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	127
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	106
Prevalence and sample sizes in pre-clinical studies	98
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	95
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	95
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	78
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	76
Risk assessment and pharmacokinetic modeling of incidental ingestion of ethanol from mouthwash	73
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	53
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	49
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	49
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	45
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	45
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	44
Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology	44
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	43
Nonclinical development of advanced therapies: Best practices for translational and regulatory success	43
Editorial Board	40
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	39
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	37
Retraction of Williams et al. (2000) does not affect the conclusions of the 2016 FAO/WHO JMPR evaluation of glyphosate	37
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	37
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	36
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	35
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	34

False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	33
Expert panel evaluation of the tumor modes of action for 1,4-dioxane and their implications for human risk assessment	32
Inter-species variability in 4,4′-methylenedianiline metabolism: insights from human and rat precision-cut liver slices	32
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	30
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	30
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	29
Editorial Board	28
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	28
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	28
Editorial Board	27
Editorial Board	27
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	26
Evaluating H295R steroidogenesis assay data for robust interpretation	25
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	25
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	25
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	25
Editorial Board	25
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	25
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	24
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	24
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	24
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	23
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	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
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
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	21
Contamination and adulteration of food supplements: Risk perception and regulatory awareness in recreational athletes	21
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	21
Retrospective evaluation of the use of non-human primates for fertility assessment of pharmaceuticals submitted for marketing approval in the EU	20
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	20
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	20
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	20
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	19
Smoke Flavoring-a case study demonstrating the value of using Benefit-risk analysis for foods (BRAFO) to provide transparency for risk management decisions	19
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	18
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
Evaluation of mutagenicity and genotoxicity of food additive maltitol (E 965 i)	18
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	18
Dose level selection for developmental and reproductive toxicology (DART) studies: Insights from the EUROTOX 2024 satellite workshop	18
Exposure and disease burden of fumonisins and aflatoxins from sorghum consumption in Ethiopia	18
Integrating systemic toxicity and toxicokinetic data to inform the need for subchronic dog studies in human health safety assessments of agrochemicals	18
Evaluating cancer risks: The impact of thirdhand smoke exposure on carcinogenesis	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
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	17
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	16
Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements	16
Modeling extraction of medical device polymers for biocompatibility evaluation	16

Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	16
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	16
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	15
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	15
In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	15
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	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
Regulatory experience with the comparative in vitro metabolism study based on an analysis of 70 studies with pesticide active ingredients – a reality check	15
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	14
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	14
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	14
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	14
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	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
Carcinogenicity testing in drug development: Getting it right	14
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	14
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	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
Development of a digital tool for semi-quantitative assessment of pesticide exposure risk in greenhouses	13
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	13
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	13
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	13
A new method of consistency evaluation of brain drugs: a case study of edaravone	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
Occurrence and exposure risk to potentially toxic metals from oral hygiene products in Nigeria	13
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	13
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	12
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
Editorial Board	12
The critical nature of a robust weight of evidence assessment to conclude on endocrine disruption using diflufenican as a case study	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
Prolonged exposure to nitrate in drinking water does not adversely impact prenatal or birth outcomes in a rat model	12
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	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
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	12
Evaluation of good review practices at the Food and Drugs Authority of Ghana as it strives to become a World Health Organization-listed agency	12
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	12
The difference between hazard and risk: the dose range prevalent in toxicological studies vs real life fragrance exposure	11
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	11
Nonclinical Safety Profile for DCR-AUD GalNAc-Conjugated siRNA: Subchronic Versus Chronic Findings in Mouse and Non-Human Primate	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
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
Demonstration of safety for rice bran wax and sunflower wax based on bridging to other naturally derived waxes used in foods	11
Oncology drugs: Target organ findings seen in animal toxicity testing	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
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	11
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	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
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	10
Serial blood collection in anaesthetised rats: Enhancing animal welfare without the need for jugular vein catheterisation	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	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
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	10
Use of whole slide images for primary pathology evaluation of non-clinical toxicology studies in a GLP-validated environment	10
Towards EU regulatory hazard assessment of metabolic endocrine disrupters: Integrating new biomarkers into OECD test guidelines	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	10
Pesticide residues in non-primary edible plant parts: Regulatory considerations and dietary risk assessment of guava leaves	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
Editorial Board	9
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	9
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	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
Nitrosamine drug substance-related impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation	9
Health safety of parabens evaluated by selected in vitro methods	9
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	9
Establishing best practice for N-nitrosamine read-across and surrogate selection	9
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	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
Lack of significant risk from everyday dietary nickel: Rethinking the application of oral toxicity reference values	9
Assessment of chronic toxicity study designs and development of a weight-of-evidence-based decision-making model for biopharmaceuticals: A survey of Japanese pharmaceutical companies	9
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Editorial Board	8
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	8
Preclinical evidence of cannabis-induced oxidative stress: A systematic review and meta-analysis	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
Editorial Board	8
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	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
Advancing nonclinical blood pressure assessment: Current practices and future directions in drug development	8
40-Week Repeat-Dose Toxicity, Toxicokinetics, and Immunogenicity of Efsubaglutide Alfa Following Subcutaneous Administration in Cynomolgus Monkeys	8
A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs	8
The new paradigm in animal testing – “3Rs alternatives”	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	8
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	8
Toxicology of bromoform, a natural constituent of the seaweed Asparagopsis spp. used to inhibit methanogenesis in cattle, suggests negligible risks to humans	8
Substantiating chemical groups for read-across using molecular response profiles	8
Reproductive and developmental toxicity risk assessment for 4-methylimidazole	8
Response to letter to editor “letter to the editors regarding “the Conundrum of the PFOA human half-life, an international collaboration.”	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	8
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	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