NOAEL Data REACH Registered Cosmetic Ingredient

Betaine

Also known as: 4-04-00-02369, BRN 3537113, (Carboxymethyl)trimethylammonium hydroxide, inner salt, EINECS 203-490-6, Jortaine (+15 more)

CAS 107-43-7

Betaine (CAS 107-43-7) is a chemical substance. Key regulatory status: REACH registered, 13 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, ECHA REACH.

View cosmetic safety profile for Betaine →

SOURCE noael studies public
NOAEL studies
56
SOURCE chemical inventory jurisdictions
Regulatory lists
13
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
Betaine
CAS Number
107-43-7
DTXSID
DTXSID8022666
Molecular Formula
C5H11NO2
InChI Key
KWIUHFFTVRNATP-UHFFFAOYSA-N
Monoisotopic Mass
117.078979
Synonyms
4-04-00-02369BRN 3537113(Carboxymethyl)trimethylammonium hydroxide, inner saltEINECS 203-490-6JortaineNSC 166511GlykokollbetainUNII-3SCV180C9WAcidin-PepsinNovobetaineHepastyl(trimethylammoniumyl)acetate

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 26 records
HumectantAnti-static agentSoftener and conditionerViscosity modifierProcessing aids not otherwise specifiedDispersing agentWetting agent (non-aqueous)Flavouring and nutrient

Regulatory Lists

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

SOURCE EPA CPDat 13 records
ListKeywordSource
pharmaceuticalFDAUnited States Food and Drug Administration (FDA)
active_ingredient; animal_products; Europe; pharmaceutical; residueEUCPCat
Europe; pharmaceuticalEuropean Medicines AgencyPROTECT ADR database
children; Europe; Personal careDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - body hygiene - body washDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - hair styling and care - shampooDanish Environmental Protection AgencyDanish EPA
Europe; Personal careDanish Environmental Protection AgencyDanish EPA
Europe; Personal careDanish Environmental Protection AgencyDanish EPA
Europe; Personal careDanish Environmental Protection AgencyDanish EPA
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
SCIL (9/2019)USEPASafer Chemical Ingredients List
Canada; pharmaceuticalDrugBankDrugBank
Canada; pharmaceuticalDrugBankDrugBank

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 50 of 56 studies
ValueUnitEndpointRouteSpeciesSource
=131mg/kg bw/dayBMDL (05)oralRatToxValDB_EFSA
3SCV180C9WUNIIFDA UNII substance identifier--openFDA substances
3SCV180C9WUNIIFDA UNII substance identifier--openFDA substances
3SCV180C9WUNIIFDA UNII substance identifier--openFDA substances
3SCV180C9WUNIIFDA UNII substance identifier--openFDA substances
>11148mg/kg bwLD50oralRatNTP_ICE_acute_oral
>11179mg/kg bwLD50oralRatNTP_ICE_acute_oral
>11204mg/kg bwLD50oralRatNTP_ICE_acute_oral
=4000mg/dayLELoralHumanToxValDB_EFSA
=10000mg/kg bw/dayLELoralPigToxValDB_EFSA
=5%NOAELoralratCIR_vision_codex
=5%NOAELoralratCIR_vision_codex
=5%NOAELoralratCIR_vision_codex
=5%NOAELoralratCIR_vision_codex
=20mg/kg/dNOAELoralratCIR_vision_codex
=20mg/kg/dNOAELoralratCIR_vision_codex
=20mg/kg/dNOAELoralratCIR_vision_codex
=20mg/kg/dNOAELoralratCIR_vision_codex
=40mg/kg/dNOAELoralratCIR_vision_codex
=40mg/kg/dNOAELoralratCIR_vision_codex
=40mg/kg/dNOAELoralratCIR_vision_codex
=40mg/kg/dNOAELoralratCIR_vision_codex
=50mg/kg bw/dNOAELoralratCIR_vision_codex
=50mg/kg bw/dNOAELoralratCIR_vision_codex
=50mg/kg bw/dNOAELoralratCIR_vision_codex
=50mg/kg bw/dNOAELoralratCIR_vision_codex
=100mg/kg bw/dNOAELoralratCIR_vision_codex
=100mg/kg bw/dNOAELoralratCIR_vision_codex
=100mg/kg bw/dNOAELoralratCIR_vision_codex
=100mg/kg bw/dNOAELoralratCIR_vision_codex
=150mg/kgNOAELoralratCIR_vision_codex
=150mg/kgNOAELoralratCIR_vision_codex
=150mg/kgNOAELoralratCIR_vision_codex
=150mg/kgNOAELoralratCIR_vision_codex
=250mg/kg/dNOAELoralratCIR_vision_codex
=250mg/kg/dNOAELoralratCIR_vision_codex
=250mg/kg/dNOAELoralratCIR_vision_codex
=250mg/kg/dNOAELoralratCIR_vision_codex
=300mg/kg/dNOAELoralratCIR_vision_codex
=300mg/kg/dNOAELoralratCIR_vision_codex
=300mg/kg/dNOAELoralratCIR_vision_codex
=300mg/kg/dNOAELoralratCIR_vision_codex
>5771mg/kg bw/dNOAELoralratCIR_vision_codex
>5771mg/kg bw/dNOAELoralratCIR_vision_codex
>5771mg/kg bw/dNOAELoralratCIR_vision_codex
>5771mg/kg bw/dNOAELoralratCIR_vision_codex
<1%NOELoralRatToxValDB_HESS
20mg/kg/ddevelopmental toxicityoralratUnifiedCodex:CIR:beta.noael_studies
40mg/kg/ddevelopmental toxicityoralratUnifiedCodex:CIR:beta.noael_studies
5%repeated dose toxicityoralratUnifiedCodex:CIR:beta.noael_studies

Showing 50 of 56 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records
StatusNameEC NumberLink
RegisteredBetaine203-490-6ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

Cosmetic Safety Profile

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

SOURCE CosIng / Ingredients DB
EU Status
permitted
Max
8.7% (rinse-off)
Category
humectant
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE EMBL-EBI ChEMBL GLYCINEBETAINE
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
0
View full pharmaceutical profile →

Food Safety Data

Same-CAS food additive, ADI, and GRAS records where available.

SOURCE EFSA / FDA GRAS 1 records

ADI: No safety concern at current levels of intake when used as a flavouring agent mg/kg bw

View full food safety profile →

Cannabis Data

Same-CAS cannabis compliance and lab records where available.

SOURCE Cannabis regulatory / lab data efsa substances

1 cannabis record found in efsa substances.

View full cannabis profile →

Frequently Asked Questions

What is the NOAEL for Betaine?

Betaine has 56 NOAEL studies in the database. The lowest reported value is 131 mg/kg bw/day via oral in Rat. Source: ToxValDB_EFSA.

What regulatory lists include Betaine?

Betaine appears on 10 regulatory/inventory lists including pharmaceutical, active_ingredient; animal_products; Europe; pharmaceutical; residue, Europe; pharmaceutical, and 7 more. Source: EPA CPDat.

Is Betaine used in cosmetics?

Yes, Betaine is also indexed as a cosmetic ingredient under the name Betaine. 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 Betaine come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.

Is Betaine used outside industrial chemicals?

Betaine also appears in cosmetics, pharmaceutical, food safety, cannabis databases.