Moderate Cosmetic Ingredient NOAEL Data

Diethyl Sebacate

INCI: DIETHYL SEBACATE

CAS Number
110-40-7
Function
Skin Conditioning, Emollient, Plasticizer, Solvent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel (December 2010, 7-1 vote) concluded safe as used in present practices and concentrations. Maximum reported use at time of CIR review was 1.5% in dermal contact products.

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Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Diethyl Sebacate. 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 15000 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB

Expert Verdict

CIR-concluded safe at up to 1.5% use concentrations, but multiple published allergic contact dermatitis case reports from pharmaceutical vehicles at higher concentrations represent a real sensitization risk. No quantitative dermal absorption or margin of safety data exist. Formulators should stay at or below 1.5%.

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Concern Level: Moderate

Regulatory Flags

cir-safe sensitization-risk acd-case-reports no-sccs-opinion no-mos-calculated penetration-enhancer ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Diethyl Sebacate safe in cosmetics?

CIR-concluded safe at up to 1.5% use concentrations, but multiple published allergic contact dermatitis case reports from pharmaceutical vehicles at higher concentrations represent a real sensitization risk. No quantitative dermal absorption or margin of safety data exist. Formulators should stay at or below 1.5%. The EU classifies Diethyl Sebacate as "permitted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is Diethyl Sebacate allowed in the EU?

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

What does Diethyl Sebacate do in cosmetics?

Diethyl Sebacate functions as: Skin Conditioning, Emollient, Plasticizer, Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 110-40-7.

What is the Margin of Safety for Diethyl Sebacate?

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 Diethyl Sebacate?

The NOAEL (No Observed Adverse Effect Level) for Diethyl Sebacate is 15000 mg/kg bw/day based on a Special Toxicology Study study via oral route in mouse. Source: COSMOS_DB.

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