Good Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

HC Blue No. 2

INCI: HC BLUE NO. 2

CAS Number
33229-34-4
Function
Hair dyeing - nitroaminophenol-type semi-permanent direct dye
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 2.8%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted under coal tar hair dye exemption (21 CFR 740.2). Listed in FDA VCRP database.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for HC Blue No. 2. 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 300 mg/kg bw/day oral rat oral REACH

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir York 0 1994
Verdict: unknown

Sensitization Profile

Contact sensitization data for HC Blue No. 2 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: IVDK; NACDG; ESSCA

Expert Verdict

Must not be used with nitrosating agents due to risk of nitrosamine formation. Rigorous nitrosamine testing mandated by SCCS. Max purity specifications and standard Annex III warnings required.

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Concern Level: Moderate

Regulatory Flags

eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is HC Blue No. 2 safe in cosmetics?

Must not be used with nitrosating agents due to risk of nitrosamine formation. Rigorous nitrosamine testing mandated by SCCS. Max purity specifications and standard Annex III warnings required. The EU classifies HC Blue No. 2 as "restricted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is HC Blue No. 2 allowed in the EU?

HC Blue No. 2 EU regulatory status: restricted. Maximum allowed concentration: 2.8%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Blue No. 2 do in cosmetics?

HC Blue No. 2 functions as: Hair dyeing - nitroaminophenol-type semi-permanent direct dye. It is classified as a cosmetic ingredient in our database. CAS number: 33229-34-4.

What is the Margin of Safety for HC Blue No. 2?

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 HC Blue No. 2?

The NOAEL (No Observed Adverse Effect Level) for HC Blue No. 2 is 300 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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