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EC number: 255-449-7 | CAS number: 41583-09-9
- 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
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- Nanomaterial aspect ratio / shape
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restricitions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Responses of the L5178Y tk+/tk- Mouse lymphoma cell forward mutation assay III. 72 Coded Chemicals.
- Author:
- McGregor DB, Brown A, Cattanach P, Edwards I, McBride D, Riach C, Caspary W
- Year:
- 1 988
- Bibliographic source:
- Environ. Mol. Mutagen., 12, 85-154
- Reference Type:
- secondary source
- Title:
- Predicition of chemical carcinogenicity in rodents from in vitro genotoxcity assays
- Author:
- Tennant R.W
- Year:
- 1 987
- Bibliographic source:
- Science, 236, 933-941
- Reference Type:
- secondary source
- Title:
- Induction of forward mutations at the thymidine kinase locus of mouse lymphoma cells: evidence for electrophilic and non-electrophilic mechanisms
- Author:
- Henry B. et al.
- Year:
- 1 998
- Bibliographic source:
- Mutation Research, 397, 313-335
- Reference Type:
- secondary source
- Title:
- Annual Plan Fiscal Year 1986
- Author:
- NTP
- Year:
- 1 986
- Bibliographic source:
- US NTP, p.74
- Reference Type:
- secondary source
- Title:
- Melamine
- Author:
- Trochimowicz H. J. et al.
- Year:
- 2 001
- Bibliographic source:
- Patty´s Toxicology, 5th Edition, Vol.4
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- Method: other: Clive and Spector (1975); Clive et al. (1979) with modifications;
performed according to NTP-Standards (US NTP Study ID 091419) - GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
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:
- - Analytical purity: 99%
The chemical was supplied from the US National Toxicology Program Chemical Repository , Radian Corporation, Austin, TX 78766 (USA)
Constituent 1
Method
- Target gene:
- tk
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mis from male rats injected with Aroclor 1254
- Test concentrations with justification for top dose:
- 0; 10; 20; 40; 80; 100; 120; 140; 160 µg/ml;
Testing of melamine was limited to 160 µg/ml by its solubility in the exposure medium. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without MA: Ethylmethanesulfonate (EMS, 250 µg/ml); with MA: 3-methylcholanthren (3-MC, 2.5 µg/ml)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Preincubation period: not specified
- Exposure duration: 4h
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 11-14 days
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: not applicable; mutants producted from 10 exp 6 cells were counted.
DETERMINATION OF CYTOTOXICITY
- Method: Cloning efficiency
OTHER: Cells were obtained from Dr . D. Clive, Burroughs Wellcome Co ., Research Triangle Park, NC 27709, and stored in liquid nitrogen. Absecne of mycoplasma contamination was confirmed. On a single occasion, within 1 week of the start of an experiment, cultures were purged of tk-/tk- mutants by exposure for 1 day to Flop containing THMG (thymidine, 6 μg/ml hypoxanthine, 5 μg/ml, glycine, 7 .5 μg/ml and methotrexate, 0 .1 μg/ml), then for 3 days to Flop containing THG only, (i .e ., THMG without methotrexate) .
The tk+/tk- -3.7.2C heterozygote of L5178Y mouse lymphoma cells was obtained from Dr. D. Clive, Burroughs Wellcome Co., Research Triangle Park, NC 27709, and stored in liquid nitrogen. Thawed samples were cultured and used for up to 3 months, then discarded. Laboratory cultures were confirmed as free from mycoplasma by cultivating or Hoechst staining techniques and maintained in Fischer's medium at 37°C on gyratory tables. Fischer's medium (designated F0) was supplemented with 2 mM L-glutamine, sodium pyruvate, 110 µg/mL, 0.05% pluronic F68, antibiotics, and 10% heat-inactivated donor horse serum (v/v) (designated F10P). On a single occasion, within 1 week of the start of an experiment, cultures were purged of tk-/tk- mutants by exposure for 1 day to F1OP containing THMG (thymidine, 6 mg/mL hypoxanthine, 5 mg/mL, glycine, 7.5 µg/mL and methotrexate, 0.1 µg/mL), then for 3 days to FlOP containing THG only, (i.e., THMG without methotrexate). - Evaluation criteria:
- Positive reponse: Out of three trials, a positive trial was reproducible (The dose-related trend and the response at one of the three highest acceptable doses were statistically significant)
Negative response: Out of three trials, a positive response or a positive dose was not reproducible . - Statistics:
- Chi-square test for consistency
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results tables were not included in the publication. They can be viewed at
http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=108-78-1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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