Regulatory Toxicology and Pharmacology

Article	Citations
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	92
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	71
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	70
Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen	66
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	64
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	63
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	62
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	53
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	53
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	51
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	48
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	47
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	43
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	43
A review of common approaches to determining allocation factors and relative source contribution factors for drinking water contaminants: caveats and areas for improvement	41
Editorial Board	40
Editorial Board	40
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	40
Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats	39
Nonclinical safety assessment of engineered T cell therapies	37
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	35
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	34
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	34
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	31
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	30

Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	30
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	29
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	28
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	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	28
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	27
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	27
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	27
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	26
The Dilemma of perfluorooctanoate (PFOA) human half-life	26
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database	25
Editorial Board	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
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	24
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	23
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	23
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	23
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	23
Editorial Board	23
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	23
Editorial Board	23
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	22
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
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	20
Evaluating H295R steroidogenesis assay data for robust interpretation	20
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	19
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	19
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	19
Commentary on FDA`s Shift from Animal Testing and Implications for Drug Attrition – The Time to Act is Now	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
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	18
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	18
Modeling extraction of medical device polymers for biocompatibility evaluation	18
The purity of tattoo inks, screening substances of high concern	18
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	18
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	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	18
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	17
A systematic approach to evaluate plausible modes of actions for mouse lung tumors in mice exposed to 4-methylimidozole	17
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)	17
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	17
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	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

The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	15
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	15
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley 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	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
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	15
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	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
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
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	14
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	14
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug 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
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
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
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents	13
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	13
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	13
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	13
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	13
Carcinogenicity testing in drug development: Getting it right	13
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
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
R-ODAF: Omics data analysis framework for regulatory application	12
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles	12
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	12
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	12
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	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
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	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	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
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	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
Application of a new approach method (NAM) for inhalation risk assessment	11
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	11
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	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]	11
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Editorial Board	11
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	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
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	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
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	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
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	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
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	10
Editorial Board	9
Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches	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
Health safety of parabens evaluated by selected in vitro methods	9
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	9
Developing a database of systematic reviews of animal studies	9
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	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
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Editorial Board	9
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9

GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	8
The safety of a Kluyveromyces lactis strain lineage for enzyme production	8
A 90-day subchronic toxicity study of Myrrh in F344 rats	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	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 toxicological effects and exposure levels between triclosan and its structurally similar chemicals using in vitro tests for read-across case study	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
Substantiating chemical groups for read-across using molecular response profiles	8
Editorial Board	8
The new paradigm in animal testing – “3Rs alternatives”	8
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	8
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Afidopyropen: Challenges and impact of a toxicokinetic study designed to identify a point of inflection from dose-proportionality	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	8