Inherent Safety Assessment of Industrial-Scale Production of Chitosan Microbeads Modified with TiO2 Nanoparticles.

In this study, the inherent safety analysis of large-scale production of chitosan microbeads modified with TiO2 nanoparticles was developed using the Inherent Safety Index (ISI) methodology. This topology was structured based on two main stages: (i) Green-based synthesis of TiO2 nanoparticles based on lemongrass oil extraction and titanium isopropoxide (TTIP) hydrolysis, and (ii) Chitosan gelation and modification with nanoparticles. Stage (i) is divided into two subprocesses for accomplishing TiO2 synthesis, lemongrass oil extraction and TiO2 production. The plant was designed to produce 2033 t/year of chitosan microbeads, taking crude chitosan, lemongrass, and TTIP as the primary raw materials. The process was evaluated through the ISI methodology to identify improvement opportunity areas based on a diagnosis of process risks. This work used industrial-scale process inventory data of the analyzed production process from mass and energy balances and the process operating conditions. The ISI method comprises the Chemical Inherent Safety Index (CSI) and Process Inherent Safety Index (PSI) to assess a whole chemical process from a holistic perspective, and for this process, it reflected a global score of 28. Specifically, CSI and PSI delivered scores of 16 and 12, respectively. The analysis showed that the most significant risks are related to TTIP handling and its physical-chemical properties due to its toxicity and flammability. Insights about this process's safety performance were obtained, indicating higher risks than those from recommended standards.

[Present and Future of the Japanese Pharmacopoeia in the Clinical Setting and Pharmacy Education].

The Japanese Pharmacopoeia (JP) has played a major role in ensuring the quality of drugs used in Japan as the ultimate source of information on pharmaceuticals. Physicians and pharmacists can reliably use drugs in the clinical setting because they trust the quality when medical treatment progresses smoothly. When there is a problem or challenge, they can refer to the JP. For pharmacists, both the quality of the drug and information on its efficacy and safety are indispensable. Twelve years have passed since the introduction of a 6-year course in pharmacy education, but the weight placed upon the JP has not increased in the educational curriculum. A specific behavioral objective of describing the significance and structure of the JP is included in the revised model core curriculum for pharmacy education. However, fewer than 60% of pharmacy schools have courses specifically focusing on the JP. Professors of physical chemistry, analytical chemistry, pharmaceutics, and pharmacognosy often teach the relevant sections of the JP in their lectures. The foundations of the Japanese manufacturing industry have been questioned because data falsification and inspection fraud have been disclosed in numerous fields. Therefore, ethical education for those who use the JP is a prerequisite for ensuring the reliability of pharmaceuticals.

Vision of a near future: Bridging the human health-environment divide. Toward an integrated strategy to understand mechanisms across species for chemical safety assessment.

There is a growing recognition that application of mechanistic approaches to understand cross-species shared molecular targets and pathway conservation in the context of hazard characterization, provide significant opportunities in risk assessment (RA) for both human health and environmental safety. Specifically, it has been recognized that a more comprehensive and reliable understanding of similarities and differences in biological pathways across a variety of species will better enable cross-species extrapolation of potential adverse toxicological effects. Ultimately, this would also advance the generation and use of mechanistic data for both human health and environmental RA. A workshop brought together representatives from industry, academia and government to discuss how to improve the use of existing data, and to generate new NAMs data to derive better mechanistic understanding between humans and environmentally-relevant species, ultimately resulting in holistic chemical safety decisions. Thanks to a thorough dialogue among all participants, key challenges, current gaps and research needs were identified, and potential solutions proposed. This discussion highlighted the common objective to progress toward more predictive, mechanistically based, data-driven and animal-free chemical safety assessments. Overall, the participants recognized that there is no single approach which would provide all the answers for bridging the gap between mechanism-based human health and environmental RA, but acknowledged we now have the incentive, tools and data availability to address this concept, maximizing the potential for improvements in both human health and environmental RA.

Eating jellyfish: safety, chemical and sensory properties.

BACKGROUND: People's preference for fish with a high trophic level, like Atlantic cod and tuna, leads to a large food footprint. Responsible seafood consumption should include underutilised local products; hence the culinary use of edible jellyfish can be an effective contribution. The present work focused on Catostylus tagi to contribute to the consumption of edible jellyfish in the West. RESULTS: A questionnaire conducted with 192 young people showed an interest in tasting jellyfish-based food (64.6%). The resulting product, obtained by an alternative cooking process to traditional Asian ones, was chemically characterised and underwent microbiological and heavy metals control. The results indicated its non-toxicity. Patients who were allergic to seafood as well as non-allergic volunteers revealed no allergic reaction to the jellyfish umbrella product (intakes up to 5 mg/kg body weight and 8 mg/kg, respectively). Seafood-trained panellists defined the product's main impact on the mouth as freshness (72 mg/kg body weight). The preliminary snack, a pâté, was positively accepted by allergic (7 in 9; n = 20) and non-allergic volunteers (6 in 7; n = 21). CONCLUSION: The present study confirmed that jellyfish intake is safe, even for allergic individuals, and its organoleptic properties were accepted by the study population. © 2018 Society of Chemical Industry.

Safety assessment of animal- and plant-derived amino acids as used in cosmetics.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of animal- and plant-derived amino acid mixtures, which function as skin and hair conditioning agents. The safety of α-amino acids as direct food additives has been well established, based on extensive research through acute and chronic dietary exposures and the Panel previously has reviewed the safety of individual α-amino acids in cosmetics. The Panel focused its review on dermal irritation and sensitization data relevant to the use of these ingredients in topical cosmetics. The Panel concluded that these 21 ingredients are safe in the present practices of use and concentration as used in cosmetics.

Antioxidant capacity versus chemical safety of wheat bread enriched with pomegranate peel powder.

Pomegranate peel powder (PP), a by-product of the pomegranate juice industry rich in polyphenols, was explored for use in bread production, due to its potential health effects. Wheat bread was prepared using different levels for replacement of flour with PP (0 to 10 g per 100 g flour) resulting in antioxidant levels expressed as Trolox equivalent antioxidant capacity values (TEAC) ranging from 1.8 to 6.8 µmol TEAC per g bread for fresh bread. TEAC remained constant during 5 days of storage in polyethylene bags at room temperature. The oxidative stability was evaluated by detection of radicals by direct electron spin resonance (ESR) spectroscopy, and peroxide value, and the highest capacity of scavenging of radicals (Fremy's salt) and the lowest content of peroxide values were found in bread with the highest percentage of PP. Safety evaluation was performed by the Artemia salina assay. An increased death rate of the brine shrimp larvae was found as a function of the replacement of wheat flour with PP in fortified bread providing a general screening method for the toxicological test of polyphenol fortified bread to be recommended for use in product development in addition to subjective evaluation. Based on both toxicological and subjective evaluations an addition of 2.5% PP is recommended for the actual product.

Comparison of microcalorimetric fingerprint profiles of Lonicerae japonicae Flos and Lonicerae Flos.

To compare the microcalorimetric fingerprint profiles of Lonicerae japonicae Flos (Lj.F) and Lonicerae Flos (L.F), microcalormietry was applied to find the heat change regularity of Bacillus shigae (B. shigae) metabolism affected by Lj.F and L.F (we choose Lonicera macranthoides Hand.-Mazz in this paper) with different concentrations. The thermogenic curves and thermodynamics parameters were investigated as evaluation index, and then the date of experiment was studied by similarity analysis. All the results indicated that the Lj.F and Lonicera macranthoides Hand.-Mazz (L.m.H-M) significantly impacted the microbial growth and had good similarity in its inhibitory activities. The combination approach of chemical analysis with bioassay was developed and employed to ensure the safety and efficacy of Chinese herbal medicines.

Comparison of microcalorimetric fingerprint profiles of Lonicerae japonicae Flos and Lonicerae Flos / 药学学报

To compare the microcalorimetric fingerprint profiles of Lonicerae japonicae Flos (Lj.F) and Lonicerae Flos (L.F), microcalormietry was applied to find the heat change regularity of Bacillus shigae (B. shigae) metabolism affected by Lj.F and L.F (we choose Lonicera macranthoides Hand.-Mazz in this paper) with different concentrations. The thermogenic curves and thermodynamics parameters were investigated as evaluation index, and then the date of experiment was studied by similarity analysis. All the results indicated that the Lj.F and Lonicera macranthoides Hand.-Mazz (L.m.H-M) significantly impacted the microbial growth and had good similarity in its inhibitory activities. The combination approach of chemical analysis with bioassay was developed and employed to ensure the safety and efficacy of Chinese herbal medicines.