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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: NTP studies are considered as high quality studies, even if GLP was formally not stated and some standard methods were not applied. The studies are peer reviewed.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NTP standards
- Principles of method if other than guideline:
- Groups of five male and five female rats were administered single doses of melamine (2150 to 10000 mg/kg body weight) in corn oil by gavage.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- 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
- Details on test material:
- - Name of test material (as cited in study report): melamine.
- Analytical purity: Results of purity and identity analyses conducted at Midwest Research Institute (MRI) indicated that both lots were similar in purity in all respects.
Results of elemental analyses for both lots agreed with the theoretical values. Titration of one amino group indicated that both lots were approximately 100 % ± 1 % pure. For both lots, only one spot was detected by thin-layer chromatography.
- Impurities (identity and concentrations): Several minor impurities were detected in both lots by high-performance liquid chromatography (HPLC). The impurities were not further characterized, but 6-amino-s-triazine-2,4-diol and 4,6-diamino-s-triazine- 2-ol are reported to be common impurities in melamine.
The differences in purity determined by HPLC and titration could be due to impurities with titratable amine groups, such as the impurities mentioned above, that would result in an apparently high titration value. In addition, the detector response in HPLC is highly dependent upon the absorbance of the substance at the detector wavelength used. The values reported are absolute areas expressed as percentages of the area of the major peak and do not take into account the different values of the compound and its impurities at 254 nm. Therefore, the relative areas determined by HPLC do not necessarily reflect the actual weight percentages of the impurities in the sample.
- The infrared and ultraviolet spectra of both lots were consistent with the literature spectra.
- Lot/batch No.: Technical-grade melamine was obtained in two batches from American Cyanamid Company (Bound Brook, NJ).
Lot No. A7-11-75 was used for the single-dose and prechronic studies and for the first 14 months of the chronic study.
Lot No. A13179 was used for the remainder of the chronic studies.
- Stability under test conditions: The chemical was stable at 60 °C for 2 weeks and therefore required no special storage temperature.
- Storage condition of test material: The chemical was stored at 4 °C throughout the study, and periodic analyses by thin-layer chromatography and infrared spectroscopy indicated that no significant degradation occurred over the lifetime of the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Center, Frederick, MD
- Age at study initiation: 10 weeks.
- Housing: Rats were housed two-three per cage in polycarbonate cages covered with nonwoven polyester filter sheets. Racks and filters were changed once every 2 weeks. Cages, bedding, and glass water bottles (equipped with stainless steel sipper tubes) were replaced twice per week.
- Diet: Purina Laboratory Chow. Ralston Purina Co. Stainless steel feed containers were changed once per week.
- Water: tap water (acidified with hydrochloric acid to pH 2.5)
Test diets, control diets, and tap water were available ad libitum.
- Bedding: Absorb-Dri heat-treated hardwood chips, changed twice per week.
- Acclimation: 6 weeks
- Randomization: No.
ENVIRONMENTAL CONDITIONS
- Temperature, humidity: The temperature in the animal rooms was 22 °- 26 °C and the relative humidity was 30 %-70 %.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- corn oil. - Doses:
- 2150, 3160, 4640, 6810 or 10000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for mortality every 30 min. for first 8 hrs. and then daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No. - Statistics:
- Probit analysis (Finney, 1964) which based on deaths occurring within 14 days of administration of melamine.
Results and discussion
- Preliminary study:
- No
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 161 mg/kg bw
- 95% CL:
- ca. 1 344 - 4 722
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 828 mg/kg bw
- 95% CL:
- ca. 2 787 - 5 255
- Mortality:
- Deaths of animals administered a single dose of melamine were dose related. All rats that received 6810 or 10000 mg/kg body weight died.
- Clinical signs:
- other: no data.
- Gross pathology:
- White crystals (not further identified) were found in the stomach of 3/5 males and 4/5 females that received 10000 mg/kg body weight, 4/5 males and 5/5 females that received 6810 mg/kg body weight, 1/5 males and 2/5 females that received 3160 mg/kg body weight, and 1/5 males that received 2150 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Melamine has a low acute toxicity.
- Executive summary:
Groups of five male and five female rats were administered single doses of melamine (2150 to 10000 mg/kg body weight) in corn oil by gavage. Animals were observed for 2 weeks.
Deaths of animals administered a single dose of melamine were dose related. All rats that received 6810 or 10000 mg/kg body weight died. The LD50 was calculated to 3161 mg/kg for males and 3828 mg/kg for females.
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