| Comment Record |
|
Commentor |
Miss Ann Mallon |
Date/Time |
2003-04-06 14:03:53 |
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Organization |
Pem |
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Category |
Health Professional |
| Comments for FDA General |
| Questions |
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1. General Comments
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Dear Mark McClellan M.D Ph.D.,
I am deeply concerned to hear that you are using sensitive species for five
animal tests (skin corrosion, irritation experiments, skin absorption,
phototoxicity and pyrogenicity)
It is unethical and cruel to put restraining devices around rabbits and put
corrosive chemicals on their shaven skin. The chemical is considered to be
corrosive if it eats through the skin, burning away several layers of
tissue. Like all the other animal tests, no painkillers or aesthetics are
provided.
Humane and relevant non-animal tests do exist. Human skin tests, such as
EpiDerm (Trademark) and EpiSkin (Trademark) which use artificial skin, can
measure chemical corrosivity. The method called Corrositex (TM)uses a
protein membrane which is designed to function like skin.
Regarding skin irritation tests, Canada accepts skin-patch tests as it is
non-invasive and relates directly to people. Before reaching this stage, the
chemical would have successfully passed non-animal methods of testing
(computer models and other test-tube studies) to make sure that it does not
have any harmful properties.
I feel it is deeply wrong to smear chemicals on the backs of shaved rats. An
internationally accepted non-animal test for skin absorption
measure the passage of of a test chemical into and across skin to a fluid
reservoir using real or artificial skin.
Phototoxicity experiments causes swelling and sores from test chemicals
being applied to patches of shaved skin. The 3T3 NRU Phototoxicity, on the
other hand, is a non-animl test which exposes cells to a test chemical in
the presence and absence of light. The degree to which the light absorbes a
special neutral red dye tells us the toxicity of a test chemical.
Breathing problems, circulatory and orghan failure and fatal shock often
result from the pyrogenicity test on animals (injection of a test substance
into the bloodstream of rabits). A non-animal test-tube method, the in
vitro pyrogen test, provides accurate and cruelty-free information as to
whether drugs are contaminated with fever and inflammation causing
substances (pyrogens).
I would be grateful if you could switch to these the cruelty-free non-animal
tests today.
Thank you very much indeed for taking the time to read this letter an I look
forward to hearing from you shortly.
Yours sincerely,
Ann Mallon
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