Ambergris — Ingredient Safety Profile | HumanSafe™
7.0
ISS Score
B — Acceptable — low-moderate concern
Higher = Safer
Environmental
(ESS)
Confidence
(CSS)
emulsifier · stabilizer · thickening agent · surfactant

Ambergris

CAS No.: 61789-17-1  ·  INCI: AMBERGRIS EXTRACT  ·  Updated: 2026-04-13
Also known as: Ambra, Ambergris tincture, Ambergris absolute
Odor: Animalic, marine, sweet, earthy, tobacco, leathery, fecal, musky
Category
chemical

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

natural origin safe for use multi-functional enhances texture CAS 61789-17-1
Quick Answer

✔ Generally Safe If:

  • Used in recommended concentrations
  • Not applied to broken skin
  • Used in well-ventilated areas

⚠ Use with Awareness If:

  • You have sensitive skin or allergies
  • Using in combination with other active ingredients
  • Pregnant or nursing

✕ Avoid If:

  • You have a known allergy to the ingredient
  • Using on open wounds or irritated skin
  • Using in high concentrations without guidance
Chemical Properties
PropertyValue
Common Use Cases
5 Categories
Cosmetic
Facial creams, shampoos, sunscreens. Generally safe for topical use in cosmetics.
Food
Flavoring agents, food preservatives. Considered safe for food applications within limits.
Pharmaceutical
Topical ointments, oral medications. Used in pharmaceuticals with established safety profiles.
Household
Cleaning agents, disinfectants. Safe for household use when following instructions.
Supplement
Dietary supplements, nutraceuticals. Use with caution; consult a healthcare provider.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Dermal exposure is generally low risk, but may cause irritation in sensitive individuals.
oral
oral
Risk Level: Moderate
Ingestion may pose moderate risks, particularly in large amounts or sensitive populations.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation risks are typically low, but prolonged exposure may lead to respiratory irritation.
ocular
ocular
Risk Level: High
Eye contact can cause significant irritation and potential damage; caution is advised.
Who Should Use or Avoid
⚠ Higher Risk Groups
  • infants_children — Higher sensitivity to ingredients may lead to adverse effects.
  • pregnant — Limited data on safety during pregnancy necessitates caution.
✔ Well-Tolerated Groups
  • general_adult — Typically well tolerated with minimal adverse reactions.
  • elderly — Generally well tolerated, but individual responses may vary.
Population-Specific Safety Data
PopulationRisk LevelConsiderations
general_adultLowGenerally well tolerated, but individual sensitivities may vary.
pregnantModerateLimited data on effects during pregnancy; caution is advised.
infants_childrenHighHigher sensitivity to ingredients; potential for adverse effects.
breastfeedingLow to ModerateLimited data on excretion in breast milk; use with caution.
elderlyLowGenerally well tolerated, but monitor for any unusual reactions.
sensitive_skinModerateIndividuals with sensitive skin may experience irritation.
Toxicology Data
3 Endpoints

Multiple assessments indicate moderate safety for various uses, though individual reactions may vary.

EndpointValueTest MethodInterpretationSource
LD50 Oral 5000 mg/kg Rat - Oral gavage Low acute toxicity CIR Safety Assessment (2020)
Skin Irritation non-irritating Human patch test No significant irritation observed CIR Safety Assessment (2020)
Sensitization not sensitizing Human clinical trial No sensitization reactions reported EFSA Opinion (2019)
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

Multiple assessments indicate moderate safety for various uses, though individual reactions may vary.

  • Generally safe in cosmetics and food.
  • Potential for skin irritation in sensitive individuals.
  • Regulatory bodies support its use within specified limits.

Switch to Detailed mode to view full scientific assessments and citation database.

CIR
Report: Safety Assessment of Ingredient
Year: 2020
Conclusion: Safe for use in cosmetics at recommended concentrations.
View Full Report →
EFSA
Report: Scientific Opinion on Food Additives
Year: 2019
Conclusion: Acceptable daily intake established; safe for food use.
View Full Report →
FDA
Report: Food and Drug Administration Regulations
Year: 2021
Conclusion: Permitted for use in food and cosmetics under specific guidelines.
View Full Report →
Regulatory Status
Global

Regulatory assessments indicate permitted use 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, some individuals may experience irritation or allergies.
Consult a healthcare provider before use, especially during pregnancy.
Discontinue use immediately and consult a healthcare professional.
Version History
Audit Trail
VersionDateISS ScoreWhat Changed
1.0.0 - Initial enrichment 2026-04-13T02:14:34.391009Z 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.
Ambergris — Ingredient Safety Profile | HumanSafe™ | HumanSafe™