NOAEL Data Cosmetic Ingredient

Neotame

Also known as: E961, N-(N-(3,3-dimethylbutyl)-L-alpha-aspartyl)-L-phenylalanine 1-methyl ester, UNII-VJ597D52EX, N-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine methyl ester

CAS 165450-17-9

Neotame (CAS 165450-17-9) is a chemical substance. Key regulatory status: 1 regulatory/inventory list, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat.

View cosmetic safety profile for NEOTAME →

SOURCE noael studies public
NOAEL studies
22
SOURCE chemical inventory jurisdictions
Regulatory lists
1
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 10 fields
Name
Neotame
CAS Number
165450-17-9
DTXSID
DTXSID50167950
Molecular Formula
C20H30N2O5
InChI Key
HLIAVLHNDJUHFG-HOTGVXAUSA-N
Monoisotopic Mass
378.215472
Synonyms
E961N-(N-(3,3-dimethylbutyl)-L-alpha-aspartyl)-L-phenylalanine 1-methyl esterUNII-VJ597D52EXN-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine methyl ester

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 5 records
DeodorizerFlavouring and nutrient

Regulatory Lists

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

SOURCE EPA CPDat 1 records
ListKeywordSource
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 22 of 22 studies
ValueUnitEndpointRouteSpeciesSource
<=2mg/kgADIoralHumanToxValDB_WHO_JECFA_ADI
<=2mg/kg bw/dayADI-ConsumersEFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
<=2mg/kg bw/dayADI-ConsumersEFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
VJ597D52EXUNIIFDA UNII substance identifier--openFDA substances
VJ597D52EXUNIIFDA UNII substance identifier--openFDA substances
VJ597D52EXUNIIFDA UNII substance identifier--openFDA substances
VJ597D52EXUNIIFDA UNII substance identifier--openFDA substances
50mg/kg bw/dayNOAELoralratCOSMOS_DB
100mg/kg bw/dayNOAELoralratCOSMOS_DB
200mg/kg bw/dayNOAELoraldogCOSMOS_DB
=200mg/kg bw/dayNOAELoralDogToxValDB_EFSA
=200mg/kg bw/dayNOAELoral: feedDogEFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=200mg/kg bw/dayNOAELoral: feedDogEFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
300mg/kg bw/dayNOAELoralmouseCOSMOS_DB
500mg/kg bw/dayNOAELoralrabbitCOSMOS_DB
800mg/kg bw/dayNOAELoraldogCOSMOS_DB
956mg/kg bw/dayNOAELoralratCOSMOS_DB
1000mg/kg bw/dayNOAELoralratCOSMOS_DB
2000mg/kg bw/dayNOAELoralratCOSMOS_DB
2500mg/kg bw/dayNOAELoralratCOSMOS_DB
4000mg/kg bw/dayNOAELoralmouseCOSMOS_DB
8000mg/kg bw/dayNOAELoralmouseCOSMOS_DB

Showing 22 of 22 studies

Cosmetic Safety Profile

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

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

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE EMBL-EBI ChEMBL CHEMBL3718532
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

E961 — ADI: 2 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 Neotame?

Neotame has 22 NOAEL studies in the database. The lowest reported value is 2 mg/kg via oral in Human. Source: ToxValDB_WHO_JECFA_ADI.

What regulatory lists include Neotame?

Neotame appears on 1 regulatory/inventory list including food_additive; Substances Added to Food (formerly EAFUS) (2/2019). Source: EPA CPDat.

Is Neotame used in cosmetics?

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

Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, 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 Neotame used outside industrial chemicals?

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