Regulatory Toxicology and Pharmacology

Article	Citations
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	119
A review of common approaches to determining allocation factors and relative source contribution factors for drinking water contaminants: caveats and areas for improvement	82
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	75
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	73
Prevalence and sample sizes in pre-clinical studies	68
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	65
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	63
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	56
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	55
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	49
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	48
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	46
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	46
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	45
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	41
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	40
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	37
A tool to support food substance safety evaluations in the United States	37
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	36
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	35
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	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
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	32
Editorial Board	32

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	31
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	31
Nonclinical safety assessment of engineered T cell therapies	30
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	30
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	29
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	29
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	29
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	29
Editorial Board	28
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	27
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	26
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	25
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	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
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	23
Editorial Board	23
Editorial Board	23
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	22
Evaluating H295R steroidogenesis assay data for robust interpretation	21
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	21
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	21
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	20
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	20
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	20
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	20
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	20
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	19
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	19
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	19
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	18
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	18
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	18
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	18
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	17
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	17
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	17
Modeling extraction of medical device polymers for biocompatibility evaluation	16
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	16
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	16
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	16
Dose level selection for developmental and reproductive toxicology (DART) studies: Insights from the EUROTOX 2024 satellite workshop	16
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	16
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	15
Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements	15
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	15
In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	15
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	15

Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	15
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 2 b: Reactive cobalt substances induce oxidative stress in ToxTracker and activate hypoxia target genes	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
The purity of tattoo inks, screening substances of high concern	15
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	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
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	14
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	14
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	14
Residue depletion profiles and withdrawal interval estimations of meloxicam in eggs and ovarian follicles following intravenous (Meloxicam solution for injection) and oral (Meloxidyl®) administration	14
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	14
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	14
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	14
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	13
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	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
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
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	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
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
A new method of consistency evaluation of brain drugs: a case study of edaravone	12
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	12
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	12
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	12
R-ODAF: Omics data analysis framework for regulatory application	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	12
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	12
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles	12
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	12
Carcinogenicity testing in drug development: Getting it right	12
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	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
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	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
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	11
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	11
Editorial Board	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	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
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	11
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	10
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	10
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	10
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	10
Application of a new approach method (NAM) for inhalation risk assessment	10
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	10
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	10
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	10
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	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
Editorial Board	9
Effects of as-if risk framing of hazards on risk perception and its rebuttal	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
Development of COVID-19 therapies: Nonclinical testing considerations	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
Health safety of parabens evaluated by selected in vitro methods	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
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	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
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
The new paradigm in animal testing – “3Rs alternatives”	8

Reproductive and developmental toxicity risk assessment for 4-methylimidazole	8
REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	8
Toxicology of bromoform, a natural constituent of the seaweed Asparagopsis spp. used to inhibit methanogenesis in cattle, suggests negligible risks to humans	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
A scoping review of infant and children health effects associated with cadmium exposure	8
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses	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
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	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
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
Recommendation for an occupational exposure limit for toluene	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8