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 Ferric Ammonium Citrate. 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 | 244 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 100 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 100 ppm | 1995 | rat | inhalation | REACH |
| NOAEL | 287 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| LOAEL | 1.4 2105 | 1992 | rabbit | inhalation | REACH |
| NOAEL | 0.5 other | oral | rat | oral | REACH |
| NOAEL | 197 ppm | 1995 | rat | inhalation | REACH |
| NOAEL | 98 mg/kg bw/day | other | rat | oral | REACH |
| NOAEL | 1200 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 595.9 mg/kg bw/day | oral | rat | oral | REACH |
Expert Verdict
Iron staining potential; FDA limits for specific drug applications (NTE 3% for suture use); may discolor formulations; confirm cosmetic-specific use is within supplier specifications
Regulatory Flags
Frequently Asked Questions
Is Ferric Ammonium Citrate safe in cosmetics?
Iron staining potential; FDA limits for specific drug applications (NTE 3% for suture use); may discolor formulations; confirm cosmetic-specific use is within supplier specifications The EU classifies Ferric Ammonium Citrate as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Ferric Ammonium Citrate allowed in the EU?
Ferric Ammonium Citrate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Ferric Ammonium Citrate do in cosmetics?
Ferric Ammonium Citrate functions as: Cosmetic colorant, Oral care agent. It is classified as a cosmetic ingredient in our database. CAS number: 1185-57-5.
What is the Margin of Safety for Ferric Ammonium Citrate?
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 Ferric Ammonium Citrate?
The NOAEL (No Observed Adverse Effect Level) for Ferric Ammonium Citrate is 244 mg/kg bw/day based on a dermal study via dermal route in code:3484. A total of 10 study endpoints are available. Source: REACH.
Compliance Tools
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