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6 Testing and Evaluation
Pages 138-150

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From page 138...
... policy prohibits most tests using real agents and studies with human volunteers (except with surrogate agents)
From page 139...
... DPK models may provide kinetic details and suggest mechanisms that could supplement traditional clinical studies. Therefore, DPK models can be used to evaluate both percutaneous absorption (Gupta et al., 1993; Shah et al., 1991, 1993; Zhai and Maibach, 1996)
From page 140...
... The following 10 factors should be included in rigorous evaluations of percutaneous absorption (Wester and Maibach, 1983~: · vehicle release · absorption kinetics · excretion kinetics · cellular and tissue distribution · substantivity · wash and rub resistance · volatility · binding · anatomical pathways · cutaneous metabolism For more detailed scientific information on these 10 factors, see Appendix E Vehicle Release Percutaneous absorption of a drug from a vehicle (i.e., mechanism of transport)
From page 141...
... Cellular and Tissue Distribution The concentration of chemical in the skin is usually highest near the surface and lowest in the dermis. Differences in percutaneous absorption depend not only on the thickness, surface area, and number of cell layers in the stratum corneum, but also on lipid composition and concentration distribution of the chemical in the skin layers.
From page 142...
... Mechanical stress on the skin, such as friction from clothing, may alter both the distribution of the applied dose and percutaneous absorption. Volatility Volatility refers to the partition of a chemical between its vehicle on the skin surface and the surrounding air (an important factor for mosquito repellents)
From page 143...
... Evaluation of Barrier Creams Recently, DPD models and noninvasive bioengineering techniques have been adapted to quantify the efficacy of protective or decontaminating barrier creams. These tests provide accurate, reproducible, and objective observations that can reveal subtle differences before visual clinical signs (e.g., blisters)
From page 144...
... . umea pigs Humans with a history of allergic reactions to test allergens Humans who had positive patch tests to toxicodendron extract n-Hexane, trichloroethylene, and toluene cutting oil epoxy resin, glyceryl monothioglycolate, frullania, and tansy toxicodendron extract 3 waterer 2 barrier 1 barrier various ~ preparati Guinea pigs and humans sodium lauryl sulfate, sodium several b, hydroxide, toluene, and lactic acid Human skin dyes (eosin, methylviolet, oil red 0)
From page 145...
... oil red 0) 16 barrier creams Various protection Treffel et al., 1994 effects.
From page 146...
... Models In Vivo Animals or Irritants Barrier In Vitro Human or Allergens Cream Humans water 2 barrier a moistu Humans 10% sodium lauryl sulfate, 4 barrier 1% NaOH, 30% lactic acid, and white pe undiluted toluene Humans toluene several b Humans toluene and NaOH several b Guinea pigs sulphur mustard povidon~ ointment Humans self-application of barrier cream oil-in-we Human skin [35S] -SLS 3 quaterr (Q18B)
From page 147...
... None prevented the skin erythema induced by toluene. One barrier cream, as well as petrolatum and a fatty cream, protected the skin significantly against NaOH.
From page 148...
... Another problem with the MIST study was that the comparability of MES to H or V agents was not taken fully into account. Thus, the MIST review committee judged that the MIST data might be used qualitatively to rank some types of PPE, but that the data could not be used to make quantitative assessments because the information obtained using the passive dosimeters (i.e., samplers)
From page 149...
... This may require better coordination among groups at SBCCOM and Dugway Proving Ground. Current mask filters are extremely efficient and afford adequate protection under expected challenge conditions.
From page 150...
... Recommendation. Active samplers or improved passive samplers for mask testing using simulants should be developed and made available for tests of the joint service lightweight integrated suit technology (ISLIST)


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