ToxMinds BVBA

🌟 Updated Assessment of the Genotoxic Potential of Titanium Dioxide (TiO2) 🌟 A recent publication by Kirkland et al. provides an updated analysis of the genotoxic potential of titanium dioxide (TiO2) particularly in the context of its use as a food additive (E171). This analysis is especially relevant in light of the European Food Safety Authority (EFSA) banning its use in foods due to genotoxicity concerns. 🔍 Key Findings 👉 In-depth review: The study reviewed an additional 70 publications on TiO2, focusing on in vitro comet assays, mode of action, and cellular uptake studies. 👉 Inconsistencies in data: The findings reveal that published data on TiO2's genotoxicity are often inconsistent and of varying quality, complicating interpretation. 👉 Mechanism of action: While some evidence of cytoplasmic uptake was noted, there remains a lack of convincing evidence for nuclear uptake. The main mechanism of TiO2's genotoxicity is likely indirect DNA damage through reactive oxygen species (ROS), rather than direct DNA interaction. 👉 Regulatory impact: The prevailing conclusion remains: there is no direct DNA-damaging mechanism for TiO2 (including nano forms); instead, its genotoxic effects are likely due to indirect DNA damage through the generation of ROS. This assessment provides a clearer picture of the safety profile of TiO2 and underscores the need for further research to address ongoing uncertainties. 📖 For more details, check the full article here: https://lnkd.in/dfekRjDs #TiO2 #TitaniumDioxide #Genotoxicity #FoodSafety #E171 #CosmeticIngredients #PersonalCareProducts #Nanomaterials

🎉 Happy Diwali from our Bangalore Team! 🎉 As we celebrate the Festival of Lights, our team in Bangalore came together to spread joy, positivity, and warmth. Diwali reminds us of the triumph of light over darkness, knowledge over ignorance, and good over evil. Here's to a prosperous, joyful, and bright year ahead! 🌟 May this Diwali fill our lives with new hopes, opportunities, and the strength to achieve greater heights together. Happy Diwali to all our colleagues, clients, and friends! 🪔✨ #DiwaliCelebration #TeamSpirit #FestivalOfLights #HappyDiwali #ToxMinds #Diwali2024

🚨 In an interesting article, Drury et al. (2024) evaluated IARC’s classification of PFOA as ‘carcinogenic to humans’ (Group 1) and PFOS as ‘possibly carcinogenic to humans’ (Group 2B), considering the available epidemiological, experimental animal and mechanistic evidence. The authors concluded that the IARC Working Group overstated the available evidence for the carcinogenicity of these compounds. 👉 Epidemiology studies have shown weak and inconsistent associations across studies. 👉 Studies reporting increased incidences of tumours in experimental animals exposed to PFOA or PFOS had statistically significant results that were driven by the presence of benign adenomas. 👉  IARC’s KCC (key characteristics of carcinogens) approach failed to consider the quality, external validity, and relevance of the mechanistic evidence, hence the agency’s approach does not constitute a robust or systematic approach for evaluating potential carcinogenicity. 👉  The authors suggested that IARC should use a rigorous method to evaluate the plausibility and human relevance of mechanistic evidence Link: https://lnkd.in/dhi-yT5Z #IARC #PFOS #PFOA #Carcinogenicity #KeyCharactericsofCarcinogens #MechanisticEvidence

🚨 The Hyalella azteca test, HYBIT, is approved to be used as the standard information requirement for evaluating bioaccumulation in aquatic environments under REACH Recently, the Member State Committee (MSC) in its October meeting unanimously approved OECD Test Guideline 321, the non-vertebrate Hyalella azteca test (HYBIT) to be used under REACH as standard information requirement to assesses the bioaccumulation potential of substances in aquatic environments. It is based on non-vertebrate aquatic organisms, potentially replacing testing in fish. https://lnkd.in/eafbuy66 #HYBIT #AnimalAlternatives #Bioaccumulation #Fish #OECDTG321 #ECHA #REACH #MemberStateCommittee #HyalellaAzteca

📢 Regulatory update: Review of Titanium dioxide (TiO2) (E171) as a food additive by the Committee on Mutagenicity (COM) Triggered by concerns over the safety of the food additive titanium dioxide (E171) in multiple evaluations by the European Food Safety Authority (EFSA), the UK Committee on Mutagenicity (COM) conducted a thorough review of its potential genotoxicity. The COM evaluated existing in vitro and in vivo studies, concluding that evidence for the genotoxicity of TiO2 nanoparticles is limited, particularly via oral exposure. The COM highlighted that many of the reviewed studies did not adhere to OECD test guidelines, raising concerns about the reliability of their findings. While some studies reported positive effects at lower doses, these results were inconsistent and often associated with cytotoxicity rather than direct genotoxic mechanisms. The COM emphasised the need for high-quality studies that accurately represent the nanoparticulate fraction in E171 to better assess its safety. Overall, the COM’s review highlights the need for robust, well-designed studies to better clarify TiO2's safety profile, particularly given its widespread use in food products. Link:https://lnkd.in/dh9qYp2m #TitaniumDioxide #FoodAdditive #E171 #EFSA #UKCOM #NanoParticles #Genotoxicity #Mutagenicity 

European Commission requests the Scientific Committee on Consumer Safety (SCCS) for scientific opinions on the safety of certain fragrances and UV filters used in cosmetic products: 👉 Butylated Hydroxyanisole (BHA) (CAS No. 25013-16-5, EC No. 246-563-8) - potential endocrine disruptor Link: https://lnkd.in/gm9E-EB3 👉Benzophenone-2 (BP-2) (CAS No. 131-55-5, EC No. 205-028-9) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1, EC No. 613-918-7)- potential endocrine disruptor Link: https://lnkd.in/gzH3sKQD 👉Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1): CMR exemption Link: https://lnkd.in/ga5QTViu 👉Methyl Salicylate (methyl 2-hydroxybenzoate; CAS/EC No. 119-36-8/204-317-7) Link: https://lnkd.in/geS367NP 👉Diethylamino Hydroxybenzoyl Hexyl Benzoate (CAS/EC No. 302776-68-7/443-860-6).. Link: https://lnkd.in/gVAEjRvg #EC #Cosmetics #UV_filters #SCCS #PersonalCareProducts #Endocrine_Disrupting #CMR #BHA #TTO #BP_2 #DHHB

Discover the new hazard classes under the EU CLP Regulation in a free webinar on 21 Nov. Experts will share updated guidance from ECHA. No registration needed! Submit your questions in advance. #EU_CLP #ChemicalSafetyEU #CLP

🌟 Exploring New Approach Methodologies (NAMs) for respiratory irritation assessment in cleaning products🌟 The use of in vitro NAMs for assessing respiratory irritation in cleaning products is advancing rapidly! 🚀 At a recent workshop organised by the American Cleaning Institute (ACI), experts gathered to review the latest developments and challenges in this field. Key takeaways included: 🔬 The importance of exposure methods and the design of cell/tissue-based test systems for relevant results. ⚙️ A focus on mechanistic understanding of molecular initiating events (MIEs) and key events (KEs) to guide better test system selection. 📊 Integration of NAMs-derived data with other sources for improved in vitro to in vivo extrapolation in risk assessment. The workshop highlighted the need for robust characterisation, assay validation, and the alignment of NAMs-based points of departure (PoD) with traditional risk assessment methods. Exciting times ahead for innovation in human health protection! For expert insights on assessment of cleaning products and the use of NAMS, contact ToxMinds for our specialised team! For more information contact us at info@toxminds.com💡 #CleaningProducts #NAMs #MIE #Toxicology #RiskAssessment #InVitro #ACI Link: https://lnkd.in/dkrMPVKR

New Blog Alert: Unravelling the EU's ERA Guidelines for Medicinal Products 💊 We're happy to share our latest blog article, "Unravelling the EU's ERA Guidelines for Medicinal Products: What’s in the Box and What’s Still Missing?" In this piece, we explore the recent updates to the EU's Environmental Risk Assessment (ERA) guidelines, which aim to ensure the environmental safety of our pharmaceuticals.   Dive into the complexities of balancing environmental stewardship with the need for essential medications. How can those guidelines be further improved? 👉 Read the full article https://lnkd.in/dFwFHZHt and join the conversation! Your insights and feedback are always welcome. Contact us at info@toxminds.com if you require further information. Our experts Dr. Francesca Tencalla and Dr. Emma Jack will be happy to help! #Pharmaceuticals #Environment #EnvironmentalRiskAssessment #EMA #EMAGuidelines #Sustainability #ERA  #ToxMinds

🚨 A publication by Constantine et al. (2024) evaluates log D/pH-specific log Kow and bioconcentration factor (BCF) data for 64 active pharmaceutical ingredients (APIs). The goals were to test, 1) the validity of the current European Medicines Agency (EMA) conservative trigger of log Kow ≥ 3 for conducting, in Phase II of environmental risk assessments (ERA), a bioconcentration study in fish (OECD TG305) and 2) whether testing two dose levels plus a control (involving the use of 200 fish), as per guideline, was always necessary to determine appropriate hazard classification and labelling. 👉 Based on their findings, the authors propose to increase the EMA Phase II BCF testing trigger to log Kow ≥4. The results also indicated a strong correlation between the lipid normalized log-transformed BCF values obtained at low- and high-test concentrations. Overall, this suggests that conducting the study at one dose level is sufficiently conclusive, reducing the number of fish used in the studies and aligning with the 3R principles (refinement, reduction, and replacement). Link: https://lnkd.in/deyNvy8i #EMA #ERA #3Rs #NAMs #BCF #OECD_305