Recent study with dogs on Bisphenol A has severe limitations
Results from highly artificial tests not relevant for human health assessment
Recent media reports about a new study from the French National Institute for Agricultural Research
, Institut National de la Recherche Agronomique), claiming “high bioavailability of Bisphenol A
through sublingual exposure” must be put into perspective of the chosen methodology and existing
scientific knowledge. Industry is concerned about highly experimental exposure studies being
presented to the public as evidence of dangers for human health. In this context, the
Polycarbonate/Bisphenol A group of PlasticsEurope would like to make the following statement:
The authors´ suggested conclusion that exposure to Bisphenol A (BPA) via sub-lingual
administration might be higher than exposure via the gastro-intestinal tract is not relevant for
human risk assessment. The authors themselves acknowledge that their study design is artificial.
In their experiment, the authors exposed six dogs via different application routes to different doses of
BPA: 0.5 mg/kg bodyweight and 5 mg/kg bodyweight under the tongue (sublingually) and directly into the
blood (intravenous), and 20 mg/kg bodyweight directly into the stomach via a stomach tube. In order to
manage the sublingual exposure, three dogs were narcotized, BPA was dissolved in alcohol and the
solution was deposited under the tongue of the dogs. BPA concentrations were analyzed in blood
collected from the jugular vein.
The study has severe limitations. The authors themselves acknowledge that their dosing is artificial and
indicate that their artificial sublingual dosing is not relevant for human dietary exposure. In addition,
anesthetized dogs don´t swallow, and the authors did not take into account the data of the first blood
collections, but started their analysis after an arbitrary delay of 8 minutes because “The disadvantage of
this blood collection site [jugular vein] is that the corresponding plasma BPA concentrations do not
properly reflect the BPA systemic exposure… during the absorption phase”
This highly experimental study design – applying BPA in highly concentrated ethanol to
anesthetized dogs – is not relevant for humans, and it is not appropriate to indicate conclusions
from such tests as relevant for human risk assessment.
Furthermore, the authors´ general claim that sublingual absorption of BPA may contribute to much higher
internal exposure is not substantiated by this study, and is neglecting the actual realistic exposure
situation. Contrary to sublingual exposure in dogs, studies in humans (Teeguarden et al) that exposed
people via the relevant oral route (diet), as well as data from comprehensive guideline animal studies (Tyl
et al, Stump et al) include chewing and swallowing the diet as the normal route of administration to display
a realistic exposure situation.
The public should be confident that BPA is one of the most studied chemicals and has a safety track
record of 50 years. The European Food Safety Agency EFSA, the US Food and Drug Administration FDA
and other regulatory bodies from around the world have concluded that the science supports the safety of
BPA in its current uses, including its continued use in food-contact products.
Polycarbonate/Bisphenol A group
ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE AISBL
Avenue E. Van Nieuwenhuyse 4/3 – B -1160 Brussels – Belgium
Tel (32-2) 675 32 97 – Fax (32-2) 675 39 35
VAT BE 416 155 338 – WWW.PLASTICSEUROPE.ORG
Only very recently, in April 2013, the US Food and Drug Administration FDA unequivocally reconfirmed
that BPA is safe for its approved uses: Is BPA safe? Yes. Based on FDA’s ongoing safety review of
scientific evidence, the available information continues to support the safety of BPA for the currently
approved uses in food containers and packaging.
FDA’s current perspective is based on its review of hundreds of studies, as well as its comprehensive research on BPA.
For more information:
Tel: +32 2 676 17 38
Fax: +32 2 675 39 35
*High Bioavailability of Bisphenol A from Sublingual Exposure
, Marlène Z. Lacroix1,2, Séverine H. Collet1,2, Catherine Viguié1,2, Alain
Bousquet-Melou1,2, Pierre-Louis Toutain1,2, Nicole Picard-Hagen1,2
INRA (Institut National de la Recherche Agronomique), UMR1331 (Unité Mixe de Recherche 1331),
Toxalim, Research Center in Food Toxicology, F-31027 Toulouse, France; 2Université de Toulouse, INPT
(Institut National Polytechnique de Toulouse), ENVT (Ecole Nationale Vétérinaire de Toulouse), EIP
(Ecole d’Ingénieurs de Purpan), UPS (Université Paul Sabatier), F-31076 Toulouse, France