Abstract

DIAZ BESTARD, Jorge et al. Oral acute toxicity and irritation on buccal mucosa evaluation of the CM-95 solution magnetically treated. Acta toxicol. argent. [online]. 2008, vol.16, n.2, pp.34-40. ISSN 1851-3743.

CM-95 solution magnetically treated is a product which showed immunologic properties in preliminary tests, characteristic that makes it adequate as inmunopotentiator candidate. In this study the possible preclinical toxic effects of CM-95 Solution magnetically treated were evaluated, by the Acute Toxicity Class method and oral mucosa irritation test, adapting guideline OECD 423 and ISO 10993-10. In Acute Toxicity Class method was used the Limit Test, in Sprague Dawley females rats, where the dose was related to the magnetic induction level, in this case 0.16 T, applied to CM-95 Solution; and the administration volume of aqueous solution was calculated on base 2 ml per 100 g body weight. Determination of oral mucosa irritation was carried out in female golden Syrian hamsters by means of a repeated doses test during 7 days of treatment in right gular bag, with a cotton pellet impregnated with 0.5 ml of CM-95 Solution magnetically treated with the same induction. Neither mortality nor evidences of toxic signs were observed for the test of acute toxicity, and an irritation index of 0 was obtained on oral mucosa irritation test, reason why the studied substance was framed as "not classified" and "non irritating" according to the applied methodology. These results will complement other toxicological studies to guarantee the safety of this Solution for its future use as a drug by oral route.

Keywords : Acute toxicity; ACT; Immunopotentiator; CM-95 Solution magnetically treated.

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