RIFM low-exposure fragrance ingredients safety assessment. (March 2021)

• Record Type: Journal Article
• Authors: Api, A.M.; Belsito, D.; Biserta, S.; Botelho, D.; Bruze, M.; Burton, G.A.; Buschmann, J.; Cancellieri, M.A.; Dagli, M.L.; Date, M.; Dekant, W.; Deodhar, C.; Fryer, A.D.; Gadhia, S.; Jones, L.; Joshi, K.; Lapczynski, A.; Lavelle, M.; Liebler, D.C.; Na, M.; O'Brien, D.; Patel, A.; Penning, T.M.; Ritacco, G.; Rodriguez-Ropero, F.; Romine, J.; Sadekar, N.; Salvito, D.; Schultz, T.W.; Siddiqi, F.; Sipes, I.G.; Sullivan, G.; Thakkar, Y.; Tokura, Y.; Tsang, S.;
• Is Part Of: Food and chemical toxicology. Volume 149(2021)Supplement 1
• Publication Date: 2021-03
• Subjects: Genotoxicity -- Repeated dose, developmental, and reproductive toxicity -- Skin sensitization -- Phototoxicity/photoallergenicity -- Local respiratory toxicity -- Environmental safety -- Low exposure fragrance materials; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2021.111981
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm 2 and 64 μg/cm 2, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1. Highlights: A safety assessment of 167 low-exposure fragrance ingredients based on RIFM's criteria. A safety assessment based on 7 human health endpoints plus environmental. All endpoints were cleared using TTC, except for genotoxicity, which also uses target data and read-across analogs.