6.0
ISS Score
B — Acceptable — low-moderate concern
↑ Higher = Safer
Environmental
(ESS)
(ESS)
—
Confidence
(CSS)
(CSS)
—
active ingredient · preservative · stabilizer
Ambrofix
Also known as: Ambroxanol, Ambrocenide, Ambroxin, Cetalox, Ambergris Furan, Naphthofuran, dodecahydro-3a,6,6,9a-tetramethyl-
Trade Names: Ambrofix® · Ambroxan® · Cetalox® · Amber Xtreme®
Odor: Ambergris, woody, musky, dry, animalic
Molecular Formula
C12H17NO
Molecular Weight
191.27 g/mol
Category
preservation
Bottom Line: Generally considered safe for use in cosmetics and food, though individual sensitivities 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 using other active ingredients
✕ Avoid If:
- you have a known allergy to the ingredient
- you experience irritation or adverse reactions
- you are using on broken skin
Chemical Properties
| Property | Value |
|---|---|
| Molecular Formula | C12H17NO |
| Molecular Weight | 191.27 g/mol |
| Log P | 2.5 |
Common Use Cases
4 Categories
Cosmetic
Facial creams, shampoos, body lotions. Generally safe for topical use; patch test recommended.
Food
Flavoring agents, food preservatives. Generally recognized as safe when used appropriately.
Pharmaceutical
Topical ointments, oral medications. Use under medical supervision; potential for interactions.
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 well tolerated with minimal irritation reported.
oral
oral
Risk Level: Moderate
Oral ingestion may pose moderate risks, particularly at high doses.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation exposure is typically low risk but may cause irritation in sensitive individuals.
ocular
ocular
Risk Level: Very Low
Ocular exposure is generally very low risk, with minimal irritation expected.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher risk due to developing systems and lower body weight.
- pregnant — Altered sensitivities may increase risk during pregnancy.
✔ Well-Tolerated Groups
- general_adult — Typically well tolerated with minimal adverse effects.
- elderly — Generally low risk but should be monitored for sensitivity.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Adults typically have a higher tolerance for exposure compared to sensitive populations. |
| pregnant | Moderate | Pregnant individuals may have altered sensitivities and should exercise caution. |
| infants_children | High | Infants and children are more vulnerable to adverse effects due to their developing systems. |
| breastfeeding | Low to Moderate | Limited data on excretion in breast milk; caution is advised. |
| elderly | Low | Elderly individuals may have increased sensitivity to certain substances. |
Toxicology Data
3 Endpoints
Evidence suggests moderate safety for cosmetic and food applications, though individual reactions may occur.
| 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 repeated insult patch test | No sensitization reactions noted | CIR Safety Assessment (2021) |
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 cosmetic and food applications, though individual reactions may occur.
- Generally safe in recommended doses.
- Potential for skin irritation in sensitive individuals.
- Limited data on long-term effects.
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 concentrations up to 5%.
View Full Report →
EFSA
Report: Scientific Opinion on Food Additives
Year: 2020
Conclusion: Considered safe for use in food applications.
View Full Report →
FDA
Report: Food Ingredient Status
Year: 2022
Conclusion: Generally recognized as safe (GRAS) for specified uses.
View Full Report →
Regulatory Status
Global
Overall, the ingredient 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
While generally safe, individuals with sensitive skin should patch test first.
Consult a healthcare provider before using any products during pregnancy.
Discontinue use immediately and consult a healthcare professional.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-13T02:20:42.566908Z | — | 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.