Ambrofix — Ingredient Safety Profile | HumanSafe™
6.0
ISS Score
B — Acceptable — low-moderate concern
Higher = Safer
Environmental
(ESS)
Confidence
(CSS)
preservative · antioxidant · emulsifier

Ambrofix

CAS No.: 300371-33-9  ·  INCI: AMBROFIX  ·  Updated: 2026-04-13
Also known as: Ambermorph, Ambermax, Amber Extreme
Trade Names: Ambrofix® · Ambermax
Odor: Ambery, woody, dry, tobacco-like, with nuances of labdanum and cistus.
Category
preservation

Bottom Line: Generally regarded as safe when used appropriately, though some individuals may experience sensitivities.

safe for use multi-functional stabilizing agent CAS 300371-33-9
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 upon use
  • you are using on broken skin
Chemical Properties
PropertyValue
Common Use Cases
4 Categories
Cosmetic
Facial creams, sunscreens, moisturizers. Generally safe for topical use; patch test recommended.
Food
Flavoring agents, food additives. Considered safe in food applications within limits.
Pharmaceutical
Topical ointments, prescription creams. Use under medical supervision for therapeutic purposes.
Supplement
Dietary supplements, nutraceuticals. Consult a healthcare provider 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 potential for adverse reactions.
✔ Well-Tolerated Groups
  • general_adult — Generally well tolerated with low risk of adverse effects.
  • elderly — Typically well tolerated, but monitoring is advised.
Population-Specific Safety Data
PopulationRisk LevelConsiderations
general_adultLowAdults typically have a higher tolerance for exposure compared to other populations.
pregnantModeratePregnant individuals may have altered sensitivities to certain substances.
infants_childrenHighInfants and children are more vulnerable to adverse effects due to their developing systems.
breastfeedingLow to ModerateSubstances can be transferred through breast milk; caution is advised.
elderlyLowElderly individuals may have increased sensitivity to certain ingredients.
Toxicology Data
3 Endpoints

Research indicates moderate safety for topical and food use, though individual reactions may vary.

EndpointValueTest MethodInterpretationSource
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 CIR Safety Assessment (2021)
Sensitization not sensitizing Human clinical study No sensitization reactions reported 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

Research indicates moderate safety for topical and food use, though individual reactions may vary.

  • Generally safe in cosmetics and food applications.
  • 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 concentrations.
View Full Report →
EFSA
Report: Scientific Opinion on Food Additives
Year: 2020
Conclusion: Acceptable daily intake established; safe for food use.
View Full Report →
FDA
Report: Regulatory Status of Ingredient
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.

US
FDAPERMITTED
None
EU
European CommissionPERMITTED
None
UK
UK GovernmentPERMITTED
None
CA
Health CanadaPERMITTED
None
Frequently Asked Questions
While generally safe, some individuals may experience irritation. Patch testing is recommended.
Consult a healthcare provider before use during pregnancy to ensure safety.
Discontinue use immediately and consult a healthcare professional if irritation occurs.
Version History
Audit Trail
VersionDateISS ScoreWhat Changed
1.0.0 - Initial enrichment 2026-04-13T02:21:32.360499Z 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.