Comparative study between in vivo and in vitro toxicological methods and microbiological quality assessment in disposable hygienic products

The purpose of this study was to compare both in vivo and in vitro methods evaluating toxicity and microbiological quality of 60 disposable hygienic products samples commercialized in the city of Sao Paulo. For in vivo toxicity testing, both "Draize", and modified Magnusson-Kligman Method" were carried out, and "agar diffusion" was used for in vitro testing, employing NCTC clone 929 (ATCC-CCL1) and SIRC (ATCC-CCL-60) cell lines. Microbiological analysis was performed according to "Bacteriological Analytical Manual On Line", 2001. The analyzed products neither caused primary skin rash, nor cumulative dermal rash, nor cutaneous sensitization, though on in vitro test, slight to severe toxicities were observed in 18 samples on both cell lines, with zone index (ZI) of 2.0 - 4.0. Microbiological analysis revealed high number of mesophilic aerobic microorganisms counting, positive results for molds, and presence of Enterobacter sp, Enterobacter agglomerans and Enterobacter cloacae. Based on the observed data in order to guarantee the consumer - health safety it should be stated the use of in vitro cytotoxicity test for both products of internal and external use, in addition to the tests referred by effective Brazilian laws. The preceding accomplishment of this test might be established as screening test.