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Background/aims: Certain consumer products, such as feminine hygiene products, and baby and adult diapers, are worn for prolonged periods of time in close proximity to the skin. A sensitive test method was needed to evaluate these products and their components for the potential to cause mechanical irritation during use., Methods: We investigated several test sites on the body where normal, daily activities provided the opportunity for movement and, therefore, friction. These test sites were: the back of the knee, the axilla, and the wrist. Three exposure regimens were tested: 6-h daily for 4 days, 24-h daily for 3 days, and 24-h daily for 4 days. Controls consisted of satin fabric (a non-irritating material) or burlap (an irritating material). Test materials were secured to the test sites using an Ace elastic bandage (on the back of the knee), a snug fitting garment (on the axilla), or an athletic band (on the wrist). Test sites were scored for irritation on a visual scale prior to the initial application and 30-60 min after removal each day. Data were evaluated for the ability to reliably detect irritating materials, and for the ability to consistently differentiate between irritating and non-irritating materials. Quantitative measures of these abilities were used to rank the overall effectiveness of various test protocols as a model for mechanical irritation., Results/conclusion: The results of these studies indicated that a protocol using the back of the knee as a test site with an exposure regimen of 6-h daily for 4 days, best met the success criteria for an effective test system for evaluating mechanical irritation.

Methods are described for assessing the gynecologic, dermatologic, and microbiologic effects of deodorant and non-deodorant catamenial pad use over a 6-month period. A controlled, randomized, investigator-blind parallel study was conducted with 190 women between the ages of 18 and 45 years. Data on medical histories, physical examinations, diagnostic laboratory tests, gynecologic and dermatologic examinations and microbiology were collected. No significant differences in gynecologic, dermatologic, or microbiologic parameters were observed between control and treated groups, and no pad-related adverse health effects were observed in this clinical study.

Objective: The goals of this study were 1) to better define the labial microflora and 2) to evaluate whether extended non-menstrual use of panty liners would increase genital carriage of undesirable bacteria and predispose to infection., Methods: Healthy female volunteers (224) were prospectively randomized into panty liner wear groups A (Always((R)) deodorant) and B (Always((R)) non-deodorant) and into a control group C (no panty liner wear) with instructions for non-menstrual +/- menstrual use >/=5 h daily for 6 months. Selected aerobic bacteria were semiquantitatively cultured from the inner labial groove, the posterior fornix of the vagina, and the cervix pre-study and post-study. Used panty liners were quantitatively cultured, and vaginal secretions were examined by gas chromatography for fatty acid ratios as a measure of microbial flora shifts., Results: At the pre-study, labial microflora in this study population contained significantly higher frequencies of Staphylococcus, coliforms, other gram-negative rods, and enterococci, and a decreased frequency of Gardnerella vaginalis relative to the vaginal microflora. After 6 months use of panty liners the frequencies (and densities) of the selected microorganisms in these two sites had not changed compared to controls, and fatty acid analyses of vaginal secretions gave no evidence of shifts in the microbial flora., Conclusions: Frequencies of selected genital microflora were different for the labia compared to the vagina. No increased carriage of medically important species was detected for either site after 6 months of daily (average 7.8 h) panty liner use.

The immune defence mechanisms of fish seem to be related and similarly competent to those of mammals. Because of this, there is an increased interest in the immune responses of fish as models for higher vertebrates in immunological/immunotoxicological studies. Macrophages (M phi), phagocytic cells of the mammalian and teleost immune system which reside in tissues, represent a quiescent population of cells. However, upon stimulation, alterations in the physiology of these resident M phi occur which can be defined in terms of activation. This study was undertaken to determine whether biological markers used to assess mammalian M phi activation are applicable for use with fish M phi. Cells were recovered from the peritoneal cavity of non-injected and Aeromonas salmonicida-injected fish, and differences between resident and elicited M phi were evaluated with respect to protein content, phagocytic competence, enzyme activities and hydrogen peroxide production. Results demonstrate that biological markers used to assess mammalian M phi activation, with the exception of acid phosphatase activity, can be used to characterize the activation state of trout M phi, and that the activation process in both fish and mammals may occur by similar mechanism(s).

The immune defense mechanisms of fish are not as well characterized as those of mammals but seem to be related and similarly competent. Because of this, there is an increased interest in the immune responses of fish as models for higher vertebrates in immunotoxicological studies. Prior to such studies, baseline criteria for specific components of the immune response needed to be established. For this study, we have examined trout macrophage morphology using light and scanning electron microscopy, phagocytic activity, random and stimulus-directed migration, and superoxide anion radical (O2-) production for resident and lipopolysacharide (LPS) or Aeromonas salmonicidae-elicited rainbow trout (Oncorhynchus mykiss) peritoneal macrophages (M phi). Following peritoneal lavage, greater than 89% of the cells were M phi as determined by differential counts and nonspecific esterase staining. Immunization with LPS and A. salmonicidae increased M phi number approximately 5 and 13-fold, respectively, and overall size. Trout M phi were phagocytically active engulfing serum opsonized latex particles and were mobile, migrating both randomly and in a directed fashion towards formyl-methionine-L-leucine-L-phenylalanine (FMLP) and trout serum-derived complement fragment C5a. Concentrations of FMLP (100 nM) and C5a (0.01-1%) effective for attracting trout M phi are the same as those used to attract rabbit M phi. Resident trout M phi produced negligable quantities of .O2- following stimulation with 1 micrograms/ml phorbol myristate acetate; Aeromonas-elicited M phi produced .O2- in a time-dependent manner which peaked after 60 min at 2.9 nmol per 2 x 10(5) cells and then declined. The results of this study provide a data base for future toxicological studies with trout peritoneal M phi and indicate the usefulness of this system for immunotoxicological studies.