2A.2a Report on FDA Approved Acrylic
Description
This article is from the Piercing FAQ, by Anne Greenblatt with numerous contributions by others.
2A.2a Report on FDA Approved Acrylic
by Michael Hare
The Exotic Body, Sacramento, California
http://www.exoticbody.com
mike@exoticbody.com
Presented at the Association of Professional Piercers Open Meeting
May 1998
Edited by Anne Greenblatt
We have found a Food and Drug Administration (FDA) approved acrylic
styrene copolymer (hereby referred to as "our acrylic"). Our acrylic
provides superior resistance to stress hazing and surface grazing when
compared to straight acrylic. The FDA has approved our acrylic for
applications in which it is in contact with the body. Our acrylic
meets USP XXI Class VI plastics guidelines for medical devices.
The USP XXI Class VI testing is done by United States Pharmacopoeia
which conducts biological tests for Class VI plastics. It has been
determined that our acrylic meets USP XXI Class VI specifications and
therefore is acceptable for use in medical applications. Cytotoxicity
as well as Hemolysis tests were also done. The cytotoxicity test
determine the degree of cell destruction caused by exposing certain
cell cultures to an extract of the polymer. The Hemolysis test
determines the degree of destruction of blood cells that occurs when
specific extracts of the polymer are introduced into the blood. The
results of these tests show that our acrylic is non-toxic as well as
non-hemolytic.
Glow-in-the-dark Acrylic
It is our position that no glow-in-the-dark acrylic can be safe for
the body. The phosphorescent material is carcinogenic. It should not
be in contact with the body for any time. The alternative is UV or
Black Lite acrylic which is reactive under a black light and appears
to glow. This UV material is not carcinogenic.
Sterilization and Disinfection of Acrylic
At this time no known acrylic jewelry can be sterilized by
autoclave. We have tested our acrylic in the most frequently used cold
sterilization solutions.
MadaCide: After soaking for 72 hours there was no cracking or
discoloration of the jewelry.
Isopropyl alcohol (91%): Soaking for 48 hours yielded the same result.
We are in the process of looking into Gamma Ray Radiation sterilization.
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