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

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 (control, 10 microliter IBC, and 100 microliter IBC), each group containing both mail 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 microliter of isotonic saline also by surgical implantation. Twenty-five animals were removed from the study during the first week after surgery because of underweight condition or post operative complications. All animals were examined daily and weighed and palpated monthly. The animals presented with a variety of transitory clinical signs sporadically throughout the year in addition to the more permanent sequelae of the surgical procedure (xyphoid protuberance, corneal opacity). Results of this study indicate that 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.