Toxicologic evaluation of potassium polyaspartate (A-5D K/SD): Genotoxicity and subchronic toxicity. (November 2017)

• Record Type: Journal Article
• Authors: Galbusera, C.; Casalegno, C.; Marroncelli, S.; Triulzi, G.; Santos, J.; Corsini, E.; Restani, P.
• Is Part Of: Food and chemical toxicology. Volume 109:Part 1(2017)
• Page Start: 452
• Page End: 464
• Publication Date: 2017-11
• Subjects: Potassium polyaspartate (A-5D K/SD) -- Genotoxicity -- Subchronic -- Wine stabiliser; OJEU Official Journal of the European Union -- ALP alkaline phosphatase -- ALT alanine aminotransferase -- ANOVA analysis of variance -- APTT Activated Partial Thromboplastin Time -- AST aspartate aminotransferase -- BNCs micronucleated binucleated cells -- bw body weight -- CBPI Cytokinesis Block Proliferation Index -- CPM cyclophosphamide -- EFSA European Food Safety Authority -- F female -- GLP Good Laboratory Practice -- Hb hemoglobin -- IARC Agency for Research on Cancer -- M males -- MCH Mean Corpuscular Hemoglobin -- MCHC Mean Corpuscular Hemoglobin Concentration -- MCV Mean Corpuscular Volume -- mg/kg milligrams per kilogram -- MMC mitomycin C -- MN micronucleus or micronuclei -- MTA metatartaric acid -- NOAEL No Observed Adverse Effect Level -- NTP National Toxicology Program -- OECD Organization for Economic Cooperation and Development -- OSHA Occupational Safety & Health Administration -- PCV Packed Cell Volume -- PT Prothrombin Time -- RBC red blood cell count -- S9 metabolic activation system -- SD Standard Deviation -- T3 Triiodothyronine -- T4 thyroxine -- TSH Thyroid Stimulating Hormone -- VBC vinblastine -- WBC total white blood cell count; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2017.09.036
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: Potassium polyaspartate (A-5D K/SD) is proposed for use as a stabiliser in wine, with a maximum use level of 300 mg/L and typical levels in the range of 100–200 mg/L. Potassium polyaspartate (A-5D K/SD) tested negative in a bacterial reverse mutation assay performed in accordance with OECD TG 471 and in an in vitro mammalian cell micronucleus test performed in accordance with OECD TG 487. From a 90-day oral toxicity study in male and female Wistar rats performed in accordance with OECD TG 408, a no observed adverse effect level (NOAEL) was set at 1000 mg/kg bw per day, the highest dose tested. In its opinion adopted on 9 March 2016, the EFSA-ANS Panel (European Food Safety Authority - Panel on Food Additives and Nutrient Sources added to Food), considering these data, concluded that "there was no safety concern from the proposed use and use levels of potassium polyaspartate (A-5D K/SD)". Highlights: Potassium polyaspartate (A-5D K/SD) was not mutagenic and showed no genotoxic activity. The NOAEL of the 90-day study was set at 1000 mg/kg bw/d—the highest dose tested. Results support that there is no safety concern from the proposed use and use levels of A-5D K/SD as a stabiliser in wine.