Good Active Ingredient NOAEL Data SCCS/CIR Reviewed

Soy Isoflavones

Also known as: 4H-1-Benzopyran-4-one, 5,7-dihydroxy-3-(4-hydroxyphenyl)-, 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone, Isoflavone, 4',5,7-trihydroxy-, 4',5,7-Trihydroxyisoflavone, genistein (+15 more)

INCI: SOY ISOFLAVONES

Soy Isoflavones (CAS 446-72-0) is a cosmetic active ingredient functioning as 5-alpha-reductase inhibitor; phytoestrogen blend; ER modulator;. NOAEL 4 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 4 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.

View industrial chemical safety profile for CAS 446-72-0 →

Auto-generated CPSR Part A draft with source citations
Function
5-alpha-reductase inhibitor; phytoestrogen blend; ER modulator; anti-androgenic; antioxidant; hair-growth active
Safety Rating
GOOD

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Permitted cosmetic active (genistein, daidzein, equol blend). Phytoestrogenic mechanism requires careful claim framing to avoid OTC drug classification.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Soy Isoflavones. 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 =4 mg/kg bw/day oral - NOAEL study SCCS_vision_codex
NOAEL =4 mg/kg bw/day oral - NOAEL study SCCS_vision_codex
NOAEL =4 mg/kg bw/day oral - NOAEL study SCCS_vision_codex
NOAEL =4 mg/kg bw/day oral - NOAEL study SCCS_vision_codex
NOAEL =5 mg/kg bw/d - human reproductive toxicity SCCS_vision_codex
NOAEL =5 mg/kg oral rat reproductive toxicity SCCS_vision_codex
NOAEL =5 mg/kg bw/d - human reproductive toxicity SCCS_vision_codex
NOAEL =5 mg/kg oral rat reproductive toxicity SCCS_vision_codex
NOAEL =5 mg/kg bw/d - human reproductive toxicity SCCS_vision_codex
NOAEL =5 mg/kg oral rat reproductive toxicity SCCS_vision_codex

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1641/2022 16 September 2022
Verdict: safe
NOAEL: 4 mg/kg bw/day (subcutaneous)
Max Concentration: 0.007% in general

e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein

sccs SCCS/1641/2022 16 September 2022
Verdict: safe
NOAEL: 4 mg/kg bw/day (subcutaneous)
Max Concentration: 0.02% in general

e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein

sccs SCCS/1641/2022 16 September 2022
Verdict: safe
NOAEL: 35 mg/kg (not specified)
Max Concentration: 0.007% in general

e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein

sccs SCCS/1641/2022 16 September 2022
Verdict: safe
NOAEL: 35 mg/kg (not specified)
Max Concentration: 0.02% in general

e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein

Pre-Calculated Safety Assessment

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

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
100%
DPRA Lys %
16.03%
KeratinoSens IC50
180.191 µM
hCLAT CV75
81 µg/mL
GHS: inconclusive

Source: DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe

Endocrine Disruptor Evidence (Expanded)

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

Under investigation Evidence: Moderate (2024)
Health effects: Yes
Affected pathways: Estrogenic (phytoestrogen)
Regulatory framework: Cosmetics

Source list: II (former)

Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα, ERβ, AR, PPAR-gamma
LOEC: 1 nM
EU status: restricted (max 0.01% leave-on; max 0.2% rinse-off; EU 2024/996)

agonist (ERα, ERβ, PPARγ); antagonist (AR)

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.

Additional Jurisdictional Restrictions (3)
Jurisdiction Status Max % Product Type
UK restricted - -
ASEAN restricted Updated concentration limits per 2025–2026 ACD revision Cosmetic products as active
MY restricted (updated limits) Updated per ACD 2025 revision — lower than previous All cosmetic products using as active

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Softener and conditioner

Expert Verdict

Expert safety assessment and concern-level summary for Soy Isoflavones.

Regulatory Flags

hair-growth-active 5ar-inhibitor phytoestrogen anti-androgenic soy-derived claim-sensitive cosmetic-classified

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Soy Isoflavones by CAS number or substance name.

Studies
44
Lowest NOAEL
4
Highest NOAEL
2000

Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg

SCCS_vision_codex

Known Synonyms

4H-1-Benzopyran-4-one, 5,7-dihydroxy-3-(4-hydroxyphenyl)- 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone Isoflavone, 4',5,7-trihydroxy- 4',5,7-Trihydroxyisoflavone genistein GeniVida Genistin aglycone SIPI 807-1 Climagen F C.I. 75610 FW 635I-2 5-18-04-00594 BRN 0263823 EINECS 207-174-9 UNII-DH2M523P0H 4',5, 7-Trihydroxyisoflavone 4',5,7-Trihydroxy-Isoflavone 4,5,7-Trihydroxy Iso-Flavone 5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one Differenol A

Chemical Function

Softener and conditioner

Regulatory Lists

Canada; pharmaceutical

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
GENISTEIN
ChEMBL ID
CHEMBL44
Max Phase
2
Adverse Event Associations
7
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Genistein
Food Category
preservative
View full food safety profile →

Frequently Asked Questions

Is Soy Isoflavones safe in cosmetics?

Soy Isoflavones has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Soy Isoflavones allowed in the EU?

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

What does Soy Isoflavones do in cosmetics?

Soy Isoflavones functions as: 5-alpha-reductase inhibitor; phytoestrogen blend; ER modulator; anti-androgenic; antioxidant; hair-growth active. It is classified as a Active Ingredient in our database. CAS number: 446-72-0.

What is the NOAEL for Soy Isoflavones?

The NOAEL (No Observed Adverse Effect Level) for Soy Isoflavones is =4 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Soy Isoflavones used outside cosmetics?

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

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