Good Emulsifier NOAEL Data

Sorbitan Stearate

INCI: SORBITAN STEARATE

CAS Number

1338-41-6

Function

Emulsifier; W/O co-emulsifier; stabilizer

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes CIR assessed sorbitan esters as safe as used. Non-ethoxylated sorbitan stearate (C18). HLB 4.7 — W/O emulsification range. COSMOS-eligible. Often paired with Polysorbate 60 for HLB-balanced O/W systems.

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

8 study endpoints found for Sorbitan Stearate. 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	5000 mg/kg bw/day	oral	rat	Carcinogenicity	COSMOS_DB
NOAEL	5000 mg/kg bw/day	oral	rat	Carcinogenicity	COSMOS_DB
NOAEL	5000 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	1250 mg/kg bw/day	oral	dog	Chronic	COSMOS_DB
NOAEL	2500 mg/kg bw/day	oral	rat	Multigeneration Reproductive	COSMOS_DB
NOAEL	1000 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB
dose_tested	1250 mg/kg bw/day	oral	dog	Chronic	COSMOS_DB
dose_tested	1000 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB

Expert Verdict

⚠️

Concern Level: None

Regulatory Flags

non-ethoxylated peg-free cosmos w-o-emulsifier hlb-blending solid-texture eu_children_restricted epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Sorbitan Stearate safe in cosmetics?

Non-ethoxylated sorbitan stearate (Span 60) with HLB 4.7 for W/O emulsification. CIR confirmed safe, PEG-free, COSMOS/ECOCERT eligible, and presents no 1,4-dioxane concern. Solid at room temperature, contributing structural texture to emulsions and balms. The EU classifies Sorbitan Stearate as "permitted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.

Is Sorbitan Stearate allowed in the EU?

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

What does Sorbitan Stearate do in cosmetics?

Sorbitan Stearate functions as: Emulsifier; W/O co-emulsifier; stabilizer. It is classified as a Emulsifier in our database. CAS number: 1338-41-6.

What is the Margin of Safety for Sorbitan Stearate?

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 Sorbitan Stearate?

The NOAEL (No Observed Adverse Effect Level) for Sorbitan Stearate is 5000 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Sorbitan Stearate compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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