The cyclopropenoid fatty acids (CPFA), sterculic and malvalic acids are unique fatty acids common in cotton. CPFA are naturally present in cotton and are considered to be undesirable antinutritional compounds of concern for food and feed safety. Likewise, results of CPFA analyses showed no statistical differences and therefore were not considered biologically relevant.
Total gossypol levels were measured in cottonseed and there were no statistical differences in the gossypol level obtained for event 15985 and the mean value was within the non transgenic and commercial reference ranges.
The Cry2Ab2 protein does not pose a significant allergenic risk, as it is not derived from an allergenic source, does not possess immunologically relevant sequence similarity with known allergens and does not possess the characteristics of known protein allergens. The results of bioinformatics analyses indicate that the Cry2Ab2 is not similar to any toxin or other protein relevant to animal or human health. Likewise, the Cry2Ab2 protein shares no significant sequence similarity with protein toxins relevant to animal or human health. There were no adverse effects attributed to the oral administration of Cry2Ab2 protein in male and female mice at doses up to 1450 mg/kg body weight.
The GUS protein degraded rapidly when added to stimulated gastric fluid and intestinal fluid as assessed by both western blot analysis and enzymatic activity assays.  No detectable fragments of the parent GUS protein were detected.  Western blot analyses of the GUS protein after defatted cottonseed meal derived from Cotton MON 15985 or its parental control were heated for 25 minutes at 121 0C and 30 psi to simulate the commercial processing of cottonseed meal showed a complete loss of immunodetectability.  Based on the limit of detection data, detectable GUS protein decreased by 50-70% depending on the extraction buffer used.  The GUS sequence is not homologous to protein toxins or proteins associated with animal and health risks.  There were no treatment related adverse effects in mice administered GUS protein by oral gavage at actual dosages up to 69 mg/kg body weight.