Poor Cosmetic Ingredient NOAEL Data GHS Classified

Melamine

INCI: MELAMINE

CAS Number
108-78-1
Function
Industrial resin precursor
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
moderate

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
LOAEL 12000 ppm oral rat oral REACH
NOAEL 750 ppm oral rat oral REACH
NOAEL 60 mg/kg bw/day other monkey oral REACH
NOEL ca.5000 ppm oral rat oral REACH
NOEL ca.15000 ppm oral mouse oral REACH
NOAEL 140 mg/kg bw/day oral rat oral REACH
NOEL ca.1000 mg/kg bw/day oral rat oral REACH
LOAEL 30000 mg/kg bw/day oral dog oral REACH
NOAEL 126 mg/kg bw/day oral code:3544 oral REACH
NOAEL 200 mg/kg bw/day oral pig oral REACH

GHS Hazard Classification

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

Expert Verdict

Classified Carc. 2 (suspected carcinogen); renal toxicity established in oral exposure studies; kidney stone formation; strictly prohibited in EU cosmetics; not acceptable in any cosmetic formulation

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Concern Level: High

Regulatory Flags

endocrine_disruptor

Frequently Asked Questions

Is Melamine safe in cosmetics?

Classified Carc. 2 (suspected carcinogen); renal toxicity established in oral exposure studies; kidney stone formation; strictly prohibited in EU cosmetics; not acceptable in any cosmetic formulation The EU classifies Melamine as "prohibited". Safety rating: POOR. 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 Margin of Safety for Melamine?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Melamine?

The NOAEL (No Observed Adverse Effect Level) for Melamine is 12000 ppm based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

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