Excellent Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Calcium Gluconate

INCI: CALCIUM GLUCONATE

CAS Number
299-28-5
Function
Chelating agent, Skin conditioning agent
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA GRAS under 21 CFR 184.1199 as food additive (firming agent, sequestrant, texturizer). Also used as inactive ingredient in approved drug products. No sunscreen classification; no cosmetic restrictions apply.

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

2 study endpoints found for Calcium Gluconate. 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
dose_tested 400 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.

Hazard Statements
No hazard classification according to GHS criteria

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: unknown

Expert Verdict

Calcium Gluconate (CAS 299-28-5) is unrestricted in the EU under Regulation (EC) No 1223/2009 and FDA GRAS in the US under 21 CFR 184.1199. CIR Panel (2014) determined it safe as used in cosmetics. Functions as a chelating and skin conditioning agent with negligible dermal absorption and no sensitization concerns.

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Concern Level: None

Regulatory Flags

gras cir-safe eu-unrestricted cosmos-eligible low-absorption chelating-agent no-sccs-opinion-needed epa_safer_alternative fda_food_additive jecfa_safe

Frequently Asked Questions

Is Calcium Gluconate safe in cosmetics?

Calcium Gluconate (CAS 299-28-5) is unrestricted in the EU under Regulation (EC) No 1223/2009 and FDA GRAS in the US under 21 CFR 184.1199. CIR Panel (2014) determined it safe as used in cosmetics. Functions as a chelating and skin conditioning agent with negligible dermal absorption and no sensitization concerns. The EU classifies Calcium Gluconate as "permitted". Safety rating: EXCELLENT. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Calcium Gluconate allowed in the EU?

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

What does Calcium Gluconate do in cosmetics?

Calcium Gluconate functions as: Chelating agent, Skin conditioning agent. It is classified as a cosmetic ingredient in our database. CAS number: 299-28-5.

What is the Margin of Safety for Calcium Gluconate?

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 Gluconate?

The NOAEL (No Observed Adverse Effect Level) for Calcium Gluconate is 400 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

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