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	108
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	92
Prevalence and sample sizes in pre-clinical studies	91
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	87
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	86
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	69
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	66
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	61
Risk assessment and pharmacokinetic modeling of incidental ingestion of ethanol from mouthwash	59
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	51
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	47
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	46
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	43
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	41
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	41
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	41
Nonclinical development of advanced therapies: Best practices for translational and regulatory success	39
Editorial Board	38
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
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	37
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	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
Editorial Board	34
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	34

Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	34
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	31
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	31
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	30
A tool to support food substance safety evaluations in the United States	30
Physiologically based pharmacokinetic modeling of oseltamivir in pregnant rhesus macaques to inform clinical dosing across trimesters	29
Inter-species variability in 4,4′-methylenedianiline metabolism: insights from human and rat precision-cut liver slices	29
Editorial Board	28
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	28
Expert panel evaluation of the tumor modes of action for 1,4-dioxane and their implications for human risk assessment	28
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	27
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	27
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	27
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	27
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	26
Editorial Board	26
Editorial Board	25
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	25
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	25
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	25
Retrospective evaluation of the use of non-human primates for fertility assessment of pharmaceuticals submitted for marketing approval in the EU	24
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	23
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	22
Evaluating H295R steroidogenesis assay data for robust interpretation	22
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	22
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	22
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	22
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	22
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	22
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	21
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	21
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	21
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	21
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	21
Modeling extraction of medical device polymers for biocompatibility evaluation	20
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	20
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	20
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	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
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
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	18
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	18
Exposure and disease burden of fumonisins and aflatoxins from sorghum consumption in Ethiopia	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	17
Evaluating cancer risks: The impact of thirdhand smoke exposure on carcinogenesis	17
Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements	17
In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	17
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	17
Dose level selection for developmental and reproductive toxicology (DART) studies: Insights from the EUROTOX 2024 satellite workshop	17

Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	17
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	16
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	16
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	16
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	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
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	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
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	15
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
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	15
Occurrence and dietary risk assessment of pesticide residues in bananas and kiwifruits from Turkey	15
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	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	14
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	14
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”	14
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
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
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
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	13
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	13
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	13
Carcinogenicity testing in drug development: Getting it right	13
Talc fits the framework of poorly soluble low-toxicity particles - implications for hazard classification	13
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]	13
R-ODAF: Omics data analysis framework for regulatory application	12
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	12
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	12
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
Editorial Board	12
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Prolonged exposure to nitrate in drinking water does not adversely impact prenatal or birth outcomes in a rat model	11
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
Safety and regulatory assessment of heat-killed Lactiplantibacillus plantarum strain L-137 (HK L-137) as a food ingredient	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
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Evaluation of good review practices at the Food and Drugs Authority of Ghana as it strives to become a World Health Organization-listed agency	11
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	10
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Application of a new approach method (NAM) for inhalation risk assessment	10
Demonstration of safety for rice bran wax and sunflower wax based on bridging to other naturally derived waxes used in foods	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	10
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	10
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	9
Editorial Board	9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Effects of as-if risk framing of hazards on risk perception and its rebuttal	9
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	9
Development of COVID-19 therapies: Nonclinical testing considerations	9
Towards EU regulatory hazard assessment of metabolic endocrine disrupters: Integrating new biomarkers into OECD test guidelines	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Establishing best practice for N-nitrosamine read-across and surrogate selection	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Use of NAMs in a weight of evidence approach to evaluate the safety via the inhalation route of acetylated vetiver oil, in spray products	9
Serial blood collection in anaesthetised rats: Enhancing animal welfare without the need for jugular vein catheterisation	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
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	9
Health safety of parabens evaluated by selected in vitro methods	9
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
Toxicology of bromoform, a natural constituent of the seaweed Asparagopsis spp. used to inhibit methanogenesis in cattle, suggests negligible risks to humans	8
A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs	8

10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	8
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	8
Nitrosamine drug substance-related impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Substantiating chemical groups for read-across using molecular response profiles	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	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 proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
Lack of significant risk from everyday dietary nickel: Rethinking the application of oral toxicity reference values	8
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
Editorial Board	8
The new paradigm in animal testing – “3Rs alternatives”	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	8
A scoping review of infant and children health effects associated with cadmium exposure	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
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	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
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8