Regulatory Toxicology and Pharmacology

Article	Citations
Regulatory landscape of dietary supplements and herbal medicines from a global perspective	107
Regulatory landscape of nanotechnology and nanoplastics from a global perspective	100
An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)	95
Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials	81
Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data	71
Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply?	58
Pulmonary toxicity of silver vapours, nanoparticles and fine dusts: A review	58
Toxicity of boric acid, borax and other boron containing compounds: A review	54
Review of regulatory reference values and background levels for heavy metals in the human diet	48
Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients	46
Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology	46
Human health hazard assessment of quaternary ammonium compounds: Didecyl dimethyl ammonium chloride and alkyl (C12–C16) dimethyl benzyl ammonium chloride	45
Can we define a level of protection for allergic consumers that everyone can accept?	42
Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients	39
“Natural” is not synonymous with “Safe”: Toxicity of natural products alone and in combination with pharmaceutical agents	38
Nonclinical safety assessment of repeated administration and biodistribution of a novel rabies self-amplifying mRNA vaccine in rats	38
Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER)	37
Occupational exposure to hexavalent chromium. Part II. Hazard assessment of carcinogenic effects	36
Toxicological evaluation of exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells	35
New ideas for non-animal approaches to predict repeated-dose systemic toxicity: Report from an EPAA Blue Sky Workshop	33
PBPK model reporting template for chemical risk assessment applications	32
Occupational exposure to hexavalent chromium. Part I. Hazard assessment of non-cancer health effects	32
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	32
Skin sensitization in silico protocol	30
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	30

Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds	29
Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture	29
Reflections on the OECD guidelines for in vitro skin absorption studies	28
Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations	26
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	25
Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential	24
Replacing the refinement for skin sensitization testing: Considerations to the implementation of adverse outcome pathway (AOP)-based defined approaches (DA) in OECD guidelines	24
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	23
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation	23
An evaluation of the genotoxicity and subchronic toxicity of the peel extract of Ponkan cultivar ‘Ohta ponkan’ (Citrus reticulata Blanco) that is rich in nobiletin and tangeretin with anti-dementia ac	23
Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop	22
Bolstering the existing database supporting the non-cancer Threshold of Toxicological Concern values with toxicity data on fragrance-related materials	22
Assessment of black cumin (Nigella sativa L.) as a food ingredient and putative therapeutic agent	21
New framework for a non-animal approach adequately assures the safety of cosmetic ingredients – A case study on caffeine	21
A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals	21
Short-term toxicogenomics as an alternative approach to chronic in vivo studies for derivation of points of departure: A case study in the rat with a triazole fungicide	20
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	20
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	20
Antimony release from polyester textiles by artificial sweat solutions: A call for a standardized procedure	20
Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future	20
Role of Diosmin in protection against the oxidative stress induced damage by gamma-radiation in Wistar albino rats	19
Evaluation of the toxicity of sodium dodecyl sulphate (SDS) in the MucilAir™ human airway model in vitro	19
Read-across can increase confidence in the Next Generation Risk Assessment for skin sensitisation: A case study with resorcinol	19
Analysis of variability in the rabbit skin irritation assay	19
Considerations for determining safety of probiotics: A USP perspective	19
A comprehensive review of mechanistic insights into formaldehyde-induced nasal cavity carcinogenicity	19
R-ODAF: Omics data analysis framework for regulatory application	18
Regulating human safety: How dose selection in toxicity studies impacts human health hazard assessment and subsequent risk management options	18
Assessment of the potential allergenicity and toxicity of Pichia proteins in a novel leghemoglobin preparation	18
Use of the kinetically-derived maximum dose concept in selection of top doses for toxicity studies hampers proper hazard assessment and risk management	18
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines	17
Compounded conservatism in European re-entry worker risk assessment of pesticides	17
Human Biomonitoring (HBM)-I values for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) - Description, derivation and discussion	17
Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and	17
Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines	17
A weight of evidence review of the genotoxicity of titanium dioxide (TiO2)	17
Characterization of tea tree oil nanoemulsion and its acute and subchronic toxicity	17
Risk assessment of unintentional phthalates contaminants in cosmetics	16
Safety assessment of astaxanthin from Haematococcus pluvialis: Acute toxicity, genotoxicity, distribution and repeat-dose toxicity studies in gestation mice	16
The performance, reliability and potential application of in silico models for predicting the acute oral toxicity of pharmaceutical compounds	16
Human biomonitoring (HBM)-II values for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) - Description, derivation and discussion	16
Application of a new approach method (NAM) for inhalation risk assessment	16
Determination of inorganic arsenic, heavy metals, pesticides and mycotoxins in Indian rice (Oryza sativa) and a probabilistic dietary risk assessment for the population of Saudi Arabia	16
Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updates	16
Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies	15
Advances in selecting appropriate non-rodent species for regulatory toxicology research: Policy, ethical, and experimental considerations	15
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	15
Using historical control data in bioassays for regulatory toxicology	15
Evaluation of the carcinogenicity of dichloromethane in rats, mice, hamsters and humans	15
Development of improved QSAR models for predicting the outcome of the in vivo micronucleus genetic toxicity assay	15

10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	15
Acute and sub-chronic toxicity studies of Benincasa hispida (Thunb.) cogniaux fruit extract in rodents	14
Adeno-associated virus (AAV)-based gene therapy products: What are toxicity studies in non-human primates showing us?	14
Next generation risk assessment for skin allergy: Decision making using new approach methodologies	14
A systematic review of adverse health effects associated with oral cadmium exposure	14
Safety evaluation of Eucommia ulmoides extract	14
Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)	14
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	14
Application of structural and functional pharmacokinetic analogs for physiologically based pharmacokinetic model development and evaluation	14
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions	14
Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassay	14
Establishing health-based biological exposure limits for pesticides: A proof of principle study using mancozeb	13
Automated read-across workflow for predicting acute oral toxicity: I. The decision scheme in the QSAR toolbox	13
Selecting a minimal set of androgen receptor assays for screening chemicals	13
Acute and repeated dose 28-day oral toxicity of Chrysobalanus icaco L. leaf aqueous extract	13
Assessment of veterinary drug residues in food: Considerations when dealing with sub-optimal data	13
Comparisons of PNEC derivation logic flows under example regulatory schemes and implications for ecoTTC	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]	13
Application of the dermal sensitization threshold concept to chemicals classified as high potency category for skin sensitization assessment of ingredients for consumer products	13
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	13
Recommendations for further revisions to improve the International Agency for Research on Cancer (IARC) Monograph program	13
A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling	13
A matched molecular pair (MMP) approach for selecting analogs suitable for structure activity relationship (SAR)-based read across	13
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	13
Effect of low- and high-level groundwater arsenic on peripheral blood and lung function of exposed rural women	13
A scoping review of infant and children health effects associated with cadmium exposure	13
A review to support the derivation of a worst-case dermal penetration value for nanoparticles	12
Model systems and organisms for addressing inter- and intra-species variability in risk assessment	12
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	12
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	12
Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen	12
Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts	12
Development of peptide therapeutics: A nonclinical safety assessment perspective	12
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	12
Review of the pharmacokinetics and metabolism of triclopyr herbicide in mammals: Impact on safety assessments	12
Metabolic fate in adult and pediatric population of steviol glycosides produced from stevia leaf extract by different production technologies	12
Considerations for setting occupational exposure limits for novel pharmaceutical modalities	12
An interim internal Threshold of Toxicologic Concern (iTTC) for chemicals in consumer products, with support from an automated assessment of ToxCast™ dose response data	12
“New statistics” in regulatory toxicology?	11
Non-dioxin-like polychlorinated biphenyl neurotoxic equivalents found in environmental and human samples	11
Mercury in skin-care products in India and consumer exposure risks	11
Dose-response assessment for impaired memory from chronic exposure to domoic acid among native American consumers of razor clams	11
Opportunities and challenges related to saturation of toxicokinetic processes: Implications for risk assessment	11
How the 62-year old Delaney Clause continues to thwart science: Case study of the flavor substance β-myrcene	11
The Dilemma of perfluorooctanoate (PFOA) human half-life	11
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 3: Inflammatory response following acute inhalation exposure correlates with lower tier data	11
Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?	11
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations	11
Safety and health risk assessment methodology of dermal and inhalation exposure to formulated products ingredients	11
Lay people and experts’ risk perception of pharmaceuticals in the environment in Southwestern Europe	11
A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products	11
Use compatibility intervals in regulatory toxicology	11
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	10
The Conundrum of the PFOA human half-life, an international collaboration	10
Aloe gel-base food products: Chemical, toxicological, and regulatory aspects	10
Determination of “fitness-for-purpose” of quantitative structure-activity relationship (QSAR) models to predict (eco-)toxicological endpoints for regulatory use	10
Support vector machine-based model for toxicity of organic compounds against fish	10
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	10
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices	10
Occupational exposure to Cr(VI) in Finland in 1980–2016 and related lung cancer risk assessment	10
Carcinogenicity and chronic toxicity of acrolein in rats and mice by two-year inhalation study	10
Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies	10
Determination of the stereoisomeric distribution of R-(−)- and S-(+)-methamphetamine in Thai pills in the legal context of “not inconsiderable quantities"	10
A tiered approach to investigate the inhalation toxicity of cobalt substances. Introduction: Cobalt's essential role in nature and technology	9
Next generation risk assessment for skin sensitisation: A case study with propyl paraben	9
A novel approach to monitor skin permeation of metals in vitro	9
Toxicological risk assessment of bisphenol a released from dialyzers under simulated-use and exaggerated extraction conditions	9
Comparison of threshold of toxicological concern (TTC) values to oral reference dose (RfD) values	9
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations	9
Analysis and reflection on the role of the 90-day oral toxicity study in European chemical risk assessment	9
Toxicological assessment method for evaluating the occupational risk of dynamic olfactometry assessors	9
Evaluating chemical similarity as a measure to identify potential substances of very high concern	9
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	9
In silico assessment of genotoxicity. Combinations of sensitive structural alerts minimize false negative predictions for all genotoxicity endpoints and can single out chemicals for which experimentat	9
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	9
In vitro skin penetration of bronidox, bronopol and formaldehyde from cosmetics	9
In vivo safety testing of Antibody Drug Conjugates	9
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)	9
A weight of evidence assessment of the genotoxicity of 2,6-xylidine based on existing and new data, with relevance to safety of lidocaine exposure	9
Non-sugar sweeteners and cancer: Toxicological and epidemiological evidence	9

Computational identification of preservatives with potential neuronal cytotoxicity	8
Toxicological evaluation of, red rice yeast extract, Xuezhikang: Acute, 26-week chronic and genotoxicity studies	8
An analysis of the setting of the acute reference dose (ARfD) for pesticides in Europe	8
Confidence interval function analysis to evaluate the risk of mesothelioma among an expanded international cohort of cosmetic talc miners and millers	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
Performance of the GHS Mixtures Equation for Predicting Acute Oral Toxicity	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
Exposure to environmentally-relevant concentrations of hexavalent chromium does not induce ovarian toxicity in mice	8
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 2a: Grouping cobalt compounds based on their capacity to stabilize HIF-1α in human alveolar epithelial cells in vitr	8
The Threshold of Toxicological Concern (TTC) is a pragmatic tool for the safety assessment: Case studies of cosmetic ingredients with low consumer exposure	8
Conformity assessment of medicines containing antibiotics – A multivariate assessment	8
Evaluation of the predictivity of Acute Oral Toxicity (AOT) structure-activity relationship models	8
Metribuzin-induced non-adverse liver changes result in rodent-specific non-adverse thyroid effects via uridine 5′-diphospho-glucuronosyltransferase (UDPGT, UGT) modulation	8
Facilitation of risk assessment with evidence-based methods – A framework for use of systematic mapping and systematic reviews in determining hazard, developing toxicity values, and characterizing unc	8
Updating the Dermal Sensitisation Thresholds using an expanded dataset and an in silico expert system	8
Evaluation of the sub-acute toxicity of Acacia catechu Willd seed extract in a Wistar albino rat model	8
Rethinking agrochemical safety assessment: A perspective	8
Systematic review of the potential carcinogenicity of bisphenol A in humans	8
Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data	8
Safety evaluation of water extract of Gastrodia elata Blume: Genotoxicity and 28-day oral toxicity studies	8
In vitro and in vivo evaluation of probiotic potential and safety assessment of Bacillus coagulans SKB LAB-19 (MCC 0554) in humans and animal healthcare	8
Association of dietary intake and urinary excretion of inorganic arsenic in the Japanese subjects	8
Genotoxicity evaluation of a valsartan-related complex N-nitroso-impurity	8
Integration of in vitro data from three dimensionally cultured HepaRG cells and physiologically based pharmacokinetic modeling for assessment of acetaminophen hepatotoxicity	8
Beyond dermal exposure: The respiratory tract as a target organ in hazard assessments of cosmetic ingredients	7
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	7
DP-2Ø2216-6 maize does not adversely affect rats in a 90-day feeding study	7
Nonclinical & clinical interface - extrapolation of nonclinical data to support Phase I clinical studies	7
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	7
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	7
A flow scheme for cumulative assessment of pesticides for adverse liver effects	7
Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers	7
Heavy metal contamination in recorded and unrecorded spirits. Should we worry?	7
Ni and Cr impurities profile in Valeriana officinalis L., radix-based herbal medicinal product available in polish pharmacies due to ICH Q3D guideline	7
The genotoxicity of an organic solvent mixture: A human biomonitoring study and translation of a real-scenario exposure to in vitro	7
The purity of tattoo inks, screening substances of high concern	7
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies	7
Expanding the toxicologist's statistical toolbox: Using effect size estimation and dose-response modelling for holistic assessments instead of generic testing	7
Artificial intelligence and real-world data for drug and food safety – A regulatory science perspective	7
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	7
Safety of medicinal comfrey cream preparations (Symphytum officinale s.l.): The pyrrolizidine alkaloid lycopsamine is poorly absorbed through human skin	7
Making in silico predictive models for toxicology FAIR	7
Use of the kinetically-derived maximum dose: Opportunities for delivering 3Rs benefits	7
The safety of a Kluyveromyces lactis strain lineage for enzyme production	7
A toxicological evaluation of geranylgeraniol	7
Standardization, in-silico and in-vivo safety assessment of methanol extract of Ziziphus mauritiana Lam leaves	7
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	7
Comparison of the potential mechanisms for hepatotoxicity of p-dialkoxy chlorobenzenes in rat primary hepatocytes for read-across	7
Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes	7