Range-Finding and Pilot Study For: Extended Fragrance Ingredients Surveillance Study (EFISS) - Surveillance Study to Monitor the Frequency of Contact Allergy to a Defined Group of Fragrance Ingredients with a View to Providing Reliable Information on Trends - Pilot study: Extended Fragrance Ingredients Surveillance Study (EFISS)

Start Date21 Apr 2022

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International Fragrance Association

100 Clinical Results associated with International Fragrance Association

0 Patents (Medical) associated with International Fragrance Association

Literatures (Medical) associated with International Fragrance Association

01 Jul 2024·Archives of Toxicology

In vitro to in vivo extrapolation to derive a metabolism factor for estimating the aggregate exposure to salicylic acid after dermal exposure of its esters

Article

Author: Natsch, Andreas ; Grégoire, Sebastien ; Cardamone, Estefania ; Selechnik, Dan ; Wall, Brian ; Griem, Peter ; Hewitt, Nicola ; Nicol, Beate ; Swinscoe, Angus ; Golbamaki, Nazanin ; Boisleve, Fanny ; Masini-Etévé, Valérie ; Api, Anne Marie ; Najjar, Abdulkarim ; Irizar, Amaia

AbstractAs part of the safety assessment of salicylate esters in cosmetics, we developed a metabolism factor based on in vitro to in vivo extrapolation (IVIVE) to provide a better estimation of the aggregate internal exposure to the common metabolite, salicylic acid. Optimal incubation conditions using human liver S9 were identified before measuring salicylic acid formation from 31 substances. Four control substances, not defined as salicylic esters but which could be mistaken as such due to their nomenclature, did not form salicylic acid. For the remaining substances, higher in vitro intrinsic clearance (CLint, in vitro) values generally correlated with lower LogP values. A “High-Throughput Pharmacokinetic” (HTPK) model was used to extrapolate CLint, in vitro values to human in vivo clearance and half-lives. The latter were used to calculate the percentage of substance metabolised to salicylic acid in 24 h in vivo following human exposure to the ester, i.e. the “metabolism factor”. The IVIVE model correctly reproduced the observed elimination rate of 3 substances using in silico or in vitro input parameters. For other substances, in silico only-based predictions generally resulted in lower metabolism factors than when in vitro values for plasma binding and liver S9 CLint, in vitro were used. Therefore, in vitro data input provides the more conservative metabolism factors compared to those derived using on in silico input. In conclusion, these results indicate that not all substances contribute equally (or at all) to the systemic exposure to salicylic acid. Therefore, we propose a realistic metabolism correction factor by which the potential contribution of salicylate esters to the aggregate consumer exposure to salicylic acid from cosmetic use can be estimated.

01 Oct 2023·Regulatory Toxicology and Pharmacology

Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum

Article

Author: Ball, Nicholas ; Bercaru, Ofelia ; Tremblay, Raphaël T ; Bender, Hans ; Beken, Sonja ; Franco, Antonio ; Westmoreland, Carl ; Mehta, Jyotigna M ; Corvaro, Marco ; Irizar, Amaia ; Maxwell, Gavin ; Rogiers, Vera ; Desert, Paul ; Escher, Sylvia E ; Dawson, Jeffrey L ; Caneva, Laura ; Cronin, Mark T D ; Currie, Richard A

Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

01 Dec 2022·Regulatory Toxicology and Pharmacology

Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432

Article

Author: Vey, Matthias ; Irizar, Amaia ; Lenouvel, Véronique ; Cluzel, Magalie ; Sauvage, Céline ; Penichot, Christophe ; Hais, Gaëlle ; Wolf, Nicolas ; Nash, J Frank

The phototoxic potential of a number of furocoumarins is well established. On the other hand, studies have shown that bergamottin, a furocoumarin containing a bulky, hydrophobic side chain, has significantly less or is even absent of phototoxicity potential. The OECD Test Guideline 432 3T3/Neutral Red Uptake (NRU) in vitro phototoxicity test has shown to be a highly predictive test for identifying compounds that exhibit no phototoxicological potential. In this study using OECD 432, the established phototoxic furocoumarin 5-methoxypsoralen (5-MOP), 8-methoxypsoralen (8-MOP) and psoralen were phototoxic, whereas bergamottin showed no phototoxic potential. When compared to 5-MOP, 8-MOP and psoralen, bergamottin was clearly negative at molar-adjusted concentrations that were more than 9 times higher than those that produced phototoxicity in 8-MOP; nearly 16 times than those for psoralen and more than 36 times higher than those for 5-MOP. These data using in vitro 3T3 NRU Phototoxicity Test (OECD 432) are supportive of earlier studies showing bergamottin does not exhibit phototoxicological properties. The detection and quantification of bergamottin should therefore not contribute to the potential marker furocoumarins for risk management interventions intended to reduce the phototoxicity of natural furocoumarin containing preparations.

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100 Translational Medicine associated with International Fragrance Association

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