Biological evaluation of a polyvinyl siloxane impression material

Objectives The aim of this study was to determine the irritant properties of a new polyvinyl siloxane impression material (Ghenesil™, Lascod-Italy) after single application to intact skin of the rabbit. Methods The material was evaluated for primary skin irritation according to the UNI EN ISO 10993-10:1996 using three healthy male New Zealand White rabbits. The back of the animals was clipped free of fur and divided into four sites with the same area 24 h before application of the sample. The material was applied to only two sites; the other two were used as controls. All the sites were covered by gauze and the back of the rabbit was wrapped with a non-occlusive bandage. After 4 h, the bandage and the test material were removed; 1 h later the sites were examined for skin irritation and the observation was repeated after 24, 48 and 72 h. The Score of Primary Irritation (SPI) was calculated for each animal and the Primary Irritation Index (PII) was calculated as the arithmetical mean of SPI values. Results The PII of the test material resulted 0.06. Significance Based on present results, it can be concluded that the primary skin irritation of the polyvinyl siloxane impression material tested can be considered negligible.