Good Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Basic Yellow 57

INCI: BASIC YELLOW 57

CAS Number
68391-31-1
Function
Hair dyeing (semi-permanent cationic dye)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel concluded safe for use as a hair dye at present practices of use and concentration

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 Basic Yellow 57. 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 100 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
NOAEL: 300 mg/kg bw/d (not specified)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 20 mg/kg bw/d (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 300 mg/kg/d (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 20 mg/kg (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 100 mg/kg bw/d (not specified)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

Sensitization Profile

Contact sensitization data for Basic Yellow 57 based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

Expert Verdict

No systemic toxicity concerns at current use levels; restricted under EU Annex III with concentration limits.

โš ๏ธ
Concern Level: Low

Regulatory Flags

eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is Basic Yellow 57 safe in cosmetics?

No systemic toxicity concerns at current use levels; restricted under EU Annex III with concentration limits. The EU classifies Basic Yellow 57 as "restricted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Basic Yellow 57 allowed in the EU?

Basic Yellow 57 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Yellow 57 do in cosmetics?

Basic Yellow 57 functions as: Hair dyeing (semi-permanent cationic dye). It is classified as a cosmetic ingredient in our database. CAS number: 68391-31-1.

What is the Margin of Safety for Basic Yellow 57?

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 Yellow 57?

The NOAEL (No Observed Adverse Effect Level) for Basic Yellow 57 is 100 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

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