Moderate Cosmetic Ingredient NOAEL Data

Acid Red 27 (Amaranth)

INCI: CI 16185

CAS Number
915-67-3
Function
Cosmetic colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Banned - FD&C Red No. 2 was banned by FDA in 1976 due to carcinogenicity concerns

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Acid Red 27 (Amaranth). 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 47 mg/kg bw/day oral rat oral REACH
NOAEL 0.1 other dermal code:3543 dermal REACH
NOAEL 1260 mg/kg bw/day oral rat oral REACH
NOAEL 50 mg/kg bw/day oral mouse oral REACH
NOAEL 2462 mg/kg bw/day oral rat oral REACH

Expert Verdict

Banned in the US; EFSA found not genotoxic or carcinogenic but lowered ADI significantly due to reproductive toxicity at high doses; high-exposure consumers could exceed ADI

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Concern Level: High

Regulatory Flags

colorant eu_banned_cosmetics eu_children_restricted fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Acid Red 27 (Amaranth) safe in cosmetics?

Banned in the US; EFSA found not genotoxic or carcinogenic but lowered ADI significantly due to reproductive toxicity at high doses; high-exposure consumers could exceed ADI The EU classifies Acid Red 27 (Amaranth) as "permitted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.

Is Acid Red 27 (Amaranth) allowed in the EU?

Acid Red 27 (Amaranth) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Red 27 (Amaranth) do in cosmetics?

Acid Red 27 (Amaranth) functions as: Cosmetic colorant. It is classified as a cosmetic ingredient in our database. CAS number: 915-67-3.

What is the Margin of Safety for Acid Red 27 (Amaranth)?

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 Acid Red 27 (Amaranth)?

The NOAEL (No Observed Adverse Effect Level) for Acid Red 27 (Amaranth) is 47 mg/kg bw/day based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.

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