Excellent Cosmetic Ingredient NOAEL Data GHS Classified Dermal Penetration

Citric Acid Hydrate

INCI: CITRIC ACID

CAS Number
5949-29-1
Function
pH adjuster, chelating agent, buffering
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Generally Recognized As Safe (GRAS) by FDA; widely used as food and cosmetic acidulant and pH adjuster

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

10 study endpoints found for Citric Acid Hydrate. 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 272 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 800 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 241 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 295 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 4670 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 600 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1380 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 425 mg/kg bw/day oral rabbit Developmental COSMOS_DB

GHS Hazard Classification

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

Short-term Exposure Effects
The aerosol is irritating to the eyes, skin and respiratory tract.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Citric Acid Hydrate, relevant to systemic exposure and MoS calculations.

Absorption %
3-6%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
192.1 Da
Log P
-1.72
Systemic Absorption
minimal
Topical Bioavailability
2-4%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: CIR

Expert Verdict

Citric acid monohydrate (CAS 5949-29-1) is a widely used pH adjuster and chelating agent with excellent safety. CIR Expert Panel assessed citric acid and citrate salts as safe in cosmetics (2014). FDA GRAS status confirmed. Naturally occurring metabolite in human metabolism with minimal systemic absorption at cosmetic use levels. Non-sensitizing and well-tolerated across all skin types.

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Concern Level: None

Regulatory Flags

ph-adjuster chelating-agent gras cir-assessed buffering low-hazard epa_safer_alternative

Frequently Asked Questions

Is Citric Acid Hydrate safe in cosmetics?

Citric acid monohydrate (CAS 5949-29-1) is a widely used pH adjuster and chelating agent with excellent safety. CIR Expert Panel assessed citric acid and citrate salts as safe in cosmetics (2014). FDA GRAS status confirmed. Naturally occurring metabolite in human metabolism with minimal systemic absorption at cosmetic use levels. Non-sensitizing and well-tolerated across all skin types. The EU classifies Citric Acid Hydrate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Citric Acid Hydrate allowed in the EU?

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

What does Citric Acid Hydrate do in cosmetics?

Citric Acid Hydrate functions as: pH adjuster, chelating agent, buffering. It is classified as a cosmetic ingredient in our database. CAS number: 5949-29-1.

What is the Margin of Safety for Citric Acid Hydrate?

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 Citric Acid Hydrate?

The NOAEL (No Observed Adverse Effect Level) for Citric Acid Hydrate is 272 mg/kg bw/day based on a Developmental study via oral route in hamster. A total of 10 study endpoints are available. Source: COSMOS_DB.

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