Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

HC Orange No. 1

INCI: HC ORANGE NO. 1

CAS Number
54381-08-7
Function
Hair dyeing — semi-permanent direct dye (orange)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status prohibited
EU Max Conc. 1.0%
🇺🇸 US Status permitted
US Notes Permitted under coal-tar hair dye exemption; CIR concluded safe at ≤3.0%

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

1 study endpoint found for HC Orange No. 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
LOAEL 2.5 mg/kg bw/day oral rat Subchronic COSMOS_DB

Safety Opinions

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

cir
Verdict: safe

d, the Expert Panel was reques- ted to consider a conclusion that this ingredient is safe for use in hair dyes at concentrations of at least 1% (Clairol 1996). In support of this position, the comment analyzed the possible human exposure levels that took into consideration the concentrati

Sensitization Profile

Contact sensitization data for HC Orange No. 1 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

GHS H312 (harmful in contact with skin), H315 (skin irritation); acute oral exposure produced little toxicity; sub-chronic feeding at 0.5% caused increased liver/kidney weights; no reproductive/developmental toxicity at ≤1.25%

⚠️
Concern Level: High

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is HC Orange No. 1 safe in cosmetics?

GHS H312 (harmful in contact with skin), H315 (skin irritation); acute oral exposure produced little toxicity; sub-chronic feeding at 0.5% caused increased liver/kidney weights; no reproductive/developmental toxicity at ≤1.25% The EU classifies HC Orange No. 1 as "prohibited". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is HC Orange No. 1 allowed in the EU?

HC Orange No. 1 EU regulatory status: prohibited. Maximum allowed concentration: 1.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Orange No. 1 do in cosmetics?

HC Orange No. 1 functions as: Hair dyeing — semi-permanent direct dye (orange). It is classified as a cosmetic ingredient in our database. CAS number: 54381-08-7.

What is the Margin of Safety for HC Orange No. 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 HC Orange No. 1?

The NOAEL (No Observed Adverse Effect Level) for HC Orange No. 1 is 2.5 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

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