RIFM fragrance ingredient safety assessment, hexadeca-1,5-lactone, CAS Registry Number 7370-44-7

Area of Science:

• Toxicology
• Chemical Safety Assessment
• Fragrance Ingredient Safety

Background:

• Hexadeca-1,5-lactone is a chemical compound used in various applications.
• A comprehensive safety assessment is required to ensure its safe use.
• Existing data and read-across approaches are utilized for evaluating potential hazards.

Purpose of the Study:

• To evaluate the safety of Hexadeca-1,5-lactone across multiple toxicological endpoints.
• To determine potential risks associated with genotoxicity, systemic toxicity, and local effects.
• To assess environmental safety, including Persistence, Bioaccumulation, and Toxicity (PBT) criteria.

Main Methods:

• Genotoxicity was assessed using data from the target material and read-across analog hydroxynonanoic acid, δ-lactone.
• Repeated dose and reproductive toxicity were evaluated using analog δ-decalactone, calculating the Margin of Exposure (MOE).
• Skin sensitization, phototoxicity/photoallergenicity, and local respiratory toxicity were assessed using analog data and established thresholds (Threshold of Toxicological Concern - TTC).

Main Results:

• Hexadeca-1,5-lactone is not expected to be genotoxic.
• A Margin of Exposure (MOE) > 100 was calculated for repeated dose and reproductive toxicity.
• No safety concerns for skin sensitization, phototoxicity/photoallergenicity, or local respiratory toxicity were identified under current use levels.
• The material is not considered Persistent, Bioaccumulative, and Toxic (PBT).

Conclusions:

• The safety data support the use of Hexadeca-1,5-lactone as described in the assessment.
• No significant toxicological or environmental hazards were identified for Hexadeca-1,5-lactone.
• Further risk screening was not possible due to a lack of reported usage volumes.