Regulatory Toxicology and Pharmacology

Article	Citations
Regulatory landscape of nanotechnology and nanoplastics from a global perspective	121
Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials	86
Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data	82
Toxicity of boric acid, borax and other boron containing compounds: A review	65
Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply?	65
Review of regulatory reference values and background levels for heavy metals in the human diet	57
Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology	53
Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients	53
Human health hazard assessment of quaternary ammonium compounds: Didecyl dimethyl ammonium chloride and alkyl (C12–C16) dimethyl benzyl ammonium chloride	52
Can we define a level of protection for allergic consumers that everyone can accept?	47
Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients	43
Occupational exposure to hexavalent chromium. Part II. Hazard assessment of carcinogenic effects	43
Occupational exposure to hexavalent chromium. Part I. Hazard assessment of non-cancer health effects	42
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)	41
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	39
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	39
Skin sensitization in silico protocol	33
Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations	33
Reflections on the OECD guidelines for in vitro skin absorption studies	32
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	30
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	27
Assessment of black cumin (Nigella sativa L.) as a food ingredient and putative therapeutic agent	26
Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop	26
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]	25
Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential	25

Analysis of variability in the rabbit skin irritation assay	24
New framework for a non-animal approach adequately assures the safety of cosmetic ingredients – A case study on caffeine	24
A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals	24
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions	24
Considerations for determining safety of probiotics: A USP perspective	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
Bolstering the existing database supporting the non-cancer Threshold of Toxicological Concern values with toxicity data on fragrance-related materials	23
Assessment of the potential allergenicity and toxicity of Pichia proteins in a novel leghemoglobin preparation	23
A weight of evidence review of the genotoxicity of titanium dioxide (TiO2)	23
Evaluation of the toxicity of sodium dodecyl sulphate (SDS) in the MucilAir™ human airway model in vitro	22
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	22
Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future	22
R-ODAF: Omics data analysis framework for regulatory application	21
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	21
A comprehensive review of mechanistic insights into formaldehyde-induced nasal cavity carcinogenicity	21
Read-across can increase confidence in the Next Generation Risk Assessment for skin sensitisation: A case study with resorcinol	21
Human Biomonitoring (HBM)-I values for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) - Description, derivation and discussion	21
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines	20
Antimony release from polyester textiles by artificial sweat solutions: A call for a standardized procedure	20
Model systems and organisms for addressing inter- and intra-species variability in risk assessment	20
Acute and sub-chronic toxicity studies of Benincasa hispida (Thunb.) cogniaux fruit extract in rodents	20
Next generation risk assessment for skin allergy: Decision making using new approach methodologies	19
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	18
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	18
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	18
Compounded conservatism in European re-entry worker risk assessment of pesticides	18
Human biomonitoring (HBM)-II values for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) - Description, derivation and discussion	18
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	18
Characterization of tea tree oil nanoemulsion and its acute and subchronic toxicity	18
Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies	18
Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updates	18
Application of a new approach method (NAM) for inhalation risk assessment	18
A systematic review of adverse health effects associated with oral cadmium exposure	18
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	17
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	17
Considerations for setting occupational exposure limits for novel pharmaceutical modalities	17
Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines	17
Using historical control data in bioassays for regulatory toxicology	16
A scoping review of infant and children health effects associated with cadmium exposure	16
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	16
The performance, reliability and potential application of in silico models for predicting the acute oral toxicity of pharmaceutical compounds	16
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	16
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations	16
A review to support the derivation of a worst-case dermal penetration value for nanoparticles	16
Adeno-associated virus (AAV)-based gene therapy products: What are toxicity studies in non-human primates showing us?	16
Evaluation of the carcinogenicity of dichloromethane in rats, mice, hamsters and humans	16
Non-sugar sweeteners and cancer: Toxicological and epidemiological evidence	16
Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts	16
Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)	15
A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling	15

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	15
Advances in selecting appropriate non-rodent species for regulatory toxicology research: Policy, ethical, and experimental considerations	15
Comparisons of PNEC derivation logic flows under example regulatory schemes and implications for ecoTTC	14
Automated read-across workflow for predicting acute oral toxicity: I. The decision scheme in the QSAR toolbox	14
Safety evaluation of Eucommia ulmoides extract	14
Assessment of veterinary drug residues in food: Considerations when dealing with sub-optimal data	14
Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies	14
Selecting a minimal set of androgen receptor assays for screening chemicals	14
A matched molecular pair (MMP) approach for selecting analogs suitable for structure activity relationship (SAR)-based read across	14
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	14
Application of the dermal sensitization threshold concept to chemicals classified as high potency category for skin sensitization assessment of ingredients for consumer products	13
Dose-response assessment for impaired memory from chronic exposure to domoic acid among native American consumers of razor clams	13
Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?	13
Opportunities and challenges related to saturation of toxicokinetic processes: Implications for risk assessment	13
The Dilemma of perfluorooctanoate (PFOA) human half-life	13
Review of the pharmacokinetics and metabolism of triclopyr herbicide in mammals: Impact on safety assessments	13
The 2022 world health organization reevaluation of human and mammalian toxic equivalency factors for polychlorinated dioxins, dibenzofurans and biphenyls	13
A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products	13
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations	12
Lay people and experts’ risk perception of pharmaceuticals in the environment in Southwestern Europe	12
Advancing the science of a read-across framework for evaluation of data-poor chemicals incorporating systematic and new approach methods	12
Development of peptide therapeutics: A nonclinical safety assessment perspective	12
Mercury in skin-care products in India and consumer exposure risks	12
Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen	12
Non-dioxin-like polychlorinated biphenyl neurotoxic equivalents found in environmental and human samples	12
Determination of the stereoisomeric distribution of R-(−)- and S-(+)-methamphetamine in Thai pills in the legal context of “not inconsiderable quantities"	12
Metabolic fate in adult and pediatric population of steviol glycosides produced from stevia leaf extract by different production technologies	12
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach	11
In vivo safety testing of Antibody Drug Conjugates	11
Evaluation of the predictivity of Acute Oral Toxicity (AOT) structure-activity relationship models	11
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	11
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	11
Safety and health risk assessment methodology of dermal and inhalation exposure to formulated products ingredients	11
Artificial intelligence and real-world data for drug and food safety – A regulatory science perspective	11
Occupational exposure to Cr(VI) in Finland in 1980–2016 and related lung cancer risk assessment	11
Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data	11
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	11
Support vector machine-based model for toxicity of organic compounds against fish	11
“New statistics” in regulatory toxicology?	11
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices	11
Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers	11
Genotoxicity evaluation of a valsartan-related complex N-nitroso-impurity	11
Use compatibility intervals in regulatory toxicology	11
Evaluating chemical similarity as a measure to identify potential substances of very high concern	11
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	11
The Conundrum of the PFOA human half-life, an international collaboration	11
Aloe gel-base food products: Chemical, toxicological, and regulatory aspects	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
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	10
Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439	10
A tiered approach to investigate the inhalation toxicity of cobalt substances. Introduction: Cobalt's essential role in nature and technology	10
Performance of the GHS Mixtures Equation for Predicting Acute Oral Toxicity	10
Fluoride concentrations in drinking water and health risk assessment in the south of Algeria	10
Next generation risk assessment for skin sensitisation: A case study with propyl paraben	10
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	10
Updating the Dermal Sensitisation Thresholds using an expanded dataset and an in silico expert system	10
2000–2023 over two decades of ICH S7A: has the time come for a revamp?	10
Rethinking agrochemical safety assessment: A perspective	10
Toxicological assessment method for evaluating the occupational risk of dynamic olfactometry assessors	10
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	10
Carcinogenicity and chronic toxicity of acrolein in rats and mice by two-year inhalation study	10
Determination of “fitness-for-purpose” of quantitative structure-activity relationship (QSAR) models to predict (eco-)toxicological endpoints for regulatory use	10
Analysis and reflection on the role of the 90-day oral toxicity study in European chemical risk assessment	10
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	10
In vitro skin penetration of bronidox, bronopol and formaldehyde from cosmetics	10
Computational identification of preservatives with potential neuronal cytotoxicity	9
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	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
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow	9
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	9
Systematic review of the potential carcinogenicity of bisphenol A in humans	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
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
Exposure to environmentally-relevant concentrations of hexavalent chromium does not induce ovarian toxicity in mice	9
Making in silico predictive models for toxicology FAIR	9
Beyond dermal exposure: The respiratory tract as a target organ in hazard assessments of cosmetic ingredients	9
Toxicological risk assessment of bisphenol a released from dialyzers under simulated-use and exaggerated extraction conditions	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
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines	9
Expanding the toxicologist's statistical toolbox: Using effect size estimation and dose-response modelling for holistic assessments instead of generic testing	8

Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats	8
Experimental study for the establishment of a chemotherapy-induced ovarian insufficiency model in rats by using cyclophosphamide combined with busulfan	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
Report on investigation of ISO 10993–12 extraction conditions	8
Evaluation of the mode of action and human relevance of liver tumors in male mice treated with epyrifenacil	8
Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey	8
Metribuzin-induced non-adverse liver changes result in rodent-specific non-adverse thyroid effects via uridine 5′-diphospho-glucuronosyltransferase (UDPGT, UGT) modulation	8
Association of dietary intake and urinary excretion of inorganic arsenic in the Japanese subjects	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
Safety of medicinal comfrey cream preparations (Symphytum officinale s.l.): The pyrrolizidine alkaloid lycopsamine is poorly absorbed through human skin	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
DP-2Ø2216-6 maize does not adversely affect rats in a 90-day feeding study	8
The purity of tattoo inks, screening substances of high concern	8
Plant extracts, polymers and new approach methods: Practical experience with skin sensitization assessment	8
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	8
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	8
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches	8
Heavy metal contamination in recorded and unrecorded spirits. Should we worry?	8
Conformity assessment of medicines containing antibiotics – A multivariate assessment	8
The genotoxicity of an organic solvent mixture: A human biomonitoring study and translation of a real-scenario exposure to in vitro	8
The safety of a Kluyveromyces lactis strain lineage for enzyme production	8
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	7
A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential	7
A flow scheme for cumulative assessment of pesticides for adverse liver effects	7
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	7
Current ecotoxicity testing needs among selected U.S. federal agencies	7
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	7
A 90-day drinking water study in mice to characterize early events in the cancer mode of action of 1,4-dioxane	7
Standardization, in-silico and in-vivo safety assessment of methanol extract of Ziziphus mauritiana Lam leaves	7
Developing a database of systematic reviews of animal studies	7
Development of COVID-19 therapies: Nonclinical testing considerations	7
Sub-structure-based category formation for the prioritisation of genotoxicity hazard assessment for pesticide residues: Sulphonyl ureas	7
Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes	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
Recommendation for an occupational exposure limit for toluene	7
Use of in vitro metabolism and biokinetics assays to refine predicted in vivo and in vitro internal exposure to the cosmetic ingredient, phenoxyethanol, for use in risk assessment	7
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	7
RespiraTox – Development of a QSAR model to predict human respiratory irritants	7
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies	7
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	7
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	7
Effects of an ethanolic extract and fractions from Piper glabratum (Piperaceae) leaves on pain and inflammation	7
Use of the kinetically-derived maximum dose: Opportunities for delivering 3Rs benefits	7
A toxicological evaluation of geranylgeraniol	7
Nonclinical & clinical interface - extrapolation of nonclinical data to support Phase I clinical studies	7