Regulatory Toxicology and Pharmacology

Article	Citations
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	206
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	87
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	69
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	67
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	63
Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen	62
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	62
Twenty six-week repeat dose oral rat toxicity study of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	61
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	50
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	50
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	47
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	46
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	44
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	42
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	42
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	39
Editorial Board	38
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	38
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	38
Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats	37
Editorial Board	37
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	35
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	33
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	32
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	31

Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	30
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	29
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	28
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	28
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	28
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	28
Derivation of an occupational exposure limit for β-glucans	27
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	27
The Dilemma of perfluorooctanoate (PFOA) human half-life	26
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	26
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	25
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	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	24
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	24
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database	24
Nonclinical safety assessment of engineered T cell therapies	24
Editorial Board	24
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	23
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	23
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	22
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	22
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	22
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	22
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	22
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	21
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	21
Safety evaluation of recycling process used to produce recycled pulp for adult paper diapers	20
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	20
Disease area and mode of action as criteria to assign a default occupational exposure limit	20
Editorial Board	19
Editorial Board	19
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	18
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	18
Evaluating H295R steroidogenesis assay data for robust interpretation	18
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	18
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	18
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	18
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	17
The purity of tattoo inks, screening substances of high concern	17
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	17
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	17
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	16
Modeling extraction of medical device polymers for biocompatibility evaluation	16
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)	16
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	16
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	16
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	16
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	16
Preclinical safety assessment of the crude extract from Sida rhombifolia L. aerial parts in experimental models of acute and repeated-dose 28 days toxicity in rats	15
A systematic approach to evaluate plausible modes of actions for mouse lung tumors in mice exposed to 4-methylimidozole	15

Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	15
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	15
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	15
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	15
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	15
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	14
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	14
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	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
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	14
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	14
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	14
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	14
A comprehensive review of mechanistic insights into formaldehyde-induced nasal cavity carcinogenicity	14
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	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
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	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
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	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
Carcinogenicity testing in drug development: Getting it right	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
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	13
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	13
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	13
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	12
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles	12
R-ODAF: Omics data analysis framework for regulatory application	12
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	12
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	12
Unknown Confidence in Chemical Characterization Identification Levels: When Tentative Identifications Are Adequate for Toxicological Risk Assessment of Medical Devices	12
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
Refinement of decision tree to assess the consequences of increased serum ALP in dogs: Additional analysis on toxicity studies of pesticides evaluated recently in Japan	12
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	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
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents	11
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	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
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	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 Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	11
Comprehensive analysis of chronic rodent inhalation toxicity studies for methyl acrylate with attention to test conditions exceeding a maximum tolerated concentration	11
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	11
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	11
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	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
Editorial Board	11
Nicotine dosimetry and stability in cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Extended One-Generation Reproductive Toxicity (EOGRT) study of benzoic acid in Sprague Dawley rats	11
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	11
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]	10
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	10
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	10
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	10
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	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
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	9
Developing a database of systematic reviews of animal studies	9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Editorial Board	9
Development of COVID-19 therapies: Nonclinical testing considerations	9
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	9
Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
Editorial Board	9
Derivation of Biomonitoring Equivalents for aluminium for the interpretation of population-level biomonitoring data	9
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	9

Effects of as-if risk framing of hazards on risk perception and its rebuttal	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
Application of a new approach method (NAM) for inhalation risk assessment	9
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	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
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	9
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	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
The safety of a Kluyveromyces lactis strain lineage for enzyme production	8
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	8
Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	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
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	8
A scoping review of infant and children health effects associated with cadmium exposure	8
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	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
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	8