Moderate Cosmetic Ingredient NOAEL Data

HC Orange No. 2

INCI: HC ORANGE NO. 2

CAS Number
85765-48-6
Function
Hair dyeing — semi-permanent direct dye (orange)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status permitted
US Notes Permitted under coal-tar hair dye exemption (FD&C Act §601(a))

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.

Toxicological Studies

1 study endpoint found for HC Orange 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
LOAEL 5 mg/kg bw/day oral rat Developmental COSMOS_DB

Expert Verdict

Nitroaromatic structure with Annex III concentration limits; mandatory labelling required with patch test advisory recommended on packaging.

⚠️
Concern Level: Moderate

Regulatory Flags

eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is HC Orange No. 2 safe in cosmetics?

Nitroaromatic structure with Annex III concentration limits; mandatory labelling required with patch test advisory recommended on packaging. The EU classifies HC Orange No. 2 as "restricted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is HC Orange No. 2 allowed in the EU?

HC Orange No. 2 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Orange No. 2 do in cosmetics?

HC Orange No. 2 functions as: Hair dyeing — semi-permanent direct dye (orange). It is classified as a cosmetic ingredient in our database. CAS number: 85765-48-6.

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

The NOAEL (No Observed Adverse Effect Level) for HC Orange No. 2 is 5 mg/kg bw/day based on a Developmental study via oral route in rat. Source: COSMOS_DB.

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