Details

Autor(en) / Beteiligte

• Vij, Puneet
• Donahue, Douglas A.
• Burke, Keith P.
• Hayashi, Shim-mo
• Maronpot, Robert R.

Titel

Lack of skin sensitization hazard potential for alpha-glycosyl isoquercitrin (AGIQ) utilizing the Local Lymph Node Assay

Ist Teil von

• Toxicology reports, 2022-01, Vol.9, p.1291-1296

Ort / Verlag

Ireland: Elsevier B.V

Erscheinungsjahr

2022

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• 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. [Display omitted] •Topical application of AGIQ in DMF resulted in SI value less than 1.6.•All animals survived in-life phase of the study and were observed to be normal.•AGIQ is not a dermal sensitizer in the LLNA.•AGIQ did not produce a SI value greater than 1.6 and an EC1.6 therefore could not be calculated.•Concentration and homogeneity of AGIQ formulations were within acceptance criteria.