Evaluation of dermal corrosion and irritation by Cytoreg in rabbits.

ABSTRACT

Cytoreg is an experimental therapeutic platform consisting of an aqueous solution of six acids (hydrofluoric, hydrochloric, sulfuric, phosphoric, citric, and oxalic) with oncolytic, antiviral, immune modulatory and antibacterial activities. Cytoreg may be formulated for topical, oral, and parenteral administration. In the present study, a skin corrosion/irritation screen was conducted on three albino rabbits for the Cytoreg topical formulation at three dilutions; one animal each received a dilution of 100 %, 4 %, or 2 % in physiological saline solution. Three intact skin test sites per animal/concentration were evaluated. Each test site was treated with 0.5 mL of the appropriate test substance solution. Site one was dosed for 3 min, then observed. Dose site two was wrapped for 1 h, then both first and second test sites were observed. Dose site three was wrapped for 4 h. One hour after unwrapping the third site, all three test sites were observed for skin irritation and/or corrosion, and again at 24, 48 and 72 h after final unwrap. Based on the 4 -h dose scores through 72 h, the primary irritation index (PII) for Cytoreg is 0.00 at 2 % and 4 %, with a descriptive rating of non-irritating, and 0.25 PII with slightly irritating rating at 100 %.