Excellent Antioxidant NOAEL Data Sensitization Data

Tocopheryl Acetate

INCI: TOCOPHERYL ACETATE

CAS Number
58-95-7
Function
Antioxidant; stable ester form of vitamin E; skin-conditioning agent; requires hydrolysis by skin esterases to release active alpha-tocopherol
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel final report: safe as used in cosmetics; present in thousands of formulations; FDA VCRP listed; no concentration restrictions.

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 Tocopheryl Acetate. 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 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 5.5 mg/kg bw/day oral rabbit Subchronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1600 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 1600 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1600 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 1600 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 125 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 47 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Sensitization Profile

Contact sensitization data for Tocopheryl Acetate based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
botanical
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; ESSCA; NACDG

Expert Verdict

Preferred form of vitamin E in cosmetic formulations due to superior oxidative stability. Ester cleavage by skin esterases is incomplete, reducing bioactivity compared to free tocopherol. Recommended at 0.05โ€“0.5% for skin conditioning and antioxidant benefit. Safe for all cosmetic categories. CIR confirmed safety. Synergistic with vitamin C and ferulic acid for antioxidant networks.

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Concern Level: None

Regulatory Flags

antioxidant lipophilic stable-ester lower-bioactivity requires-esterase synergistic-with-vitamin-c cir-reviewed widely-used epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Tocopheryl Acetate safe in cosmetics?

Preferred form of vitamin E in cosmetic formulations due to superior oxidative stability. Ester cleavage by skin esterases is incomplete, reducing bioactivity compared to free tocopherol. Recommended at 0.05โ€“0.5% for skin conditioning and antioxidant benefit. Safe for all cosmetic categories. CIR confirmed safety. Synergistic with vitamin C and ferulic acid for antioxidant networks. The EU classifies Tocopheryl Acetate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Tocopheryl Acetate allowed in the EU?

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

What does Tocopheryl Acetate do in cosmetics?

Tocopheryl Acetate functions as: Antioxidant; stable ester form of vitamin E; skin-conditioning agent; requires hydrolysis by skin esterases to release active alpha-tocopherol. It is classified as a Antioxidant in our database. CAS number: 58-95-7.

What is the Margin of Safety for Tocopheryl Acetate?

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 Tocopheryl Acetate?

The NOAEL (No Observed Adverse Effect Level) for Tocopheryl Acetate is 500 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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