Moderate Cosmetic Ingredient NOAEL Data

CI 45430

INCI: ACID RED 87

CAS Number
16423-68-0
Function
Colorant (red iodine-based xanthene dye)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted as FD&C Red No. 3; permanently listed for drugs and cosmetics; food use delisted effective Jan 2027

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 45430. 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 800 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 500 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral swine Subchronic 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 500 mg/kg bw/day oral gerbil Carcinogenicity COSMOS_DB
NOAEL 750 mg/kg bw/day oral gerbil Chronic COSMOS_DB

Expert Verdict

Iodine content raises thyroid disruption concern at systemic levels; FDA food use revocation signals regulatory scrutiny; patch testing recommended; E 127 purity criteria mandatory in EU

⚠️
Concern Level: Moderate

Regulatory Flags

colorant eu_children_restricted fda_food_additive

Frequently Asked Questions

Is CI 45430 safe in cosmetics?

Iodine content raises thyroid disruption concern at systemic levels; FDA food use revocation signals regulatory scrutiny; patch testing recommended; E 127 purity criteria mandatory in EU The EU classifies CI 45430 as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is CI 45430 allowed in the EU?

CI 45430 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 45430 do in cosmetics?

CI 45430 functions as: Colorant (red iodine-based xanthene dye). It is classified as a cosmetic ingredient in our database. CAS number: 16423-68-0.

What is the Margin of Safety for CI 45430?

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 CI 45430?

The NOAEL (No Observed Adverse Effect Level) for CI 45430 is 800 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check CI 45430 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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