Good Surfactant NOAEL Data

Tocopherol (Vitamin E)

INCI: TOCOPHEROL

CAS Number
1406-66-2
Function
Antioxidant
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 5.4%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted

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

10 study endpoints found for Tocopherol (Vitamin E). 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 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 13 mg/kg bw/day oral guinea pig Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 750 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral hamster Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 750 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 66 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 40 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Good safety profile with antioxidant efficacy; restricted in EU with concentration limits, permitted in US.

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Concern Level: Low

Regulatory Flags

EU Restricted fda_food_additive

Frequently Asked Questions

Is Tocopherol (Vitamin E) safe in cosmetics?

Good safety profile with antioxidant efficacy; restricted in EU with concentration limits, permitted in US. The EU classifies Tocopherol (Vitamin E) as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Tocopherol (Vitamin E) allowed in the EU?

Tocopherol (Vitamin E) EU regulatory status: restricted. Maximum allowed concentration: 5.4%. This is based on EU Regulation 1223/2009 and its amendments.

What does Tocopherol (Vitamin E) do in cosmetics?

Tocopherol (Vitamin E) functions as: Antioxidant. It is classified as a Surfactant in our database. CAS number: 1406-66-2.

What is the Margin of Safety for Tocopherol (Vitamin E)?

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 Tocopherol (Vitamin E)?

The NOAEL (No Observed Adverse Effect Level) for Tocopherol (Vitamin E) is 1000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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