Good Active Ingredient NOAEL Data

Daidzein

INCI: DAIDZEIN

CAS Number
486-66-8
Function
Skin-conditioning agent, phytoestrogen-class active (ERβ agonist; soy isoflavone; precursor to equol via microbial metabolism; collagen and hyaluronic acid support)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted as cosmetic ingredient; hormonal claims trigger FDA drug classification. Co-occurs with genistein in soy isoflavone extracts. Converted by microbial enzymes to equol (a more potent metabolite). No specific FDA or CIR restrictions at cosmetic concentrations.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Daidzein. 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 =19 mg/kg/day oral rat reproductive SCCS

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Daidzein.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
50 mg/kg/day 150 mg/kg/day Oral Rat Developmental/reproductive (Gestational/neonatal period) 20 SCCS/1641/22 (2022)

Expert Verdict

Daidzein is the principal soy isoflavone precursor to equol, the metabolite responsible for much of soy's phytoestrogenic activity. Clinical studies of combined soy isoflavones (genistein + daidzein) over 12–24 weeks showed improvements in skin dryness, thickness, wrinkles, hyaluronic acid levels, and collagen I/III in postmenopausal women. Individual topical data for daidzein alone is less established than genistein. Claim compliance is the primary formulation risk — hormonal mechanism claims trigger drug classification in both EU and US.

⚠️
Concern Level: Low

Regulatory Flags

phytoestrogen erb-agonist equol-precursor soy-isoflavone claim-risk-hormonal menopausal-skin-target no-concentration-limit endocrine_disruptor

Frequently Asked Questions

Is Daidzein safe in cosmetics?

Daidzein is the principal soy isoflavone precursor to equol, the metabolite responsible for much of soy's phytoestrogenic activity. Clinical studies of combined soy isoflavones (genistein + daidzein) over 12–24 weeks showed improvements in skin dryness, thickness, wrinkles, hyaluronic acid levels, and collagen I/III in postmenopausal women. Individual topical data for daidzein alone is less established than genistein. Claim compliance is the primary formulation risk — hormonal mechanism claims trigger drug classification in both EU and US. The EU classifies Daidzein as "permitted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database.

Is Daidzein allowed in the EU?

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

What does Daidzein do in cosmetics?

Daidzein functions as: Skin-conditioning agent, phytoestrogen-class active (ERβ agonist; soy isoflavone; precursor to equol via microbial metabolism; collagen and hyaluronic acid support). It is classified as a Active Ingredient in our database. CAS number: 486-66-8.

What is the Margin of Safety for Daidzein?

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 Daidzein?

The NOAEL (No Observed Adverse Effect Level) for Daidzein is =19 mg/kg/day based on a reproductive study via oral route in rat. Source: SCCS.

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