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EC number: 605-140-1 | CAS number: 158237-07-1
- 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:
- supporting study
- Study period:
- 28 Feb - 26 Apr 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 29 Jul 2016
- Deviations:
- yes
- Remarks:
- yes, sampling of the negative control only once at the latest sampling time point, only one dose < 2000 mg/kg bw tested, plasma levels of test substance not determined, only 1000 polychromatic erythrocytes counted instead of 4000
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
- EC Number:
- 605-140-1
- Cas Number:
- 158237-07-1
- Molecular formula:
- C16H20ClN5O2
- IUPAC Name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
1
Test animals
- Species:
- mouse
- Strain:
- other: Hsd/Win: NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single administration
- Post exposure period:
- 16, 24 and 48 h
Doses / concentrations
- Dose / conc.:
- 1 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide dissolved in deionized water
- Route of administration: intraperitoneal
- Doses / concentrations: 20 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Evaluation criteria:
- - A test was considered positive if, at any of the intervals, there was a relevant and significant increase in the number of polychromatic erythrocytes showing micronuclei in comparison to the negative control.
- A test was considered negative if there was no relevant or significant increase in the rate of micronucleated polychromatic erythrocytes at any time.
- A test was also considered negative if there was a significant increase in that rate which, according to the laboratory's experience was within the range of negative controls.
- A test was considered equivocal if there was an increase of micronucleated polychromatic erythrocytes above the range of attached historical negative controls, provided the increase was not significant and the result of the negative control was not closely related to the data of the respective treatment group. In this case, a second test had to be performed at the most sensitive interval. - Statistics:
- - Number of polychromatic erythrocytes having micronuclei and the number of normochromatic erythrocytes were checked by Wilcoxon's non-parametric rank sum test.
- The rate of normochromatic erythrocytes containing micronuclei was examined if the micronuclear rate for polychromatic erythrocytes was already relevantly increased. In this case, the group with the highest mean was compared with the negative control using the one-sided chiz-test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- indicated by apathy, roughened fur, staggering gait, difficulty in breathing, eyelids stuck together, slitted eyes and diarrhoea.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
PCE/NCE ratio:
The ratio of polychromatic (PCE) to normochromatic erythrocytes (NCE) was altered by the treatment, being 1000: 798 (1s=493) in the negative control, 1000: 1130 (1s=302) in the 16 h group, 1000: 1982
(1s=2099) in the 24 h group and 1000: 2483 (ls=528) in the 48 h group.
Micronuclei formation:
No biologically important or statistically significant variations existed between the negative control and the groups treated intraperitoneally with the test substance, with respect to the incidence of micronucleated polychromatic erythrocytes. The incidence of these micronucleated cells was 1.8/1000 (1s=1.2) in the negative control, and 2.2/1000 (1s=1.9), 1.6/1000 (1s=1.0) and 1.8/1000 (1s=1.8) in the treated groups. The positive control caused a clear in crease in the number of polychromatic erythrocytes with micronuclei indictaed by an incidence of micronucleated cells of 12.2/1000 (1s=3.6), which represents a biologically relevant increase in comparison to the negative control.
Applicant's summary and conclusion
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