Questions & Answers

Is it true that I could be endangering my health by using cosmetics or perfume containing DEP?

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 lives.
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.

Phthalates have 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 disrupters.

Some phthalates 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.

Studies on non-human primates do not show adverse effects even after high phthalate exposure.

The Japanese authorities have recently confirmed that phthalates should not be included among substances considered human endocrine disrupters.

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 human population.

But I have heard that DEP has been linked with reduced sperm count. Is that true?

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 subjects.”
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 was needed.
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 (MEP).

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?

All the 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”.