Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- repeated dose toxicity: inhalation
- Remarks:
- other: study, with some elements of a subchronic toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Insufficient description of the study. It is not even clear, if a vapour, a dust or an aerosol was applied.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 4-months study with some elements of a toxicity and a reproduction toxicity study was performed.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: hybrid albino
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- No data.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The amount of melamine in the air prevailing in the treatment cages was determined by thin-layer chromatography, using the method developed by V.V. Tarasov et al. The detection limit for melamine in this method was 2 μg in the volume of sample to be analyzed, and it was 0.007 mg/m3 in the air when 300 liters of air were taken for a sample.
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- 24 h, continuously.
Doses / concentrations
- Remarks:
- Doses / Concentrations: 0.50 - 0.058 - 0.011 - 0.00 mg/m3
Basis: nominal conc.
- No. of animals per sex per dose:
- 36 males
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no data
Examinations
- Observations and examinations performed and frequency:
- To study the general toxicity of melamine, the behavior of the animals, the weight, and the following parameters were determined:
- aggregate threshold value (ATV),
- level of the sulfhydryl (thiol) group in the blood,
- cholinesterase activity in whole blood,
- blood level of lactic acid and glutaric (pyrotartaric) acid,
- activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST),
- serum lysozyme level, and
- the total and fractional protein values in the serum. - Sacrifice and pathology:
- After the four-month exposure period, the internal organs of the animals were subjected to pathological and histochemical examination.
- Statistics:
- Data obtained were processed statistically with the aid of Student’s t test.
Results and discussion
Results of examinations
- Details on results:
- The experimental animals in the dosed groups were active during the chronic toxicity test and showed a moderate weight increase. They did not exhibit any noticeable difference in behavior from the controls.
ATV was decreased in the mid and high dosed group.
Cholinesterase: cyclic variations in the mid and high dosed group.
Fractional protein values: changes in the mid and high dosed group.
ALT and AST: changes in the mid and high dosed group.
Glutaric (pyrotartaric) acid: changes in the mid and high dosed group.
Sulfhydryl (thiol) group in the blood: changes in the mid and high dosed group.
The pathological and histochemical investigations indicated some changes in the high and mid dose group, characterized by a basic hematopoietic disorder and by dystrophic alterations in the internal organs (brain, lungs, liver, spleen and testicles). However, no pathological changes were observed in the low dose group.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 0.01 mg/m³ air
- Sex:
- male
- Basis for effect level:
- other: Various toxic effects.
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.058 mg/m³ air
- System:
- other: A basic hematopoietic disorder and dystrophic alterations in the internal organs (brain, lungs, liver, spleen and testicles)
- Treatment related:
- yes
- Dose response relationship:
- no
- Relevant for humans:
- no
Applicant's summary and conclusion
- Conclusions:
- The study is not considered to be reliable.
- Executive summary:
A 4-months toxicity study with some elements of a reproduction toxicity study was performed with rats.
A melamine concentration of 0.058 mg/m3 was found to be the threshold value. In a concentration of 0.01 mg/m3, melamine did not cause any general toxic or gonadotoxic symptoms and is therefore now classed as inactive at this concentration.
This is an unreliable study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.