Good Cosmetic Ingredient NOAEL Data

Pigment Red 63:1

INCI: CI 15880:1

CAS Number
6417-83-0
Function
Colorant (calcium azo lake pigment)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes D&C Red No. 34 โ€” external use only (no lips, no eye area)

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

2 study endpoints found for Pigment Red 63:1. 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 >=0.3 other oral rat oral REACH
NOAEL >=0.3 other oral - oral REACH

Expert Verdict

US restricts to external use only; prohibited in lip and eye products. EU permits broader use. Dual-market formulations must follow the more restrictive FDA rule.

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Concern Level: Low

Regulatory Flags

colorant eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Pigment Red 63:1 safe in cosmetics?

US restricts to external use only; prohibited in lip and eye products. EU permits broader use. Dual-market formulations must follow the more restrictive FDA rule. The EU classifies Pigment Red 63:1 as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Pigment Red 63:1 allowed in the EU?

Pigment Red 63:1 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Pigment Red 63:1 do in cosmetics?

Pigment Red 63:1 functions as: Colorant (calcium azo lake pigment). It is classified as a cosmetic ingredient in our database. CAS number: 6417-83-0.

What is the Margin of Safety for Pigment Red 63:1?

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 Pigment Red 63:1?

The NOAEL (No Observed Adverse Effect Level) for Pigment Red 63:1 is >=0.3 other based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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