Is Tranexamic Acid safe in cosmetics?
Tranexamic Acid has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Tranexamic Acid
Also known as: trans Amcha, 3-14-00-00868, trans-1-Aminomethylcyclohexane-4-carboxylic acid, trans-4-Aminomethylcyclohexane-1-carboxylic acid, BRN 2207452 (+15 more)
INCI: TRANEXAMIC ACID
Tranexamic Acid (CAS 1197-18-8) is a cosmetic active ingredient functioning as Plasmin pathway inhibitor; synthetic lysine analogue that inhibits. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Function
Plasmin pathway inhibitor; synthetic lysine analogue that inhibits plasminogen/plasmin activation in keratinocytes, reducing UV-induced PGE2 and arachidonic acid release that would otherwise upregulate MITF-driven melanogenesis; brightening via indirect upstream mechanism rather than direct tyrosinase suppression
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No FDA restriction for topical cosmetic use at typical 2–5% brightening concentrations. Oral TXA is an FDA-approved prescription drug (Lysteda) for heavy menstrual bleeding — systemic risk profile of oral/IV does NOT apply to topical cosmetic use. Claim strategy critical: structural brightening claims are acceptable; physiological depigmentation claims risk FDA drug classification.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Tranexamic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Tranexamic Acid, relevant to systemic exposure and MoS calculations.
Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
157.2 Da
Log P
-2.2
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: J Cosmet Dermatol 2020
EPA ToxValDB — Toxicity Values
1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >10000 mg/kg | Mouse | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Serum | 1–5 | 5 | Industry |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Astringent
Pharmaceutical
Softener and conditioner
Editorial summary
Preliminary editorial summary for Tranexamic Acid — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
brightening
melasma
pih
plasmin-pathway
pge2-inhibition
mitf-suppression
synergistic-niacinamide
non-tyrosinase-mechanism
quasi-drug-japan-2002
otc-oral-japan-2007
2025-rct-equivalent-oral-topical
niosomal-superior
outperforms-hq
hq-alternative
eu-not-listed
no-us-restriction
Known Synonyms
trans Amcha
3-14-00-00868
trans-1-Aminomethylcyclohexane-4-carboxylic acid
trans-4-Aminomethylcyclohexane-1-carboxylic acid
BRN 2207452
Carxamin
EINECS 214-818-2
Emorhalt
Frenolyse
Hexapromin
Hexatron
NSC 291305
Rikavarin
Rikavarin-S
Spiramin
Tranexamsaeure
Tranexan
Tranhexamic acid
Transamlon
Trasamlon
Chemical Function
Astringent
Softener and conditioner
Pharmaceutical
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
Canada; Personal care; Substances in PCP - Canada (4/2014)
active_ingredient; Australia
Canada; Personal care; Substances in PCP - Canada (4/2014)
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
Europe; pharmaceutical
Canada; pharmaceutical
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
TRANEXAMIC ACID
ChEMBL ID
CHEMBL877
Max Phase
4
Adverse Event Associations
1992
Frequently Asked Questions
Is Tranexamic Acid allowed in the EU?
Tranexamic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Tranexamic Acid do in cosmetics?
Tranexamic Acid functions as: Plasmin pathway inhibitor; synthetic lysine analogue that inhibits plasminogen/plasmin activation in keratinocytes, reducing UV-induced PGE2 and arachidonic acid release that would otherwise upregulate MITF-driven melanogenesis; brightening via indirect upstream mechanism rather than direct tyrosinase suppression. It is classified as a Active Ingredient in our database. CAS number: 1197-18-8.
Is Tranexamic Acid used outside cosmetics?
Tranexamic Acid also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Tranexamic Acid compliance across multiple jurisdictions:
Ingredient Decoder
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Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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TRACHELOSPERMUM JASMINOIDES EXTRACT
GOOD
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Skin Conditioning
TRAMETES VERSICOLOR EXTRACT
GOOD
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Hair Conditioning
TRANS, TRANS-2,4-DECADIENAL
GOOD
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Perfuming
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