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.

GARD ™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations
In conclusion, GARDskin and GARDpotency showed satisfactory performance in this initial proof-of-concept study, which supports consideration of agrochemical formulations being within the applicability domain of the test methods.PMID:38453128 | DOI:10.1016/j.yrtph.2024.105595 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - March 7, 2024 Category: Toxicology Authors: Marco Corvaro Joseph Henriquez Raja Settivari Ulrika Mattson Andy Forreryd Robin Gradin Henrik Johansson Sean Gehen Source Type: research

Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure
Regul Toxicol Pharmacol. 2024 Mar 4:105596. doi: 10.1016/j.yrtph.2024.105596. Online ahead of print.ABSTRACTTo fulfil the promise of reducing reliance on mammalian in vivo laboratory animal studies, new approach methods (NAMs) need to provide a confident basis for regulatory decision-making. However, previous attempts to develop in vitro NAMs-based points of departure (PODs) have yielded mixed results, with PODs from U.S. EPA's ToxCast, for instance, appearing more conservative (protective) but poorly correlated with traditional in vivo studies. Here, we aimed to address this discordance by reducing the heterogeneity of in...
Source: Regulatory Toxicology and Pharmacology : RTP - March 6, 2024 Category: Toxicology Authors: En-Hsuan Lu Lucie C Ford Zunwei Chen Sarah D Burnett Ivan Rusyn Weihsueh A Chiu Source Type: research

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 and new approach methods: Practical experience with skin sensitization assessment" ()"
Regul Toxicol Pharmacol. 2024 Feb 28;148:105593. doi: 10.1016/j.yrtph.2024.105593. Online ahead of print.NO ABSTRACTPMID:38428632 | DOI:10.1016/j.yrtph.2024.105593 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - March 1, 2024 Category: Toxicology Authors: Susanne N Kolle Source Type: research

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 and new approach methods: Practical experience with skin sensitization assessment" ()"
Regul Toxicol Pharmacol. 2024 Feb 28:105593. doi: 10.1016/j.yrtph.2024.105593. Online ahead of print.NO ABSTRACTPMID:38428632 | DOI:10.1016/j.yrtph.2024.105593 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - March 1, 2024 Category: Toxicology Authors: Susanne N Kolle Source Type: research

Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate
Regul Toxicol Pharmacol. 2024 Feb 27:105588. doi: 10.1016/j.yrtph.2024.105588. Online ahead of print.ABSTRACTAll cosmetics products, including nail care products, must be evaluated for their safety. The assessment of systemic exposure is a key component of the safety assessment. However, data on the exposure, especially via ungual route (nail plate) are limited. Based on the physicochemical properties of human nails and permeability data of topical onychomycosis drugs, the nail plate is considered a good barrier to chemicals. We examine factors impacting penetration of nail care ingredients through the nail plate, includin...
Source: Regulatory Toxicology and Pharmacology : RTP - February 29, 2024 Category: Toxicology Authors: Xuejun J Yin Nicola J Hewitt Steffen Erler Paul Bryson Brunhilde Bl ömeke Anthony A Gaspari Carsten Goebel Source Type: research

Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary
Regul Toxicol Pharmacol. 2024 Feb 28;148:105584. doi: 10.1016/j.yrtph.2024.105584. Online ahead of print.ABSTRACTThe increasing drive to understand the likelihood of skin sensitisation from plant protection products (PPPs) in workers and the general public has resulted in recent initiatives to establish a quantitative risk assessment (QRA) methodology applicable to these products and their exposure scenarios. The effective evaluation of skin sensitising substances requires not only the identification of that toxicological hazard, but also determination of relative sensitising potency. Typically, this has been achieved by i...
Source: Regulatory Toxicology and Pharmacology : RTP - February 28, 2024 Category: Toxicology Authors: David Basketter Namali Corea Marco Corvaro Arthur Grivel Felix M Kluxen Neil Morgan Christiane Wiemann Source Type: research

Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on "Plant extracts, polymers and new approach methods: Practical experience with skin sensitization assessment" ()"
Regul Toxicol Pharmacol. 2024 Feb 24:105582. doi: 10.1016/j.yrtph.2024.105582. Online ahead of print.NO ABSTRACTPMID:38408599 | DOI:10.1016/j.yrtph.2024.105582 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - February 26, 2024 Category: Toxicology Authors: David W Roberts Source Type: research

Considerations for the development of guidance on dose level selection for developmental and reproductive toxicity studies
Regul Toxicol Pharmacol. 2024 Feb 23:105585. doi: 10.1016/j.yrtph.2024.105585. Online ahead of print.ABSTRACTIn 2022, the European Chemicals Agency issued advice on the selection of high dose levels for developmental and reproductive toxicity (DART) studies indicating that the highest dose tested should aim to induce clear evidence of reproductive toxicity without excessive toxicity and severe suffering in parental animals. In addition, a recent publication advocated that a 10% decrease in body weight gain should be replaced with a 10% decrease in bodyweight as a criterion for dose adequacy. Experts from the European Centr...
Source: Regulatory Toxicology and Pharmacology : RTP - February 25, 2024 Category: Toxicology Authors: R W Lewis A K Andrus J Arroyo S Brescia P A Botham M Corvaro G P Daston T Hofmann C Rodriguez F Sewell B van Ravenzwaay K Wiench S Marty Source Type: research

The role of trust in the use of artificial intelligence for chemical risk assessment
Regul Toxicol Pharmacol. 2024 Feb 23:105589. doi: 10.1016/j.yrtph.2024.105589. Online ahead of print.ABSTRACTRisk assessment of chemicals is a time-consuming process and needs to be optimized to ensure all chemicals are timely evaluated and regulated. This transition could be stimulated by valuable applications of in silico Artificial Intelligence (AI)/Machine Learning (ML) models. However, implementation of AI/ML models in risk assessment is lagging behind. Most AI/ML models are considered 'black boxes' that lack mechanistical explainability, causing risk assessors to have insufficient trust in their predictions. Here, we...
Source: Regulatory Toxicology and Pharmacology : RTP - February 25, 2024 Category: Toxicology Authors: Pim N H Wassenaar Jordi Minnema Jelle Vriend Willie J G M Peijnenburg Jeroen L A Pennings Anne Kienhuis Source Type: research