A Chronic Aquatic Hazard Assessment for the Perfume Raw Material Octahydro‐tetramethyl‐naphthalenyl‐ethanone

Abstract

AbstractOctahydro‐tetramethyl‐naphthalenyl‐ethanone (OTNE) is a high–production volume fragrance material used in various down‐the‐drain consumer products. To assess aquatic risk, the Research Institute for Fragrance Materials (RIFM) uses a tiered data‐driven framework to determine a risk characterization ratio, where the ratio of the predicted‐environmental concentration to the predicted‐no‐effect concentration (PNEC) of <1 indicates an acceptable level of risk. Owing to its high production volume and the conservative nature of the RIFM framework, RIFM identified the need to utilize a species sensitivity distribution (SSD) approach to reduce the PNEC uncertainty for OTNE. Adding to the existing Daphnia magna, Danio rerio, and Desmodesmus subspicatus chronic studies, eight new chronic toxicity studies were conducted on the following species: Navicula pelliculosa, Chironomus riparius, Lemna gibba, Ceriodaphnia dubia, Hyalella azteca, Pimephales promelas, Anabaena flos‐aquae, and Daphnia pulex. All toxicity data were summarized as chronic 10% effect concentration estimates using the most sensitive biological response. Daphnia magna was the most sensitive (0.032 mg/L), and D. subspicatus was the least sensitive (>2.6 mg/L, the OTNE solubility limit). The 5th percentile hazardous concentration (HC5) derived from the cumulative probability distribution of the chronic toxicity values for the 11 species was determined to be 0.0498 mg/L (95% confidence interval 0.0097–0.1159 mg/L). A series of “leave‐one‐out” and “add‐one‐in” simulations indicated the SSD was stable and robust. Add‐one‐in simulations determined that the probability of finding a species sensitive enough to lower the HC5 two‐ or threefold was 1/504 and 1/15,300, respectively. Given the high statistical confidence in this robust SSD, an additional application factor protection is likely not necessary. Nevertheless, to further ensure the protection of the environment, an application factor of 2 to the HC5, resulting in a PNEC of 0.0249 mg/L, is recommended. When combined with environmental exposure information, the overall hazard assessment is suitable for a probabilistic environmental risk assessment. Environ Toxicol Chem 2024;43:1378–1389. © 2024 The Author(s). Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.