Abstract
Skin sensitization is an important aspect of safety assessment and is a key component in the toxicological evaluation of chemicals. alpha-Glycosyl isoquercitrin (AGIQ), is marketed in Japan as a food additive and is generally recognized as safe (GRAS) by the expert panel of the Flavor and Extract Manufacturers Association (FEMA) in 2005 and the U.S. Food and Drug Administration (FDA) in 2007. The Local Lymph Node Assay (LLNA) was used to assess AGIQ's potential to cause skin sensitization. Results indicate that no excessive irritation was observed after the irritation screen (ear swelling < 25 % and erythema score < 3) when AGIQ was tested at 5 %, 10 %, and 25 % in N, N-dimethyl formamide [DMF]. Based on lack of irritation, AGIQ was further evaluated at 10 %, 25 %, and 50 % in DMF in the main test resulting in stimulation indices of less than the positive threshold of 1.6 i.e., 1.2, 1.4, and 1.2 respectively. Therefore, AGIQ was not a dermal sensitizer in the LLNA.