| Prophetic patch
testing for irritancy, contact sensitization, phototoxicity or other studies is an
integral step in the safety assessment process for products which, directly or indirectly,
come into contact with the skin. Thus, IRSI continues its focus on programs which will
result in improved methodology to assure that appropriate and useful data can be developed
from these tests. Since risk assessment
triggers the risk management process, IRSI protocols are designed to aid in the
development of the toxicological profile of the test material. It is important to
emphasize that patch testing allows for exaggerated exposure to the test material relative
to anticipated exposure thus providing a benchmark for the Risk Assessment Process.
Defining potential sensitization risk under exaggerated exposure scenarios aids in the
subsequent management of that risk.
IRSI is modifying the experimental design
so that the focus is on (A) the “dose density” of the test substance being
applied and (B) the use of Finn Chambers to assure a more uniform exposure to the
delivered “dose”.
In addition, it has added shorter irritation
exposures (10 and 14 days) to assist companies in obtaining critical data, faster and more
economically.
At the challenge phase, test sites will be examined
at 48 and 96 hours with an option for a 72 hour reading. The consulting dermatologist will
assess reactions at the challenge site(s) and subjects will automatically be rechallenged
when appropriate to confirm positive reactions. Further, IRSI, believing strongly in
maximizing data, offers challenge patching with all of its irritation work.
IRSI is committed to “The
voice-of-our-client” and recognizes the importance of this commitment in preparing
the final protocol. We will LISTEN, in order to provide the greatest flexibility in design
of a study to fit our client’s research needs. I
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