RIFM Natural Complex Substance (NCS) fragrance ingredient safety assessment, benzoin infusion, Sumatra, CAS Registry Number 9000-05-9, RIFM ID 104-K2.31

Abstract

Benzoin infusion, Sumatra was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data for the components of the NCS do not show a concern for genotoxicity. Benzoin infusion, Sumatra was evaluated for the repeated dose and reproductive toxicity endpoints on the basis of component analysis using a combination of target data, read-across data, and the threshold of toxicological concern (TTC); benzoin infusion, Sumatra is safe for use under the conditions described in this safety assessment for the repeated dose and reproductive toxicity endpoints. Data for the components of the NCS do not show a concern for skin sensitization under the current, declared levels of use. The photoirritation endpoint was evaluated based on data and ultraviolet/visible (UV/Vis) absorption spectra for the components of the NCS; benzoin infusion, Sumatra is not expected to be photoirritating. Benzoin infusion, Sumatra has not been fully evaluated for photoallergenicity due to a lack of suitable data and validated in vitro tests. To address this data gap, RIFM is sponsoring an in vitro photoallergy research program to evaluate the photoallergy potential of benzoin infusion, Sumatra. The local respiratory toxicity endpoint for this NCS was evaluated using the inhalation TTC for a Cramer Class III material, and the inhalation exposure to benzoin infusion, Sumatra is below the TTC (0.47 mg/day). Based on the component assessment, benzoin infusion, Sumatra does not contain Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent, very Bioaccumulative (vPvB) components as per the IFRA Environmental Standards. In addition, following the RIFM Environmental Framework and based on individual component assessment, benzoin infusion, Sumatra does not present a risk to the aquatic environment (i.e., its screening-level PEC/PNEC <1) at the current reported VoU.