Poor Active Ingredient NOAEL Data SCCS/CIR Reviewed

Coal Tar

INCI: COAL TAR

CAS Number
8007-45-2
Function
Anti-dandruff active; antipruritic; antiproliferative
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
EU Max Conc. 0%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA OTC Monograph M032: 0.5โ€“5% for dandruff, seborrheic dermatitis, and psoriasis; mandatory warning labels required; 1.8% solution may combine with 1.5% menthol

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Coal Tar. 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 0.5 other oral mouse oral REACH
NOAEL 0.5 other oral - oral REACH
NOAEL 0.5 other oral mouse oral REACH
NOAEL 0.5 other oral mouse oral REACH
NOAEL 0.5 other oral - oral REACH
NOAEL 0.5 other oral mouse oral REACH

Safety Opinions

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

cir
Verdict: unknown
NOAEL: 0.1 % (LOAEL-oral)

Expert Verdict

IARC Group 1 known human carcinogen. Banned in EU cosmetics under Annex II. FDA OTC Monograph M032 permits 0.5โ€“5% with mandatory warning labels for severe dandruff, seborrheic dermatitis, and psoriasis. Use only where medically justified in US OTC context; avoid in EU markets entirely.

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Concern Level: High

Regulatory Flags

eu-banned iarc-group-1 known-carcinogen otc-drug-us mandatory-warning eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Coal Tar safe in cosmetics?

IARC Group 1 known human carcinogen. Banned in EU cosmetics under Annex II. FDA OTC Monograph M032 permits 0.5โ€“5% with mandatory warning labels for severe dandruff, seborrheic dermatitis, and psoriasis. Use only where medically justified in US OTC context; avoid in EU markets entirely. The EU classifies Coal Tar as "prohibited". Safety rating: POOR. 6 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Coal Tar allowed in the EU?

Coal Tar EU regulatory status: prohibited. Maximum allowed concentration: 0%. This is based on EU Regulation 1223/2009 and its amendments.

What does Coal Tar do in cosmetics?

Coal Tar functions as: Anti-dandruff active; antipruritic; antiproliferative. It is classified as a Active Ingredient in our database. CAS number: 8007-45-2.

What is the Margin of Safety for Coal Tar?

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 Coal Tar?

The NOAEL (No Observed Adverse Effect Level) for Coal Tar is 0.5 other based on a oral study via oral route in mouse. A total of 6 study endpoints are available. Source: REACH.

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