Titanium dioxide

nanoparticles
in cosmetics:
a safety review

What is titanium dioxide?

Titanium dioxide (TiO2) is widely used in a variety of products including some foods, paints, cosmetics, orthodontic
composites, toothpastes and sunscreens. In cosmetics, TiO2 may be used either as a white pigment in its microcrystalline
form only, or as an inorganic ultraviolet filter primarily in sunscreens, but also in some day creams, foundations, lip balms,
etc.(1) TiO2 in its nanoparticle form (nano-TiO2) is now the only form used as a UV filter. Nano-TiO2 particles range from
1–100 nm in size and promote either dispersion or resistance to photoactivity.(2)

TiO2 particles can also vary in structure, and are found as both anatase and rutile crystal forms. Nano-TiO2 used in
sunscreens is mostly of the rutile crystal structure or a rutile/anatase combination; they are rarely made up of the anatase
structure alone.(2, 3)

Finally, nano-TiO2 is photoreactive with a resulting increase in reactive oxygen species (ROS) known to be implicated in
cellular damage. This issue has been solved by coating nanoparticles with alumina or silica, to reduce the production
of ROS. As coating improves the dispersion of TiO2 nanoparticles and their compatibility with other ingredients within
sunscreen formulations, nano-TiO2 is always used in its coated form in cosmetics.(4)

Where does the safety concern for nano-TiO2 come from?

The scientific evidence suggests that nano-TiO2 is an effective UV filter for the prevention of skin cancers and sunburn;
however some concerns have been raised about its safety.(5)

Nano-TiO2 has been accused of penetrating dermal, respiratory or gastrointestinal barriers, and disseminating in the body,
and therefore presenting a potential risk for the consumer.(6)

It is worth noting that many toxicological studies of nano-TiO2 use AEROXIDE P25 (Evonik, Germany), consisting mostly of
nano-TiO2 less than 25 nm in size under their anatase form.(7) However, P25 is not used in cosmetics and P25 nano-TiO2 is
not coated to reduce photoactivity.

This safety review concerning the use of nano-TiO2 in cosmetic products to provide UV protection is based on data
published by the Scientific Committee on Consumer Safety (SCCS) and the French Agency for Food, Environmental
and Occupational Health and Safety (ANSES) and data available in the scientific literature since those opinions were
published.(3, 6, 8)

Available: www.skin-alliance.com
Titanium dioxide nanoparticles in cosmetics: a safety review

Oral exposure to nano-TiO2

nanoparticles
Dermal exposure to TiO2 a. Nano-TiO2 particles absorption is negligible
via the oral route
nanoparticles
As some manufacturers can also use nano-TiO2 in UV-
a. Absorption and distribution of nano-TiO2 particles protecting lip balms that may be incidentally ingested,
into the skin is limited to the stratum corneum(9, 10) the potential ability of nano-TiO2 to penetrate oral and
gastrointestinal mucosa has thus been investigated.
More than 20 studies either in animals or in humans
have investigated the dermal penetration of In a human model of the buccal mucosa, nano-TiO2
nano-TiO2 in healthy skin.(3) Most of these studies penetrated the epithelium, with most of the particles
reported that nano-TiO2 remains on the skin after remaining in the upper third of the epithelial tissue.(18)
‘real-life’ application of a sunscreen formulation, Another study administering a single dose of nano-TiO2 to 9
with only a small proportion of nano-TiO2 penetrating subjects reported that only negligible absorption occurred
deeper in the stratum corneum. The nanoparticles do via the gastrointestinal tract after 2, 4, 24, and 48 h.(19)
not reach the viable epidermis or dermis cells.(3)
This data demonstrates some nano-TiO2 penetration
Five studies demonstrated that nano-TiO2 contained through the oral mucosa, but negligible absorption, if
in a sunscreen formulation did not penetrate any, via the gastrointestinal tract after oral exposure to
compromised skin (stripped/dermabraded, sunburnt or nano-TiO2 either in rats or in humans.(20-22)
psoriatic).(3) Even if nano-TiO2 penetrated deeper in the
stratum corneum of psoriatic skin compared to healthy b. Nano-TiO2 particles are distributed in the body
skin, it did not reach living cells in either psoriatic or
healthy skin.(3) Two studies were analysed in a report from the French
Institute for Industrial, Environment and Risks (INERIS).(23) One
b. Nano-TiO2 particles are considered study reported that 2 weeks after a single administration
to be a mild- or non-irritant to skin of nano-TiO2 (25 and 80 nm, 5 g/kg bw), particles
accumulated mainly in the liver, spleen, kidneys, and lungs
There are currently no studies available that are in mice.(24) However the very high nano-TiO2 dose used
relevant for assessing the acute dermal toxicity of in this study is not representative of the levels of human
nano-TiO2.(3) exposure.( 25)
In contrast, a second study administering oral nano-TiO2
Studies performed in guinea pigs and mice analysed daily for 13 weeks reported no significant increase of
by the SCCS and by the Therapeutic Goods titanium in liver, spleen, kidney and brain, and no dose-
Administration (TGA), Department of Health, Australia response relationship in rats.(21)
reported that nano-TiO2 is not a skin sensitiser.(3, 11-13)
However, a more recent study using radiolabelled
c. Uncoated nano-TiO2 particles may cause nano-TiO2 reported distribution into rat liver, lungs,
phototoxicity in human skin cells kidneys, brain, spleen, uterus and skeleton, 7 days after
administration of a single dose of nano-TiO2 (~40 μg/kg/
Six out of seven studies analysed reported that bw), even if the estimated amount absorbed was low at
nano-TiO2 could induce the formation of reactive 0.09–0.98 ng/g depending on the organ.(22)
oxygen species (ROS), which may be a cause of In conclusion, following oral intake, nano-TiO2 can potentially
cytotoxicity. These studies found that ROS induction permeate the gastrointestinal lining, but to a limited extent.
in HaCaT cells was enhanced by UV (14) and UVB(15)
irradiation, but not by UVC irradiation(16), suggesting c. Nano-TiO2 has low rates of oral toxicity
that nano-TiO2 leads to phototoxicity in human skin
keratinocytes. The SCCS has stated that surface Studies performed in rodents showed low oral acute
coating of nano-TiO2 is important to reduce its toxicity of nano‐TiO2 except one study using very
phototoxic effects.(3) It is worth noting that the coated high doses. Repeated dose studies report that oral
form is always used in cosmetics. administration of nano-TiO2 leads to toxicity at various
levels (central nervous system, kidney, spleen), but
d. Nano-TiO2 particles are not carcinogenic the doses used were far higher than those to which
through dermal exposure humans can be exposed to in the context of incidental
oral exposure through cosmetics use.(26-32)
The Committee for Risk Assessment (RAC,
European Chemicals Agency (ECHA)) considers that d. Nano-TiO2 particles do not have any
there is no evidence for TiO2 carcinogenicity for the carcinogenic potential via oral exposure
dermal route.(17)
The few available data do not seem to indicate any
In 2014, the SCCS concluded that nano-TiO2 potential carcinogenic activity associated with oral exposure
at a concentration up to 25%, as a UV-filter in to nano-TiO2.(23) The Committee for Risk Assessment (RAC)
sunscreens does not pose any risk of adverse also considers that there is no experimental evidence to
effects in humans after application on healthy, suggest that oral TiO2 may be carcinogenic.(17)
intact or sunburnt skin.(3)
e. High-dose nano-TiO2 may affect reproduction

Studies performed in rats showed abnormal lung development

and some neurotoxic effects in neonates after high doses of
nano-TiO2 administered to pregnant females.(33,34)
Titanium dioxide nanoparticles in cosmetics: a safety review

Inhalation of TiO2 suspected or possible carcinogen in humans by

other organisations (International Agency for Research
nanoparticles in Cancer (IARC), the National Institute for Occupational
Safety and Health (NIOSH) and the Committee for Risk-
a. Nano-TiO2 can be absorbed into the lungs via Assessment-European Chemical Agency (RAC-ECHA)).
spray formulations but is not widely distributed Nevertheless, results obtained with the P25 form of
nano-TiO2 cannot be extrapolated to other forms of
Considering the size of the nanoparticles, the SCCS nano-TiO2, and the concentrations used in these studies
has indicated that spray products could lead to greatly exceeds the maximum human exposure.
lung exposure to nano-TiO2 by inhalation.(35) Studies
have demonstrated that inhaled nanoparticles are e. Nano-TiO2 inhalation may affect reproduction
mainly found in the upper airways (nose, mouth,
pharynx, larynx and trachea), but can also reach the Nine studies, performed in mice (N=4)(50-53) or rats
deeper lungs and deposit in the alveoli. Particles can (N=5)(54-58) suggest a possible effect of pre- or
be removed via coughing, mucociliary clearance peri-natal inhalation exposure to nano-TiO2. Studies in
and macrophages.(35, 36) Furthermore, inhaled nano- mice reported lung inflammation in gestating females,
TiO2 particles can cross the lung barrier and travel along with moderate neurobehavioral changes and
throughout the body, although this phenomenon gene expression changes in the liver in the offspring.
appears to be limited.(8, 22, 36-40)

b. Nano-TiO2 is associated with cytotoxicity

in lung cells
Nano-TiO2 used in cosmetics
are unlikely to be genotoxic
Four studies analysed by Zhang et al. demonstrated
that nano-TiO2 inhalation induces oxidative stress and/ The genotoxicity of nano-TiO2, has been widely
or apoptosis in the human lung cancer cell line reported.(3, 8, 13) However the forms of nano-TiO2 used in
A549 in vitro.(41) these studies varied, with different shape, size, coating,
surface reactivity, charge, and crystallinity, leading to
In conclusion, cytotoxicity of nano-TiO2 seems to be inconsistent results.
mediated by ROS production and enhanced by UVA
or UVB irradiation in vitro. Consequently, nano-TiO2 can be considered as a
weak genotoxic agent, as stated by national and
c. There is no causal link observed between TiO2 international governmental organisations (ANSES, IARC,
inhalation exposure and observed effects in acute NIOSH and the UK Organisation for Economic
and repeated-dose toxicity studies Co-operation and Development (OECD)).

The ANSES report evaluated several animal studies

reporting the occurrence of nano-TiO2 toxicity at several
levels (pulmonary, neurological, cardiovascular, liver,
etc). First of all, these doses far exceed levels of human
exposure, including cases of occupational exposure.(8)
Nano-TiO2 does not penetrate the skin
Furthermore, most of the data focused on studies beyond the surface layers to viable
performed with the P25 form of nano-TiO2 (anatase cells and does not reach the general
80–90%/rutile 10–20%) which is not used in cosmetic
applications. Additionally, several biases were present circulation after application to either
in the studies, which limits their interpretation. healthy or compromised skin. Nano-TiO2
from sunscreens does not present any
Finally, 8 studies assessed nano-TiO2 toxicological
effects on humans exposed to nano-TiO2 by inhalation. health risks when applied on the skin at a
Results suggested a possible pulmonary and concentration of up to 25%.
cardiovascular effect. No conclusions could be drawn,
as no causal link could be established between TiO2 After oral exposure, nano-TiO2 absorption
inhalation exposure and the observed effects. and toxicity seem to be limited. Incidental
oral exposure to nano-TiO2 contained in lip
d. Nano-TiO2 particles may have some carcinogenic balms is thus not expected to induce
potential via inhalation in their P25 form
adverse health effects.
One study reported an increase in the incidence of lung Finally, even if human data are sparse
tumours in rats exposed to repeated inhalation of
nano-TiO2 (7.2–14.8 mg/m3 for 16 months).(42) Seven and inconsistent and, may include
epidemiological studies in humans reported increased studies on the P25 form of nano-TiO2,
mortality rates due to lung cancer following inhalation of lung inflammation has been reported in
nano-TiO2, however no causal relationship could be
established.(43-49) animal studies. Therefore, the SCCS does
not recommend the use of nano-TiO2 in
We can conclude from the study of Heinrich et al.(42)
formulations that may lead to exposure
that nano-TiO2 (P25 as material tested) is a lung
carcinogen in rats at a concentration resulting in of the lungs by inhalation, i.e., sprayable
pulmonary inflammation and altered clearance. This is products and powders.
consistent with the previous nano-TiO2 classification as a
Titanium dioxide nanoparticles in cosmetics: a safety review

This executive summary is a short version of the complete article available in the JEADV supplement :
https://onlinelibrary.wiley.com/toc/14683083/2019/33/S7

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