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Coll. Antropol. 27 Suppl.

1 (2003) 23–30
UDC 614.37:614.75
Original scientific paper

Migration of Phthalates from Plastic


Products to Model Solutions

Jasna Bo{nir1, Dinko Puntari}1, Ivo [kes1, Maja Klari}2,


Spomenka [imi}3 and Ivan Zori}4
1 Department of Health Ecology, Public Health Institute, Zagreb, Croatia
2 Public Health Institute of Osijek-Baranja County, Osijek, Croatia
3 University Hospital »Osijek«, Osijek, Croatia
4 School of Medicine, University of Split, Split, Croatia

ABSTRACT

The aim of this investigation was to determine the level and rate of migration of
phthalates, compounds used as plastic softeners, from various plastic products into mo-
del solutions and to assess the possible adverse effects of the phthalate amounts released
on human health, thus to contribute to harmonization of the opinions on the maximal
allowed human exposure to these compounds through environmental factors. Nine spec-
imens of plastic toys, 16 specimens of plastic food containers and 10 specimens of other
plastic consumer goods were analyzed. The specimens of plastic products were submit-
ted to 10-day action of model solutions. Three model solutions were used: distilled wa-
ter, 10% ethyl alcohol, and 3% acetic acid. Identification and quantification of the
phthalates released were performed by the method of gas chromatography on days 1, 5
and 10 of exposure, at a detection limit of 0.005 mg/kg. On day 10, the highest level of re-
leased phthalates (54.5 mg/kg) was measured in distilled water, followed by 44.4 mg/kg
in 3% acetic acid and 32.3 mg/kg in 10% ethyl alcohol. According to plastic product cat-
egories, the highest pooled level of phthalates released to all three solutions was recor-
ded for plastic toys (66.2 mg/kg), followed by food containers (37.6 mg/kg) and other con-
sumer goods (27.4 mg/kg). According to plastic product categories, toys showed the most
rapid phthalate release, with 65.4% (43.3 of 66.2 mg/kg) of the pooled level of phthalates
released to all three solutions recorded on day 1. As indicated by the study results, the
levels of phthalates released would not present a hazard for human health, not even
over a prolonged period of time. However, data on the highest and fastest pooled
phthalate release from plastic toys, and this especially to distilled water simulating sal-
ivary action, point to the need of continuous evaluation and amendments of the legisla-
tion on phthalates in consumer goods.
Key words: phthalates, toys, containers, consumer goods, solution model, Croatia.

Received for publication January 7, 2003

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J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30

Introduction ducts)11,23–25, extensive and occasionally


continuous utilization of such products
Plastic products intended for some spe- (dialysis)26,27, or average usage and expo-
cific purposes have to meet the require- sure to these products28–31. On the one
ments of elasticity and flexibility, in addi- hand, according to the World Health Or-
tion to other conditions required for plastic ganization (WHO) conclusions and rec-
products in general. The properties of ommendations, exposure to phthalates
elasticity and flexibility are required in a represents a risk and caution is advised,
great variety of plastic products used, for this being a strong argument for those
example, in medicine1–4. The so-called advocating such an attitude to propose
consumer goods are a very large and var- reduction in the number and types (pur-
ied category of plastic products where poses) of plastic products10,31–34. Other re-
these properties are desirable. By defini- searchers, on the other hand, emphasize
tion, consumer goods include: (a) vessels, that the doses administered to experi-
equipment and devices for the production mental animals are several dozen to sev-
of food and consumer goods, and contain- eral hundred times greater than those re-
ers for food and consumer goods; (b) chil- ceived by the people at highest level of
dren's toys; (c) toiletries, face and body exposure, and that this exposure is pro-
care accessories, and beauty products; (d) tracted over a long period of time (years
cleaning agents; (e) tobacco, tobacco prod- or even decades)11,35.
ucts and smoking accessories; and (f)
some objects and agents coming in direct These contradictions have resulted in
contact with the skin or mucosa on their quite generalized legislation in the field,
usage5. especially in Croatia, merely defining the
total allowed amount of phthalates in
Phthalates, phthalic acid esters, have plastic products, which should not exceed
for decades been most widely used as 35%, without considering the purpose of
plastic softeners (plasticizers). Among the product, the length of its usage, and
them, diethylhexyl phthalate (DEHP) the age of the user36. At the same time,
has been most commonly used6–11. Exten- paradoxically, consumer goods made from
sive production of phthalates, which ex- other materials have to stand very strict
ceeds 25 million tons per year, and the simulation of the conditions in which
fact that plastic products are utilized in they may be used in daily routine. So,
virtually every human activity, have im- there are legal regulations on the con-
posed the need of continuous investiga- sumer goods to be submitted to the action
tions conducted all over the world on the of so-called model solutions (10% ethyl al-
possible harmful effects of plastic prod- cohol, distilled water, and 3% acetic acid)
ucts and phthalates used in their manu- to determine the possible release of heavy
facture on human health7,12–16. metals (Pb, Cd, Cr, etc.), and low-molecu-
The studies performed to date have lar organic and inorganic substances. The
provided evidence for the mutagenic, te- latter is termed global migration and in-
ratogenic, carcinogenic and many other cludes release of compounds such as pri-
adverse effects in experimental animals mary aromatic amines expressed as ani-
exposed to high doses of phthalates17–22. line, secondary aromatic amines expres-
The opinions on the possible harmful ef- sed as diphenylamine, and residual per-
fect of phthalates on human health are oxides expressed as active oxygen. Also,
contradictory, irrespective of the mode consumer goods are expected not to lose
and level of exposure, e.g., occupational stain. The objects are immersed in model
(manufacture of phthalates or plastic pro- solutions for at least 24 hours, then the

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J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30

type and amount of the compounds and solution, group of plastic products, and
elements released to the solution are de- dynamics of phthalate release. Phthalate
termined with the aim to approximately identification was performed by the me-
predict the release of these substances in thod of gas chromatography with a spe-
contact with the skin and mucosa, human cific electron capture detector (ECD) on a
secreta and excreta, and with food in- Perkin Elmer PE AutoSystem XL sup-
tended for human use, including alcohol plied with ECD with 63 Ni (Norwalk,
and nonalcohol beverages5. USA) gas chromatograph37,38. Under stan-
Taking the requirements stated in the dard gas chromatography conditions,
act on safety of foods and consumer goods detection limits of 0.005 and 0.040 mg/l
not made from plastics, the aim and pur- for butyl benzyl phthalate (BBP) and dioc-
pose of the present study were to deter- tyl phthalate (DOP), respectively, were
mine whether and to what an extent and achieved.
dynamics phthalates were released to
model solutions, and whether the amount
Results
of phthalates thus released could pose a
risk for human health at long run. The On day 10 of exposure, the highest
endpoint was to hopefully contribute to level of released phthalates (54.4 mg/kg)
the harmonization of opinions on the ma- was found in distilled water. According to
ximal allowed amount of phthalates to groups of products, the highest pooled
which humans can be safely exposed dur- level of phthalates released to all three
ing lifetime through daily usage of con- solutions was recorded for toys (66.2 mg/
sumer goods and total environmental kg), whereas the levels of phthalates re-
phthalate exposure. leased from food containers and other
consumer goods were considerably lower
(37.6 and 27.4 mg/kg, respectively) (Table 1).
Material and Methods The highest rate of phthalate release
Plastic consumer goods, domestic and was recorded in 3% acetic acid, where as
imported, referred to the Institute of Pub- much as 62.2% of the total amount of
lic Health, Zagreb, Croatia, for assess- phthalate release was found on day 1. A
ment of their safety, were classified into similar pattern of phthalate release was
three groups. Group 1 included 9 speci- observed in distilled water, with 58.1% of
mens of plastic toys, group 2 had 16 speci- total phthalate release recorded on day 1.
mens of plastic food containers, and group The rate of phthalate release in 10%
3 had 10 specimens of other plastic prod- ethyl alcohol was considerably lower (Ta-
ucts (disposable saucers, glasses and cut- ble 1).
lery) intended for common usage. The According to the group of products, the
specimens of plastic products were sub- highest rate of phthalate release was re-
mitted to 10- day action of model solu- corded for toys, with 65.4% (43.3 of 66.2
tions. Three model solutions were used: mg/kg) of the pooled level of phthalates
distilled water, 10% ethyl alcohol, and 3% released to all three model solutions re-
acetic acid. The method of gas chromatog- corded on day 1. Food containers and
raphy was employed for identification and other consumer goods showed a consider-
quantification of released phthalates. The ably slower dynamics of phthalate relea-
level of phthalates released was mea- se, with 52.9% (19.9 of 37.6 mg/kg) and
sured on days 1, 5 and 10 of exposure, 39.1% (10.7 of 27.4 mg/kg) of the pooled
and as a pool. The values obtained were level of phthalates released to all three
processed according to the type of model solutions recorded on day 1.

25
26
TABLE 1
PHTHALATE RELEASE FROM SPECIMENS OF PLASTIC CONSUMER PRODUCTS UPON EXPOSURE TO MODEL SOLUTIONS (MG/KG)

Products Distilled water 10% Ethyl alcohol 3% Acetic acid


(N)
Total on Total on Total on
Day 1 Day 5 Day 10 Day 1 Day 5 Day 10 Day 1 Day 5 Day 10 Total
day 10 day 10 day 10

Plastic toys 17.6±3.1 5.2±1.8 4.9±1.3 27.7±2.1 6.1±1.3 3.0±0.9 2.4±0.7 11.5±1.0 19.6±5.8 4.7±1.5 2.7±0.7 27.0±2.7
(N=9) (63.6%) (18.7%) (17.7%) (100%) (52.5%) (26.6%) (20.9%) (100%) (72.4%) (17.5%) (10.1%) (100%) 66.2±1.9

Plastic food con- 9.6±2.4 2.6±0.3 4.1±0.9 16.3±1.2 3.5±1.4 2.9±0.6 2.4±0.4 8.8±0.8 6.8±6.8 1.5±1.0 4.2±0.9 12.5±2.9
tainers (N=16) (59.0%) (16.0%) (25.0%) (100%) (40.1%) (33.2%) (26.7%) (100%) (54.3%) (11.7%) (34.0%) (100%) 37.6±1.6

Other plastic 4.4±2.0 4.0±1.4 2.1±0.2 10.5±1.2 5.1±0.3 5.0±1.1 1.9±0.3 12.0±0.6 1.2±0.4 2.4±0.7 1.3±0.4 4.9±0.5
products (N=10) (42.3%) (37.9%) (19.8%) (100%) (42.3%) (42.18%) (15.48%) (100%) (25.4%) (48.4%) (26.2%) (100%) 27.4±0.8

Total 31.6±2.6 11.7±1.2 11.1±0.8 54.5±1.5 14.7±1.0 11.0±0.9 6.6±0.5 32.3±0.8 27.6±4.3 8.5±1.1 8.3±0.7 44.4±2.0
(N=35) (58.1%) (21.6%) (20.3%) (100%) (45.4%) (34.1%) (20.5%) (100%) (62.2%) (19.1%) (18.7%) (100%) 131.2±1.4
J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30
J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30

Discussion prevalence of spontaneous abortion17,


stillbirth, low birth weight, and fetal mal-
Analysis of the results revealed the formations, i.e. teratogenic effects, has
highest level of phthalates to be released also been reported19,39,40. Changes in the
to distilled water, which is used as a activities of particular liver enzymes42, a
model solution to imitate the action of mild estrogenic effect, and an adverse go-
chemically similar saliva. Accordingly, the nadal effect in male experimental ani-
action of sweat, blood, gastric acid and mals 18,21,42 have been described. Carcino-
other media in and on the human body on genic43 and mutagenic44,45 effects of phtha-
plastic products should be expected to be lates are a 'classic' finding. However,
less aggressive. This is by no means neg- common to all these studies irrespective
ligible considering the common and wide of the duration and mode of exposure is
usage of plastic products in medicine. that marked health impact in experimen-
Toys were definitely found to be by far tal animals occurred at doses exceeding
least resistant to the action of body se- 500 mg/kg body weight39,40,42–44.
creta and excreta, for at least two rea- No detrimental effects of phthalates
sons. First, toys showed quantitatively have to date been definitely demonstra-
highest phthalate release. Second, about ted in humans. Some authors describe
two thirds of total phthalates were re- some mild discomforts such as headache
leased from toys in all three model solu- and neurovegetative system disturbances
tions, i.e. under the action of all body flu- (sleep disturbance, increased sweating)
ids simulated by the solutions, on the in individuals occupationally exposed to
very first day of exposure. Neither this phthalates in the manufacture of phtha-
information should be underestimated, lates or plastic products with phthalates
knowing that plastic toys are intendend used as plasticizers23–25.
for children of various age and grade of There is still much controversy on the
maturity, and that toys are mostly put issue, which has resulted in recommen-
into the mouth by children under the age dations on the limited amounts of phtha-
of 2 years, yet fully unaware of the hy- lates in particular media. For example,
gienic and other aspects of this motion. the amount of DEHP, the most widely
After all, the European Union recommen- used phthalate, has been limited to 6
dations on the use of plastic toys have re- mg/L drinking water and 5 mg/cubic me-
sulted from similar studies30–34. ter air per 8-hour work time or 10 mg/cu-
One of the aims of the present study bic meter air per 15-minute exposure10.
was to assess the presence and effect of Other authors performed mega-analy-
the phthalates thus released on human sis of all studies on the issue to demon-
health. According to the literature re- strate that the phthalate exposure in hu-
ports available, phthalates undoubtedly mans is several times lower than the
have adverse effects on experimetnal ani- levels used in animal experiments, and
mals17–22. These effects vary in severity therefore cannot have any major effect on
and impact on animal general health, human health. They found the doses in
and as a rule depend on the level, mode case of highest human exposure and un-
(oral, percutaneous, inhalatory, etc.) and der worst conditions to be dozens to hun-
length of phthalate exposure. Mild alter- dreds times lower as compared with ani-
ations manifested as body weight loss mal experiments. The highest and most
and insignificant reduction of life expec- unfavorable variant of exposure is exem-
tancy in exposed animals as compared plified by infants on life sustaining extra-
with the control group11,35. An increased corporeal oxygenation or patients of other

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J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30

age groups treated at intensive care units only a prolonged exposure to a dose of
for a variable period of time, all with 2,700 mg could entail some effect. Total
phthalate exposure expressed as body phthalate release from all three groups of
weight percentage as a common deno- products in all three model solutions on
minatoryy11,35. According to these stud- day 1 characterized by highest and fast-
ies, daily animal exposure to phthalates est phthalate release yielded a maximal
at a level of 0.025% of their body weight daily level of 73.9 mg phthalates, i.e. an
for several years will definitely have no amount by far less than those that might
adverse effects on their health. In some have any notable effect on the health of
but not all animals, impairments occur- exposed individuals. The more so, in real
red on phthalate exposure at a level of conditions the amount of phthalates re-
0.09% of their body weight, however, only leased from the tested products is several
when applied for most of their life times lower and body weight of those ex-
span11,35. posed is significantly greater. In addition,
In our study, the levels of phthalates cutaneous absorption of phthalates from
were expressed in mg/kg product. The the gastrointestinal tract in humans is by
worst variant was simultaneous exposure 10% to 20% lower than in rodents, and
per kilogram of all three-product groups the metabolism of detoxification in hu-
and their simultaneous 'dissolving' by mans differs from and is considered more
three body fluids (three model solutions efficient than that in animals11,35.
simulating body fluids). In real life, this All these considerations support the
would be considered a 'science fiction', be- opinion that man during his lifetime
cause an average toy is rarely weighing could theoretically be daily exposed to
more than 100 g, not to speak of food con- phthalate doses of several hundreds to
tainers or disposable saucers in kilo- even thousands of milligrams without
grams. Furthermore, the worst variant any major adverse effects on his health. It
would imply continuous phthalate re- should be remembered, though, that man
lease at the rate recorded on day 1 (when is exposed to phthalates from various
more than a half of the total phthalate sources, e.g., water, food, air, medicinal
amount was released) and exposure of a products, etc., the doses received being
newborn weighing 3 kg. Thus, the worst cumulated in the body10,11,23–31. Although
variant, i.e. 0.025% of 3 kg, theoretical phthalate toxicity is obviously low, their
birth weight of a newborn exposed to the maximal levels in environmental factors
effects of phthalates, would yield 0.85 g or should be determined, first of all because
850 mg; and 0.09% would make 2.7 g or of possible accidents (e.g., in the plants
2,700 mg. By analogy with animals, daily manufacturing phthalates or plastics),
exposure to a dose of 850 mg phthalates when short-term exposure may increase
should not induce any disturbances, and several times.

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D. Puntari}

Department of Health Ecology, Public Health Institute, Mirogojska c. 16, 10000 Zagreb,
Croatia

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J. Bo{nir et al.: Migration of Phthalates, Coll. Antropol. 27 Suppl. 1 (2003) 23–30

MIGRACIJA FTALATA IZ PLASTI^NIH PROIZVODA


U MODEL OTOPINE

SA@ETAK

Cilj istra`ivanja bio je utvrditi koli~inu i brzinu migracije ftalata, spojeva koji se
koriste kao omek{iva}i plastike, iz razli~itih plasti~nih proizvoda, u model otopine. Iz-
laganje pokusnih `ivotinja ftalatima pokazala su kancerogeno, mutageno i teratogeno
djelovanje. Istra`ivanjem se `eljelo pokazati mogu li otpu{tene koli~ine ftalata {tetno
djelovati na zdravlje ljudi, te doprinjeti usagla{avanju mi{ljenja o maksimalno dozvo-
ljenoj izlo`enosti ljudi tim spojevima putem faktora okoli{a. Analizirano je 9 uzoraka
plasti~nih dje~jih igra~aka, 16 uzoraka plasti~ne ambala`e za prehrambene proizvode i
10 uzoraka drugih plasti~nih proizvoda namjenjenih op}oj uporabi. Uzorci plasti~nih
proizvoda bili su podvrgnuti 10-dnevnom djelovanju model otopina. Kori{tene su 3 mo-
del otopine: destilirana voda, 10% etilni alkohol i 3% octena kiselina. Identifikacija i
kvantifikacija otpu{tenih ftalata ra|ena je 1., 5. i 10. dan izlaganja metodom plinske
kromatografije. Granica detekcije metode bila je 0.005 mg/kg. Nakon 10 dana, najvi{e
otpu{tenih ftalata (54.5 mg/kg) na|eno je u destiliranoj vodi, u 3% octenoj kiselini na-
|eno je 44.4 mg/kg ukupnih ftalata, dok ih je u 10% etilnom alkoholu utvr|eno 32.3
mg/kg. Prema skupinama proizvoda, nakon 10 dana, ukupno najvi{e otpu{tenih ftala-
ta (66.2 mg/kg), u sve tri model otopine zajedno, utvr|eno je iz dje~jih igra~aka, dok su
koli~ine utvr|enih ftalata iz prehrambene ambala`e (37.6 mg/kg) i iz ostalih proizvoda
op}e uporabe (27.4 mg/kg), bile znatno manje. Prema skupinama proizvoda, najbr`e
otpu{tanje ftalata utvr|eno je kod igra~aka, kod kojih je ve} nakon prvog dana izla-
ganja u sve tri model otopine ukupno otpu{teno 65.4% ftalata (43.3 od 66.2 mg/kg).
Utvr|ene otpu{tene koli~ine ftalata, po svemu sude}i, ne mogu ugroziti zdravlje ljudi,
niti kroz dulji vremenski period. Ipak, ~injenica da su ukupno najvi{e koli~ine ftalata
otpu{tene iz igra~aka, da je otpu{tanje iz igra~aka najbr`e, a posebice da je to najna-
gla{enije u destiliranoj vodi, koja simulira djelovanje sline, govori o potrebi stalnog
evaluiranja i dopunjavanja zakonske regulative o ftalatima u predmetima op}e upo-
rabe.

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