Poor Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Basic Brown 16

INCI: BASIC BROWN 16

CAS Number
26381-41-9
Function
Hair colorant (direct, non-oxidative azo dye)
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Coal tar hair dye exemption applies with required labeling

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Basic Brown 16. 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 50 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 150 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 33 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 33 mg/kg bw/day oral rat subchronic SCCS_PDF_extraction
NOAEL 59 mg/kg bw/day oral - reproductive SCCS_PDF_extraction
NOAEL 0.095 mg/kg bw/day oral rat subchronic SCCS_PDF_extraction
NOAEL 50 mg/kg bw/day oral rat subchronic SCCS_PDF_extraction
NOAEL 59 mg/kg bw/day - - - SCCS_PDF_extraction

Safety Opinions

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

sccs SCCS/1684/25 2 February 2026
Verdict: unknown
NOAEL: 33 mg/kg bw/day (oral)
sccs SCCS/1684/25 2 February 2026
Verdict: unknown
NOAEL: 59 mg/kg bw/d (oral)

Sensitization Profile

Contact sensitization data for Basic Brown 16 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

Mutagenic with positive in vitro bacterial gene mutation and mammalian cell assays; contains azo bond with potential aromatic amine release; eye irritant; oral LD50 2-4 g/kg bw.

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Concern Level: High

Regulatory Flags

colorant

Frequently Asked Questions

Is Basic Brown 16 safe in cosmetics?

Mutagenic with positive in vitro bacterial gene mutation and mammalian cell assays; contains azo bond with potential aromatic amine release; eye irritant; oral LD50 2-4 g/kg bw. The EU classifies Basic Brown 16 as "prohibited". Safety rating: POOR. 8 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Basic Brown 16 allowed in the EU?

Basic Brown 16 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Brown 16 do in cosmetics?

Basic Brown 16 functions as: Hair colorant (direct, non-oxidative azo dye). It is classified as a cosmetic ingredient in our database. CAS number: 26381-41-9.

What is the Margin of Safety for Basic Brown 16?

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 Basic Brown 16?

The NOAEL (No Observed Adverse Effect Level) for Basic Brown 16 is 50 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

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