Excellent Active Ingredient NOAEL Data GHS Classified

Niacinamide Cosmetic

INCI: NIACINAMIDE

CAS Number
98-92-0
Function
Water-soluble B3 vitamin, cosmetic-grade. Multi-mechanism active: barrier reinforcement via ceramide/fatty acid upregulation; sebum reduction; melanosome transfer inhibition for hyperpigmentation correction; anti-inflammatory via PGE2 suppression; anti-glycation. Effective 2–10%. Below ~2% functional benefits are unlikely.
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted without restriction. Cosmetic-grade purity specification. Flushing risk reduced vs pharmaceutical niacin grade. MoCRA safety substantiation required.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

9 study endpoints found for Niacinamide Cosmetic. 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 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 600 mg/kg bw/day oral rabbit Short Term Toxicity COSMOS_DB
NOAEL 800 mg/kg bw/day oral guinea pig Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 600 mg/kg bw/day oral rabbit Short Term Toxicity COSMOS_DB
dose_tested 800 mg/kg bw/day oral guinea pig Short Term Toxicity COSMOS_DB
NOAEL 215 mg/kg bw/day oral rat oral REACH
NOAEL 12.5 mg/kg bw/day oral - oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Hazard Statements
Causes eye irritation
Short-term Exposure Effects
The substance is irritating to the eyes.

Expert Verdict

Cosmetic-grade niacinamide offers evidence-backed multi-mechanism benefits with reduced flushing risk from lower niacin impurity levels; efficacy confirmed for barrier function, sebum reduction, and hyperpigmentation at concentrations ≥2%.

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Concern Level: None

Regulatory Flags

evidence-backed barrier-function hyperpigmentation sebum-control anti-aging verify-concentration cosmetic-grade fda_food_additive

Frequently Asked Questions

Is Niacinamide Cosmetic safe in cosmetics?

Cosmetic-grade niacinamide offers evidence-backed multi-mechanism benefits with reduced flushing risk from lower niacin impurity levels; efficacy confirmed for barrier function, sebum reduction, and hyperpigmentation at concentrations ≥2%. The EU classifies Niacinamide Cosmetic as "permitted". Safety rating: EXCELLENT. 9 toxicological study endpoint(s) are available in our database.

Is Niacinamide Cosmetic allowed in the EU?

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

What does Niacinamide Cosmetic do in cosmetics?

Niacinamide Cosmetic functions as: Water-soluble B3 vitamin, cosmetic-grade. Multi-mechanism active: barrier reinforcement via ceramide/fatty acid upregulation; sebum reduction; melanosome transfer inhibition for hyperpigmentation correction; anti-inflammatory via PGE2 suppression; anti-glycation. Effective 2–10%. Below ~2% functional benefits are unlikely.. It is classified as a Active Ingredient in our database. CAS number: 98-92-0.

What is the Margin of Safety for Niacinamide Cosmetic?

adequate 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 Niacinamide Cosmetic?

The NOAEL (No Observed Adverse Effect Level) for Niacinamide Cosmetic is 1000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.

Is Niacinamide Cosmetic classified as hazardous under GHS?

Niacinamide Cosmetic carries a GHS signal word of "WARNING". Hazard statements: Causes eye irritation. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

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