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

SOURCE Chemical inventory jurisdictions

Regulatory lists

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

Melatonin

CAS Number

73-31-4

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

List	Keyword	Source
Canada; consumer_product; Substances in Products - Canada (4/2014)	Government of Canada	CPCat
active_ingredient; Australia	Australian Pesticides and Veterinary Medicines Authority	CPCat
Canada; Personal care; Substances in PCP - Canada (4/2014)	Government of Canada	CPCat
pharmaceutical	FDA	United States Food and Drug Administration (FDA)
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
Canada; pharmaceutical	DrugBank	DrugBank
Canada; pharmaceutical	DrugBank	DrugBank

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 29 of 29 studies

Value	Unit	Endpoint	Route	Species	Source
5	mg/kg bw/day	-	-	rat	Regulatory source
5	mg/kg bw/day	-	oral	rat	Regulatory source
0	uL/min/10^6 cells	Clint	-	Human	NTP ICE adme parameters
JL5DK93RCL	UNII	FDA UNII substance identifier	-	-	openFDA substances
0.498	fraction	Fu	-	Human	NTP ICE adme parameters
=3	mg/kg bw/day	LOEL	injection	Rat	ToxValDB ECOTOX
0	unitless	Model Score	-	-	NTP ICE endocrine
=0.3	%	NOAEL	oral	rat	SCCS Opinion
=0.5	mg/kg bw/day	NOAEL	oral	rat	SCCS Opinion
=0.5	mg/kg bw	NOAEL	dermal	rat	SCCS Opinion
=0.5	mg/kg bw/d	NOAEL	dermal	human	SCCS Opinion
=5	mg/kg bw/day	NOAEL	-	rat	SCCS Opinion
=100	mg/kg bw/day	NOAEL	intravenous	rat	SCCS Opinion
=200	mg/kg/day	NOAEL	oral	rat	SCCS Opinion
=200	mg/kg bw/day	NOAEL	-	-	SCCS Opinion
=0.5	mg/kg bw/day	NOEL	oral	Rat	ToxValDB ECOTOX
=10	mg/kg bw/day	NOEL	oral	Rat	ToxValDB ECOTOX
=0.5	mg/kg bw	dermal absorption	dermal	rat	Regulatory source
0.5	mg/kg bw/d	dermal absorption	dermal	human	Regulatory source
0.5	mg/kg bw/d	dermal absorption	oral	human	Regulatory source
100	mg/kg bw/day	developmental toxicity	intravenous	rat	Regulatory source
0.3	%	repeated dose toxicity	oral	rat	Regulatory source
0.5	mg/kg bw/day	repeated dose toxicity	oral	rat	Regulatory source
0.5	mg/kg bw/day	repeated dose toxicity	-	-	Regulatory source
5	mg/kg bw/day	repeated dose toxicity	oral	rat	Regulatory source
200	mg/kg/day	repeated dose toxicity	oral	rat	Regulatory source
200	mg/kg bw/day	repeated dose toxicity	oral	rat	Regulatory source
100	mg/kg bw/day	reproductive toxicity	-	-	Regulatory source
200	mg/kg bw/day	reproductive toxicity	-	-	Regulatory source

Showing 29 of 29 studies

SCCS Opinions

EU Scientific Committee opinions tied to the matched substance.

SOURCE SCCS Opinion 2 opinions

Opinion	Date	Conclusion	Max Conc.	Concerns
SCCS/1392/10	23 March 2010	not safe (pharmacological activity)	Not safe as cosmetic ingredient	Potent pharmacological/hormonal activity; regulates circadian rhythm; endocrine activity; not appropriate for cosmetic products; use prohibited
SCCS/1315/10	2010-03-23	The SCCS is of the opinion that the use of melatonin in hair products in a concentration of 0.0033% w/w (33 ug/g) does not pose a risk for the health of the consumer.	0.0033% w/w (33 ug/g)	Mutagenicity/genotoxicity testing battery not fully covered, but endogenous molecule with only marginal increases of physiological melatonin levels under in-use conditions; not phototoxic.

Cosmetic Safety Profile

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

SOURCE CosIng / Ingredients DB

EU Status

permitted

Max

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed MELATONIN

ChEMBL Phase

Adverse Events

4879

Bioactivity

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 29 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.