Moderate Cosmetic Ingredient NOAEL Data Sensitization Data

HC Red No. 13

INCI: HC RED NO. 13

CAS Number
94158-13-1
Function
Hair dyeing - semi-permanent direct dye providing red to reddish-brown tones
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Allowed under the coal tar hair dye exemption. Must bear the statutory caution labeling and patch-test instructions.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for HC Red No. 13. 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 75 mg/kg bw/day oral rat Subchronic COSMOS_DB

Sensitization Profile

Contact sensitization data for HC Red No. 13 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

Potential skin sensitizer. As a nitroaniline derivative, it carries the standard concern for nitrosamine formation and should not be combined with nitrosating systems. Purity specifications require control of impurities.. Bis-hydroxyethyl amino group improves aqueous solubility and hair fiber affinity. Supplied commercially by specialty dye manufacturers such as DKSH.

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Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is HC Red No. 13 safe in cosmetics?

Potential skin sensitizer. As a nitroaniline derivative, it carries the standard concern for nitrosamine formation and should not be combined with nitrosating systems. Purity specifications require control of impurities.. Bis-hydroxyethyl amino group improves aqueous solubility and hair fiber affinity. Supplied commercially by specialty dye manufacturers such as DKSH. The EU classifies HC Red No. 13 as "restricted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is HC Red No. 13 allowed in the EU?

HC Red No. 13 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Red No. 13 do in cosmetics?

HC Red No. 13 functions as: Hair dyeing - semi-permanent direct dye providing red to reddish-brown tones. It is classified as a cosmetic ingredient in our database. CAS number: 94158-13-1.

What is the Margin of Safety for HC Red No. 13?

not established 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 Red No. 13?

The NOAEL (No Observed Adverse Effect Level) for HC Red No. 13 is 75 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

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