|
Abstract:
Battelle's Medical Research and Evaluation Facility (MREF) was tasked to determine the decontaminant effectiveness of Reactive Skin Decontaminant Lotion (RSDL) and to assist U.S. Army Medical Materiel Development Activity (USAMMDA) in requesting a marketing clearance from the U.S. Food and Drug Administration (FDA) as part of the Foreign Comparative Testing (FCT) program and the Joint Services Fixed Site Decontamination System (JSFXD) Program. The task was divided into two phases. Phase I was comprised of a review of open literature and supplemental information provided by USAMMDA. The review included verification of existing decontaminant efficacy data, and identification of the requirements for filing a Premarket Notification Application 510(k) with FDA center for Devices and Readiological Health (CDRH). Phase II was comprised of four laboratory tasks: three modules and a study to evaluate the offgassing of agent from the applicators following use. Module 1 assessed RSDL performance against VX and HD relative to that of the M291 SDK. Module 2 assessed RSDL's compatibility with fielded materials when decontaminating O-ethyl S-2- (DIISOPROPYLAMINO)ETHYL (VX) and Sulfur Mustard (HD). The third module, labeled Module 8, was comprised of three clinical studies to evaluate RSDL for production of human skin irritation, phototoxicity, and photoallergy. The studies were a 2 1-day cumulative irritation study of RSDL in humans, a repeated insult patch test in humans, and evaluation of phototoxicity and photoallergy. The clinical studies indicated that RSDL exhibits minimal irritation and did not produce phototoxicity or photosensitivity.
| Limitations: |
 APPROVED FOR PUBLIC RELEASE DOCUMENT PARTIALLY ILLEGIBLE |
| Description: |
Annual rept. 1 Jun 2003-31 May 2004 |
| Pages: |
18 |
| Report Date: |
AUG 2004 |
| Contract Number: |
DAMD17-99-D-0010 |
| Report Number: |
A380724 |
|
|
|
|
Keywords relating to this report:
