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 CI 19140 (Tartrazine). 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 | 750 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 2641 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 984 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
Expert Verdict
CI 19140 (Tartrazine, CAS 1934-21-0) is authorized in the EU as a colorant in Annex IV Part 1 and permitted in all cosmetic product types including eye area; as a hair dye ingredient (Annex III) the maximum concentration is 0.5%. In the US, it is permanently listed as FD&C Yellow No. 5 with batch certification required and is approved for cosmetics including eye area. Negligible dermal absorption (0.26%) and absence of contact sensitization support safety at authorized concentrations.
Regulatory Flags
Frequently Asked Questions
Is CI 19140 (Tartrazine) safe in cosmetics?
CI 19140 (Tartrazine, CAS 1934-21-0) is authorized in the EU as a colorant in Annex IV Part 1 and permitted in all cosmetic product types including eye area; as a hair dye ingredient (Annex III) the maximum concentration is 0.5%. In the US, it is permanently listed as FD&C Yellow No. 5 with batch certification required and is approved for cosmetics including eye area. Negligible dermal absorption (0.26%) and absence of contact sensitization support safety at authorized concentrations. The EU classifies CI 19140 (Tartrazine) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is CI 19140 (Tartrazine) allowed in the EU?
CI 19140 (Tartrazine) EU regulatory status: permitted. Maximum allowed concentration: 0.5% (hair dye use). This is based on EU Regulation 1223/2009 and its amendments.
What does CI 19140 (Tartrazine) do in cosmetics?
CI 19140 (Tartrazine) functions as: Colorant, Hair Dyeing Agent. It is classified as a Colorant in our database. CAS number: 1934-21-0.
What is the Margin of Safety for CI 19140 (Tartrazine)?
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 CI 19140 (Tartrazine)?
The NOAEL (No Observed Adverse Effect Level) for CI 19140 (Tartrazine) is 750 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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