What is the NOAEL for Betaine?
Betaine has 26 NOAEL studies in the database. The lowest reported value is 131 mg/kg bw/day via oral in Rat. Source: EFSA.
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.
SOURCE
NOAEL studies
NOAEL studies
26
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
25 fields
Name
Betaine
CAS Number
107-43-7
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
| List | Keyword | Source |
|---|---|---|
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| active_ingredient; animal_products; Europe; pharmaceutical; residue | EU | CPCat |
| Europe; pharmaceutical | European Medicines Agency | PROTECT ADR database |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - body hygiene - body wash | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - hair styling and care - shampoo | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 26 of 26 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| =131 | mg/kg bw/day | BMDL (05) | oral | Rat | EFSA |
| 3SCV180C9W | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| >1.115e+4 | mg/kg bw | LD50 | oral | Rat | NTP ICE acute oral |
| >1.118e+4 | mg/kg bw | LD50 | oral | Rat | NTP ICE acute oral |
| >1.120e+4 | mg/kg bw | LD50 | oral | Rat | NTP ICE acute oral |
| =4000 | mg/day | LEL | oral | Human | EFSA |
| =1.000e+4 | mg/kg bw/day | LEL | oral | Pig | EFSA |
| =5 | % | NOAEL | oral | rat | CIR Safety Assessment |
| =20 | mg/kg/d | NOAEL | oral | rat | CIR Safety Assessment |
| =40 | mg/kg/d | NOAEL | oral | rat | CIR Safety Assessment |
| =50 | mg/kg bw/d | NOAEL | oral | rat | CIR Safety Assessment |
| =100 | mg/kg bw/d | NOAEL | oral | rat | CIR Safety Assessment |
| =150 | mg/kg | NOAEL | oral | rat | CIR Safety Assessment |
| =250 | mg/kg/d | NOAEL | oral | rat | CIR Safety Assessment |
| =300 | mg/kg/d | NOAEL | oral | rat | CIR Safety Assessment |
| >5771 | mg/kg bw/d | NOAEL | oral | rat | CIR Safety Assessment |
| <1 | % | NOEL | oral | Rat | ToxValDB HESS |
| 20 | mg/kg/d | developmental toxicity | oral | rat | Regulatory source |
| 40 | mg/kg/d | developmental toxicity | oral | rat | Regulatory source |
| 5 | % | repeated dose toxicity | oral | rat | Regulatory source |
| 50 | mg/kg bw/d | repeated dose toxicity | oral | rat | Regulatory source |
| 100 | mg/kg bw/d | repeated dose toxicity | oral | rat | Regulatory source |
| 150 | mg/kg | repeated dose toxicity | oral | rat | Regulatory source |
| 250 | mg/kg/d | repeated dose toxicity | oral | rat | Regulatory source |
| 300 | mg/kg/d | repeated dose toxicity | oral | rat | Regulatory source |
| >5771 | mg/kg bw/d | repeated dose toxicity | oral | rat | Regulatory source |
Showing 26 of 26 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Betaine | 203-490-6 | ECHA overview → |
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
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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
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
ChEMBL / DailyMed
GLYCINEBETAINE
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
0
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA
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 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.