Regulatory Toxicology and Pharmacology

Article	Citations
Systematic review of epidemiological studies evaluating the association between exposure to man-made vitreous fibers and non-malignant respiratory diseases	142
Resource and animal use implications of the proposed REACH information requirements for endocrine disruptor assessment	69
Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply?	67
The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test	62
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	55
Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers	52
Sensory irritation and use of the best available science in setting exposure limits: Issues raised by a scientific panel review of formaldehyde human research studies	50
Comprehensive analysis of chronic rodent inhalation toxicity studies for methyl acrylate with attention to test conditions exceeding a maximum tolerated concentration	50
28-Day oral (gavage) and 13-week (dietary) toxicity studies of DHA canola oil and DHA canola meal in rats	45
Quantitative risk assessment of skin sensitising pesticides: Clinical and toxicological considerations	41
Preclinical safety, toxicokinetics and metabolism of BIIB131, a novel prothrombolytic agent for acute stroke	40
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids	33
Letter to the editors regarding “The conundrum of the PFOA human half-life, an international collaboration”	33
Editorial Board	31
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia	30
Inhalation exposure assessments under REACH – Problems encountered using the approach recommended by the ECHA guidance R.15	29
Editorial Board	27
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	26
Probabilistic methods for non-cancer health effects	26
Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment	26
Pathogenetic role of alveolar surfactant depleted by phosgene: Biophysical mechanisms and peak inhalation exposure metrics	25
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	25
Editorial Board	25
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	25
Use of nonclinical toxicity studies to support biosimilar antibody development	25

A simplified index to quantify the irritation/corrosion potential of chemicals – Part II: Eye	24
Editorial Board	24
Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen	24
Applicability of nanomaterial-specific guidelines within long-term Daphnia magna toxicity assays: A case study on multigenerational effects of nTiO2 and nCeO2 exposure in the presence of artificial da	22
Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary	22
Characterization of false positive, contaminant-driven mutagenicity in impurities associated with the sotorasib drug substance	22
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline	21
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	21
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	21
Richardia brasiliensis Gomes: phytochemical characterization, antiproliferative capacity and in vitro and in vivo toxicity	21
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments	21
Editorial Board	21
Particle size distribution in the evaluation of the inhalation toxicity of cosmetic spray products	20
Monosodium glutamate in a type 2 diabetes context: A large scoping review	20
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	20
Uncertainty in the results from oral repeated dose toxicity tests: Impact on regulatory classifications	19
Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios	19
Retrospective analysis of dog study data from food and color additive petitions	19
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?	19
A retrospective study on EU harmonised classifications for carcinogenicity to guide future research	18
SCCS Scientific Opinion on Acid Yellow 3 (submission II) – SCCS/1631/21	18
Skin and eye irritancy assessment of six lactic acid bacteria strains	18
Evidence-based regulations for bioinformatic prediction of allergen cross-reactivity are needed	18
Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach	18
SCCS scientific opinion on HAA299 (nano) - SCCS/1634/21	18
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	18
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	17
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 3: Inflammatory response following acute inhalation exposure correlates with lower tier data	17
Extended One-Generation Reproductive Toxicity (EOGRT) study of benzoic acid in Sprague Dawley rats	17
A systematic assessment of the epidemiologic literature regarding an association between acetaminophen exposure and cancer	17
Regulatory safety pharmacology and toxicity assessments of a standardized stem extract of Cassia occidentalis Linn. in rodents	16
Egg residue and depletion in Rhode Island Red hens (Gallus gallus domesticus) following multiple oral doses of trimethoprim-sulfamethoxazole	16
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	16
Enzymes and sensitization via skin exposure: A critical analysis	16
Analysis for data-derived extrapolation factors for procymidone	16
Non-mutagenic impurities – Recent industry experience of using dose durational limits in drug development	16
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	16
Safety assessment of phytase transgenic maize 11TPY050 in Sprague-Dawley rats by 90-day feeding study	15
Editorial Board	15
Mercury in skin-care products in India and consumer exposure risks	15
Integrating toxicokinetics into toxicology studies and the human health risk assessment process for chemicals: Reduced uncertainty, better health protection	15
Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies	15
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test	14
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines	14
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	14
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	14
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	14
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations	13
Nicotine dosimetry and stability in cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions	13
Probabilistic pharmacokinetic modeling of airborne lead corresponding to toxicologically relevant blood lead levels in workers	13

Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	13
Ethylene oxide derived glycol ethers: A review of the alkyl glycol ethers potential to cause endocrine disruption	13
A roadmap towards a human-centric safety assessment of advanced therapy medicinal products	12
Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency	12
Implications of variability on medical device chemical equivalence assessment	12
Editorial Board	12
Determination of “fitness-for-purpose” of quantitative structure-activity relationship (QSAR) models to predict (eco-)toxicological endpoints for regulatory use	12
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	12
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	12
Detailed aggregate exposure analysis shows that exposure to fragrance ingredients in consumer products is low: Many orders of magnitude below thresholds of concern	12
Compounded conservatism in European re-entry worker risk assessment of pesticides	12
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	12
Experimental study for the establishment of a chemotherapy-induced ovarian insufficiency model in rats by using cyclophosphamide combined with busulfan	12
Dose response effect of chemical surface concentration on percutaneous penetration in human: In vivo + in vitro	11
Non-sugar sweeteners and cancer: Toxicological and epidemiological evidence	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
Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world	11
Toxicity reference values (TRVs) for force health protection: Gap identification and TRV prediction	11
Twenty six-week repeat dose oral rat toxicity study of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	11
Characterization of tea tree oil nanoemulsion and its acute and subchronic toxicity	11
Grouping of short alkyl-chain branched carboxylic acids for developmental toxicity	11
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	11
A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products	11
Toxicological evaluation of a glycan preparation from an enzymatic hydrolysis of Saccharomyces cerevisiae	11
Incorporating lines of evidence from New Approach Methodologies (NAMs) to reduce uncertainties in a category based read-across: A case study for repeated dose toxicity	11
A multi-tiered hierarchical Bayesian approach to derive toxic equivalency factors for dioxin-like compounds	11
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	11
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	11
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?	10
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	10
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	10
Specificity of the local lymph node assay (LLNA) for skin sensitisation	10
A deep dive into historical Ames study data for N-nitrosamine compounds	10
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	10
Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes	10
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	10
An integrated assessment of the 1,4-dioxane cancer mode of action and threshold response in rodents	10
The contribution of larval zebrafish transcriptomics to chemical risk assessment	10
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	10
Biomonitoring Equivalents for glyphosate	10
A systematic review of adverse health effects associated with oral cadmium exposure	10
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	10
Data collection initiatives of the crop protection industry – A mission to improve non-dietary risk assessment in Europe	9
Impact of repeated micro and macro blood sampling on clinical chemistry and haematology in rats for toxicokinetic studies	9
An evolution of risk assessment for potential carcinogens in food: Scientific session proceedings	9
The definition of chemical contaminants in food: Ambiguity and consequences	9
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	9
Editorial Board	9
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	9
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	9
Editorial Board	9
An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice	9
Considerations and derivations of permitted daily exposure limits for impurities from intravitreal pharmaceutical products	8
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	8
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	8
Automated read-across workflow for predicting acute oral toxicity: I. The decision scheme in the QSAR toolbox	8
Sub-structure-based category formation for the prioritisation of genotoxicity hazard assessment for pesticide residues: Sulphonyl ureas	8
Assessing utility of thyroid in vitro screening assays through comparisons to observed impacts in vivo	8
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	8
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	8
Ethyl acrylate (EA) exposure and thyroid carcinogenicity in rats and mice with relevance to human health	8
Enhancing reliability of embryo-fetal developmental toxicity studies: A proposed design of replicate studies	8
In silico evaluation of the potential allergenicity of a fungal biomass from Rhizomucor pusillus for use as a novel food ingredient	8
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	8
The Dilemma of perfluorooctanoate (PFOA) human half-life	8
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	8
Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards	8
A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10	8
Risk assessment of predicted serum concentrations of bisphenol A in children and adults following treatment with dental composite restoratives, dental sealants, or orthodontic adhesives using physiolo	8
Toxicokinetic and toxicodynamic mixture effects of plant protection products: A case study	8
DeepAmes: A deep learning-powered Ames test predictive model with potential for regulatory application	8
The 2022 world health organization reevaluation of human and mammalian toxic equivalency factors for polychlorinated dioxins, dibenzofurans and biphenyls	8
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	8
Ambient air concentrations of plant protection products: Data collection for the combined air concentration database and associated risk assessment	8
Editorial Board	7
Curing of UV prints – Assessment of possible toxicological hazard for consumers	7
Editorial Board	7
Global regulatory considerations and practices for tumorigenicity evaluation of cell-based therapy	7
Current trends in safety assessment of cosmetics ingredients	7
Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database	7

A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	7
Subchronic oral toxicity assessment of a cannabis extract	7
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	7
Application of physiologically-based pharmacokinetic modeled toluene blood concentration in the assessment of short term exposure limits	7
Pharmacokinetics of cyadox and its main metabolites in rats, pigs, chickens, and carps following oral administration at three dosage	7
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	7
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	7
A repeated dose 28-day oral toxicity study of sodium dehydroacetate (DHA-S) in Wistar rats	7
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	7
Editorial Board	7
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	7
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)	7
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	7
Derivation of an occupational exposure limit for β-glucans	7
Unraveling Caco-2 cells through functional and transcriptomic assessments	7
Serial blood sampling effects in rat embryo-fetal development studies for toxicokinetics	7
Editorial Board	7
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	7
Workshop report: Challenges faced in developing inhalation thresholds of Toxicological Concern (TTC) - State of the science and next steps	7
Metabolism-based category formation for the prioritisation of genotoxicity hazard assessment for plant protection product residues (part 3): Strobilurins	7
Effect of hydrophilic and lipophilic statins on early onset cataract: A nationwide case-control study	6
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	6
Adverse effects in traditional and alternative toxicity tests	6
Aloe gel-base food products: Chemical, toxicological, and regulatory aspects	6
Response to the Letter to the Editor by David W Roberts “Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on “Plant extracts, polymers an	6
Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics	6
Monitoring and risk assessment of hazardous chemicals in toy-slime and putty in the Netherlands	6
An orthogonal methods assessment of topical drug concentrations in skin and the impact for risk assessment in the viable epidermis	6
Editorial Board	6
A UK framework for the assessment and integration of different scientific evidence streams in chemical risk assessment	6
Non-dioxin-like polychlorinated biphenyl neurotoxic equivalents found in environmental and human samples	6
Genotoxicity and subchronic toxicity studies of supercritical carbon dioxide and acetone extracts of rosemary	6
The last resort requirement under REACH: From principle to practice	6
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	6
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	6
Margin of exposure to free formaldehyde in personal care products containing formaldehyde-donor preservatives: Evidence for consumer safety	6
Levels of mercury in Moroccan breast milk and the affecting factors: CONTAMILK study	6
Editorial Board	6
Assessment of black cumin (Nigella sativa L.) as a food ingredient and putative therapeutic agent	6
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	6
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices	6
Appraisal of the human health related toxicological information available on dicyclopentadiene (DCPD) in view of assessing the substance's potential to cause endocrine disruption	6
The use of weight-of-evidence approaches to characterize developmental toxicity risk for therapeutic monoclonal antibodies in humans without in vivo studies	6
Skin sensitisation prediction using read-across, an illustrative next generation risk assessment (NGRA) case study for vanillin	6
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	6
Editorial Board	6
Skin immune cell characterization in juvenile and adult Göttingen Minipigs	6
Evaluation of 28-day repeated oral dose toxicity of SUNACTIVE Zn–P240 in rats	6
New limits proposed for the management of non-mutagenic impurities	6
Correlation between dietary and dislodgeable foliar (DFR) crop residues decline data; A proposed approach to refine non-dietary risk assessment	6