Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Mar 2020
Estimation of time to compromised tenability in fires: is it time to change paradigms?
The ISO standard 13571 estimates the time to the compromised tenability of people in enclosed fires. This is understood as the time which must be available for the structural design to pass an evacuation, or an escape paradigm for the evacuation of burning buildings. As with all emergency response planning values, such once-in-a-lifetime events cannot readily be validated side-by-side. ⋯ Consistent with published evidence from humans, carboxyhemoglobin (COHb) saturation-a biomarker of exposure rather than of effect-failed to reliably predict effect-based outcomes. Unlike the LCt01 × 1/3 threshold approach, the COHb-based median approach used by ISO TS 13571 is inconsistent with human evidence and both over- and under-estimates the CO-related potency for causing incapacitation at non-toxic and critically-toxic C × 's, respectively. In summary, it seems timely that the ISO TS 13571 standard pays attention to scientific progress in relevant toxicity information and refinements to scientific methods shown to adequately predict human risks.
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Regul. Toxicol. Pharmacol. · Oct 2019
Use of social media to establish vapers puffing behaviour: Findings and implications for laboratory evaluation of e-cigarette emissions.
The recent growth in e-cigarette use has presented many challenges to Public Health research, including understanding the potential for e-cigarettes to generate toxic aerosol constituents during use. Recent research has established that the way e-cigarettes are puffed influences the magnitude of emissions from these devices, with puff duration the dominant driving force. Standardised puffing machine methods are being developed to harmonise testing approaches across laboratories, but critical to their success is the degree with which they accurately reflect vapers real-world puffing behaviours (topography). ⋯ A range of new behavioural patterns have been identified whose impact on aerosol exposure need to be considered. Public-domain video records of vapers provides valuable and accessible insights into real-world use behaviours. It is freely available, and constantly updated with new material, and therefore provides a valuable resource for scientists seeking to understand real-world vaping behaviours.
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Regul. Toxicol. Pharmacol. · Aug 2019
The selective determination of potentially carcinogenic polycyclic aromatic compounds in lubricant base oils by the DMSO extraction method IP346 and its correlation to mouse skin painting carcinogenicity assays.
Mineral oils are produced by vacuum distillation of crude oil at temperatures from ∼300 °C to ∼600 °C. Subsequent refining processes to eliminate the carcinogenic potential of mineral oils (by extraction and/or hydrotreatment) are based on the principle of removing substances associated with carcinogenic activity; i.e. PAC (polycyclic aromatic compounds), which include PAH and N or S heterocycles. ⋯ The DMSO based IP346 is thus a simple but clear reflection of refinement efficacy. It links manufacturing conditions to carcinogenic potential of an oil, supported by solid physical-chemical and toxicological associations. In Europe it is the only legally binding method to assess, classify and label lubricating base oils and inherently more reliable for hazard assessment than the determination of an arbitrary selection of PAH.
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Regul. Toxicol. Pharmacol. · Apr 2019
ReviewShort commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products.
A range of generic valsartan products have been found to be contaminated with nitrosamines (principally N-nitrosodimethylamine; NDMA). We present information and discuss various elements of this phenomenon including: actions taken by regulatory agencies, source of the nitrosamine impurities, range of possible risk assessments based mainly on ICH M7 criteria, epidemiological assessment and analytical aspects.
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Regul. Toxicol. Pharmacol. · Feb 2019
ReviewLegal aspects of zebrafish neuropharmacology and neurotoxicology research.
Despite the growing emphasis on translational neuropharmacology and drug discovery research, the legality underlying these fields are seldom considered. The zebrafish (Danio rerio) is an increasingly utilized model organism in neuropharmacology and neurotoxicology. ⋯ Here, we discuss a wide range of regulatory topics relevant to zebrafish research, such as the bioethics of experimentation (including studies of stress and pain), welfare protection laws, the recent advances in CNS drug discovery, and specific legal aspects of controlled substance research in this aquatic species. The conceptualization and understanding of the zebrafish welfare and its promise as a model in toxicology can also potentially shape environmental protection practices and inform policy making.