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EC number: 619-020-1 | CAS number: 94361-06-5
- 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:
- 3 Dec 1984 to 19 Dec 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 2000
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
- Cas Number:
- 94361-06-5
- Molecular formula:
- C15H18ClN3O
- IUPAC Name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Remarks:
- random
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: not reported
- Housing: Animals were group-housed up to 20 mice per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days
IN-LIFE DATES: 3 Dec 1984 to 19 Dec 1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: DMSO
- Frequency of treatment:
- Single dose
- Post exposure period:
- Test group: 24, 48 and 72 hours.
Control animals: 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 16.7 mg/kg diet
- Remarks:
- Low dose
- Dose / conc.:
- 55.7 mg/kg diet
- Remarks:
- Mid dose
- Dose / conc.:
- 167 mg/kg diet
- Remarks:
- High dose
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Cyclophosphamide (CP)
- Route of administration: intraperitoneal injection
- Doses: 100 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow, Polychromatic erythrocytes (PCEs) and the number of mature erythrocytes (RBCs)
- Details of tissue and slide preparation:
- BONE MARROW EXTRACTION:
Animals were killed with CO2 or by cervical dislocation and the adhering soft tissue and epiphyses of both tibiae were removed. The marrow was flushed from the bone and transferred to centrifuge tubes containing 3 mL fetal calf serum (one tube for each animal).
DETAILS OF SLIDE PREPARATION:
Following centrifugation to pellet the tissue, the supernatant was drawn off, the cells resuspended in a drop of serum, and the suspension spread on slides and air-dried. The slides were then fixed in methanol, stained in May-Gruenwald solution followed by Giemsa, and rinsed in deionized water (Schmid, 1975).
METHOD OF ANALYSIS:
One thousand PCEs per animal were scored. The frequency of micronucleated cells was expressed as percent micronucleated cells based on the total PCEs present in the scored optic field. The frequency of PCEs versus mature RBCs was determined by scoring the number of mature erythrocytes (RBCs) observed in the optic fields while scoring the first 1000 PCEs for micronuclei. For control of bias, all slides were coded prior to scoring. - Evaluation criteria:
- The criteria for the identification of micronuclei were those of Schmid (1976). Micronuclei were darkly stained and generally round, although almond and ring-shaped micronuclei occasionally occur. Micronuclei had sharp borders and were generally between 1/20 and 1/5 the size of the PCE. The unit of scoring was the micronucleated cell, not the micronucleus; thus the occasional cell with more than one micronucleus was counted as one micronucleated PCE, not two (or more) micronuclei. The staining procedure permitted the differentiation by colour of polychromatic and normochromatic erythrocytes (bluish-grey and red, respectively).
- Statistics:
- Two-tailed student's t-test
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Animals exposed to test substance showed no significant increase in micronucleus frequency at any dose level, kill-time or sex. In addition no increase in the numbers of micronuclei was observed when the data for both sexes were pooled. The positive control, cyclophosphamide, induced a large and statistically significant increase in the frequencies of micronuclei (p ≤ 0.02 for males, p ≤ 0.01 females).
Any other information on results incl. tables
Table 1. Mean percentage (±SD) of micronucleated PCEs in mouse bone marrow
Test substance (concentration) |
Sex |
24 hours |
48 hours |
72 hours |
167 mg/kg
|
Males Females Mean |
0.32 ± 0.12 0.10 ± 0.06 0.21 ± 0.07
|
0.28 ± 0.11 0.06 ± 0.05 0.16 ± 0.06
|
0.40 ± 0.40 0.18 ± 0.08 0.24 ± 0.11
|
55.7 mg/kg
|
Males Females Mean
|
0.30 ± 0.14 0.16 ± 0.05 0.23 ± 0.07
|
0.16 ± 0.11 0.06 ± 0.02 0.11 ± 0.06
|
0.25 ± 0.07 0.10 ± 0.00 0.17 ± 0.04
|
16.7 mg/kg
|
Males Females Mean
|
0.14 ± 0.05 0.26 ± 0.14 0.20 ± 0.07
|
0.44 ± 0.20 0.26 ± 0.14 0.35 ± 0.12 |
0.24 ± 0.14 0.18 ± 0.04 0.21 ± 0.07 |
Negative control Vehicle (DMSO) |
Males Females Mean |
0.10 ± 0.05 0.34 ± 0.06 0.22 ± 0.05 |
|
|
Positive control Cyclophosphamide |
Males Females Mean |
1.94 ± 0.41* |
|
|
*) p ≤ 0.02 **) p ≤ 0.01
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce any significant increase in micronucleus frequencies in bone marrow polychromatic erythrocytes of the mouse. Therefore, the test substance was considered inactive under the conditions of this assay
- Executive summary:
The test substance was evaluated for its ability to induce micronuclei in polychromatic erythrocytes (PCE’s) of male and female Swiss mouse bone marrow in a study following GLP principles and performed similar to OECD TG 474. Dose selection was based upon the LD50 (200 mg/kg for male mice and 218 mg/kg for female mice), using 80% of the combined LD50 for both sexes. Groups of 5 animals per sex per dose were received a single dose of 167.0, 55.7 and 16.7 mg/kg bw via oral gavage. The test substance was dissolved in Dimethylsulfoxide (DMSO). The positive control received an intraperitoneal injection of Cyclophosphamide (CP) at 100 mg/kg. Groups of animals were killed 24, 48 and 72 hours after administration of the test substance, the vehicle control and the positive control.
Results showed that animals exposed to the test substance showed no significant increase in micronucleus frequency at any dose level, kill time or sex. Also, no elevation of the numbers of micronuclei was observed if the data for the sexes are pooled. The positive control compound, cyclophosphamide (CP), induced large and statistically significant increases in the frequencies of micronuclei (p 0.02 ≤ males, p ≤ 0.01 females).
The test substance did not induce any significant increase in micronucleus frequencies in bone marrow polychromatic erythrocytes of the mouse. The test substance showed no mutagenicity under the conditions of this assay.
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