What is the NOAEL for Methotrexate?
Methotrexate has 26 NOAEL studies in the database. The lowest reported value is developmental listing type. Source: California Proposition 65.
NOAEL Data
IARC Group 3
Prop 65
Cosmetic Ingredient
Methotrexate
Also known as: MTX, (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]methylamino]benzoyl]amino]pentanedioic acid, CL 14377, Caditrex, EMT 25299 (+15 more)
CAS 59-05-2
Methotrexate (CAS 59-05-2) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: California Proposition 65, 7 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, IARC, CA Prop 65.
Cross-Vertical Regulatory Divergence
Methotrexate is prohibited in EU cosmetics but has active industrial GHS classifications (H301, H315, H319, H340, H360).
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
SOURCE
noael studies public
NOAEL studies
26
SOURCE
chemical inventory jurisdictions
Regulatory lists
7
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
26 fields
Name
Methotrexate
CAS Number
59-05-2
DTXSID
DTXSID4020822
Molecular Formula
C20H22N8O5
InChI Key
FBOZXECLQNJBKD-ZDUSSCGKSA-N
Monoisotopic Mass
454.171316
Synonyms
MTX(2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]methylamino]benzoyl]amino]pentanedioic acidCL 14377CaditrexEMT 25299EmtexateEmthexate PFEmtrexateFolexFolex PFSFolitraxMerex
IARC Carcinogen Classification
Carcinogenic hazard classification from IARC monograph evaluations.
SOURCE
IARC Monographs on the Identification of Carcinogenic Hazards to Humans
1 records
| Group | Meaning | Evaluated | Volume |
|---|---|---|---|
| Group 3 | Not classifiable | 1987 | 26, Sup 7 |
California Proposition 65
California OEHHA listing status and toxicity category.
SOURCE
California OEHHA Proposition 65 List
1 records
| Chemical | Toxicity Type | Cancer | Developmental | Listed |
|---|---|---|---|---|
| - | developmental | No | Yes | - |
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
1 records
No specific technical function
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
7 records
| List | Keyword | Source |
|---|---|---|
| Canada; consumer_product; Substances in Products - Canada (4/2014) | Government of Canada | CPCat |
| pharmaceutical | US International Trade Commission | CPCat |
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| OEHHA Proposition 65 (3/2019) | STATE OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY | OEHHA Proposition 65 List |
| Canada; pharmaceutical | DrugBank | DrugBank |
| OEHHA Proposition 65 (1/2023) | California Office of Environmental Health Hazard Assessment | OEHHA Proposition 65 List |
| banned; Europe; Personal care | European Commission | CosIng |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 26 of 26 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| - | uL/min/10^6 cells | Clint | - | Human | NTP_ICE_adme_parameters |
| YL5FZ2Y5U1 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| YL5FZ2Y5U1 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| YL5FZ2Y5U1 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| YL5FZ2Y5U1 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0.432 | fraction | Fu | - | Human | NTP_ICE_adme_parameters |
| 3 | IARC group | IARC carcinogenicity classification | - | - | IARC Monographs |
| 3 | unitless | IARC group | - | - | NTP_ICE_cancer |
| >135 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| =180 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| <225 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| =0.4 | mg/L | LOEL | environmental | Rat | ToxValDB_ECOTOX |
| =0.8 | mg/L | LOEL | environmental | Rat | ToxValDB_ECOTOX |
| - | unitless | Model Score | - | - | NTP_ICE_endocrine |
| =0.012 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.02 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.025 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.055 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.075 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.1 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.12 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
| =0.15 | mg/L | NOEC | environmental | Rat | ToxValDB_ECOTOX |
Showing 26 of 26 studies
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
prohibited
Max
-
Category
Cosmetic Ingredient
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
METHOTREXATE
ChEMBL Phase
4
Adverse Events
2431
Bioactivity
49
Frequently Asked Questions
What regulatory lists include Methotrexate?
Methotrexate appears on 6 regulatory/inventory lists including Canada; consumer_product; Substances in Products - Canada (4/2014), pharmaceutical, OEHHA Proposition 65 (3/2019), and 3 more. Source: EPA CPDat.
Is Methotrexate a carcinogen according to IARC?
Methotrexate is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1987). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.
Is Methotrexate on the California Proposition 65 list?
Yes, Methotrexate is listed under California Proposition 65 for developmental. Source: California OEHHA Proposition 65.
Is Methotrexate used in cosmetics?
Yes, Methotrexate is also indexed as a cosmetic ingredient under the name Methotrexate. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Methotrexate come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, IARC Monographs, California Proposition 65, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does Methotrexate have different safety status in cosmetics vs industrial chemicals?
Methotrexate is prohibited in EU cosmetics but has active industrial GHS classifications (H301, H315, H319, H340, H360).
Is Methotrexate used outside industrial chemicals?
Methotrexate also appears in cosmetics, pharmaceutical databases.