Good Cosmetic Ingredient NOAEL Data

Sclareolide

INCI: SCLAREOLIDE

CAS Number
564-20-5
Function
Fragrance (amber/woody fixative), Skin Conditioning (anti-pigmentation, anti-inflammatory)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted; FEMA GRAS No. 3794 (flavor/fragrance use)

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Sclareolide. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 7.9 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

No dedicated SCCS/CIR monograph. Inhibits 5-lipoxygenase and COX-1 (bioactive — ensure use levels are appropriate). Patent literature describes use for hyperpigmentation treatment at 0.1–40% w/w — higher concentrations require dedicated safety assessment. Formula: C₁₆H₂₆O₂

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Concern Level: Low

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Sclareolide safe in cosmetics?

No dedicated SCCS/CIR monograph. Inhibits 5-lipoxygenase and COX-1 (bioactive — ensure use levels are appropriate). Patent literature describes use for hyperpigmentation treatment at 0.1–40% w/w — higher concentrations require dedicated safety assessment. Formula: C₁₆H₂₆O₂ The EU classifies Sclareolide as "permitted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database.

Is Sclareolide allowed in the EU?

Sclareolide EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Sclareolide do in cosmetics?

Sclareolide functions as: Fragrance (amber/woody fixative), Skin Conditioning (anti-pigmentation, anti-inflammatory). It is classified as a cosmetic ingredient in our database. CAS number: 564-20-5.

What is the Margin of Safety for Sclareolide?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Sclareolide?

The NOAEL (No Observed Adverse Effect Level) for Sclareolide is 7.9 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. Source: COSMOS_DB.

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