NOAEL Data Cosmetic Ingredient

Methylene blue

Also known as: D and C Blue No. 1, D And C Blue Number 1, C.I. Basic Blue 9, M-B Tabs, Aizen Methylene Blue BH (+15 more)

CAS 61-73-4

Methylene blue (CAS 61-73-4) is a chemical substance. Key regulatory status: 8 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat.

View cosmetic safety profile for Basic Blue 9 (Methylene Blue) →

SOURCE noael studies public
NOAEL studies
34
SOURCE chemical inventory jurisdictions
Regulatory lists
8
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
Methylene blue
CAS Number
61-73-4
DTXSID
DTXSID0023296
Molecular Formula
C16H18N3S.ClH
InChI Key
CXKWCBBOMKCUKX-UHFFFAOYSA-M
Monoisotopic Mass
320.098821
Synonyms
D and C Blue No. 1D And C Blue Number 1C.I. Basic Blue 9M-B TabsAizen Methylene Blue BHAizen Methylene Blue FZCalcozine Blue ZFCaswell No. 567Ceruleum methylenumCI Basic Blue 9EINECS 200-515-2EPA Pesticide Chemical Code 039505

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 2 records
Dye

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 8 records
ListKeywordSource
inert_ingredient; non_food_use; PesticidesEPACPCat
CEDIFDAUnited States Food and Drug Administration (FDA)
Indirect additives food contact (10/2018)FDAUnited States Food and Drug Administration (FDA)
Canada; pharmaceuticalDrugBankDrugBank
Canada; pharmaceuticalDrugBankDrugBank
pharmaceuticalUS International Trade CommissionCPCat
active_ingredient; Europe; PesticidesCommission of the European CommunitiesCPCat
banned; Europe; Personal careEuropean CommissionCosIng

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 34 of 34 studies
ValueUnitEndpointRouteSpeciesSource
18.5295744813443uMAC50--NTP_ICE_endocrine
48.3519738192217uMAC50--NTP_ICE_endocrine
6.790072082uMACC--NTP_ICE_endocrine
17.5220106521944uMACC--NTP_ICE_endocrine
13.9uL/min/10^6 cellsClint-HumanNTP_ICE_adme_parameters
8NAP7826UBUNIIFDA UNII substance identifier--openFDA substances
8NAP7826UBUNIIFDA UNII substance identifier--openFDA substances
8NAP7826UBUNIIFDA UNII substance identifier--openFDA substances
8NAP7826UBUNIIFDA UNII substance identifier--openFDA substances
0.38fractionFu-HumanNTP_ICE_adme_parameters
=1180mg/kg bwLD50oralRatNTP_ICE_acute_oral
>=0.25mg/kg bw/dayLELinjectionDogToxValDB_ECHA_IUCLID
>=0.5mg/kg bw/dayLELinjectionDogToxValDB_ECHA_IUCLID
=1mg/kg bw/dayLELinjectionDogToxValDB_ECHA_IUCLID
>=25mg/kg bw/dayLELoralRatToxValDB_ECHA_IUCLID
>=50mg/kg bw/dayLELoralRatToxValDB_ECHA_IUCLID
>=100mg/kg bw/dayLELoralRatToxValDB_ECHA_IUCLID
=200mg/kg bw/dayLELoralRatToxValDB_ECHA_IUCLID
-unitlessModel Score--NTP_ICE_endocrine
0.00154unitlessModel Score--NTP_ICE_endocrine
0.0591unitlessModel Score--NTP_ICE_endocrine
0.237unitlessModel Score--NTP_ICE_endocrine
<=1mg/kg bw/dayNOELintravenousdog (Beagle; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=1mg/kg bw/dayNOELintravenousdog (Beagle; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=1mg/kg bw/dayNOELintravenousdog (Beagle; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=1mg/kg bw/dayNOELintravenousdog (Beagle; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=50mg/kg bw/dayNOEL2207mouse (B6C3F1; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=50mg/kg bw/dayNOEL2207mouse (B6C3F1; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=50mg/kg bw/dayNOEL2207mouse (B6C3F1; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=50mg/kg bw/dayNOEL2207mouse (B6C3F1; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=350mg/kg bw/dayNOELoral: gavagerat (Sprague-Dawley; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=350mg/kg bw/dayNOELoral: gavagerat (Sprague-Dawley; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=350mg/kg bw/dayNOELoral: gavagerat (Sprague-Dawley; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z
<=350mg/kg bw/dayNOELoral: gavagerat (Sprague-Dawley; male/female)FDA_Toxicity_9dca54be-d7e9-4fbd-aac8-155d2777da95_dossier.i6z

Showing 34 of 34 studies

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Colorant
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE EMBL-EBI ChEMBL METHYLENE BLUE ANHYDROUS
ChEMBL Phase
4
Adverse Events
23
Bioactivity
17
View full pharmaceutical profile →

Frequently Asked Questions

What is the NOAEL for Methylene blue?

Methylene blue has 34 NOAEL studies in the database. The lowest reported value is 0.25 mg/kg bw/day via injection in Dog. Source: ToxValDB_ECHA_IUCLID.

What regulatory lists include Methylene blue?

Methylene blue appears on 7 regulatory/inventory lists including inert_ingredient; non_food_use; Pesticides, CEDI, Indirect additives food contact (10/2018), and 4 more. Source: EPA CPDat.

Is Methylene blue used in cosmetics?

Yes, Methylene blue is also indexed as a cosmetic ingredient under the name Basic Blue 9 (Methylene Blue). 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 Methylene blue come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.

Is Methylene blue used outside industrial chemicals?

Methylene blue also appears in cosmetics, pharmaceutical databases.