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Sucralose, a sugar substitute first approved for use in 1991, is a non-caloric sweetener regulated globally as a food additive. Based on numerous experimental animal studies (dating to the 1980s) and human epidemiology studies, international health agencies have determined that sucralose is safe when consumed as intended. A single lifetime rodent carcinogenicity bioassay conducted by the Ramazzini Institute (RI) reported that mice fed diets containing sucralose develop hematopoietic neoplasia, but controversy continues regarding the validity and relevance of these data for predicting health effects in humans. The present paper addresses the controversy by providing the perspective of experienced pathologists on sucralose-related animal toxicity and carcinogenicity data generally, and the RI carcinogenicity bioassay findings specifically, using results from publicly available papers and international regulatory authority decisions. In the authors' view, flaws in the design, methodology, data evaluation, and reporting of the RI carcinogenicity bioassay for sucralose diminish the value of the data as evidence that this agent represents a carcinogenic hazard to humans. This limitation will remain until the RI bioassay is repeated under Good Laboratory Practices and the design, data, and accuracy of the pathology diagnoses and interpretations are reviewed by qualified pathologists with experience in evaluating potential chemically-induced carcinogenic hazards. [ABSTRACT FROM AUTHOR]

The growing world population, changing dietary habits, and increasing pressure on agricultural resources are drivers for the development of novel foods (including new protein sources as well as existing protein sources that are produced or used in an alternative way or in a different concentration). These changes, coupled with consumer inclination to adopt new dietary trends, may heighten the intake of unfamiliar proteins, or escalate consumption of specific ones, potentially amplifying the prevalence of known and undiscovered food allergies. Assessing the allergenicity of novel or modified protein-based foods encounters several challenges, including uncertainty surrounding acceptable risks and assessment criteria for determining safety. Moreover, the available methodological tools for gathering supportive data exhibit significant gaps. This paper synthesises these challenges, addressing the varied interpretations of "safe" across jurisdictions and societal attitudes towards allergenic risk. It proposes a comprehensive two-part framework for allergenicity assessment: the first part emphasises systematic consideration of knowledge and data requirements, while the second part proposes the application of a generic assessment approach, integrating a Threshold of Allergological Concern. This combined framework highlights areas that require attention to bridge knowledge and data gaps, and it delineates research priorities for its development and implementation. [ABSTRACT FROM AUTHOR]

PFOA is one of the most representative compounds in the family of perfluorinated organic compounds. Due to its varying toxicity, alternatives to PFOA are beginning to emerge. HFPO-TA is an alternative for PFOA. It is currently unclear whether HFPO-TA affects glucose and lipid metabolism. In this study, rats were used as an animal model to investigate the effects of HFPO-TA on liver glucose and lipid metabolism. We found that HFPO-TA can affect glucose tolerance. Through omics analysis and molecular detection, it was found that HFPO-TA mainly affects the PPAR signaling pathway in the liver of rats, inhibiting liver glycolysis while promoting glucose production. HFPO-TA not only promotes the synthesis of fatty acids in the liver, but also promotes the breakdown of fatty acids, which ultimately leads to the disruption of hepatic glucose and lipid metabolism. The effects of HFPO-TA on metabolism are discussed in this paper to provide a reference for the risk assessment of this PFOA substitute. [Display omitted] • HFPO-TA affects the genes, metabolites involved in glucose and lipid metabolism. • HFPO-TA inhibits glycolysis while promoting glucose synthesis. • HFPO-TA affects the PPAR signaling pathway. [ABSTRACT FROM AUTHOR]

Rutin is a flavonoid present in numerous fruits and vegetables and therefore widely consumed by humans. It is also a popular dietary supplement of 250–500 mg/day. There is considerable consumer interest in rutin due to numerous reports in the biomedical literature of its multi-system chemo-preventive properties. The present paper provides the first assessment of rutin-induced hormetic concentration/dose responses, their quantitative features and mechanistic basis, along with their biological, biomedical, clinical, and public health implications. The findings indicate that rutin-induced hormetic dose responses are widespread, being reported in numerous biological models and cell types for a wide range of endpoints. Of critical importance is that the optimal hormetic findings shown in in vitro systems are currently not achievable for human populations due to low gastrointestinal tract bioavailability. These findings have the potential to strengthen future experimental studies with rutin, particularly concerning study design parameters. [Display omitted] • Rutin is a flavonoid present in fruits and vegetables consumed by humans. • Rutin displays multi-system chemo-preventive properties. • First assessment of rutin-induced hormetic dose responses and its implications. • Several biological models and cells show rutin-induced hormetic dose responses. • Findings have the potential to strengthen future experimental studies with rutin. [ABSTRACT FROM AUTHOR]

Quercetin is a polyphenol present in numerous fruits and vegetables and therefore widely consumed by humans with average daily dietary intakes of 10–20 mg/day. It is also a popular dietary supplement of 250-1000 mg/day. However, despite the widespread consumer interest in quercetin, due to its possible chemopreventive properties, the extensively studied quercetin presents a highly diverse and complex array of biological effects. Consequently, the present paper provides the first assessment of quercetin-induced hormetic concentration/dose responses, their quantitative features and mechanistic foundations, and their biological, biomedical, clinical, and public health implications. The findings indicate that quercetin-induced hormetic dose responses are widespread, being independent of biological model, cell type, and endpoint. These findings have the potential to enlighten future experimental studies with quercetin especially with respect to study design parameters and may also affect the appraisal of possible public health benefits and risks associated with highly diverse consumer consumption practices. • Quercetin commonly induces hormetic responses. • Hormetic responses induced by quercetin occur in numerous cell types. • Hormetic mechanisms have been reported in numerous studies. • Public health applications are provided. [ABSTRACT FROM AUTHOR]

Cannabis sativa L., commonly known as industrial hemp, is a versatile plant with applications ranging from medicinal to agricultural and industrial uses. Despite its benefits, there is a notable gap in regulatory toxicology, in understanding the extent of element accumulation in hemp, which is critical due to its ability to absorb various elements from the soil, including heavy metals (Pb, Cd, Hg, and As), uptakes potential toxic elements (e.g., Sb, Sn, Sr, Bi, Tl), problematic elements (Ni, Cr, Co), and essential elements (Zn, Cu, Fe, Mn). The paper aims to enrich current understandings by offering a comprehensive analysis of elements absorption in industrial hemp. This study emphasizes the potential health risks linked with hemp consumption including regulatory toxicology aspects: limits, Permitted Daily Exposures (PDE), recommendations in different countries and from different agencies/bodies (like the WHO and the EU) based on route of administration, jurisdiction and actual literature review. This review contributes significantly to the knowledge base on hemp safety, serving as a valuable resource for researchers, regulatory bodies, and industry stakeholders. • Hemp (C. sativa) has the ability to absorb heavy metals from the soil. • Hemp is used in phytoremediation due to the accumulation of toxic elements. • Hemp bioaccumulation varies by plant part, species, and geographical region. • Studies of elemental impurities in hemp products are crucial for consumer safety. [ABSTRACT FROM AUTHOR]

The chemical safety of poly (butylene adipate- co -terephthalate) (PBAT) based food contact articles (FCAs) has aroused increasing toxicological concerns in recent years, but the chemical characterization and associated risk assessment still remain inadequate as it fails to elucidate the distribution pattern and discern the potential genotoxic and carcinogenic hazards of the identified substances. Herein, the volatile organic compounds (VOCs) in 50 batches of PBAT-based FCAs of representative categories and 10 batches of PLA and PBAT pellets were characterized, by which 237 VOCs of 10 chemical categories were identified and exhibited characteristic distribution patterns in the chemical spaces derived from their molecular descriptors. Chemical hazards associated with the identified VOCs were discerned by a hazard-driven classification scheme integrating hazard-related knowledge from multiple publicly available sources, and 34 VOCs were found to bear genotoxic or carcinogenic hazards and to feature higher average molecular weight than the other VOCs. Finally, the Risk and hazard quotient (HQ) calculated as the metrics of risk suggested that all identified VOCs posed acceptable risks (Risk<10–4 or HQ < 1), whereas oxolane, butyrolactone, N,N-dimethylacetamide, 2-butoxyethanol, benzyl alcohol, and 1,2,3-trichloropropane posed non-negligible (Risk>10–6) genotoxic or carcinogenic risk and thus should be of prioritized concern to promote the chemical safety of PBAT-based FCAs. [Display omitted] • VOCs in 50 batches of PBAT-based FCAs characterized by untargeted HS-SPME-GC-MS. • 213 VOCs of 10 chemical categories identified in 5 categories of the FCAs. • A hazard-driven scheme was proposed for classifying chemical hazards of the VOCs. • 34 VOCs found to be associated with genotoxic or carcinogenic hazards. • Acceptable risk for all VOCs but 6 VOCs need attention due to non-negligible risk. [ABSTRACT FROM AUTHOR]