Citric Acid Hydrate
INCI: CITRIC ACID
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
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.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Citric Acid Hydrate, relevant to systemic exposure and MoS calculations.
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.
Regulatory Flags
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.
Compliance Tools
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