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EC number: 222-695-1 | CAS number: 3576-88-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May - 6 July 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-iminobis[4,6-diamino-1,3,5-triazine]
- EC Number:
- 222-695-1
- EC Name:
- 2,2'-iminobis[4,6-diamino-1,3,5-triazine]
- Cas Number:
- 3576-88-3
- Molecular formula:
- C6H9N11
- IUPAC Name:
- N~2~-(4,6-diamino-1,3,5-triazin-2-yl)-1,3,5-triazine-2,4,6-triamine
- Reference substance name:
- melam
- IUPAC Name:
- melam
- Details on test material:
- Name of test material (as cited in study report): Melam
Chemical name: 2,2'-iminobis[4,6-diamino-1,3,5-triazine]
Lot No.: ACES062008
CAS No.: 3576-88-3
Appearance: Crystalline powder
Molecular formula, Molecular weight: C6H9N11,235.21
Purity: 98.45%
pH: 9.6
Density: 1679 kg/m3 (at 20°C)
Melting point: > 300 °C
Particle size: 0.138 - 30.200 µm
Manufacturing date: Feb. 17, 2009
Expiry date: Feb. 16, 2010
Storage condition: Room temperature (21.7-24.9 °C)
Handling & notice: Routine hygienic procedures were used to ensure the health and safety of the personnel according to MSDS.
Receipt date: May 18,2009
Residue treatment: Disuse after completion of the study
Constituent 1
Constituent 2
Method
- Target gene:
- histidine- Salmonella typhimurium (TA98, TA100, TA1535, and TA1537)
tryptophan- Escherichia coli (WP2uvrA(pKM101)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient broth medium
- Properly maintained: yes
- Periodically checked for karyotype stability: yes
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient broth medium
- Properly maintained: yes
- Periodically checked for karyotype stability: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Range finding test: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 µg/plate.
Main test: 313, 625, 1250, 2500, 5000 µg/plate. - Vehicle / solvent:
- - Vehicle used: water for injection
- Justification for choice of vehicle: From the information of solubility of the test substance provided by the Sponsor and the result of preliminary solubility test, the test substance was suspended in water for injection (50 mg/mL); therefore, water for injection was determined as the vehicle for this study.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle of test substance was used as the negative control.
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- See: Any other information on materials and methods incl. tables
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: in a shaking water bath at 37°C for 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 8.5 hours
SELECTION AGENT (mutation assays):
Salmonella typhimurium: 0.5 mM L-Histidine/D-Biotin (Sigma-Aldrich, U.S.A.) in the ratio of 10 to 1
Escherichia coli: 0.5 mM L-Tryptophan (Sigma-Aldrich, U.S.A.) solution in the ratio of 10 to 1
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: the number of revertant colonies was automatically counted by the
colony counter (ProtoCOL, SINBIOSIS, UK). If automatic counting was considered not
to be accurate, the number of revertant colonies was counted macroscopically.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test substance was considered as positive if the following conditions were met:
- The test substance should be increased at least twice as compared with the negative control group at one or more doses in the number of relevant colonies per plate in at least one strain.
- The number of relevant colonies should be increased dose dependently. - Statistics:
- Other than the calculations of individual plate count, the mean value and standard deviation of relevant colonies, statistical analysis was
not performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- The precipitation did not interfere with the colony counting.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- The precipitation did not interfere with the colony counting.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
The mean number of revertant colonies for negative and positive controls was within the
range of the historical control data.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance, Melam, did not show the mutagenic potential under the conditions of this study. - Executive summary:
This study was performed to determine the mutagenic potential for Melam using histidine-requiring Salmonella typhimurium (TA98, TA100, TA1535, and TA1537) and tryptophan-requiring Escherichia coli (WP2uvrA(pKM101)) strains.
In the dose range finding test, no growth inhibition was observed at any dose levels of all strains in the absence and presence of metabolic activation. The precipitation was observed more than 800 µg/plate in all strains in the absence of metabolic activation and more than 2000 µg/plate in all strains in the presence of metabolic activation, but it did not interfere with the colony counting. Therefore, 5000 µg/plate in all strains as the highest dose level of the main test was selected. And these were sequentially diluted by the geometric ratio of 2 to produce 4 additional lower dose levels (2500, 1250, 625, and 313 µg/plate). Also, the negative and positive control groups were set.
As a result of the main test, the mean number of revertant colonies was less than twice compared with the negative control values at all dose levels of the test substance in the absence and presence of metabolic activation without dose-related increase. The growth inhibition was not observed at any dose levels of all strains in the absence and presence of metabolic activation. The precipitation was observed more than 625 µg/plate in all strains
in the absence of metabolic activation and more than 1250 µg/plate in all strains in the presence of metabolic activation, but it did not interfere with the colony counting.
The mean number of colonies of positive control was distinctly increased as compared with negative control group.
In conclusion, the test substance Melam did not show a mutagenic potential under the conditions of this study.
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