Regulatory Toxicology and Pharmacology

Article	Citations
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	98
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	74
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	74
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	72
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	69
Prevalence and sample sizes in pre-clinical studies	68
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	63
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	57
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	57
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	52
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	52
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	50
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	49
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	45
Editorial Board	44
Editorial Board	42
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	41
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	41
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	39
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	36
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	35
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	33
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	32
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	31

Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	31
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
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	29
The Dilemma of perfluorooctanoate (PFOA) human half-life	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
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	28
Nonclinical safety assessment of engineered T cell therapies	28
Editorial Board	27
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	27
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database	27
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	26
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	25
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	25
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	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	24
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	24
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	24
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	24
Editorial Board	23
Editorial Board	23
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	23
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	21
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	21
Evaluating H295R steroidogenesis assay data for robust interpretation	21
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	21
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	20
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	20
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	19
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	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
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	19
The purity of tattoo inks, screening substances of high concern	19
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	19
A systematic approach to evaluate plausible modes of actions for mouse lung tumors in mice exposed to 4-methylimidozole	18
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Modeling extraction of medical device polymers for biocompatibility evaluation	18
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	18
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	18
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	18
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	16
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	16
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	16
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	16
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
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	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

A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	15
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
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
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
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	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
Carcinogenicity testing in drug development: Getting it right	14
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	14
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	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	14
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	14
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	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
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	13
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles	13
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	13
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	13
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	13
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	13
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	13
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents	13
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	13
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	13
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
Editorial Board	12
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	12
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	12
R-ODAF: Omics data analysis framework for regulatory application	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	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
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	12
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	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
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	11
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	11
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	11
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	11
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	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 utility of hERG channel inhibition data in the derivation of occupational exposure limits	11
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	11
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	11
Application of a new approach method (NAM) for inhalation risk assessment	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
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”	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
Editorial Board	10
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	10
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	9
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Health safety of parabens evaluated by selected in vitro methods	9
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	9
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	9
Editorial Board	9
Development of COVID-19 therapies: Nonclinical testing considerations	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches	9
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	9
Effects of as-if risk framing of hazards on risk perception and its rebuttal	9
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	9
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	9
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
The new paradigm in animal testing – “3Rs alternatives”	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Best practices for exposure model peer review – A SciPinion advisory panel report	8

Editorial Board	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	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
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
What happened to quinacrine non-surgical female sterilization?	8
Afidopyropen: Challenges and impact of a toxicokinetic study designed to identify a point of inflection from dose-proportionality	8
The safety of a Kluyveromyces lactis strain lineage for enzyme production	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
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
Case analysis of kinetics investigations in toxicity studies of pesticides to identify the nonlinearity of internal exposure and the influences of nonlinearity on the toxicological interpretation of p	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
A 90-day subchronic toxicity study of Myrrh in F344 rats	8