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Diss Factsheets
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EC number: 203-615-4 | CAS number: 108-78-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Melamine has a low acute toxicity by the oral, dermal and inhalation route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 3 161 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Value:
- mg/m³ air
Additional information
Per oral application: 4 studies on the acute oral toxicity in rats are available and 2 with mice. Each study result provides an LD50 > 3000 mg/kg bw. The most reliable study, the NTP study, was selected as the key study. It reports an LD50 = 3161 mg/kg bw for male rats, and slightly higher for females.
Inhalation route: Only one study (Muijser 1988) is considered to be sufficiently reliable. The LC50inhalation,rat >5190 mg/m3 (a value that can not be entered in the field above). The other two studies are insufficiently described and not sufficiently reliable, leaving the method of generation of the test substance-air mixture unclear in Ubaydullayev 1993, and not reaching a high enough concentration in the study of Hofmann 1969.
Dermal exposure: The study is waived, applying the REACH criteria: "Testing for acute toxicity by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin."
Criteria (1) and (3) are not fulfilled, therefore testing is not appropriate. Criterion (1): Inhalation is not unlikely and an investigation of the acute toxicity by inhalation was performed, see 7.2.2. Criterion (3): Melamine has a low acute oral toxicity, see 7.2.1., it is therefore and because of the expected low dermal absorption unlikely that the acute dermal toxicity exceeds the oral toxicity. The low dermal absorption is estimated from the low partition coefficient, see Section 7.1.2.
The available old study on the acute dermal toxicity reporting an LD50dermal,rat of >1000 mg/kg bw (a value that can not be entered in the field above) supports the estimated low acute dermal toxicity.
Justification for classification or non-classification
No classification due to acute toxicity of melamine is required, because:
The LD50oral,rat >3000 mg/kg bw.
The LC50inhalation, rat >5190 mg/m3.
The determination of the LD50dermal,rat is waived; but based on the low acute oral toxicity and the low estimated skin penetration of melamine, the LD50dermal,rat is considered to be >2000 mg/kg bw. This is supported by an old study yielding an LD50dermal,rat >1000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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