Methotrexate

INCI: METHOTREXATE

CAS Number
59-05-2
Function
Antimetabolite / cytotoxic agent (pharmaceutical - NOT a cosmetic function)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Prohibited - classified as a prescription drug (antineoplastic/immunosuppressant); its presence in any cosmetic product would render it an adulterated/misbranded drug under the FD&C Act

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.

Expert Verdict

Severe - cytotoxic, teratogenic (Category X), hepatotoxic, myelosuppressive, nephrotoxic. Causes bone marrow suppression, mucositis, and potentially fatal toxicity at therapeutic doses. Absolutely no legitimate cosmetic application.. A folic acid antagonist that inhibits dihydrofolate reductase (DHFR), blocking DNA/RNA synthesis. Its appearance on this list should raise an immediate red flag - any product claiming to contain methotrexate as a "cosmetic" ingredient is either mislabeled, adulte...

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Concern Level: High

Regulatory Flags

prop65 eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Methotrexate safe in cosmetics?

Severe - cytotoxic, teratogenic (Category X), hepatotoxic, myelosuppressive, nephrotoxic. Causes bone marrow suppression, mucositis, and potentially fatal toxicity at therapeutic doses. Absolutely no legitimate cosmetic application.. A folic acid antagonist that inhibits dihydrofolate reductase (DHFR), blocking DNA/RNA synthesis. Its appearance on this list should raise an immediate red flag - any product claiming to contain methotrexate as a "cosmetic" ingredient is either mislabeled, adulte... The EU classifies Methotrexate as "prohibited". Safety rating: MODERATE.

Is Methotrexate allowed in the EU?

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

What does Methotrexate do in cosmetics?

Methotrexate functions as: Antimetabolite / cytotoxic agent (pharmaceutical - NOT a cosmetic function). It is classified as a cosmetic ingredient in our database. CAS number: 59-05-2.

What is the Margin of Safety for Methotrexate?

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.

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