A Carcinogenicity Bioassay of Isobutyl 2-Cyanoacrylate (IBC) in Fischer-344 Rats -- One-Year Interim Sacrifice Report. Volume 2. Part 1

This report covers the results from the first year of a two-year carcinogenicity bioassay of the tissue adhesive, isobutyl 2-cyanoacrylate (IBC). Four hundred seven 6-week old Fischer-344 rats were randomized into three groups, each group containing both male and female animals. The IBC was administered by surgical implantation of liquid monomer directly onto the ventral capsule of the liver. The monomer was allowed to polymerize before two-layer closure of the abdominal incision. Control animals received 100 milliliters of isotonic saline also by surgical implantation. Results of this study indicate the IBC has no effect on survival, weight gain, or the clinical condition of rats during the first year following its implantation. The only gross or histopathological finding observed in the first year attributed to the IBC treatment was the presence of adhesions on and a granulomatous reaction of the liver and those adjacent organs that came in contact with the IBC. No tumors were observed during the first year that could be attributed to IBC treatment. Keywords: Toxicity, Experimental data, Tables data. See also Volume 2, Part 2, ADA197679.