Regulatory Toxicology and Pharmacology

Article	Citations
Systematic review of epidemiological studies evaluating the association between exposure to man-made vitreous fibers and non-malignant respiratory diseases	181
Resource and animal use implications of the proposed REACH information requirements for endocrine disruptor assessment	80
Applicability of the in vitro skin irritation methods (EpiSkin™, EpiDerm™ SIT) to organosilicon-based substances	80
Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers	76
Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world	67
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia	62
Applicability of nanomaterial-specific guidelines within long-term Daphnia magna toxicity assays: A case study on multigenerational effects of nTiO2 and nCeO2 exposure in the presence of artificial da	60
Characterization of false positive, contaminant-driven mutagenicity in impurities associated with the sotorasib drug substance	57
Extended One-Generation Reproductive Toxicity (EOGRT) study of benzoic acid in Sprague Dawley rats	55
Mercury in skin-care products in India and consumer exposure risks	50
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	45
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	42
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	40
A simplified index to quantify the irritation/corrosion potential of chemicals – Part II: Eye	40
Egg residue and depletion in Rhode Island Red hens (Gallus gallus domesticus) following multiple oral doses of trimethoprim-sulfamethoxazole	37
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	37
A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products	37
Regulatory safety pharmacology and toxicity assessments of a standardized stem extract of Cassia occidentalis Linn. in rodents	36
Toxicity reference values (TRVs) for force health protection: Gap identification and TRV prediction	35
Use of nonclinical toxicity studies to support biosimilar antibody development	34
Probabilistic pharmacokinetic modeling of airborne lead corresponding to toxicologically relevant blood lead levels in workers	34
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	33
Characterization of tea tree oil nanoemulsion and its acute and subchronic toxicity	33
Non-sugar sweeteners and cancer: Toxicological and epidemiological evidence	33
Sensory irritation and use of the best available science in setting exposure limits: Issues raised by a scientific panel review of formaldehyde human research studies	31

Comprehensive analysis of chronic rodent inhalation toxicity studies for methyl acrylate with attention to test conditions exceeding a maximum tolerated concentration	27
28-Day oral (gavage) and 13-week (dietary) toxicity studies of DHA canola oil and DHA canola meal in rats	27
Quantitative risk assessment of skin sensitising pesticides: Clinical and toxicological considerations	27
Preclinical safety, toxicokinetics and metabolism of BIIB131, a novel prothrombolytic agent for acute stroke	26
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids	26
Editorial Board	25
Editorial Board	25
Letter to the editors regarding “The conundrum of the PFOA human half-life, an international collaboration”	25
Inhalation exposure assessments under REACH – Problems encountered using the approach recommended by the ECHA guidance R.15	25
Probabilistic methods for non-cancer health effects	24
Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment	24
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	24
Pathogenetic role of alveolar surfactant depleted by phosgene: Biophysical mechanisms and peak inhalation exposure metrics	24
Editorial Board	22
Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary	22
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	22
Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen	22
Editorial Board	22
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments	21
Editorial Board	21
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline	21
Richardia brasiliensis Gomes: phytochemical characterization, antiproliferative capacity and in vitro and in vivo toxicity	20
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	19
Uncertainty in the results from oral repeated dose toxicity tests: Impact on regulatory classifications	18
SCCS scientific opinion on HAA299 (nano) - SCCS/1634/21	18
Monosodium glutamate in a type 2 diabetes context: A large scoping review	18
Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios	18
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?	18
Skin and eye irritancy assessment of six lactic acid bacteria strains	17
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	17
SCCS Scientific Opinion on Acid Yellow 3 (submission II) – SCCS/1631/21	17
Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach	17
A systematic assessment of the epidemiologic literature regarding an association between acetaminophen exposure and cancer	16
Re: A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication	16
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 3: Inflammatory response following acute inhalation exposure correlates with lower tier data	16
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	15
Development and application of a systematic and quantitative weighting framework to evaluate the quality and relevance of relative potency estimates for dioxin-like compounds (DLCs) for human health r	15
Analysis for data-derived extrapolation factors for procymidone	15
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	15
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	15
A multi-tiered hierarchical Bayesian approach to derive toxic equivalency factors for dioxin-like compounds	15
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	14
Safety assessment of phytase transgenic maize 11TPY050 in Sprague-Dawley rats by 90-day feeding study	14
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	14
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	14
Enzymes and sensitization via skin exposure: A critical analysis	14
Editorial Board	14
Nicotine dosimetry and stability in cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions	14
Ethylene oxide derived glycol ethers: A review of the alkyl glycol ethers potential to cause endocrine disruption	14
Non-mutagenic impurities – Recent industry experience of using dose durational limits in drug development	14

Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standa	14
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	14
Compounded conservatism in European re-entry worker risk assessment of pesticides	13
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	13
Dose response effect of chemical surface concentration on percutaneous penetration in human: In vivo + in vitro	13
Detailed aggregate exposure analysis shows that exposure to fragrance ingredients in consumer products is low: Many orders of magnitude below thresholds of concern	13
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations	13
Editorial Board	13
A roadmap towards a human-centric safety assessment of advanced therapy medicinal products	13
Toxicological evaluation of a glycan preparation from an enzymatic hydrolysis of Saccharomyces cerevisiae	13
Retrospective analysis of dog study data from food and color additive petitions	12
The definition of chemical contaminants in food: Ambiguity and consequences	12
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	12
Twenty six-week repeat dose oral rat toxicity study of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	12
Grouping of short alkyl-chain branched carboxylic acids for developmental toxicity	12
Implications of variability on medical device chemical equivalence assessment	12
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	12
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	12
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
Determination of “fitness-for-purpose” of quantitative structure-activity relationship (QSAR) models to predict (eco-)toxicological endpoints for regulatory use	11
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	11
Specificity of the local lymph node assay (LLNA) for skin sensitisation	11
Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency	11
A systematic review of adverse health effects associated with oral cadmium exposure	11
A deep dive into historical Ames study data for N-nitrosamine compounds	11
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	11
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	11
Data collection initiatives of the crop protection industry – A mission to improve non-dietary risk assessment in Europe	11
Particle size distribution in the evaluation of the inhalation toxicity of cosmetic spray products	11
The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test	11
Experimental study for the establishment of a chemotherapy-induced ovarian insufficiency model in rats by using cyclophosphamide combined with busulfan	11
Biomonitoring Equivalents for glyphosate	11
Editorial Board	11
Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes	11
An integrated assessment of the 1,4-dioxane cancer mode of action and threshold response in rodents	11
Prevalence and Sample Sizes in Pre-clinical Studies	10
An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice	10
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	10
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	10
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines	10
Integrating toxicokinetics into toxicology studies and the human health risk assessment process for chemicals: Reduced uncertainty, better health protection	10
The contribution of larval zebrafish transcriptomics to chemical risk assessment	10
Unraveling Caco-2 cells through functional and transcriptomic assessments	10
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	10
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	10
Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply?	10
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
CDSCO alerts: A retrospective dosage form - Wise analysis of quality control alerts issued to pharmaceutical companies from 2018 to 2023	10
Sub-structure-based category formation for the prioritisation of genotoxicity hazard assessment for pesticide residues: Sulphonyl ureas	9
Nonclinical safety assessment of engineered T cell therapies	9
In silico evaluation of the potential allergenicity of a fungal biomass from Rhizomucor pusillus for use as a novel food ingredient	9
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices	9
Toxicokinetic and toxicodynamic mixture effects of plant protection products: A case study	9
Ethyl acrylate (EA) exposure and thyroid carcinogenicity in rats and mice with relevance to human health	9
Updating the Dermal Sensitisation Thresholds using an expanded dataset and an in silico expert system	9
Artificial intelligence and real-world data for drug and food safety – A regulatory science perspective	9
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	9
Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats	9
A Comprehensive Safety Assessment of Algae Protein from Picochlorum for Human Consumption	9
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	9
Evaluation of toxicity profile of kratom (Mitragyna speciosa Korth) decoction in rats	9
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	9
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	9
Ambient air concentrations of plant protection products: Data collection for the combined air concentration database and associated risk assessment	8
Automated read-across workflow for predicting acute oral toxicity: I. The decision scheme in the QSAR toolbox	8
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	8
Current trends in safety assessment of cosmetics ingredients	8
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	8
Editorial Board	8
Application of physiologically-based pharmacokinetic modeled toluene blood concentration in the assessment of short term exposure limits	8
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	8
Editorial Board	8
Editorial Board	8
Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database	8
Subchronic oral toxicity assessment of a cannabis extract	8
Workshop report: Challenges faced in developing inhalation thresholds of Toxicological Concern (TTC) - State of the science and next steps	8

Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	8
Updated assessment of the genotoxic potential of titanium dioxide based on reviews of in vitro comet, mode of action and cellular uptake studies, and recent publications	8
Derivation of an occupational exposure limit for β-glucans	8
Curing of UV prints – Assessment of possible toxicological hazard for consumers	8
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	8
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)	8
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	8
An orthogonal methods assessment of topical drug concentrations in skin and the impact for risk assessment in the viable epidermis	7
Levels of mercury in Moroccan breast milk and the affecting factors: CONTAMILK study	7
Editorial Board	7
Exploring the potential of ToxCast™ data for mechanism-based prioritization of chemicals in regulatory context: Case study with priority existing chemicals (PECs) under K-REACH	7
Re-evaluation of the reduced heart weights in male rats in a 28-day oral repeated-dose toxicity study of tetramethylammonium hydroxide	7
The use of weight-of-evidence approaches to characterize developmental toxicity risk for therapeutic monoclonal antibodies in humans without in vivo studies	7
Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards	7
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	7
Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics	7
Monitoring and risk assessment of hazardous chemicals in toy-slime and putty in the Netherlands	7
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	7
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	7
Editorial Board	7
Application of a new approach method (NAM) for inhalation risk assessment	7
Effect of hydrophilic and lipophilic statins on early onset cataract: A nationwide case-control study	7
Correlation between dietary and dislodgeable foliar (DFR) crop residues decline data; A proposed approach to refine non-dietary risk assessment	7
Editorial Board	7
Editorial Board	7
Response to the Letter to the Editor by David W Roberts “Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on “Plant extracts, polymers an	7
New limits proposed for the management of non-mutagenic impurities	7
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	7
OECD harmonised template 201: Structuring and reporting mechanistic information to foster the integration of new approach methodologies for hazard and risk assessment of chemicals	7
Comprehensive assessment of water quality and associated health risks in an arid region in south Iran	6
Evaluation of 28-day repeated oral dose toxicity of SUNACTIVE Zn–P240 in rats	6
A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10	6
Skin sensitisation prediction using read-across, an illustrative next generation risk assessment (NGRA) case study for vanillin	6
Global regulatory considerations and practices for tumorigenicity evaluation of cell-based therapy	6
Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology	6
Editorial Board	6
Pharmacokinetics of cyadox and its main metabolites in rats, pigs, chickens, and carps following oral administration at three dosage	6
Appraisal of the human health related toxicological information available on dicyclopentadiene (DCPD) in view of assessing the substance's potential to cause endocrine disruption	6
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	6
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	6
The last resort requirement under REACH: From principle to practice	6
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	6
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	6
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	6
Metabolism-based category formation for the prioritisation of genotoxicity hazard assessment for plant protection product residues (part 3): Strobilurins	6
An evolution of risk assessment for potential carcinogens in food: Scientific session proceedings	6
A repeated dose 28-day oral toxicity study of sodium dehydroacetate (DHA-S) in Wistar rats	6
Adverse effects in traditional and alternative toxicity tests	6
The dual endothelin A and angiotensin II type 1 receptor antagonist sparsentan (FILSPARI®) exhibits a safe nonclinical male fertility toxicity profile	6
Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies	6
Carcinogenic and neurotoxic risks of acrylamide consumed through bread, kaak, toast, and crackers among the Lebanese Population	6
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	5
DeepAmes: A deep learning-powered Ames test predictive model with potential for regulatory application	5
Retraction notice to “Proof of concept efficacy study of intranasal stabilized isoamyl nitrite (SIAN) in Rhesus monkeys against acute cyanide poisoning” [Regul. Toxicol. Pharmacol. 123 (2021) 104927]	5
Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future	5
Assessing utility of thyroid in vitro screening assays through comparisons to observed impacts in vivo	5
Impact of repeated micro and macro blood sampling on clinical chemistry and haematology in rats for toxicokinetic studies	5
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database	5
Standardization, in-silico and in-vivo safety assessment of methanol extract of Ziziphus mauritiana Lam leaves	5
Expanding the toxicologist's statistical toolbox: Using effect size estimation and dose-response modelling for holistic assessments instead of generic testing	5
Assessment of black cumin (Nigella sativa L.) as a food ingredient and putative therapeutic agent	5
Margin of exposure to free formaldehyde in personal care products containing formaldehyde-donor preservatives: Evidence for consumer safety	5
The Dilemma of perfluorooctanoate (PFOA) human half-life	5
A proposed approach to confirm heroin administration – Regional differences in heroin purity is a major factor	5
In silico assessment of genotoxicity. Combinations of sensitive structural alerts minimize false negative predictions for all genotoxicity endpoints and can single out chemicals for which experimentat	5
Biomonitoring and risk assessment of human exposure to triazole fungicides	5
The 2022 world health organization reevaluation of human and mammalian toxic equivalency factors for polychlorinated dioxins, dibenzofurans and biphenyls	5
Serial blood sampling effects in rat embryo-fetal development studies for toxicokinetics	5
Replacing concurrent controls with virtual control groups in rat toxicity studies	5
Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice	5
A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential	5
The Conundrum of the PFOA human half-life, an international collaboration	5
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	5
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	5
Considerations and derivations of permitted daily exposure limits for impurities from intravitreal pharmaceutical products	5
A UK framework for the assessment and integration of different scientific evidence streams in chemical risk assessment	5
Enhancing reliability of embryo-fetal developmental toxicity studies: A proposed design of replicate studies	5
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	5
Quantitative Structure Use Relationships: Highlights from a technical summit meeting	5
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	5
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	5
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	5
In Memoriam: Michael "Mike" Steven Denison 1954–2022	4
Toxicological assessment compilation of selected examples of raw materials for homeopathic and anthroposophic medicinal products – Part 2	4
Plant extracts, polymers and new approach methods: Practical experience with skin sensitization assessment	4
Safety evaluation of BPL9K-4 rice in a subchronic rodent feeding study	4
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	4
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 4: Effects from a 28-day inhalation toxicity study with tricobalt tetraoxide in rats	4
Zinc deficiency induced by the chelating agent DTPA and its regulatory interpretation for developmental toxicity classification	4
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	4
Editorial Board	4
Derivation of thresholds for inhaled chemically reactive irritants: Searching for substance-specific common denominators for read-across prediction	4
Safety evaluation of recycling process used to produce recycled pulp for adult paper diapers	4
Safety assessment of Asterarcys quadricellulare, a microalga, with applications in poultry and livestock feed	4
Editorial Board	4