Poor Cosmetic Ingredient NOAEL Data

Estradiol

INCI: ESTRADIOL

CAS Number
50-28-2
Function
Skin Conditioning (estrogenic hormone)
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Restricted โ€“ FDA historically permitted hormones (estrogen, progesterone) in cosmetics at very low concentrations, but recent FDA guidance discourages this; effectively treated as drug ingredient

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Estradiol. 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
LOEL 0.4 mg/kg bw/day oral rat oral REACH
NOAEL >300 mg/kg bw/day oral rat oral REACH

Expert Verdict

CRITICAL: CMR substance (carcinogenic, mutagenic, reprotoxic); endocrine disruptor; prohibited in EU; reproductive toxicity; breast cancer risk. Do NOT formulate into cosmetics for any market targeting EU

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Concern Level: High

Regulatory Flags

prop65

Frequently Asked Questions

Is Estradiol safe in cosmetics?

CRITICAL: CMR substance (carcinogenic, mutagenic, reprotoxic); endocrine disruptor; prohibited in EU; reproductive toxicity; breast cancer risk. Do NOT formulate into cosmetics for any market targeting EU The EU classifies Estradiol as "prohibited". Safety rating: POOR. 2 toxicological study endpoint(s) are available in our database.

Is Estradiol allowed in the EU?

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

What does Estradiol do in cosmetics?

Estradiol functions as: Skin Conditioning (estrogenic hormone). It is classified as a cosmetic ingredient in our database. CAS number: 50-28-2.

What is the Margin of Safety for Estradiol?

not established 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 Estradiol?

The NOAEL (No Observed Adverse Effect Level) for Estradiol is 0.4 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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