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	166
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
Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers	55
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	52
28-Day oral (gavage) and 13-week (dietary) toxicity studies of DHA canola oil and DHA canola meal in rats	50
Comprehensive analysis of chronic rodent inhalation toxicity studies for methyl acrylate with attention to test conditions exceeding a maximum tolerated concentration	50
Quantitative risk assessment of skin sensitising pesticides: Clinical and toxicological considerations	45
Preclinical safety, toxicokinetics and metabolism of BIIB131, a novel prothrombolytic agent for acute stroke	41
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids	40
Letter to the editors regarding “The conundrum of the PFOA human half-life, an international collaboration”	39
Editorial Board	35
Inhalation exposure assessments under REACH – Problems encountered using the approach recommended by the ECHA guidance R.15	33
Editorial Board	30
Probabilistic methods for non-cancer health effects	29
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	27
Pathogenetic role of alveolar surfactant depleted by phosgene: Biophysical mechanisms and peak inhalation exposure metrics	27
Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment	27
Editorial Board	27
Editorial Board	26
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	26
Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary	25
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments	25
Editorial Board	25

Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen	25
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline	25
Particle size distribution in the evaluation of the inhalation toxicity of cosmetic spray products	24
Richardia brasiliensis Gomes: phytochemical characterization, antiproliferative capacity and in vitro and in vivo toxicity	24
Monosodium glutamate in a type 2 diabetes context: A large scoping review	24
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	24
Uncertainty in the results from oral repeated dose toxicity tests: Impact on regulatory classifications	23
Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios	22
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?	22
SCCS scientific opinion on HAA299 (nano) - SCCS/1634/21	22
Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach	21
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 3: Inflammatory response following acute inhalation exposure correlates with lower tier data	21
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	21
A systematic assessment of the epidemiologic literature regarding an association between acetaminophen exposure and cancer	21
SCCS Scientific Opinion on Acid Yellow 3 (submission II) – SCCS/1631/21	21
Skin and eye irritancy assessment of six lactic acid bacteria strains	21
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	20
Analysis for data-derived extrapolation factors for procymidone	19
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	19
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	19
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	18
Non-mutagenic impurities – Recent industry experience of using dose durational limits in drug development	18
A multi-tiered hierarchical Bayesian approach to derive toxic equivalency factors for dioxin-like compounds	18
Enzymes and sensitization via skin exposure: A critical analysis	18
Safety assessment of phytase transgenic maize 11TPY050 in Sprague-Dawley rats by 90-day feeding study	18
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	17
Editorial Board	17
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines	17
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	17
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	16
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations	16
Nicotine dosimetry and stability in cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions	16
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	16
Ethylene oxide derived glycol ethers: A review of the alkyl glycol ethers potential to cause endocrine disruption	16
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	16
Compounded conservatism in European re-entry worker risk assessment of pesticides	15
A roadmap towards a human-centric safety assessment of advanced therapy medicinal products	15
Editorial Board	15
Detailed aggregate exposure analysis shows that exposure to fragrance ingredients in consumer products is low: Many orders of magnitude below thresholds of concern	15
Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world	14
Dose response effect of chemical surface concentration on percutaneous penetration in human: In vivo + in vitro	14
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	14
Toxicological evaluation of a glycan preparation from an enzymatic hydrolysis of Saccharomyces cerevisiae	14
Twenty six-week repeat dose oral rat toxicity study of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	14
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	13
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	13
Biomonitoring Equivalents for glyphosate	13
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	13
Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes	13
Regulatory safety pharmacology and toxicity assessments of a standardized stem extract of Cassia occidentalis Linn. in rodents	12

The contribution of larval zebrafish transcriptomics to chemical risk assessment	12
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	12
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	12
Implications of variability on medical device chemical equivalence assessment	12
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	12
Extended One-Generation Reproductive Toxicity (EOGRT) study of benzoic acid in Sprague Dawley rats	12
The definition of chemical contaminants in food: Ambiguity and consequences	12
Grouping of short alkyl-chain branched carboxylic acids for developmental toxicity	12
Characterization of false positive, contaminant-driven mutagenicity in impurities associated with the sotorasib drug substance	12
Mercury in skin-care products in India and consumer exposure risks	12
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	12
A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products	11
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test	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
Integrating toxicokinetics into toxicology studies and the human health risk assessment process for chemicals: Reduced uncertainty, better health protection	11
A simplified index to quantify the irritation/corrosion potential of chemicals – Part II: Eye	11
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	11
Probabilistic pharmacokinetic modeling of airborne lead corresponding to toxicologically relevant blood lead levels in workers	11
Use of nonclinical toxicity studies to support biosimilar antibody development	11
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	11
Determination of “fitness-for-purpose” of quantitative structure-activity relationship (QSAR) models to predict (eco-)toxicological endpoints for regulatory use	11
Experimental study for the establishment of a chemotherapy-induced ovarian insufficiency model in rats by using cyclophosphamide combined with busulfan	11
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	11
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	11
Egg residue and depletion in Rhode Island Red hens (Gallus gallus domesticus) following multiple oral doses of trimethoprim-sulfamethoxazole	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
Evidence-based regulations for bioinformatic prediction of allergen cross-reactivity are needed	11
Characterization of tea tree oil nanoemulsion and its acute and subchronic toxicity	10
Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency	10
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	10
An integrated assessment of the 1,4-dioxane cancer mode of action and threshold response in rodents	10
Specificity of the local lymph node assay (LLNA) for skin sensitisation	10
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	10
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?	10
Retrospective analysis of dog study data from food and color additive petitions	10
Toxicity reference values (TRVs) for force health protection: Gap identification and TRV prediction	10
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	10
Non-sugar sweeteners and cancer: Toxicological and epidemiological evidence	10
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	10
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia	10
A systematic review of adverse health effects associated with oral cadmium exposure	10
Applicability of the in vitro skin irritation methods (EpiSkin™, EpiDerm™ SIT) to organosilicon-based substances	9
A deep dive into historical Ames study data for N-nitrosamine compounds	9
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	9
Data collection initiatives of the crop protection industry – A mission to improve non-dietary risk assessment in Europe	9
An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice	9
Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology	9
In silico evaluation of the potential allergenicity of a fungal biomass from Rhizomucor pusillus for use as a novel food ingredient	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
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	9
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	9
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	9
Ethyl acrylate (EA) exposure and thyroid carcinogenicity in rats and mice with relevance to human health	8
Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats	8
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	8
The Dilemma of perfluorooctanoate (PFOA) human half-life	8
DeepAmes: A deep learning-powered Ames test predictive model with potential for regulatory application	8
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	8
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	8
A Comprehensive Safety Assessment of Algae Protein from Picochlorum for Human Consumption	8
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	8
Evaluation of toxicity profile of kratom (Mitragyna speciosa Korth) decoction in rats	8
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices	8
Updating the Dermal Sensitisation Thresholds using an expanded dataset and an in silico expert system	8
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	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
Updated assessment of the genotoxic potential of titanium dioxide based on reviews of in vitro comet, mode of action and cellular uptake studies, and recent publications	8
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	8
Nonclinical safety assessment of engineered T cell therapies	8
Artificial intelligence and real-world data for drug and food safety – A regulatory science perspective	8
Sub-structure-based category formation for the prioritisation of genotoxicity hazard assessment for pesticide residues: Sulphonyl ureas	8
The 2022 world health organization reevaluation of human and mammalian toxic equivalency factors for polychlorinated dioxins, dibenzofurans and biphenyls	8
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	8
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	8
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
Editorial Board	7
Levels of mercury in Moroccan breast milk and the affecting factors: CONTAMILK study	7
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	7
Curing of UV prints – Assessment of possible toxicological hazard for consumers	7

Automated read-across workflow for predicting acute oral toxicity: I. The decision scheme in the QSAR toolbox	7
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	7
Editorial Board	7
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	7
Editorial Board	7
Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database	7
Editorial Board	7
Derivation of an occupational exposure limit for β-glucans	7
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	7
Subchronic oral toxicity assessment of a cannabis extract	7
Workshop report: Challenges faced in developing inhalation thresholds of Toxicological Concern (TTC) - State of the science and next steps	7
Editorial Board	7
Monitoring and risk assessment of hazardous chemicals in toy-slime and putty in the Netherlands	7
Current trends in safety assessment of cosmetics ingredients	7
Application of physiologically-based pharmacokinetic modeled toluene blood concentration in the assessment of short term exposure limits	7
Editorial Board	7
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	7
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)	7
Ambient air concentrations of plant protection products: Data collection for the combined air concentration database and associated risk assessment	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
Re-evaluation of the reduced heart weights in male rats in a 28-day oral repeated-dose toxicity study of tetramethylammonium hydroxide	6
OECD harmonised template 201: Structuring and reporting mechanistic information to foster the integration of new approach methodologies for hazard and risk assessment of chemicals	6
Non-dioxin-like polychlorinated biphenyl neurotoxic equivalents found in environmental and human samples	6
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	6
A proposed approach to confirm heroin administration – Regional differences in heroin purity is a major factor	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
Biomonitoring and risk assessment of human exposure to triazole fungicides	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
Editorial Board	6
Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies	6
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	6
Serial blood sampling effects in rat embryo-fetal development studies for toxicokinetics	6
Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards	6
Effect of hydrophilic and lipophilic statins on early onset cataract: A nationwide case-control study	6
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	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 immune cell characterization in juvenile and adult Göttingen Minipigs	6
An orthogonal methods assessment of topical drug concentrations in skin and the impact for risk assessment in the viable epidermis	6
A repeated dose 28-day oral toxicity study of sodium dehydroacetate (DHA-S) in Wistar rats	6
Application of a new approach method (NAM) for inhalation risk assessment	6
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	6
Impact of repeated micro and macro blood sampling on clinical chemistry and haematology in rats for toxicokinetic studies	5
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	5
Skin sensitisation prediction using read-across, an illustrative next generation risk assessment (NGRA) case study for vanillin	5
Comprehensive assessment of water quality and associated health risks in an arid region in south Iran	5
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	5
Metabolism-based category formation for the prioritisation of genotoxicity hazard assessment for plant protection product residues (part 3): Strobilurins	5
Appraisal of the human health related toxicological information available on dicyclopentadiene (DCPD) in view of assessing the substance's potential to cause endocrine disruption	5
An evolution of risk assessment for potential carcinogens in food: Scientific session proceedings	5
Editorial Board	5
The dual endothelin A and angiotensin II type 1 receptor antagonist sparsentan (FILSPARI®) exhibits a safe nonclinical male fertility toxicity profile	5
Toxicokinetic and toxicodynamic mixture effects of plant protection products: A case study	5
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	5
Evaluation of 28-day repeated oral dose toxicity of SUNACTIVE Zn–P240 in rats	5
Assessing utility of thyroid in vitro screening assays through comparisons to observed impacts in vivo	5
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	5
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	5
Assessment of black cumin (Nigella sativa L.) as a food ingredient and putative therapeutic agent	5
A UK framework for the assessment and integration of different scientific evidence streams in chemical risk assessment	5
Pharmacokinetics of cyadox and its main metabolites in rats, pigs, chickens, and carps following oral administration at three dosage	5
Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future	5
A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10	5
Carcinogenic and neurotoxic risks of acrylamide consumed through bread, kaak, toast, and crackers among the Lebanese Population	5
Global regulatory considerations and practices for tumorigenicity evaluation of cell-based therapy	5
Iron oxide nanoparticles exert inhibitory effects on N-Bis(2-hydroxypropyl)nitrosamine (DHPN)-induced lung tumorigenesis in rats	4
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	4
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	4
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	4
Human biomonitoring (HBM)-II values for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) - Description, derivation and discussion	4
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 4: Effects from a 28-day inhalation toxicity study with tricobalt tetraoxide in rats	4
Editorial Board	4
Safety evaluation of BPL9K-4 rice in a subchronic rodent feeding study	4
The SCCS scientific advice on the safety of nanomaterials in cosmetics	4
Animal use and opportunities for reduction in carcinogenicity studies supporting approved new drug applications in the U.S., 2015–2019	4
Development of COVID-19 therapies: Nonclinical testing considerations	4
Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice	4
Editorial Board	4
Derivation of thresholds for inhaled chemically reactive irritants: Searching for substance-specific common denominators for read-across prediction	4
Safety evaluation of recycling process used to produce recycled pulp for adult paper diapers	4
In Memoriam: Michael "Mike" Steven Denison 1954–2022	4
Development of benchmark datasets for text mining and sentiment analysis to accelerate regulatory literature review	4
Effect of chain length and branching on the in vitro metabolism of a series of parabens in human liver S9, human skin S9, and human plasma	4
Nonclinical genotoxicity and carcinogenicity profile of apremilast, an oral selective inhibitor of PDE4	4
A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential	4
Effects of as-if risk framing of hazards on risk perception and its rebuttal	4
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	4
Editorial Board	4
Safety assessment of Asterarcys quadricellulare, a microalga, with applications in poultry and livestock feed	4
Editorial Board	4
Zinc deficiency induced by the chelating agent DTPA and its regulatory interpretation for developmental toxicity classification	4
Carcinogenic assessment of cobalt-containing alloys in medical devices or cobalt in occupational settings: A systematic review and meta-analysis of overall cancer risk from published epidemiologic stu	4
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	4