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.
US NotesPermitted cosmetic active (genistein, daidzein, equol blend). Phytoestrogenic mechanism requires careful claim framing to avoid OTC drug classification.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Soy Isoflavones.
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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).
sccsSCCS/1641/202216 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
sccsSCCS/1641/202216 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
sccsSCCS/1641/202216 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
sccsSCCS/1641/202216 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 investigationEvidence: 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.
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.
Compliance Tools
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