RIFM fragrance ingredient safety assessment, hexyl isovalerate, CAS Registry Number 10032-13-0

Area of Science:

• Chemical safety assessment
• Toxicology
• Environmental risk evaluation

Background:

• Hexyl isovalerate is a chemical compound used in various applications.
• Comprehensive safety data is crucial for regulatory approval and consumer confidence.

Purpose of the Study:

• To evaluate the safety of hexyl isovalerate across multiple toxicological and environmental endpoints.
• To determine the suitability of hexyl isovalerate for its intended uses based on scientific data.

Main Methods:

• Utilized read-across methodologies using data from structurally similar compounds (analogs).
• Assessed genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, and skin sensitization.
• Evaluated environmental safety, including persistence, bioaccumulation, and toxicity (PBT) criteria and risk quotients (PEC/PNEC).

Main Results:

• Hexyl isovalerate is not expected to be genotoxic based on read-across from hexyl isobutyrate.
• Margin of Exposure (MOE) >100 for repeated dose and reproductive toxicity, indicating safety.
• No indication of skin sensitization based on read-across from hexyl 2-methylbutyrate.
• Not expected to be phototoxic/photoallergenic based on UV spectra.
• Local respiratory exposure is below the Threshold of Toxicological Concern (TTC).
• Hexyl isovalerate is not considered Persistent, Bioaccumulative, and Toxic (PBT) and has risk quotients <1.

Conclusions:

• The available data support the safe use of hexyl isovalerate as described in the safety assessment.
• Hexyl isovalerate demonstrates a favorable safety profile across key toxicological and environmental endpoints.
• The findings provide a basis for regulatory acceptance and continued use of hexyl isovalerate.