Excellent Emollient NOAEL Data GHS Classified

Magnesium Stearate

INCI: MAGNESIUM STEARATE

CAS Number
557-04-0
Function
Binder; lubricant; slip agent in pressed powder formulations
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted for eye-area use; no concentration cap; also used as pharmaceutical excipient with strong safety record

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Magnesium 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 2500 mg/kg bw/day oral rat Subchronic COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Routes of Exposure
The substance can be absorbed into the body by inhalation.

Expert Verdict

Magnesium salt of stearic acid functioning as a binder and lubricant in pressed eye shadow and eyeliner powder formulations. Standard component of pan-pressing systems with one of the longest-established safety records as a pharmaceutical tablet excipient. No significant ophthalmological concerns or regulatory restrictions for eye-area use.

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Concern Level: None

Regulatory Flags

binder lubricant eye-shadow pressed-powder eye-area pharma-grade-available well-tolerated epa_safer_alternative fda_food_additive jecfa_safe

Frequently Asked Questions

Is Magnesium Stearate safe in cosmetics?

Magnesium salt of stearic acid functioning as a binder and lubricant in pressed eye shadow and eyeliner powder formulations. Standard component of pan-pressing systems with one of the longest-established safety records as a pharmaceutical tablet excipient. No significant ophthalmological concerns or regulatory restrictions for eye-area use. The EU classifies Magnesium Stearate as "permitted". Safety rating: EXCELLENT. 1 toxicological study endpoint(s) are available in our database.

Is Magnesium Stearate allowed in the EU?

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

What does Magnesium Stearate do in cosmetics?

Magnesium Stearate functions as: Binder; lubricant; slip agent in pressed powder formulations. It is classified as a Emollient in our database. CAS number: 557-04-0.

What is the Margin of Safety for Magnesium Stearate?

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 Magnesium Stearate?

The NOAEL (No Observed Adverse Effect Level) for Magnesium Stearate is 2500 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

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