicological studies and has been thoroughly
risk assessed by at least two teams of independent expert
scientists. The teams involved were those of:
The World Health Organisation (WHO) Programme on Chemical Safety
(IPCS) who produced the Concise International Chemical Assessment
Document (CICAD) 52 on DEP in 2003. After considering all the
studies the WHO concluded that the level of exposure at which no
adverse effects of any sort are observed in the mouse is 1.600
mg/kg bw/day. This is an enormous dose, significantly higher
than the usual maximum dose of 1.000 mg/kg bw/day used in such
studies. They then incorporated a margin of safety of 300 (100 is
normally considered adequate) and derived a Tolerable Daily Intake
(TDI) for DEP of 5 mg/kg bw /day. This is the level that a human
can safely consume each day for the whole of their
The European Union (EU) Scientific Committee on Cosmetics and Non
Food Products intended for the consumer adopted an Opinion on DEP
in June 2002. This opinion was reviewed in the light of new
publications and reconfirmed in December 2003. Their stated opinion
is that the safety profile of DEP supports its use in cosmetic
products at current levels.
been used for more than 50 years without a single known case of
anyone having been harmed as a result.
Is it true that
phthalates are endocrine disrupters?
There is no
evidence that any Phthalate plasticisers are human endocrine
cause reproductive effects at high doses in rats and mice by a
process which apparently involves the endocrine system. However,
these effects have only been seen at levels of exposure many times
higher than those normally experienced by humans.
non-human primates do not show adverse effects even after high
authorities have recently confirmed that phthalates should not be
included among substances considered human endocrine
Within the past
few years all the major phthalates have been comprehensively risk
assessed by European Union Member State experts who have
conclusively agreed that they do not pose a risk to the general
But I have heard
that DEP has been linked with reduced sperm count. Is that
This comment most
likely refers to the studies of Duty and co-workers –
- Their first publication in July 2003 describes their attempt to
discover if there is a link between human exposure to phthalates
(based on the level of phthalate metabolites in urine) and DNA
damage in human sperm. They found no link with the levels of
metabolites from dimethyl phthalate (DMP), dibutyl phthalate (DBP),
butylbenzyl phthalate (BBP) or di-2-ethylhexyl phthalate
(DEHP). Surprisingly the only link found was that between the
level of DEP metabolites and one measure of DNA damage. The authors
state that “Although the data in the present study suggest an
association between MEP and increased DNA migration in the comet
assay, they must be interpreted cautiously because the phthalate
levels are based on a single urine study from a limited number of
- The SCCNFP reviewed their Opinion on DEP in December 2003 to
take this study into consideration. They agreed with the authors
that the small number of selected people (140 men from an
infertility clinic) and other shortcomings meant that a more
comprehensive study was required.
- The second study of Duty et al was published later in 2003. In
this instance they studied the possible link between urinary
phthalate metabolite levels and three measures of semen quality
(concentration, motility and morphology) in 168 men from the same
clinic. A weak correlation was found between the metabolites of
DMP, DBP and BBP and one or more of the semen parameters. No
link was found with DEP or DEHP. Again the authors
considered that the results were inconclusive and that further work
- The third study published in April 2004 involved examining the
semen quality and urinary phthalate metabolite levels in a larger
sample of men (220) from the same infertility clinic. In this case
the more sensitive technique of Computer Aided Sperm Motion
Analaysis (CASA) was used to measure sperm progression, vigour and
swimming pattern. The study concluded that there was no
statistically significant association between sperm quality and
adult exposure to phthalates.
As DEP is an
ingredient of perfumes this presumably means that exposure to it
would come from both inhalation and from absorption through the
skin. Is this true?
The levels of DEP
in personal air samples reported in a study by Adibi et al (2003)
are a little higher than those found in typical indoor air samples.
This is one route of exposure and another is likely to be
adsorption via the skin. Whatever the route of exposure, DEP will
not be retained in the body but will be rapidly and extensively
metabolised and excreted in the urine and the level of exposure can
be calculated from this urinary concentration. The level of the
metabolite MEP has been measured in many urine samples,
particularly those from a large (2541 people) representative sample
of the US population. In this latest study (Silva et al, 2004) the
mean and 95 percentile exposures are 6.4 and 77.6 µg/kg
bw/day. These levels are far below the Tolerable Daily Intake
of 5.000 µg/kg bw/day identified by the WHO in 2003.
How much perfume
can I be exposed to before I should be concerned?
Far more than you
are ever likely to be. The highest level of DEP found in any
perfume that we are aware of is 2.8%. If you could manage to use
(and afford!) 2.4 litres of this perfume a day – every day
– and you managed to absorb all the DEP in it, you would
still not reach an exposure level at which it is known no effects
occur in rodents (please refer to the article on phthalates and
your health on the Phthalate Information Centre web site: http://www.phthalates.org/yourhealth/personal_care.asp
). Even using the very conservative WHO Tolerable Daily Intake
figure you would still have to use more than 100 ml per week.
Is DEP a chemical
that builds up in our bodies (bioaccumulates)?
DEP is definitely
not such a chemical. It is very rapidly broken down in the body
(metabolised) and excreted in the urine as monoethyl phthalate
Is DEP considered
or classified as a hazardous chemical?
DEP is not
hazardous according to independent experts and is therefore not
classified as such. In general, if a substance is hazardous (based
on its intrinsic properties) it may present a potential risk to
health depending on the level of exposure. As DEP is not hazardous
it poses no risk.
Does DEP pose a
threat to the environment?
phthalates, including those used in cosmetics and those in
plasticized PVC have been studied for many years by numerous
academic, regulatory and industrial scientists and their risks to
man and the environment have been assessed. Many of these studies
have been carried out over multiple generations of animals and so
their long term effects are well understood and have been taken
into consideration in the risk assessments. In addition these
phthalates are not slow to break down in the environment; they are
defined as “readily biodegradable”.