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	113
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	78
A review of common approaches to determining allocation factors and relative source contribution factors for drinking water contaminants: caveats and areas for improvement	78
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	77
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	70
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	69
Prevalence and sample sizes in pre-clinical studies	64
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	62
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	60
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	55
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	53
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	51
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	48
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	47
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	44
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	43
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	40
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	37
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	36
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	36
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	35
Editorial Board	34
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	33
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	33
Editorial Board	31

Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	31
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	31
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	30
Nonclinical safety assessment of engineered T cell therapies	30
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	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
The Dilemma of perfluorooctanoate (PFOA) human half-life	29
A tool to support food substance safety evaluations in the United States	28
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	28
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	26
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	26
Editorial Board	26
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	26
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	25
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	25
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
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	23
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	22
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	22
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	21
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	21
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	20
Editorial Board	20
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	20
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	20
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	20
Editorial Board	20
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	19
Evaluating H295R steroidogenesis assay data for robust interpretation	19
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	19
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	19
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	18
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	18
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	18
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	18
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	17
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	17
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	17
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	17
Modeling extraction of medical device polymers for biocompatibility evaluation	17
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	17
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	16
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	16
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	16
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	16
The purity of tattoo inks, screening substances of high concern	16
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	15
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	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
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	15

Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	15
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	15
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
In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	15
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	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
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	14
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	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
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	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
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
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	14
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	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
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	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
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	13
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	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
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents	13
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	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]	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
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
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	12
R-ODAF: Omics data analysis framework for regulatory application	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
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	11
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	11
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	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
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
Carcinogenicity testing in drug development: Getting it right	11
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	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
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	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
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	11
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Editorial Board	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
Application of a new approach method (NAM) for inhalation risk assessment	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	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
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
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	10
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	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	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Development of COVID-19 therapies: Nonclinical testing considerations	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
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
Editorial Board	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	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
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
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	9
Editorial Board	9
The new paradigm in animal testing – “3Rs alternatives”	8
A scoping review of infant and children health effects associated with cadmium exposure	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8

A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	8
Health safety of parabens evaluated by selected in vitro methods	8
The safety of a Kluyveromyces lactis strain lineage for enzyme production	8
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses	8
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	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
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
Editorial Board	8
Reproductive and developmental toxicity risk assessment for 4-methylimidazole	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	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
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	8
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	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