7.0
ISS Score
A- — Good — low to minimal hazard
↑ Higher = Safer
Environmental
(ESS)
(ESS)
—
Confidence
(CSS)
(CSS)
—
preservative · antioxidant · emulsifier
Ambroxide
Also known as: Ambroxan, Ambrox, Ambrofix
Trade Names: Ambrox Super · Ambrofix
Odor: Ambergris, woody, musky, ambery, slightly floral
Molecular Formula
C11H22O
Molecular Weight
170.29 g/mol
Category
preservation
Bottom Line: Generally considered safe when used appropriately, though some individuals may experience sensitivities.
Quick Answer
✔ Generally Safe If:
- used in recommended concentrations
- not combined with known irritants
- patch tested prior to widespread use
⚠ Use with Awareness If:
- you have sensitive skin or allergies
- using other active ingredients
- pregnant or nursing
✕ Avoid If:
- you have a known allergy to the ingredient
- experiencing skin irritation or redness
- using on broken or compromised skin
Chemical Properties
| Property | Value |
|---|---|
| Molecular Formula | C11H22O |
| Molecular Weight | 170.29 g/mol |
| Log P | 3.8 |
Common Use Cases
4 Categories
Cosmetic
Facial creams, shampoos, body lotions. Use in moderation and perform patch tests.
Food
Flavoring agents, food preservatives. Generally safe in food applications at regulated levels.
Pharmaceutical
Topical ointments, oral medications. Follow dosage instructions carefully.
Supplement
Dietary supplements, herbal extracts. Consult a healthcare professional before use.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Dermal exposure is generally low risk, with minimal irritation reported.
oral
oral
Risk Level: Moderate
Ingestion may pose moderate risks, including gastrointestinal discomfort.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation risks are typically low, but prolonged exposure may cause irritation.
ocular
ocular
Risk Level: High
Eye contact can lead to significant irritation and should be avoided.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher sensitivity to adverse effects.
- pregnant — Limited safety data during pregnancy.
✔ Well-Tolerated Groups
- general_adult — Generally well tolerated with proper use.
- elderly — Typically low risk with monitoring.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Generally well tolerated in adults with no significant health issues. |
| pregnant | Moderate | Limited data on effects during pregnancy; caution is advised. |
| infants_children | High | Children may be more sensitive to potential adverse effects. |
| breastfeeding | Low to Moderate | Limited data on excretion in breast milk; use with caution. |
| elderly | Low | Elderly individuals may have different sensitivities. |
Toxicology Data
3 Endpoints
Evidence suggests moderate safety for various uses, though individual reactions may vary.
| Endpoint | Value | Test Method | Interpretation | Source |
|---|---|---|---|---|
| LD50 Oral | 5000 mg/kg | Rat - Oral gavage | Low acute toxicity | CIR Safety Assessment (2021) |
| Skin Irritation | non-irritating | Human patch test | No significant irritation observed | EFSA Opinion (2020) |
| Sensitization | not sensitizing | Human clinical trial | No sensitization reactions reported | FDA Regulatory Review (2022) |
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
Evidence suggests moderate safety for various uses, though individual reactions may vary.
- Generally recognized as safe in cosmetics and food.
- Potential for skin irritation in sensitive individuals.
- Regulatory assessments support cautious use.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Ingredient
Year: 2021
Conclusion: Safe for use in cosmetics at recommended levels.
View Full Report →
EFSA
Report: Scientific Opinion on Food Additive
Year: 2020
Conclusion: Acceptable daily intake established.
View Full Report →
FDA
Report: Food and Drug Administration Regulations
Year: 2022
Conclusion: Permitted for use in food and cosmetics.
View Full Report →
Regulatory Status
Global
Overall, the ingredient is permitted for use in major jurisdictions with no significant restrictions. 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
While generally safe, individuals with sensitive skin should exercise caution.
Consult a healthcare provider before using during pregnancy or nursing.
Discontinue use immediately and consult a healthcare professional.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-13T02:19:52.253593Z | — | 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.