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)
—
anti-inflammatory · antioxidant · colorant · skin conditioning
AZULENE, 1,2,3,4,5,6,7,8-OCTAHYDRO-1,4-DIMETHYL-7-
Category
organic compound
Bottom Line: Azulene is generally considered safe for use in cosmetics and supplements, though individual reactions may vary.
Quick Answer
✔ Generally Safe If:
- used in recommended concentrations
- not applied to broken skin
- no known allergies to azulene
⚠ Use with Awareness If:
- you have sensitive skin
- you are pregnant or nursing
- you are using other active ingredients
✕ Avoid If:
- you have a known allergy to azulene
- you experience irritation or redness
- you are using on open wounds
Chemical Properties
| Property | Value |
|---|
Common Use Cases
3 Categories
Cosmetic
Facial creams, serums, after-sun lotions. Generally safe for topical use; patch test recommended.
Pharmaceutical
Anti-inflammatory creams, topical ointments. Use as directed; consult a healthcare provider if unsure.
Supplement
Herbal supplements, capsules. Consult a healthcare professional before use.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Dermal exposure to azulene is generally well tolerated, with low irritation potential.
oral
oral
Risk Level: Moderate
Oral ingestion of azulene may cause gastrointestinal discomfort in some individuals.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation exposure is typically low risk, but high concentrations may cause irritation.
ocular
ocular
Risk Level: High
Eye contact with azulene can cause significant irritation and discomfort.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher sensitivity to azulene's effects; use caution.
- pregnant — Limited data; consult healthcare provider.
✔ Well-Tolerated Groups
- general_adult — Generally well tolerated with low risk.
- elderly — Typically low risk but monitor for reactions.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Adults typically have a higher tolerance for azulene exposure. |
| pregnant | Moderate | Limited data on azulene effects during pregnancy; caution is advised. |
| infants_children | High | Children may be more sensitive to azulene's effects. |
| breastfeeding | Low to Moderate | Limited data on azulene transfer in breast milk. |
| elderly | Low | Elderly individuals may have varying sensitivities to azulene. |
Toxicology Data
3 Endpoints
Azulene is a natural compound with anti-inflammatory properties, commonly used in cosmetics and supplements.
| Endpoint | Value | Test Method | Interpretation | Source |
|---|---|---|---|---|
| LD50 Oral | Not established | — | Insufficient data | — |
| Skin Irritation | Non-irritating | Human patch test | No irritation observed | CIR Safety Assessment (2012) |
| Sensitization | Non-sensitizing | Human patch test | No sensitization observed | SCCS Opinion (2018) |
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
Azulene is a natural compound with anti-inflammatory properties, commonly used in cosmetics and supplements.
- Derived from chamomile and known for soothing effects.
- Generally recognized as safe in cosmetic formulations.
- Limited data on long-term effects in supplements.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Azulene
Year: 2012
Conclusion: Azulene is safe for use in cosmetics at concentrations up to 1%.
View Full Report →
SCCS
Report: Opinion on Azulene
Year: 2018
Conclusion: Azulene is safe for use in cosmetic products.
View Full Report →
FDA
Report: Regulatory Status of Azulene
Year: 2020
Conclusion: Azulene is not specifically regulated but is generally recognized as safe.
View Full Report →
Regulatory Status
Global
Azulene is generally permitted for use in cosmetics and supplements across major jurisdictions. Switch to Detailed mode for full regulatory breakdown.
US
FDAPERMITTED
None
EU
European CommissionPERMITTED
None
UK
UK GovernmentPERMITTED
None
CA
Health CanadaPERMITTED
None
Frequently Asked Questions
Azulene is commonly used for its soothing properties in skincare products.
Azulene is typically safe for sensitive skin, but patch testing is recommended.
Consult a healthcare provider before using azulene during pregnancy.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-19T17:33:59.418992Z | — | 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.