Good Cosmetic Ingredient NOAEL Data GHS Classified

Calcium Bentonite

INCI: BENTONITE

CAS Number

1302-78-9

Function

Absorbent, Bulking Agent, Soothing, Viscosity Controlling

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes GRAS as direct food additive (21 CFR 184.1155). CIR Final Amended Report (March 2023) concluded safe except insufficient data for products that may be inhaled.

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

6 study endpoints found for Calcium 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

CIR safe (2023) with caution for inhaled products. GRAS approved. Dermal/oral LD50 >2,000 mg/kg. Heavy metal traces do not penetrate skin.

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Concern Level: Low

Regulatory Flags

epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Calcium Bentonite safe in cosmetics?

CIR safe (2023) with caution for inhaled products. GRAS approved. Dermal/oral LD50 >2,000 mg/kg. Heavy metal traces do not penetrate skin. The EU classifies Calcium Bentonite as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database.

Is Calcium Bentonite allowed in the EU?

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

What does Calcium Bentonite do in cosmetics?

Calcium Bentonite functions as: Absorbent, Bulking Agent, Soothing, Viscosity Controlling. It is classified as a cosmetic ingredient in our database. CAS number: 1302-78-9.

What is the Margin of Safety for Calcium Bentonite?

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 Calcium Bentonite?

The NOAEL (No Observed Adverse Effect Level) for Calcium 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 Calcium Bentonite classified as hazardous under GHS?

Calcium 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 Calcium 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

Compare limits across jurisdictions

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