66.0
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)
—
fragrance ingredient · flavoring agent · antimicrobial agent · potential antioxidant
Sclareol
Molecular Formula
C20H36O2
Molecular Weight
308.5 g/mol
Category
natural compound
Bottom Line: Sclareol is generally considered safe for use in cosmetics and food, though individual reactions may vary.
Quick Answer
✔ Generally Safe If:
- used in recommended concentrations
- not combined with known irritants
- applied to intact skin
⚠ Use with Awareness If:
- you have sensitive skin
- you are pregnant or nursing
- you are allergic to similar compounds
✕ Avoid If:
- you have a known allergy to sclareol
- you experience irritation or adverse reactions
- you are using it in high concentrations
Chemical Properties
| Property | Value |
|---|---|
| Molecular Formula | C20H36O2 |
| Molecular Weight | 308.5 g/mol |
| Solubility | Soluble (in ethanol) |
| Log P | 4.9 |
Common Use Cases
4 Categories
Cosmetic
Fragrances, skin creams, shampoos. Generally safe in cosmetic formulations when used as directed.
Food
Flavoring agents, food supplements. Considered safe for food use in regulated amounts.
Pharmaceutical
Topical medications, therapeutic agents. Use with caution in pharmaceutical applications.
Supplement
Dietary supplements, herbal products. Consult a healthcare provider before use.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Sclareol is generally well tolerated on the skin, but may cause irritation in sensitive individuals.
oral
oral
Risk Level: Moderate
Ingestion of Sclareol may lead to gastrointestinal discomfort; caution is advised.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation exposure may cause respiratory irritation; use in well-ventilated areas.
ocular
ocular
Risk Level: High
Contact with eyes can cause significant irritation; avoid direct exposure.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher sensitivity to ingredients; potential for adverse reactions.
- pregnant — Limited data on safety during pregnancy; caution is advised.
- sensitive_skin — Higher likelihood of irritation; patch testing is essential.
✔ Well-Tolerated Groups
- general_adult — Generally well tolerated, but individual sensitivities may vary.
- elderly — Generally well tolerated, but monitor for any adverse effects.
- breastfeeding — Limited data on excretion in breast milk; use with caution.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Generally well tolerated, but individual sensitivities may vary. |
| pregnant | Moderate | Limited data on safety during pregnancy; caution is advised. |
| infants_children | Very High | Higher sensitivity to ingredients; potential for adverse reactions. |
| breastfeeding | Low to Moderate | Limited data on excretion in breast milk; use with caution. |
| elderly | Low | Generally well tolerated, but monitor for any adverse effects. |
| sensitive_skin | High | Higher likelihood of irritation; patch testing is essential. |
Toxicology Data
3 Endpoints
Sclareol 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 (2012) |
| Skin Irritation | non-irritating | Human patch test | No irritation observed | CIR Safety Assessment (2012) |
| Sensitization | not sensitizing | Human sensitization study | No sensitization observed | CIR Safety Assessment (2012) |
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
Sclareol has been evaluated for safety in cosmetics and food applications, showing low toxicity.
- Low acute toxicity in animal studies.
- Generally recognized as safe in cosmetics.
- Limited data on long-term effects.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Sclareol
Year: 2012
Conclusion: Sclareol is safe for use in cosmetics at concentrations up to 0.5%.
View Full Report →
EFSA
Report: Scientific Opinion on Sclareol
Year: 2015
Conclusion: Sclareol is safe for use as a food flavoring agent.
View Full Report →
FDA
Report: Regulatory Status of Sclareol
Year: 2020
Conclusion: Sclareol is not listed as a prohibited substance.
View Full Report →
Regulatory Status
Global
Sclareol 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
Sclareol is generally safe, but individuals with sensitive skin should test for reactions.
Yes, Sclareol is permitted as a flavoring agent in food under regulated conditions.
Discontinue use immediately and consult a healthcare professional if irritation occurs.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-29T07:29:10.918908Z | — | 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.