Registration Dossier
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EC number: 253-575-7 | CAS number: 37640-57-6
- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of 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:
- Unnamed
- Year:
- 1 993
- Reference Type:
- publication
- Title:
- Evaluation of a Three-Exposure Mouse Bone Marrow Micronucleus Protocol: Results With 49 Chemicals
- Author:
- Shelby M.D. et al.
- Year:
- 1 993
- Bibliographic source:
- Environ. Mol. Mutagen., 21, 160-179
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- only 5-7 males per dose used, differing staining agent
- Principles of method if other than guideline:
- NTP Standard protocol
- GLP compliance:
- not specified
- Type of assay:
- micronucleus 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:
- All test chemicals were received from the NTP chemical repository (Radian Corporation, Austin, TX).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male B6C3F1 mice (obtained from the National Toxicology Program production facility at Taconic Farms) of a common age between 9 and 14 weeks and weighing within a 2 g range of a mean weight between 25 and 33 g were used. Additional information on animal husbandry can be found in Tice et al. [1990a].
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- Injection volume was 0.4 ml.
- Duration of treatment / exposure:
- one injection/day on 3 consecutive days
- Frequency of treatment:
- one injection/day on 3 consecutive days
- Post exposure period:
- 1st study: For evaluation of bone marrow smears animals were sacrificed 24 hours after the 3rd exposure; for evaluation of peripheral blood smears
animals were sacrificed 48 hours after the 3rd exposure
2nd study: animals were sacrificed 24 hours after the 3rd exposure for both evaluation of bone marrow smears and evaluation of peripheral blood smears.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0; 500; 1000; 2000 mg/kg (1st study)
Basis:
- Remarks:
- Doses / Concentrations:
1000 and 2000 mg/kg (2nd study)
Basis:
- No. of animals per sex per dose:
- 5 (exemption: only 3 animals were scored at the concentration of 2000 mg/kg bw in the first study)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 7,12-dimethylbenzanthracene (12.5 mg/kg)
Examinations
- Tissues and cell types examined:
- bone marrow and peripheral blood
- Details of tissue and slide preparation:
-
DETAILS OF SLIDE PREPARATION:
Staining with acridine orange
METHOD OF ANALYSIS:
Bone marrow:
Slides were evaluated for the number of MN-PCE among 2000 PCE and for the percentage of PCE among 200 erythrocytes.
Peripheral blood:
According to the NTP-Standard protocol 2000 PCEs are evaluated for the number of MN-PCE and 1000 erythrocytes are evaluated for teh percentage of PCE among erythrocytes. - Evaluation criteria:
- Statistically significant increase in micronuclei.
- Statistics:
- When corn oil solvent control data were compared (two-tailed t-test) between laboratories, there was no statistically significant differences. But for PBS, the mean of ILS was significantly higher than that for EHRT (P = 0.009). For the positive control data, there were no significant differences between laboratories.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No signs of toxicity were observed
Any other information on results incl. tables
Table 1: MN data analysis
Dose (mg/kg) | MN-PCE/1000 (No. of animals scored) | P value (a) | Survival | %PCEs (b) | |
1st study, bone marrow (Sample collection time: 24 hours) | 0.003 | ||||
0 | 2.10 +/- 0.62 (5) | 5/5 | 57.3 | ||
500 | 1.80 +/-0.34 (5) | 0.685 | 5/5 | 56.6 | |
1000 | 2.20 +/- 0.25 (5) | 0.439 | 5/5 | 57.1 | |
2000 | 3.80 +/- 0.70 (5) | 0.013 | 6/6 | 56.1 | |
Positive control | 6.90 +/- 0.87 (5) | 0.0001 | - | - | |
2nd study, bone marrow (Sample collection time: 24 hours) | 0.340 | ||||
0 | 4.60 +/- 0.64 (5) | 5/5 | 60.9 | ||
1000 | 4.20 +/- 1.21 (5) | 0.596 | 5/5 | 51.7 | |
2000 | 5.30 +/- 1.59 (5) | 0.344 | 5/6 | 56.3 | |
Positive control | 8.40 +/- 0.56 (5) | - | - | ||
1st study, peripheral blood (c) (Sample collection time: 48 hours) | 0.964 | ||||
0 | 2.70 +/- 0.26 (5) | 5/5 | 1.2 | ||
500 | 3.50 +/- 0.91 (5) | 0.154 | 5/5 | 1.5 | |
1000 | 2.40 +/- 0.56 (5) | 0.663 | 5/5 | 1.1 | |
2000 | 1.50 +/- 0.76 (3) | 0.940 | 3/5 | 1.2 | |
2nd study, peripheral blood (Sample collection time: 24 hours) | 0.411 | ||||
0 | 4.10 +/- 0.73 (5) | no data available | no data available | ||
1000 | 3.60 +/- 0.93 (5) | 0.716 | no data available | no data available | |
2000 | 4.30 +/- 0.56 (5) | 0.413 | no data available | no data available | |
Positive control | 8.40 +/- 0.40 (5) | 0.0001 | no data available | no data available |
(a) omitting the high dose value
(b) ((No. of PCEs)/(No. of PCEs + No. of NCEs)) x 100
(c) no data on positive control available
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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