Excellent Cosmetic Ingredient NOAEL Data GHS Classified

Bentonite

INCI: BENTONITE

CAS Number
1302-78-9
Function
rheology modifier, thickener, suspending agent, absorbent
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS affirmed under 21 CFR §184.1155 as a direct food substance (processing aid, cGMP limitation, no significant residue in food). Also listed under 21 CFR §582.1155 (GRAS for animal feed) and as an indirect food additive in 21 CFR §175.105, 175.300, 176.170, and 178.3297. Not approved as a color additive in the US. Permitted for non-colorant cosmetic functions under FDA's general cosmetic ingredient safety framework. Not specifically listed in FDA OTC monographs; related clay Kaolin is approved as a skin protectant at 4-20% under 21 CFR §347.10.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Bentonite. 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 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 75000 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral swine Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 400 mg/kg bw/day oral swine Short Term Toxicity COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

GHS Hazard Classification

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

Signal Word
DANGER
Pictograms
cancer;health haz
Hazard Statements
Causes damage to the lungs through prolonged or repeated exposure if inhaled
Short-term Exposure Effects
The substance is mildly irritating to the eyes and skin.
Long-term Exposure Effects
The substance may have effects on the lungs. This may result in fibrosis (see ICSC 0808).
Routes of Exposure
The substance can be absorbed into the body by inhalation.

Expert Verdict

Bentonite is a colloidal clay permitted for unrestricted use in EU cosmetics under Regulation (EC) No. 1223/2009 and listed as colorant CI 77004. The CIR Expert Panel concluded it is safe in cosmetics at present practices of use, except available data are insufficient for products that may be incidentally inhaled due to potential respirable crystalline silica impurities. SCCS confirmed low bioavailability with dermal absorption of 0.00192% and safety in non-sprayable products, with sprayable products safe when ≤20% of particles are <10 μm. GRAS under 21 CFR §184.1155 in the US.

⚠️
Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved sccs-opinion gras-fda natural-origin colorant nano-form epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Bentonite safe in cosmetics?

Bentonite is a colloidal clay permitted for unrestricted use in EU cosmetics under Regulation (EC) No. 1223/2009 and listed as colorant CI 77004. The CIR Expert Panel concluded it is safe in cosmetics at present practices of use, except available data are insufficient for products that may be incidentally inhaled due to potential respirable crystalline silica impurities. SCCS confirmed low bioavailability with dermal absorption of 0.00192% and safety in non-sprayable products, with sprayable products safe when ≤20% of particles are <10 μm. GRAS under 21 CFR §184.1155 in the US. The EU classifies Bentonite as "permitted". Safety rating: EXCELLENT. 6 toxicological study endpoint(s) are available in our database.

Is Bentonite allowed in the EU?

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

What does Bentonite do in cosmetics?

Bentonite functions as: rheology modifier, thickener, suspending agent, absorbent. It is classified as a cosmetic ingredient in our database. CAS number: 1302-78-9.

What is the Margin of Safety for Bentonite?

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 Bentonite?

The NOAEL (No Observed Adverse Effect Level) for Bentonite is 400 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 6 study endpoints are available. Source: COSMOS_DB.

Is Bentonite classified as hazardous under GHS?

Bentonite carries a GHS signal word of "DANGER". Hazard statements: Causes damage to the lungs through prolonged or repeated exposure if inhaled. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

Compliance Tools

Check Bentonite compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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