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High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
Published on: May 10, 2016
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RIFM fragrance ingredient safety assessment, p-tolyl acetate, CAS Registry Number 140-39-6
A M Api1, F Belmonte1, D Belsito2
1Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Summary
p-Tolyl acetate safety was assessed for genotoxicity, toxicity, and environmental impact. The material is not expected to be genotoxic, phototoxic, or a skin sensitizer, with safe exposure levels for repeated dose and reproductive toxicity.
Area of Science:
- Chemical safety assessment
- Toxicology
- Environmental risk evaluation
Background:
- p-Tolyl acetate is a chemical compound requiring comprehensive safety evaluation.
- Existing data and read-across approaches are utilized to assess its toxicological profile.
- Regulatory compliance and consumer safety are paramount in chemical assessments.
Purpose of the Study:
- To evaluate the safety of p-tolyl acetate across multiple toxicological endpoints.
- To determine the genotoxicity, repeated dose toxicity, and reproductive toxicity of p-tolyl acetate.
- To assess local respiratory toxicity, phototoxicity, photoallergenicity, skin sensitization, and environmental safety.
Main Methods:
- Read-across analysis using ethyl p-tolyl carbonate for genotoxicity.
- Calculation of Margin of Exposure (MOE) using p-cresol and acetic acid data for toxicity endpoints.
- Dermal Simulation Test (DST) for skin sensitization and UV spectra analysis for phototoxicity.
- Threshold of Toxicological Concern (TTC) evaluation for local respiratory toxicity.
- Assessment of Persistent, Bioaccumulative, and Toxic (PBT) properties and risk quotients (PEC/PNEC) for environmental safety.
Main Results:
- p-Tolyl acetate is not expected to be genotoxic based on read-across data.
- Calculated MOE >100 for repeated dose and reproductive toxicity indicates safety.
- Exposure levels are below the DST for skin sensitization and TTC for local respiratory toxicity.
- p-Tolyl acetate is not phototoxic/photoallergenic and is not considered PBT.
- Environmental risk quotients (PEC/PNEC) are <1, indicating environmental safety.
Conclusions:
- The safety assessment supports the use of p-tolyl acetate as described.
- p-Tolyl acetate demonstrates a favorable safety profile across evaluated toxicological and environmental endpoints.
- The material's use is deemed safe based on current data and exposure scenarios.
