68.0
ISS Score
Moderate — Score based on regulatory approval status in 4 jurisdiction(s), route-level risk assessment across multiple routes, and 3 toxicology endpoints from safety assessments.
↑ Higher = Safer
Environmental
(ESS)
(ESS)
—
Confidence
(CSS)
(CSS)
—
emollient · thickener · stabilizer · solvent
Hexadecanolactone
Molecular Formula
C16H30O2
Molecular Weight
254.41 g/mol
Category
fatty acid lactone
Bottom Line: Hexadecanolactone is generally considered safe for use in cosmetics and food, though its effects can vary based on concentration and formulation.
Quick Answer
✔ Generally Safe If:
- Used in low concentrations in cosmetic formulations
- Ingested as part of food products within regulatory limits
⚠ Use with Awareness If:
- You have sensitive skin or allergies
- Using products containing multiple active ingredients
✕ Avoid If:
- You are pregnant or breastfeeding without consulting a doctor
- You have a known allergy to lactones or similar compounds
Chemical Properties
| Property | Value |
|---|---|
| Molecular Formula | C16H30O2 |
| Molecular Weight | 254.41 g/mol |
| Log P | 6.3 |
Common Use Cases
4 Categories
Cosmetic
Moisturizers, sunscreens, hair conditioners. Generally safe for topical use; patch test recommended.
Food
Flavoring agents, food additives. Considered safe within established food safety limits.
Pharmaceutical
Topical creams, ointments. Used in formulations; consult a healthcare provider for concerns.
Supplement
Dietary supplements, nutraceuticals. Consult a healthcare professional before use.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Hexadecanolactone is generally well tolerated on skin, with low irritation potential.
oral
oral
Risk Level: Moderate
Ingestion of hexadecanolactone may cause gastrointestinal discomfort in some individuals.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation exposure is typically low risk, but may cause irritation in sensitive individuals.
ocular
ocular
Risk Level: Low
Contact with eyes may cause mild irritation, but serious effects are unlikely.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher sensitivity to chemical exposures may lead to adverse effects.
✔ Well-Tolerated Groups
- general_adult — Typically well tolerated with low risk of irritation.
- elderly — Generally well tolerated, but individual sensitivities may vary.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Adults typically have a higher tolerance for cosmetic ingredients. |
| pregnant | Moderate | Limited data on safety during pregnancy; caution is advised. |
| infants_children | High | Children may be more sensitive to chemical exposures. |
| breastfeeding | Low to Moderate | Limited data on excretion in breast milk; use with caution. |
| elderly | Low | Elderly individuals may have varying sensitivities to ingredients. |
Toxicology Data
3 Endpoints
Hexadecanolactone has been evaluated for safety in cosmetics and food applications, showing low toxicity.
| Endpoint | Value | Test Method | Interpretation | Source |
|---|---|---|---|---|
| LD50 Oral | 18600 mg/kg | Rat - Oral gavage | Low acute toxicity | CIR Safety Assessment (2015) |
| Skin Irritation | non-irritating | Human patch test | No irritation observed | CIR Safety Assessment (2015) |
| Sensitization | non-sensitizing | Human patch test | No sensitization observed | CIR Safety Assessment (2015) |
Data Quality: All toxicology values are sourced from verified regulatory assessments (CIR, SCCS, ECHA REACH) following OECD test guidelines. Values are used to calculate the Ingredient Safety Score (ISS).
Scientific Evidence
Key Assessments
Hexadecanolactone has been evaluated for safety in cosmetics and food applications, showing low toxicity.
- Low acute toxicity in animal studies.
- Generally recognized as safe in food applications.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Hexadecanolactone
Year: 2015
Conclusion: Safe for use in cosmetics at concentrations up to 5%.
View Full Report →
EFSA
Report: Scientific Opinion on Hexadecanolactone
Year: 2018
Conclusion: Considered safe as a food additive within specified limits.
View Full Report →
FDA
Report: Food Additive Status
Year: 2020
Conclusion: Permitted for use in food products under specific conditions.
View Full Report →
Regulatory Status
Global
Hexadecanolactone is permitted for use in cosmetics and food across major jurisdictions. Switch to Detailed mode for full regulatory breakdown.
United States
FDAPERMITTED
None
European Union
European CommissionPERMITTED
None
United Kingdom
UK GovernmentPERMITTED
None
Canada
Health CanadaPERMITTED
None
Frequently Asked Questions
Hexadecanolactone is commonly used in cosmetics, food flavoring, and pharmaceuticals for its emulsifying properties.
While generally safe, individuals with sensitive skin should perform a patch test before use.
Yes, it is considered safe for consumption within regulatory limits in food products.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-29T07:09:39.669256Z | — | Initial data enrichment via 3-phase structured outputs |
⚠ Important Notice: This information is for educational purposes only and does not constitute medical, professional, or regulatory advice. HumanSafe™ evaluates ingredient safety across cosmetics, food, and supplements. Scores are exposure-route and context-specific. Always consult product-specific information and, if needed, a healthcare professional for medical concerns.