Moderate Cosmetic Ingredient Sensitization Data

HC Blue No. 11

INCI: HC BLUE NO. 11

CAS Number
910463-51-3
Function
Hair dyeing (direct/semi-permanent nitro dye)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
EU Max Conc. 3.0%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted under coal tar hair dye exemption (21 CFR 740.17)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for HC Blue No. 11 based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: SCCS; IVDK

Expert Verdict

N-Nitrosodiethanolamine (NDELA) impurity must be <50 ppb; classified as carcinogen under EU regulations; mandatory allergy warning label required.

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Concern Level: High

Frequently Asked Questions

Is HC Blue No. 11 safe in cosmetics?

N-Nitrosodiethanolamine (NDELA) impurity must be <50 ppb; classified as carcinogen under EU regulations; mandatory allergy warning label required. The EU classifies HC Blue No. 11 as "prohibited". Safety rating: MODERATE.

Is HC Blue No. 11 allowed in the EU?

HC Blue No. 11 EU regulatory status: prohibited. Maximum allowed concentration: 3.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Blue No. 11 do in cosmetics?

HC Blue No. 11 functions as: Hair dyeing (direct/semi-permanent nitro dye). It is classified as a cosmetic ingredient in our database. CAS number: 910463-51-3.

What is the Margin of Safety for HC Blue No. 11?

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.

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