Regulatory Toxicology and Pharmacology : RTP This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Benchmarking of BMDC Assay and related QSAR Study for Identifying Sensitizing Chemicals
This study expanded the BMDC benchmarking to various in vitro, in chemico, and in silico assays targeting different key events (KE) in the skin sensitization pathway, using common substances datasets. Additionally, a Quantitative Structure-Activity Relationship (QSAR) model was developed to predict the BMDC test outcomes for sensitizing or non-sensitizing chemicals. The modelling workflow involved ISIDA (In Silico Design and Data Analysis) molecular fragment descriptors and the SVM (Support Vector Machine) machine-learning method. The BMDC model's performance was at least comparable to that of all ECVAM-validated models re...
Source: Regulatory Toxicology and Pharmacology : RTP - April 17, 2024 Category: Toxicology Authors: Lisa Chedik Shamkhal Baybekov Gilles Marcou Fr édéric Cosnier M élanie Mourot-Bousquenaud Sandrine Jacquenet Alexandre Varnek Fabrice Battais Source Type: research

Ambient air concentrations of Plant Protection Products: data collection for the Combined Air Concentration Database and associated risk assessment
In conclusion, based on the CACD, measured air concentrations of PPPs are significantly lower than EFSA default limits and relevant toxicological reference values.PMID:38621522 | DOI:10.1016/j.yrtph.2024.105627 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 15, 2024 Category: Toxicology Authors: Anne-Kim Vinck Edgars Felkers Michel Urtizberea Nicola J Hewitt Kathrin B ürling Alistair Morriss Source Type: research

Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards
Regul Toxicol Pharmacol. 2024 Apr 13:105628. doi: 10.1016/j.yrtph.2024.105628. Online ahead of print.ABSTRACTNew transfer coefficient (TC) values were derived for vineyard workers handling treated grapevines during harvesting and crop maintenance activities. Re-entry exposure and dislodgeable foliar residue (DFR) studies were performed in Europe, covering hand harvesting, pruning/training, pruning/tying and pruning /shoot lifting. Foliar applications of fungicides (iprovalicarb, dimethomorph, dithianon, pyrimethanil and fenbuconazole) were made and 73 workers at 16 sites were monitored over one working day. Exposure was me...
Source: Regulatory Toxicology and Pharmacology : RTP - April 15, 2024 Category: Toxicology Authors: Udo Blaschke Edgars Felkers Nicola J Hewitt Felix M Kluxen Neil Morgan Christiane Wiemann Source Type: research

Safety assessment of Paeonia lactiflora root extract for a cosmetic ingredient employing the threshold of toxicological concern (TTC) approach
Regul Toxicol Pharmacol. 2024 Apr 12:105620. doi: 10.1016/j.yrtph.2024.105620. Online ahead of print.ABSTRACTBotanical extracts, widely used in cosmetics, pose a challenge to safety assessment due to their complex compositions. The threshold of toxicological concern (TTC) approach, offering a safe exposure level for cosmetic ingredients, proves to be a promising solution for ensuring the safety of cosmetic ingredients with low exposure level. We assessed the safety of Paeonia lactiflora root extract (PLR), commonly used in skin conditioning products, with the TTC. We identified 50 constituents of PLR extract from the USDA ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 14, 2024 Category: Toxicology Authors: Soha Jeon Eun-Young Lee Sang-Jip Nam Kyung-Min Lim Source Type: research

How the Xenopus eleutheroembryonic thyroid assay compares to the amphibian metamorphosis assay for detecting thyroid active chemicals
This study was therefore initiated to investigate and consolidate the applicability domain of the XETA regarding the following mechanisms: thyroid hormone receptor (THR) agonism, sodium-iodide symporter (NIS) inhibition, thyroperoxidase (TPO) inhibition, deiodinase (DIO) inhibition, glucocorticoid receptor (GR) agonism, and uridine 5'-diphospho-glucuronosyltransferase (UDPGT) induction. In total, 22 chemicals identified as thyroid-active or -inactive in Amphibian Metamorphosis Assays (AMAs) were tested using the XETA OECD Test Guideline. The comparison showed that both assays are highly concordant in identifying chemicals ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 13, 2024 Category: Toxicology Authors: David Du Pasquier Beno ît Salinier Katherine K Coady Alan Jones Oliver K örner Jessica LaRocca Gregory Lemkine Barbara Robin-Duchesne Lennart Weltje James R Wheeler Laurent Lagadic Source Type: research

Safety Evaluation of 8 Drug Degradants Present in Over-the-Counter Cough and Cold Medications
Regul Toxicol Pharmacol. 2024 Apr 10:105621. doi: 10.1016/j.yrtph.2024.105621. Online ahead of print.ABSTRACTAlthough the United States Food & Drug Administration (FDA) has provided guidance on the control of drug degradants for prescription drugs, there is less guidance on how to set degradant specifications for FDA OTC monograph drugs. Given that extensive impurity testing was not part of the safety paradigm in original OTC monographs, a weight of evidence (WOE) approach to qualify OTC degradants is proposed. This approach relies on in silico tools and read-across approaches alongside standard toxicity testing to det...
Source: Regulatory Toxicology and Pharmacology : RTP - April 12, 2024 Category: Toxicology Authors: Amy L Mihalchik Neepa Y Choksi Amy L Roe Michael Wisser Kylen Whitaker Donna Seibert Milind Deore Larisa Pavlick Daniele S Wikoff Source Type: research

Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?
Regul Toxicol Pharmacol. 2024 Apr 6:105622. doi: 10.1016/j.yrtph.2024.105622. Online ahead of print.ABSTRACTNovel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals. Although read-across is ...
Source: Regulatory Toxicology and Pharmacology : RTP - April 8, 2024 Category: Toxicology Authors: Jan S ündermann Annette Bitsch Rupert Kellner Theodor Doll Source Type: research

Letter to the Editors regarding "Using historical control data in bioassays for regulatory toxicology" by Kluxen et al. (2021)
Regul Toxicol Pharmacol. 2024 Apr 6;149:105624. doi: 10.1016/j.yrtph.2024.105624. Online ahead of print.NO ABSTRACTPMID:38588772 | DOI:10.1016/j.yrtph.2024.105624 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 8, 2024 Category: Toxicology Authors: J ürg A Zarn H Christoph Geiser Sebastian L B K önig Holly V Shaw Ursina A Z ürcher Source Type: research

Letter to the Editors regarding "Using historical control data in bioassays for regulatory toxicology" by Kluxen et al. (2021)
Regul Toxicol Pharmacol. 2024 Apr 6:105624. doi: 10.1016/j.yrtph.2024.105624. Online ahead of print.NO ABSTRACTPMID:38588772 | DOI:10.1016/j.yrtph.2024.105624 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - April 8, 2024 Category: Toxicology Authors: J ürg A Zarn H Christoph Geiser Sebastian L B K önig Holly V Shaw Ursina A Z ürcher Source Type: research