Use of NAMs in a weight of evidence approach to evaluate the safety via the inhalation route of acetylated vetiver oil, in spray products

Acetylated Vetiver Oil (AVO) is a fragrance ingredient. We evaluated the systemic and local toxicity of AVO via inhalation from use of cosmetic spray products. Systemic exposure after inhalation was calculated using a deterministic 2-Box model. The "local inhalation toxicological threshold of concern" (TTC_inh) was used in a weight of evidence (WoE) for the potential of AVO to cause local respiratory toxicity and the in vitro model, MucilAir™ was used to evaluate respiratory irritation. AVO exposure by inhalation of sprayed cosmetic products does not add significant exposure compared to dermal exposure. The Margin of Safety (NOAEL compared to total systemic AVO exposure) is > 400, indicating no concern for systemic toxicity. Regarding local toxicity, total aggregate exposure to AVO in sprayable cosmetic products is significantly lower than the TTC_inh. There were no injurious effects to MucilAir™ tissues by 0.2 % and 1 % AVO. When the NOAEL from the MucilAir™ assay (1 %) and the aggregated exposure were compared, the Margin of Exposure was 137. In conclusion, based on a WoE approach, the concentrations of AVO used in cosmetic products are not expected to carry a risk of local irritation effects on the respiratory tract or add significantly to aggregate systemic exposure.