Toxicological evaluation of a pumpkin-derived pectin preparation: in vitro genotoxicity studies and a 13-week oral toxicity study in Sprague-Dawley rats.

The safety of a rhamnogalacturonan-I-enriched pectin extract (G3P-01) from pumpkin (Cucurbita moschata var. Dickinson) was evaluated for use as an ingredient in food and dietary supplements. G3P-01 was tested in a battery of genetic toxicity studies including reverse mutagenicity and in vitro micronucleus assay. In addition, Sprague-Dawley rats were randomized and orally dosed with G3P-01 incorporated in animal diet at concentrations of 0, 9000, 18,000, and 36,000 ppm daily for 13-weeks (n=10/sex/group) in line with OECD guidelines (TG 408). The results of the in vitro bacterial reverse mutation assay and micronucleus assay in TK6 cells demonstrated a lack of genotoxicity. The 13-week oral toxicity study in Sprague-Dawley rats demonstrated that the test article, G3P-01 was well tolerated; there were no mortalities and no adverse effects on clinical, gross pathology, hematology, blood chemistry, and histological evaluation of the essential organs of the animals. The present study demonstrates that G3P-01 is non-genotoxic and is safe when ingested in diet at concentrations up to 36, 000 ppm. The subchronic no-observed-adverse-effect level (NOAEL) for G3P-01 was concluded to be 36,000 ppm, equivalent to 1,899 and 2,361 mg/kg/day for male and female rats respectively.

Low- and no-calorie sweetener intakes from beverages - an up-to-date assessment in four regions: Brazil, Canada, Mexico and the United States.

The current assessment estimated exposure to four low- and no-calorie sweeteners (LNCS) (aspartame, acesulfame potassium (AceK), steviol glycosides and sucralose) from beverages in Brazil, Canada, Mexico and the United States, using up-to-date nationally representative consumption data and industry reported-use level information. Two modelling scenarios were applied - the probabilistic model was guided by reported use level data, with estimated intake for an individual leveraging market-weighted average use level of a particular LNCS in any given LNCS-sweetened beverage type, while the distributional (brand-loyal) model assumed consumer behaviour-led patterns, namely that an individual will be brand loyal to a pre-determined beverage type. Consumer-only and general population intake estimates were derived for the overall population and individual age categories, and compared to the respective acceptable daily intake (ADI) as established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for each LNCS. The mean, 90th percentile and 95th percentile intake estimates were substantially lower than the ADI in both modelling scenarios, regardless of the population group or market. In the probabilistic model, the highest consumer-only intake was observed for AceK in Brazilian adolescents (95th percentile, 12.4% of the ADI), while the highest 95th percentile intakes in the distributional model were observed for sucralose in Canadian adults at 20.9% of the ADI. This study provides the latest insights into current intakes of LNCS from water-based non-alcoholic LNCS-sweetened beverages in these regions, aligning well with those published elsewhere.

Genotoxicity, acute, and subchronic toxicity evaluation of dried Neurospora crassa protein-rich biomass.

Filamentous fungus biomass is a protein-rich food, which can serve as an alternative to animal, plant, and legume protein sources. Neurospora crassa is a filamentous fungus that typically grows in tropical and sub-tropical regions. Traditionally, N. crassa has served as a model eukaryotic organism due to its ease of growth and propagation and suitability for genetic manipulation. However, filamentous fungi, such as Neurospora, have also been consumed or used to produce fermented foods for centuries and have been developed into protein-rich biomass ingredients to be used in conventional foods and meat substitutes. A panel of toxicological tests including genotoxic, acute, and subchronic studies were conducted on dried N. crassa biomass to support its safe use in food. The dried N. crassa biomass was found to be not genotoxic in a bacterial reverse mutation (Ames) assay, an in vitro chromosomal aberration test, and an in vivo micronucleus test. In the acute and subchronic toxicity studies, rats were orally gavaged with N. crassa biomass at concentrations of 0, 1,000, 2,500, and 5,000 mg/kg body weight/day for 14 and 90 days, respectively. At the conclusion of the studies, there were no test article-related toxicity results observed in clinical observations, body weight, food consumption, ophthalmology, hematology, clinical chemistry, coagulation, thyroid hormone, urinalysis, and macroscopic and microscopic findings. The no-observed-adverse-effect level for the dried N. crassa biomass ingredient was determined to be 5,000 mg/kg body weight/day, the highest dose tested.