Poor Cosmetic Ingredient NOAEL Data GHS Classified

Melamine

Also known as: 1,3,5-Triazine-2,4,6-triamine, 4-26-00-01253, BRN 0124341, EINECS 203-615-4, Hicophor PR (+5 more)

INCI: MELAMINE

Melamine (CAS 108-78-1) is a cosmetic cosmetic ingredient functioning as Industrial resin precursor. NOAEL 126 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 108-78-1 →

Auto-generated CPSR Part A draft with source citations
Function
Industrial resin precursor
Safety Rating
POOR

Chemistry & Identifiers

Formula
C3H6N6
MW
126.12 g/mol
EC Number
203-615-4
PubChem CID
7955
IUPAC Name
1,3,5-triazine-2,4,6-triamine
InChIKey
JDSHMPZPIAZGSV-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
US US Status prohibited
US Notes Not explicitly listed in 21 CFR Parts 700-740; however, no established cosmetic use and FDA would consider it an adulterant

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Melamine.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Melamine. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL =0.019 mg/kg bw/day - - Neurotoxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.025 mg/kg bw/day - - Neurotoxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.03 mg/kg bw - Human; Rat Acute toxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.03 mg/kg bw/day - - Neurotoxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.05 mg/kg bw/day - - Toxicology study INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.065 mg/kg bw/day - - Toxicology study INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.07 mg/kg bw/day oral - Neurotoxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.1 mg/kg bw/day - Human Toxicology study INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.2 mg/kg bw/day - - Neurotoxicity INCHEM_WHO_jmpr_jmpmono_v2006pr01
NOAEL =0.21 mg/kg bw - - Toxicology study INCHEM_WHO_jmpr_jmpmono_v2006pr01

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Melamine across SCCS product categories, with measured dermal absorption where available.

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
2B
Volume
Sup 7, 73, 119
Evaluation Year
2017

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Health Hazard
Hazard Class and Category
Carc. 2; STOT RE 2
Hazard Statements
  • H351 Suspected of causing cancer
  • H373 (urinary tract)

Inserted via ATP: ATP18

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 17-Jan-2023)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
Substance of Very High Concern (SVHC)
Included: 17-Jan-2023
Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1711
(EU) 2023/1490

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1710

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (6)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Melamine | Group 2B: Possibly carcinogenic to humans | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 73: (1999) Some Chemicals that Cause Tumours of the Kidney or Urinary Bladder in Rodents and Some Other Substances | Volume 119: (2019) Some Chemicals That Cause Tumours of the Urinar
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
Melamine | TR-245: Carcinogenesis Bioassay of Melamine (CASRN 108-78-1) in F344/N Rats and B6C3F1 Mice (Feed Study) (1983 ) | 06/16/82 | Clear Evidence | No Evidence | No Evidence | No Evidence | Under the conditions of this bioassay, melamine was carcinogenic for male F344/N rats, causing transitional-cell carcinomas in the urinary bladder. With one exception, urinary bladder stones were
Source: NTP Technical Reports
Evidence for Carcinogenicity
Cancer Classification: Group D Not Classifiable as to Human Carcinogenicity | Evaluation: There is inadequate evidence in humans for the carcinogenicity of melamine. There is sufficient evidence in experimental animals for the carcinogenicity of melamine under conditions in which it produces bladder calculi. Overall evaluation: In making the overall evaluation, the Working Group noted that a non-D
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Chemical reaction regulator Degradant/impurity Flame retardant Monomers No specific technical function
Regulatory List Membership (1)
FDA Indirect Food Contact Additives

Expert Verdict

Expert safety assessment and concern-level summary for Melamine.

Regulatory Flags

endocrine_disruptor

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Melamine by CAS number or substance name.

Studies
194
Lowest NOAEL
0.019
Highest NOAEL
2000

Units vary across source rows: mg/kg bw/day, mg/kg bw

ToxValDB_ECHA_IUCLID INCHEM_WHO_jmpr_jmpmono_v2006pr01 ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Known Synonyms

1,3,5-Triazine-2,4,6-triamine 4-26-00-01253 BRN 0124341 EINECS 203-615-4 Hicophor PR NCI-C50715 s-Triazine, 2,4,6-triamino- UNII-N3GP2YSD88 Cyanuric triamide sym-triaminotriazine

Chemical Function

Flame retardant Degradant/impurity Monomers

Regulatory Lists

drinking_water; Europe; manufacturing; plastic_additive drinking_water; Europe; manufacturing; plastic_additive Indirect additives food contact (10/2018) detected; Europe; Toys and children's products Europe; plastic_additive inert_ingredient; non_food_use; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

ChEMBL ID
CHEMBL1231106
View full pharmaceutical profile →

Frequently Asked Questions

Is Melamine safe in cosmetics?

Melamine has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.

Is Melamine allowed in the EU?

Melamine EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Melamine do in cosmetics?

Melamine functions as: Industrial resin precursor. It is classified as a cosmetic ingredient in our database. CAS number: 108-78-1.

What is the NOAEL for Melamine?

The NOAEL (No Observed Adverse Effect Level) for Melamine is =0.019 mg/kg bw/day based on a Neurotoxicity study via oral route in rat. A total of 10 study endpoints are available. Source: INCHEM_WHO_jmpr_jmpmono_v2006pr01.

Is Melamine used outside cosmetics?

Melamine also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Melamine have different safety status in cosmetics vs industrial chemicals?

Melamine is prohibited in EU cosmetics but has active industrial GHS classifications (H351, H361, H361f, H373, H227, H315, H317, H336).

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