Moderate Cosmetic Ingredient NOAEL Data

CI 71105

CAS Number
4424-06-0
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Not listed as an FDA-certified or FDA-exempt color additive for cosmetic use in the US; no D&C or FD&C designation found in FDA color additive database; EU-permitted colorant (Annex IV; EINECS 224-597-4); not for use in eye or mucous membrane area

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for CI 71105. 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 >=1000 mg/kg bw/day oral rat oral REACH

Expert Verdict

EU-restricted orange vat dye (CI 71105; Vat Orange 7; Pigment Orange 43; CAS 4424-06-0) regulated under Annex IV with concentration limits; prohibited for US cosmetic use as it lacks FDA color additive approval; not permitted in eye or mucous membrane areas.

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Concern Level: Moderate

Regulatory Flags

not-fda-approved vat-dye not-for-eye-area not-for-mucous-membranes regulatory-verification-needed

Frequently Asked Questions

Is CI 71105 safe in cosmetics?

EU-restricted orange vat dye (CI 71105; Vat Orange 7; Pigment Orange 43; CAS 4424-06-0) regulated under Annex IV with concentration limits; prohibited for US cosmetic use as it lacks FDA color additive approval; not permitted in eye or mucous membrane areas. The EU classifies CI 71105 as "restricted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is CI 71105 allowed in the EU?

CI 71105 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 71105 do in cosmetics?

CI 71105 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 4424-06-0.

What is the Margin of Safety for CI 71105?

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 71105?

The NOAEL (No Observed Adverse Effect Level) for CI 71105 is >=1000 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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