HC Orange No. 1 (CAS 54381-08-7) is a cosmetic cosmetic ingredient functioning as Hair dyeing — semi-permanent direct dye (orange). Reported NOAEL =0.024 mg/kg bw in rat (SCCS Opinion); EU Regulation 1223/2009 status: prohibited, max 1.0%; 1 safety opinion reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
US NotesPermitted under coal-tar hair dye exemption; CIR concluded safe at ≤3.0%
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for HC Orange No. 1.
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Toxicological Studies
10 study endpoints 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
NOAEL
=0.024 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.024 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.024 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.024 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=25 mg/kg bw/d
-
-
carcinogenicity
SCCS Opinion
NOAEL
=25 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=25 mg/kg bw/d
-
-
carcinogenicity
SCCS Opinion
NOAEL
=25 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=25 mg/kg bw/d
-
-
carcinogenicity
SCCS Opinion
NOAEL
=25 mg/kg bw
oral
rat
dermal absorption
SCCS Opinion
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety Assessment
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
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (III - Restricted)
Product type: Hair day substance in non-oxidative hair dye products. Max: 0.01.
BRIN Brazil/India Cosmetics
India: Restricted · max 0.01
Additional Jurisdictional Restrictions (1)
Jurisdiction
Status
Max %
Product Type
CN
permitted_hair_dye
1
Non-oxidative hair dye
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured_sccs_opinion
1.03%
-
-
SCCP/1164/08
Additional Ingredient Properties
2 property records from structured ingredient metadata.
HC Orange No. 1 has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by CIR Safety Assessment.
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 NOAEL for HC Orange No. 1?
The NOAEL (No Observed Adverse Effect Level) for HC Orange No. 1 is =0.024 mg/kg bw based on a dermal absorption study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is HC Orange No. 1 used outside cosmetics?
HC Orange No. 1 also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does HC Orange No. 1 have different safety status in cosmetics vs industrial chemicals?
HC Orange No. 1 is prohibited in EU cosmetics at max 1.0% but has active industrial GHS classifications (H312, H315, H319, H332, H335, H400, H411).
Compliance Tools
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