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Update to RIFM fragrance ingredient safety assessment, propenylguaethol, CAS Registry Number 94-86-0
A M Api1, A Bartlett1, D Belsito2
1Research Institute for Fragrance Materials, Inc., 1200 MacArthur Boulevard, Suite 306, Mahwah, NJ, 07430, USA.
Summary
Propenylguaethol safety was assessed for genotoxicity, toxicity, and environmental impact. The material is not expected to be genotoxic, and exposure levels are below toxicological thresholds, supporting its safe use.
Area of Science:
- Toxicology
- Environmental Safety
- Chemical Safety Assessment
Background:
- Propenylguaethol is a chemical compound requiring safety evaluation for its intended uses.
- Comprehensive toxicological and environmental assessments are crucial for regulatory compliance and consumer safety.
Purpose of the Study:
- To evaluate the safety of propenylguaethol across multiple toxicological endpoints.
- To assess the environmental safety of propenylguaethol, including its persistence, bioaccumulation, and toxicity.
- To determine the suitability of propenylguaethol for its intended applications based on scientific data.
Main Methods:
- Genotoxicity was assessed using target data and read-across from isoeugenol.
- Repeated dose and reproductive toxicity were evaluated using Margin of Exposure (MOE) calculations based on isoeugenol data.
- Skin sensitization potential was determined by establishing a No Expected Sensitization Induction Level (NESIL).
- Photoirritation/photoallergenicity was assessed via ultraviolet/visible (UV/Vis) spectra analysis.
- Local respiratory toxicity was evaluated using the Threshold of Toxicological Concern (TTC).
- Environmental safety was assessed against International Fragrance Association (IFRA) standards, evaluating Persistence, Bioaccumulation, and Toxicity (PBT) and calculating risk quotients (RQs).
Main Results:
- Propenylguaethol is not expected to be genotoxic.
- Margins of Exposure (MOE) > 100 were calculated for repeated dose and reproductive toxicity.
- A No Expected Sensitization Induction Level (NESIL) of 2300 μg/cm² was determined for skin sensitization.
- Propenylguaethol is not expected to be photoirritating or photoallergenic.
- Exposure to propenylguaethol is below the Threshold of Toxicological Concern (TTC) for local respiratory toxicity (0.47 mg/day).
- Propenylguaethol is not Persistent, Bioaccumulative, and Toxic (PBT), and its risk quotients (RQs) are < 1 across major global regions.
Conclusions:
- The safety assessment supports the use of propenylguaethol as described.
- Propenylguaethol demonstrates a favorable safety profile across key toxicological and environmental endpoints.
- The data indicate that propenylguaethol can be used safely within its assessed exposure scenarios.
