Regulatory Toxicology and Pharmacology

Article	Citations
A review of common approaches to determining allocation factors and relative source contribution factors for drinking water contaminants: caveats and areas for improvement	110
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	94
Prevalence and sample sizes in pre-clinical studies	93
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	91
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	88
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	73
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	68
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	63
Risk assessment and pharmacokinetic modeling of incidental ingestion of ethanol from mouthwash	63
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	51
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	47
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	46
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	43
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	42
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	42
Nonclinical development of advanced therapies: Best practices for translational and regulatory success	41
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	41
Editorial Board	40
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	37
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	37
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	36
Retraction of Williams et al. (2000) does not affect the conclusions of the 2016 FAO/WHO JMPR evaluation of glyphosate	36
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	35
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	35
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	34

Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	34
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	34
Editorial Board	33
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	32
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	31
Expert panel evaluation of the tumor modes of action for 1,4-dioxane and their implications for human risk assessment	31
A tool to support food substance safety evaluations in the United States	31
Physiologically based pharmacokinetic modeling of oseltamivir in pregnant rhesus macaques to inform clinical dosing across trimesters	30
Inter-species variability in 4,4′-methylenedianiline metabolism: insights from human and rat precision-cut liver slices	30
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	29
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	29
Editorial Board	29
Editorial Board	28
Editorial Board	28
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	27
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	27
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	27
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	26
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	25
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	25
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	25
Retrospective evaluation of the use of non-human primates for fertility assessment of pharmaceuticals submitted for marketing approval in the EU	25
Evaluating H295R steroidogenesis assay data for robust interpretation	23
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	23
Evaluating the lifetime cumulative dose as a basis for carcinogenic potency of nitrosamines – a key tenet underpinning less-than-lifetime approaches for establishing acceptable intake limits	22
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	22
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	22
Editorial Board	22
Feasibility study for a downsized comparative thyroid assay with measurement of brain thyroid hormones and histopathology in rats: Case study with 6-propylthiouracil and sodium phenobarbital at high d	22
AI-enhanced cardiac digital twins extend drug proarrhythmic risk assessment through experimental data uncertainty propagation and overdose exploration: A loperamide case study	21
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	21
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	21
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	21
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	21
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	21
Erratum to “Towards EU regulatory hazard assessment of metabolic endocrine disrupters: Integrating new Biomarkers into OECD test Guidelines” [Regul. Toxicol. Pharm.(167) 106041]	21
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	20
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	20
Smoke Flavoring-a case study demonstrating the value of using Benefit-risk analysis for foods (BRAFO) to provide transparency for risk management decisions	19
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	19
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	19
Exposure and disease burden of fumonisins and aflatoxins from sorghum consumption in Ethiopia	18
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	18
Dose level selection for developmental and reproductive toxicology (DART) studies: Insights from the EUROTOX 2024 satellite workshop	18
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
Integrating systemic toxicity and toxicokinetic data to inform the need for subchronic dog studies in human health safety assessments of agrochemicals	18
Modeling extraction of medical device polymers for biocompatibility evaluation	17
Safe usage levels of aqueous Hippophae rhamnoides fruit extract in cosmetics estimated by threshold of toxicological concern, point of departure, and history of safe consumption	17
Evaluating cancer risks: The impact of thirdhand smoke exposure on carcinogenesis	17
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	17

Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	17
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	17
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	17
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	17
Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements	16
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	16
In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	16
Regulatory experience with the comparative in vitro metabolism study based on an analysis of 70 studies with pesticide active ingredients – a reality check	16
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	16
Residue depletion profiles and withdrawal interval estimations of meloxicam in eggs and ovarian follicles following intravenous (Meloxicam solution for injection) and oral (Meloxidyl®) administration	16
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	15
Integration of toxicodynamic and toxicokinetic new approach methods into a weight-of-evidence analysis for pesticide developmental neurotoxicity assessment: A case-study with DL- and L-glufosinate	15
N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular w	15
Occurrence and dietary risk assessment of pesticide residues in bananas and kiwifruits from Turkey	15
Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on “Plant extracts, polymers and new approach methods: Practical experience with skin se	15
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	15
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	14
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	14
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	14
Reply to Comment on “Reduced specificity for the local lymph node assay for lipophilic chemicals: Implications for the validation of new approach methods for skin sensitization” by Roberts and Baskett	13
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	13
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	13
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	13
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	13
Rebuttal to the letter to the editors regarding Van Berlo et al. (2022) paper titled “10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	13
Absence of developmental or reproductive toxicity in rats for MB-102, a fluorescent tracer agent for point-of-care measurement of glomerular filtration rate	13
Talc fits the framework of poorly soluble low-toxicity particles - implications for hazard classification	13
Development of a digital tool for semi-quantitative assessment of pesticide exposure risk in greenhouses	13
A new method of consistency evaluation of brain drugs: a case study of edaravone	13
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	13
Systematic review of the potential carcinogenicity of bisphenol A in humans	13
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	13
Carcinogenicity testing in drug development: Getting it right	13
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	12
Corrigendum to “Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products” [Regul. Toxicol. Pharmacol. 72 3 (2015) 673-68]	12
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	12
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
R-ODAF: Omics data analysis framework for regulatory application	12
Editorial Board	11
The critical nature of a robust weight of evidence assessment to conclude on endocrine disruption using diflufenican as a case study	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
Prolonged exposure to nitrate in drinking water does not adversely impact prenatal or birth outcomes in a rat model	11
Oncology drugs: Target organ findings seen in animal toxicity testing	11
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	11
The difference between hazard and risk: the dose range prevalent in toxicological studies vs real life fragrance exposure	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Dermal exposure of bystanders and residents to direct spray drift in low crops during pesticide application	11
Safety and regulatory assessment of heat-killed Lactiplantibacillus plantarum strain L-137 (HK L-137) as a food ingredient	11
Application of a new approach method (NAM) for inhalation risk assessment	10
Serial blood collection in anaesthetised rats: Enhancing animal welfare without the need for jugular vein catheterisation	10
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	10
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	10
Use of whole slide images for primary pathology evaluation of non-clinical toxicology studies in a GLP-validated environment	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	10
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
Evaluation of good review practices at the Food and Drugs Authority of Ghana as it strives to become a World Health Organization-listed agency	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	10
Demonstration of safety for rice bran wax and sunflower wax based on bridging to other naturally derived waxes used in foods	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Health safety of parabens evaluated by selected in vitro methods	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Editorial Board	9
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	9
Towards EU regulatory hazard assessment of metabolic endocrine disrupters: Integrating new biomarkers into OECD test guidelines	9
Establishing best practice for N-nitrosamine read-across and surrogate selection	9
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	9
Rebuttal to the letter to the editors regarding Van Berlo et al. (2022) paper titled “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	9
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9

A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	8
Food for thought — Paving the way for a UK roadmap towards optimum consumer safety: Development, Endorsement and Regulatory acceptance of New Approach Methodologies (NAMs) in Chemical Risk Assessment	8
A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	8
An extended Reference Chemical Potency List (RCPL) for characterising the performance of New Approach Methodologies (NAMs) in measuring the skin sensitisation potency of fragrance chemicals	8
Nitrosamine drug substance-related impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation	8
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
A scoping review of infant and children health effects associated with cadmium exposure	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Substantiating chemical groups for read-across using molecular response profiles	8
Lack of significant risk from everyday dietary nickel: Rethinking the application of oral toxicity reference values	8
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	8
Use of NAMs in a weight of evidence approach to evaluate the safety via the inhalation route of acetylated vetiver oil, in spray products	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	8
Development of COVID-19 therapies: Nonclinical testing considerations	8
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	8
Toxicology of bromoform, a natural constituent of the seaweed Asparagopsis spp. used to inhibit methanogenesis in cattle, suggests negligible risks to humans	8
Ames concordance with the in vivo transgenic rodent (TGR) gene mutation assay for NDSRIs and relative in vivo TGR potency with nitrosamines with robust dose-response carcinogenicity data	8
Editorial Board	8
Comparison of toxicological effects and exposure levels between triclosan and its structurally similar chemicals using in vitro tests for read-across case study	8
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	8
Preclinical evidence of cannabis-induced oxidative stress: A systematic review and meta-analysis	8
Effects of as-if risk framing of hazards on risk perception and its rebuttal	8