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Published on: April 19, 2024
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RIFM fragrance ingredient safety assessment, 2-ethyl-1-butanol, CAS Registry Number 97-95-0
Summary
This material is safe for use, with no genotoxicity or skin sensitization potential identified. Comprehensive evaluations confirm safety for repeated dose, developmental, reproductive, and respiratory toxicity, alongside environmental safety.
Area of Science:
- Toxicology
- Chemical Safety Assessment
- Environmental Risk Evaluation
Background:
- Existing data supports the current use of this material.
- A comprehensive safety assessment was performed.
- Evaluations covered multiple toxicity endpoints and environmental safety.
Purpose of the Study:
- To evaluate the genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety of the material.
- To determine the safety profile of the material for its intended applications.
- To ensure the material meets regulatory and safety standards.
Main Methods:
- Read-across methodology using analogs like 2-ethylhexanol and isopropyl alcohol for genotoxicity and skin sensitization.
- Threshold of Toxicological Concern (TTC) approach for local respiratory toxicity.
- Utilized 2-ethylhexanol, 1-heptanol, 2-propyl, and isobutyl alcohol as analogs for repeated dose and developmental/reproductive toxicity.
- UV spectra analysis for phototoxicity/photoallergenicity and RIFM Framework for environmental safety.
Main Results:
- No genotoxicity observed, supported by 2-ethylhexanol data.
- No skin sensitization potential identified, supported by isopropyl alcohol data.
- Local respiratory toxicity assessed via TTC (Cramer Class I, 1.4 mg/day).
- Margin of Exposure (MOE) > 100 for repeated dose and developmental/reproductive toxicity, using specified analogs.
- Phototoxicity/photoallergenicity determined by UV spectra; environmental safety assessed per RIFM Framework.
Conclusions:
- The material is not genotoxic and does not possess skin sensitization potential.
- Adequate safety margins (MOE > 100) were established for repeated dose and developmental/reproductive toxicity.
- The material's safety profile supports its use under current conditions, encompassing local respiratory and environmental aspects.
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