Sg. Bradley et al., IMMUNOTOXICITY OF 180 DAY EXPOSURE TO POLYDIMETHYLSILOXANE (SILICONE)FLUID, GEL AND ELASTOMER AND POLYURETHANE DISKS IN FEMALE B6C3F1 MICE, Drug and chemical toxicology, 17(3), 1994, pp. 221-269
Millions of people have been exposed to silicones which are present in
consumer goods such as cosmetics and toiletries, processed foods and
household products. In addition, silicones have been used extensively
in medical practice as a lubricant in tubing and syringes, and as impl
antable devices. A silicone widely used in medical practice is polydim
ethylsiloxane. This study was undertaken to determine the immunotoxico
logic potential of long term exposure to the principal constituents of
breast implants: silicone fluid, silicone gel and silicone elastomer.
An alternative covering for devices containing silicone gels, polyure
thane, was also included in the study. Silicone fluid and gel were inj
ected subcutaneously into female B6C3F1 mice (1 ml/mouse) and 6 mm dis
ks of silicone elastomer or polyurethane were implanted subcutaneously
. There were no treatment-related deaths or overt signs of toxicity du
ring the 180 day exposure. None of the tested materials had notable ef
fects on body or organ weights, erythrocytes or leukocytes in the bloo
d, blood chemistries such as alanine aminotransferase, urea nitrogen,
glucose, albumin or total protein, or serum CH 50 or C3 levels. The ce
llularity of the bone marrow and responses to CSF-GM and CSF-M were no
rmal. The tested silcones and polyurethane marginally reduced the leve
l of Ig(+) cells in the spleen but did not consistently alter the dist
ribution of T cell surface markers. The antibody response to sheep ery
throcytes was not markedly altered, nor were proliferative responses t
o concanavalin A, phytohemagglutinin, lipopolysaccharide or allogeneic
cells. Reticuloendothelial function was normal, as was phagocytosis o
f chicken erythrocytes and Covaspheres by adherent peritoneal cells. N
atural killer cell activity was depressed in all silicone treatment gr
oups and in mice implanted with polyurethane. No silicone or polyureth
ane treatment group displayed altered susceptibility to a challenge wi
th Listeria monocytogenes, Streptococcus pneumoniae or the B16F10 tumo
r. The only consistent effect of 180 day exposure to silicone material
s or polyurethane was a modest depression of natural killer cell activ
ity.