Excellent Active Ingredient GHS Classified

Niacinamide

Also known as: Nicotinamide, 3-Pyridinecarboxamide, Nam, EINECS 202-713-4, Pyridine, 3-carbamoyl- (+15 more)

INCI: NIACINAMIDE

Niacinamide (CAS 98-92-0) is a cosmetic active ingredient functioning as Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of. NOAEL 12.5 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 98-92-0 →

Auto-generated CPSR Part A draft with source citations
Function
Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of melanosomes from melanocytes to keratinocytes (35–68% inhibition in coculture); also reduces keratinocyte PGE2 production and AGE formation, both of which stimulate melanosome transfer; does not affect tyrosinase catalytic activity
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
202-713-4

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes No FDA concentration restriction. Used at 2–10% in OTC brightening and barrier products without drug classification concerns. Not listed in OTC skin-bleaching monograph (21 CFR 310.545). Generally recognised as safe in dietary context; topical cosmetic use unrestricted.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Niacinamide.

Calculate MoS for your specific formulation with the MoS Calculator.

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.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Niacinamide across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

4 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LD50 >2000 mg/kg Rabbit dermal acute ECHA IUCLID
NOAEL =215 mg/kg-day Rat oral short-term HESS
LD50 =2500 mg/kg Mouse oral - ChemIDplus
LD50 =3500 mg/kg Rat oral - ChemIDplus

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα (skin penetration enhancer – enhances paraben absorption)
LOEC: N/A
EU status: allowed

indirect (enhances dermal absorption of co-formulated EDCs)

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

JPKR Japan/Korea Cosmetics
Korea (Restricted): max 5.0
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
CN restricted - All products
AU therapeutic_good - skin treatment

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_in_vivo 2.2 In vivo (human) Human in vivo Kasting & Miller 2006 (2006)

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Face Cream 2–5 10 CIR/VCRP/Industry
Serum 2–10 20 CIR/Industry
Toner 2–5 10 CIR/Industry
Eye Cream 2–5 10 CIR/Industry

Additional Ingredient Properties

10 property records from structured ingredient metadata.

acne
{"cas_number": "98-92-0", "anti_acne_mechanism": "sebum_regulation/anti_inflammatory/antibacterial", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "inflammatory/non_inflammatory", "p_acnes_mic_ug_per_ml": ">1000 (mild antibacterial)", "sebum_reduction_pct_clinical": "25-30", "keratolytic_strength": "mild", "exfoliation_mechanism": "chemical", "optimal_ph_for_efficacy": "5.0-7.0", "pre…
antioxidant
{"cas_number": "98-92-0", "antioxidant_class": "vitamin", "chemical_subclass": "vitamin B3", "molecular_weight_daltons": "122.12", "orac_value_umol_te_per_g": "850", "dpph_radical_scavenging_ic50_ug_per_ml": "60-90", "abts_trolox_equivalent": "0.4", "singlet_oxygen_quenching": "moderate", "superoxide_dismutase_mimetic": "low", "hydroxyl_radical_scavenging": "moderate", "lipid_peroxidation_inhibiti…
baby_pediatric
{"cas_number": "98-92-0", "ingredient_class": "diaper_cream", "pediatric_safety_rating": "excellent", "minimum_age_months": "3", "neonatal_safe": "yes", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Barrier support, anti-inflammatory; increasingly used", "transepidermal_absorption_risk_pediatric": "low", "dose_per_kg_body_weight_concern": "Safe topically", "…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,mature,rosacea", "acne_safe": "yes", "source": "Vitamin B3 - gold standard"}
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "5.0", "typical_concentration_pct": "3.0", "product_type": "Sunscreen", "function_at_concentration": "Barrier support, antioxidant", "source": "CIR Safety Assessment"}
deodorant
{"cas_number": "98-92-0", "ingredient_class": "skin_conditioning_deo", "mechanism_of_action": "other", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "0", "odor_reduction_pct": "0", "bacteriostatic": "no", "bactericidal": "no", "microbiome_impact": "neutral", "axillary_microbiome_effect": "varies by ingredient", "MIC_value_if_antimicrobial": "varies", "astringency_…
hair_care
{"hair_function": "scalp-care", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "kerati…
interactions
{"ingredient_2": "Active ingredients", "interaction_type": "enhanced_penetration", "severity": "beneficial", "effect": "May enhance penetration of some actives", "recommendation": "Generally beneficial; improves overall formulation efficacy", "data_source": "Formulation science literature, dermatological research, cosmetic chemistry best practices", "last_updated": "2026-03-05"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Flavouring and nutrient Humectant Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Niacinamide.

Regulatory Flags

brightening melanosome-transfer-inhibitor vitamin-b3 35-68pct-transfer-inhibition pge2-reduction age-formation-reduction not-tyrosinase-direct synergistic-txa synergistic-tyrosinase-inhibitors quasi-drug-japan-2007 no-restrictions-any-market melasma pih combination-backbone eu-allowed us-allowed fda_food_additive

Dermal Absorption

View details ->
Absorption % Method Vehicle
2.2 In vivo (human) Standard cosmetic formulation

Known Synonyms

Nicotinamide 3-Pyridinecarboxamide Nam EINECS 202-713-4 Pyridine, 3-carbamoyl- Nicotinsaureamid UNII-25X51I8RD4 Acid amide Amid kyseliny nikotinove Amide PP Amixicotyn Amnicotin Austrovit PP Dipegyl Dipigyl Endobion Factor pp Hansamid Inovitan PP Mediatric

Chemical Function

Humectant Softener and conditioner

Regulatory Lists

food_additive; Substances Added to Food (formerly EAFUS) (2/2019) Canada; consumer_product; Substances in Products - Canada (4/2014) inert_ingredient; non_food_use; Pesticides pharmaceutical Europe; supplements Europe; food_additive; supplements Canada; pharmaceutical Canada; pharmaceutical inert_ingredient; non_food_use; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
NIACINAMIDE
ChEMBL ID
CHEMBL1140
Max Phase
4
Adverse Event Associations
3772
View full pharmaceutical profile →

Frequently Asked Questions

Is Niacinamide safe in cosmetics?

Niacinamide has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.

Is Niacinamide allowed in the EU?

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

What does Niacinamide do in cosmetics?

Niacinamide functions as: Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of melanosomes from melanocytes to keratinocytes (35–68% inhibition in coculture); also reduces keratinocyte PGE2 production and AGE formation, both of which stimulate melanosome transfer; does not affect tyrosinase catalytic activity. It is classified as a Active Ingredient in our database. CAS number: 98-92-0.

Is Niacinamide classified as hazardous under GHS?

Niacinamide 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.

Is Niacinamide used outside cosmetics?

Niacinamide also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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