Excellent Cosmetic Ingredient NOAEL Data

Sucrose Acetate Isobutyrate

INCI: SUCROSE ACETATE ISOBUTYRATE

CAS Number
126-13-6
Function
Plasticizer, film former, viscosity controlling agent
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR: Safe as used. Also GRAS as a direct food additive (21 CFR). Used in up to 31% concentration in eye shadow/foundation

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Sucrose Acetate Isobutyrate. 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 2592 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2247 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2226 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 450 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 2707 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1290 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 375 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL 190 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB

Expert Verdict

Lead impurities must be โ‰ค1 ppm; purity โ‰ฅ98.8%. At very high oral doses in dogs, elevated serum alkaline phosphatase and BSP retention were observed (reversible). Not a concern at cosmetic use levels

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Concern Level: Low

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Sucrose Acetate Isobutyrate safe in cosmetics?

Lead impurities must be โ‰ค1 ppm; purity โ‰ฅ98.8%. At very high oral doses in dogs, elevated serum alkaline phosphatase and BSP retention were observed (reversible). Not a concern at cosmetic use levels The EU classifies Sucrose Acetate Isobutyrate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Sucrose Acetate Isobutyrate allowed in the EU?

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

What does Sucrose Acetate Isobutyrate do in cosmetics?

Sucrose Acetate Isobutyrate functions as: Plasticizer, film former, viscosity controlling agent. It is classified as a cosmetic ingredient in our database. CAS number: 126-13-6.

What is the Margin of Safety for Sucrose Acetate Isobutyrate?

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 Sucrose Acetate Isobutyrate?

The NOAEL (No Observed Adverse Effect Level) for Sucrose Acetate Isobutyrate is 2592 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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