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.

Aflatoxins and Ochratoxin A in dried fruits from Morocco: Monitoring, regulatory aspects, and exposure assessment
Regul Toxicol Pharmacol. 2023 Sep 29:105503. doi: 10.1016/j.yrtph.2023.105503. Online ahead of print.ABSTRACTThe present study aims to investigate the presence of Aflatoxins (AF) in 180 samples dried fruits and Ochratoxin A (OTA) in 210 samples dried fruits and grape juices collected in Morocco. Mycotoxins were analyzed by high performance liquid chromatography (HPLC) coupled to fluorescence detection and immunoaffinity columns (IAC) cleanup. Contamination levels were compared with the maximum regulatory limits (MRL) recently adopted in the country, and mycotoxin exposure of adult consumers was assessed. Results showed tha...
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Nysrine Mannani Mounir El Boujamaai Aicha Sifou Mohamed Bennani Chakib El Adlouni El Hassane Abdennebi Abdellah Zinedine Source Type: research

Preclinical safety, toxicokinetics and metabolism of BIIB131, a novel prothrombolytic agent for acute stroke
Regul Toxicol Pharmacol. 2023 Sep 29:105498. doi: 10.1016/j.yrtph.2023.105498. Online ahead of print.ABSTRACTBIIB131, a small molecule, is currently in Phase 2 for the treatment of acute ischemic stroke. Safety and metabolism of BIIB131 were evaluated following intravenous administration to rats and monkeys. Exposure increased dose-proportionally in rats up to 60 mg/kg and more than dose-proportionally in monkeys at greater than 10 mg/kg accompanied by prolonged half-life and safety findings. The BIIB131 was poorly metabolized in microsomes with no inhibition of CYPs. BIIB131-glucuronide, formed by UGT1A1, accounted for 21...
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Vick Kostrubsky Ying Liu Cathy Muste Chungang Gu Melissa Kirkland Naoko Nishimura Keiko Hasegawa Keiji Hasumi Long Yuan Source Type: research

Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African medicines agency
CONCLUSIONS: As of June 2023, 35 of 55 countries have either signed and/or ratified the AMA Treaty, whilst 20 have neither signed nor ratified it. An effective AMA will need strong National Medicines Regulatory Authorities as well as regional programmes and it is imperative for more well-resourced countries to ratify the treaty to ensure access to essential medical products and technologies for the African people.PMID:37778434 | DOI:10.1016/j.yrtph.2023.105497 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Nancy Ngum Margareth Ndomondo-Sigonda Stuart Walker Sam Salek Source Type: research

Harmonisation of read-across methodology for drug substance extractables and leachables (E & amp;Ls)
In conclusion, an E&L read-across methodology has been developed to provide a consistent, health protective framework for deriving HBELs when toxicology data is limited.PMID:37748702 | DOI:10.1016/j.yrtph.2023.105494 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - September 25, 2023 Category: Toxicology Authors: Melisa Masuda-Herrera Hannah T Rosen Anders Burild Thomas Broschard Troy Griffin Tyler Bell Jessica Graham Jedd Hillegass Penny Leavitt Brian Huta Trish Parris Uma Bruen Maureen Cruz Joel Bercu Source Type: research

Subchronic oral toxicity assessment of a cannabis extract
Regul Toxicol Pharmacol. 2023 Sep 19:105496. doi: 10.1016/j.yrtph.2023.105496. Online ahead of print.ABSTRACTCannabidiol (CBD) is present in Cannabis Sativa L. and has been used in medicines and foods to deliver beneficial health effects. Despite this, research on CBD safety utilising modern testing methods is lacking. Therefore three separate safety experiments were performed on a CBD isolate. Sprague-Dawley rats were used to investigate prenatal development, a 14-day toxicity sighting study, and an OECD compliant 90-day subchronic oral toxicity trial, with 35-day off-dose recovery. The prenatal screening study demonstrat...
Source: Regulatory Toxicology and Pharmacology : RTP - September 21, 2023 Category: Toxicology Authors: Mark J Tallon Robert Child Source Type: research

Three-tiered approach for standard information requirements for polymers requiring registration under REACH
Regul Toxicol Pharmacol. 2023 Sep 18:105495. doi: 10.1016/j.yrtph.2023.105495. Online ahead of print.ABSTRACTPolymers are a very large class of chemicals comprising often complex molecules with multiple functions used in everyday products. The EU Commission is seeking to develop environmental and human health standard information requirements (SIRs) for man-made polymers requiring registration (PRR) under a revised Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Conventional risk assessment approaches currently used for small molecules may not apply to most polymers. Therefore, we p...
Source: Regulatory Toxicology and Pharmacology : RTP - September 20, 2023 Category: Toxicology Authors: Jens C Otte Heli Miriam Hollnagel Christiane Nagel Renata Friederike Gerhardt Wendel Wohlleben Nathalie Vallotton Diederik Schowanek Gordon Sanders Joe M Frasca Tushar Mahale Mark Pemberton Bjoern Hidding Robert Landsiedel Source Type: research

Quantitative risk assessment of skin sensitising pesticides: Clinical and toxicological considerations
Regul Toxicol Pharmacol. 2023 Sep 15;144:105493. doi: 10.1016/j.yrtph.2023.105493. Online ahead of print.ABSTRACTLike many other consumer and occupational products, pesticide formulations may contain active ingredients or co-formulants which have the potential to cause skin sensitisation. Currently, there is little evidence they do, but that could just reflect lack of clinical investigation. Consequently, it is necessary to carry out a safety evaluation process, quantifying risks so that they can be properly managed. A workshop on this topic in 2022 discussed how best to undertake quantitative risk assessment (QRA) for pes...
Source: Regulatory Toxicology and Pharmacology : RTP - September 17, 2023 Category: Toxicology Authors: Olivier Sanvido David A Basketter Aur élie Berthet Denise Bloch Janine Ezendam Nancy B Hopf Nicole Kleinstreuer Leona L Merolla Wolfgang Uter Christiane Wiemann Martin F Wilks Source Type: research