Excellent Cosmetic Ingredient NOAEL Data GHS Classified

Calcium Carbonate

INCI: CALCIUM CARBONATE

CAS Number
471-34-1
Function
Abrasive, Buffering, Bulking, Opacifying, Oral Care, Colorant
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Adequate (not required at typical use levels due to negligible absorption)

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

10 study endpoints found for Calcium Carbonate. 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 3000 mg/kg bw/day oral mouse Reproductive COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1015 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 9989 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1349 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 385 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 1015 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat oral REACH
NOAEL >1000 mg/kg bw/day oral - oral REACH
NOAEL >1000 mg/kg bw/day oral - oral REACH

GHS Hazard Classification

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

Hazard Statements
No hazard classification according to GHS criteria
Short-term Exposure Effects
May cause mechanical irritation to the respiratory tract and eyes.
Long-term Exposure Effects
Health effects of the substance have been investigated but none have been found

Expert Verdict

Must meet Annex IV purity criteria for heavy metals (As, Pb, Hg) when used as colorant

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Concern Level: Low

Regulatory Flags

colorant eu_children_restricted epa_safer_alternative fda_food_additive eu_cosing_listed jecfa_safe

Frequently Asked Questions

Is Calcium Carbonate safe in cosmetics?

Must meet Annex IV purity criteria for heavy metals (As, Pb, Hg) when used as colorant The EU classifies Calcium Carbonate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Calcium Carbonate allowed in the EU?

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

What does Calcium Carbonate do in cosmetics?

Calcium Carbonate functions as: Abrasive, Buffering, Bulking, Opacifying, Oral Care, Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 471-34-1.

What is the Margin of Safety for Calcium Carbonate?

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 Carbonate?

The NOAEL (No Observed Adverse Effect Level) for Calcium Carbonate is 3000 mg/kg bw/day based on a Reproductive study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS_DB.

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