NOAEL Data Cosmetic Ingredient

Melatonin

Also known as: Regulin, Circadin, 3-(2-Acetamidoethyl)-5-methoxyindole, N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide, Acetamide, N-[2-(5-methoxy-1H-indol-3-yl)ethyl]- (+15 more)

CAS 73-31-4

Melatonin (CAS 73-31-4) is a chemical substance. Key regulatory status: 9 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, SCCS.

View cosmetic safety profile for Melatonin →

SOURCE NOAEL studies
NOAEL studies
61
SOURCE Chemical inventory jurisdictions
Regulatory lists
9
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
Melatonin
CAS Number
73-31-4
DTXSID
DTXSID1022421
Molecular Formula
C13H16N2O2
InChI Key
DRLFMBDRBRZALE-UHFFFAOYSA-N
Monoisotopic Mass
232.121178
Synonyms
RegulinCircadin3-(2-Acetamidoethyl)-5-methoxyindoleN-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamideAcetamide, N-[2-(5-methoxy-1H-indol-3-yl)ethyl]-Acetamide, N-(2-(5-methoxyindol-3-yl)ethyl)-N-(2-(5-methoxyindol-3-yl)ethyl)acetamide5-22-12-00042BRN 0205542EINECS 200-797-7UNII-JL5DK93RCLMT6

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 2 records
Antioxidant

Regulatory Lists

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

SOURCE EPA CPDat 9 records
ListKeywordSource
Canada; consumer_product; Substances in Products - Canada (4/2014)Government of CanadaCPCat
active_ingredient; AustraliaAustralian Pesticides and Veterinary Medicines AuthorityCPCat
Canada; Personal care; Substances in PCP - Canada (4/2014)Government of CanadaCPCat
pharmaceuticalFDAUnited States Food and Drug Administration (FDA)
pharmaceuticalFDAUnited States Food and Drug Administration (FDA)
active_ingredient; animal_products; Europe; pharmaceutical; residueEUCPCat
Europe; pharmaceuticalEuropean Medicines AgencyPROTECT ADR database
Canada; pharmaceuticalDrugBankDrugBank
Canada; pharmaceuticalDrugBankDrugBank

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 50 of 61 studies
ValueUnitEndpointRouteSpeciesSource
5mg/kg bw/day--ratRegulatory source
5mg/kg bw/day--ratRegulatory source
5mg/kg bw/day-oralratRegulatory source
-uL/min/10^6 cellsClint-HumanNTP ICE adme parameters
JL5DK93RCLUNIIFDA UNII substance identifier--openFDA substances
JL5DK93RCLUNIIFDA UNII substance identifier--openFDA substances
JL5DK93RCLUNIIFDA UNII substance identifier--openFDA substances
JL5DK93RCLUNIIFDA UNII substance identifier--openFDA substances
0.498fractionFu-HumanNTP ICE adme parameters
=3mg/kg bw/dayLOELinjectionRatToxValDB ECOTOX
-unitlessModel Score--NTP ICE endocrine
=0.3%NOAELoralratSCCS Opinion
=0.3%NOAELoralratSCCS Opinion
=0.3%NOAELoralratSCCS Opinion
=0.3%NOAELoralratSCCS Opinion
=0.5mg/kg bw/dayNOAELoralratSCCS Opinion
=0.5mg/kg bwNOAELdermalratSCCS Opinion
=0.5mg/kg bw/dNOAELdermalhumanSCCS Opinion
=0.5mg/kg bw/dayNOAELoralratSCCS Opinion
=0.5mg/kg bwNOAELdermalratSCCS Opinion
=0.5mg/kg bw/dNOAELdermalhumanSCCS Opinion
=0.5mg/kg bw/dayNOAELoralratSCCS Opinion
=0.5mg/kg bwNOAELdermalratSCCS Opinion
=0.5mg/kg bw/dNOAELdermalhumanSCCS Opinion
=0.5mg/kg bw/dayNOAELoralratSCCS Opinion
=0.5mg/kg bwNOAELdermalratSCCS Opinion
=0.5mg/kg bw/dNOAELdermalhumanSCCS Opinion
=5mg/kg bw/dayNOAEL-ratSCCS Opinion
=5mg/kg bw/dayNOAEL-ratSCCS Opinion
=5mg/kg bw/dayNOAEL-ratSCCS Opinion
=5mg/kg bw/dayNOAEL-ratSCCS Opinion
=100mg/kg bw/dayNOAELintravenousratSCCS Opinion
=100mg/kg bw/dayNOAELintravenousratSCCS Opinion
=100mg/kg bw/dayNOAELintravenousratSCCS Opinion
=100mg/kg bw/dayNOAELintravenousratSCCS Opinion
=200mg/kg/dayNOAELoralratSCCS Opinion
=200mg/kg bw/dayNOAEL--SCCS Opinion
=200mg/kg/dayNOAELoralratSCCS Opinion
=200mg/kg bw/dayNOAEL--SCCS Opinion
=200mg/kg/dayNOAELoralratSCCS Opinion
=200mg/kg bw/dayNOAEL--SCCS Opinion
=200mg/kg/dayNOAELoralratSCCS Opinion
=200mg/kg bw/dayNOAEL--SCCS Opinion
=0.5mg/kg bw/dayNOELoralRatToxValDB ECOTOX
=10mg/kg bw/dayNOELoralRatToxValDB ECOTOX
=0.5mg/kg bwdermal absorptiondermalratRegulatory source
=0.5mg/kg bwdermal absorptiondermalratRegulatory source
=0.5mg/kg bwdermal absorptiondermalratRegulatory source
0.5mg/kg bw/ddermal absorptiondermalhumanRegulatory source
0.5mg/kg bw/ddermal absorptionoralhumanRegulatory source

Showing 50 of 61 studies

SCCS Opinions

EU Scientific Committee opinions tied to the matched substance.

SOURCE SCCS Opinion 1 opinions
OpinionDateConclusionMax Conc.Concerns
SCCS/1392/1023 March 2010not safe (pharmacological activity)Not safe as cosmetic ingredientPotent pharmacological/hormonal activity; regulates circadian rhythm; endocrine activity; not appropriate for cosmetic products; use prohibited

Cosmetic Safety Profile

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

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

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed MELATONIN
ChEMBL Phase
4
Adverse Events
4879
Bioactivity
20
View full pharmaceutical profile →

Food Safety Data

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

SOURCE EFSA 1 records

1 food-safety record found.

View full food safety profile →

Frequently Asked Questions

What is the NOAEL for Melatonin?

Melatonin has 61 NOAEL studies in the database. The lowest reported value is 0 uL/min/10^6 cells in Human. Source: NTP ICE adme parameters.

What regulatory lists include Melatonin?

Melatonin appears on 7 regulatory/inventory lists including Canada; consumer_product; Substances in Products - Canada (4/2014), active_ingredient; Australia, Canada; Personal care; Substances in PCP - Canada (4/2014), and 4 more. Source: EPA CPDat.

Is Melatonin used in cosmetics?

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

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

Is Melatonin used outside industrial chemicals?

Melatonin also appears in cosmetics, pharmaceutical, food safety databases.