Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Basic Blue 99

INCI: BASIC BLUE 99

CAS Number
68123-13-7
Function
Hair colorant (naphthoquinoneimine dye), hair conditioning agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Coal tar hair dye exemption applies. CIR 2007: safe as a hair dye ingredient. Re-opened Dec 2022 due to composition variability concerns. Non-hair dye uses (nail polish) are unlawful without FDA color additive approval.

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

3 study endpoints found for Basic Blue 99. 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 37 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 60 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 125.8 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/1683/25 2 February 2026
Verdict: safe

for which a TTC approach would be applicable. The SCCS considers a purity of only 80 % to be too low for the safety evaluation of a synthetic compound, particularly when the test material shows marked differences from the batches used in toxicological studies. SCCS/1683/25 Final version Scientific Advice on

cir
Verdict: unknown

Sensitization Profile

Contact sensitization data for Basic Blue 99 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: IVDK; NACDG; ESSCA

Expert Verdict

Composition variability is the primary concern with approximately 63% pure dye content and remainder sugars/salts containing potentially 40+ isomeric forms. Weak mutagen in some in vitro assays but CIR concluded no carcinogenic potential at hair dye use levels. Negative 90-day oral, negative DART, negative sensitization/irritation studies.

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Concern Level: High

Regulatory Flags

potential-allergen colorant eu_children_restricted

Frequently Asked Questions

Is Basic Blue 99 safe in cosmetics?

Composition variability is the primary concern with approximately 63% pure dye content and remainder sugars/salts containing potentially 40+ isomeric forms. Weak mutagen in some in vitro assays but CIR concluded no carcinogenic potential at hair dye use levels. Negative 90-day oral, negative DART, negative sensitization/irritation studies. The EU classifies Basic Blue 99 as "prohibited". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs and cir.

Is Basic Blue 99 allowed in the EU?

Basic Blue 99 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Blue 99 do in cosmetics?

Basic Blue 99 functions as: Hair colorant (naphthoquinoneimine dye), hair conditioning agent. It is classified as a cosmetic ingredient in our database. CAS number: 68123-13-7.

What is the Margin of Safety for Basic Blue 99?

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 Blue 99?

The NOAEL (No Observed Adverse Effect Level) for Basic Blue 99 is 37 mg/kg bw/day based on a toxicological study via oral route in rat. A total of 3 study endpoints are available. Source: SCCS_PDF_extraction.

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