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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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: All relevant details for evaluation are given in the literature publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetics of melamine and cyanuric Acid and their combinations in f344 rats.
- Author:
- Jacob CC, Von Tungeln LS, Vanlandingham M, Beland FA, Gamboa da Costa G.
- Year:
- 2 012
- Bibliographic source:
- Toxicol Sci. 2012 Apr;126(2):317-24
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)
- EC Number:
- 253-575-7
- EC Name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)
- Cas Number:
- 37640-57-6
- Molecular formula:
- C3H6N6.C3H3N3O3
- IUPAC Name:
- 1,3,5-triazinane-2,4,6-trione - 1,3,5-triazine-2,4,6-triamine (1:1)
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): melamine cynurate
- Substance type: solid
- Physical state:solid
- Analytical purity: The purity and identity of the test articles were confirmed by high-performance liquid chromatography (HPLC) coupled with ultraviolet detection and electrospray mass spectrometry and by gas chromatography-mass spectrometry in electron impact mode.
- Impurities (identity and concentrations): not provided
- Purity test date: not provided
- Lot/batch No.: none, the substance was synthesized by mixing 1:1 aqueous solutions of melamine and cyanuric acid. The precipitate was filtered, thoroughly washed with hot water (80–90C), and dried under reduced pressure.
- Expiration date of the lot/batch: not relevant
- Other: The publication also describes toxicokinetic investigations with either melamine or cyanuric acid or a co-exposure to melamine and cynuric acid (not the pre-formed melaminecyanurate complex)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F344 rats were obtained from the breeding colony at the US NCTR.
- Age at study initiation: 10 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: individual
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): 40 -70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/+2
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- water with 0.1% CMC
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Concentration in vehicle: 0.4 mg/L
- Amount of vehicle (if gavage): 5ml/kg bw
HOMOGENEITY AND STABILITY OF TEST MATERIAL: yes
All dosing formulations were analyzed with a Thermo Surveyor Plus HPLC (Thermo, Waltham, MA) using a Synergi Polar RP 80A, 4 lm, 2 3 250 mm column (Phenomenex, Torrance, CA) eluted isocratically at 0.4 ml/min with 95% 10mM ammonium phosphate and 5% acetonitrile. The eluate was monitored at 209 nm. The melamine cyanurate suspension was determined to be at 102.3 ± 1.4% of its nominal concentration, as determined by analysis of three independent samples drawn under simulated dosing conditions. - Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2 mg/kg bw
- No. of animals per sex per dose / concentration:
- 6
- Control animals:
- no
- Details on study design:
- - Dose selection rationale: A dose of 2 mg/kg bw was selected because it was expected to afford
quantifiable serum levels and was below the threshold of exposure at which the authors have observed
significant nephrotoxic effects in subchronic studies with a combination of melamine and cyanuric acid in rats.
- Rationale for animal assignment (if not random): The rats were weight-ranked (acceptable weight: ± 20% of the mean body weight [bw]), and randomly assigned to treatment groups. - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood
- Time and frequency of sampling: 0 (pretreatment), 0.5, 1, 2, 3, 4, 5, 6 and 8 h - Statistics:
- Statistical analyses (with the exception of Tmax statistical analyses) were
conducted by one-way ANOVA, with pairwise comparisons being conducted
by the Student-Newman-Keuls method. Statistical analyses of Tmax values were
conducted, as appropriate, by Kruskal-Wallis one-way ANOVA on Ranks, with
pairwise comparisons being conducted by Dunn’s method or Mann-Whitney
Rank Sum tests. p values < 0.05 were considered to be significant.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Tmax (Melamine) = 2h, Tmax (Cyanuric acid) = 1h
- Type:
- absorption
- Results:
- Cmax (serum, melamine) = 155 ng/ml; Cmax (serum, cyanuric acid) = 180 ng/ml
- Type:
- other: Elimination
- Results:
- t1/2 (melamine) = 3h, t1/2 (cyanuric acid) = 1.6h
- Type:
- distribution
- Results:
- AUC (melamine) = 920 - 990 ng - h/ml, AUC (cyanuric acid) = 500 - 700 ng-h/ml
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- In both male and female rats, the oral administration of melamine cyanurate complex afforded substantially lower
Cmax and AUC values than those determined in the animals exposed orally to the nearly equimolar amounts of the triazines contained in the complex. In addition, the Tmax occurred later and t1/2 values were longer in the rats administered melamine cyanurate. - Details on distribution in tissues:
- Distribution in tissues was not examined.
- Details on excretion:
- Elimination from the blood was examined.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Executive summary:
Although the oral coadministration of 1 mg/kg body weight of melamine and cyanuric acid did not alter significantly the pharmacokinetic profiles in relation to those determined upon individual oral administration of each compound, the administration of equal amounts of each triazine as the preformed melamine cyanurate complex significantly altered the pharmacokinetics, with reduced bioavailability of both compounds, lower observed maximum serum concentrations, delayed peak concentrations, and prolonged elimination half lives.
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