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EC number: 276-344-2 | CAS number: 72102-84-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- BOLLER, K. and W. SCHMID (1970), Chemische Mutagenese beim Säuger.
Das Knochenmark des Chinesischen Hamsters als in vivo-Testsystem.
Hamatologische Befunde nach Behandlung mit Trenimon.
Humangenetik 11, 35-54.
MATTER, B. and W. SCHMID (1971), Trenimon-Induced Chromosomal
Damage in Bone Marrow Cells of Six Mammalian Species, Evaluated
by the Micronucleus Test.
Mutation Res. 12, 417-425.
MULLER, D., M. LANGAUER, R. RATHENBERG, F.F. STRASSER and
R. HESS (1972), Mikrokerntest sowie Chromosomenuntersuchungen
an somatischen und gonosomalen Zellen des Chinesischen Hamsters
nach Cyclophosphamidgabe.
Verh. Dtsch. Ges. Path. 56, 381-384. - GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- EC Number:
- 276-344-2
- EC Name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- Cas Number:
- 72102-84-2
- Molecular formula:
- C12H10N6O4
- IUPAC Name:
- 5-[(1E)-2-(6-methyl-2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)diazen-1-yl]-1,3-diazinane-2,4,6-trione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: EN 63699
Test animals
- Species:
- hamster
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: female 21-27 g, male 23-28 g
- Fasting period before study: no data
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-24
- Humidity (%): 62-68
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC0.5%
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Mixing appropriate amounts with (Type of food): CMC - Duration of treatment / exposure:
- 2d
- Frequency of treatment:
- daily
- Post exposure period:
- 24h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 3 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (ENDOXAN ): 128 mg/kg in 20 ml/kg in 0.5% CMC
Examinations
- Tissues and cell types examined:
- Bone marrow was harvested from the shafts of both femurs
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: acute oral toxicity study
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): The preparation was administered orally to groups of 6 female and 6 male animals each. Treatment consisted of daily one application on 2 consecutive days. 24 h after the second application the animals were sacrificed by dislocation of the cervical vertebrae.
DETAILS OF SLIDE PREPARATION: In a siliconized pipette filled with approx. 0.5 µL rat serum the bone marrow was drawn up. In order to receive a homogeneous suspension the content of pipette was aspirated gently about three times. Small drops of the mixture were transferred on the end of a slide, spread out by pulling it behind a polished cover glass and the preparations were air-dried. Three hours later, the slides were stained in undiluted May-Griinwald solution for 2 min then in May-Griinwald solution/water 1/1 for 2 min and then in Giemsa's, 40% for 20 min. After being rinsed in methanol 55% for 5-8 sec and washed off twice in water, they were left immersed in water for approx. 2 min. After rinsing with distilled 'water and air-drying, the slides were cleared in Xylol and mounted in Eukitt.
METHOD OF ANALYSIS: The slides of three female and three male animals each of the negative control group, the positive control group and of the
groups treated with various doses of the test item were examined. 1000 bone marrow cells each were scored per animal and the following
anomalies were registered:
a) Single Jolly bodies,
b) fragments of nuclei in erythrocytes,
c) micronuclei in erythroblasts,
d) micronuclei in leucopoietic cells, e) polyploid cells. - Statistics:
- The significance of difference was assessed by chi-sqare~test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
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