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EC number: 204-068-4 | CAS number: 115-18-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-methylbut-3-en-2-ol
- EC Number:
- 204-068-4
- EC Name:
- 2-methylbut-3-en-2-ol
- Cas Number:
- 115-18-4
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-methylbut-3-en-2-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-methylbut-3-en-2-ol
- CAS No.: 115-18-4
- Batch No.: Abl. Nr. 79-1089
- Purity: 97.9 %
- Physical state: Colourless liquid
- Storage condition of test material: +4°C to +6°C
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, WIGA, D-W8741 Sulzfeld, FRG
- Weight at study initiation: mean ca. 27 g
- Assigned to test groups randomly:yes, under following basis: according to a randomization plan prepared with an appropriate computer program
- Housing: For the duration of about one week the animals were housed in Makrolon cages, type M III, in groups of 5; before the start of the treatment
the animals were transferred to Makrolon cages, type M I, and housed individually separately according to sex
- Diet: Standardized pelleted feed (Kliba Haltungsdiaet, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland); ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: aqua dest.
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
All test substance formulations were prepared immediately before administration.
The amount of substance or volume to be administered was related to the specific weight of the individual animals on the day of the experiment. - Duration of treatment / exposure:
- 16 h (high dose only), 24 h (all treatments), 48 h (high dose only)
- Frequency of treatment:
- once
- Post exposure period:
- 16, 24, 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 1500 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 20 mg/kg bw
Vincristine
- Route of administration: intraperitoneal injection
- Doses / concentrations: 0.15 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow of femora
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In a pretest, mortalitiy was observed down to a dose of 1750 mg/kg body weight whereas 1500 mg/kg body weight was survived by all animals. Therefore, a dose of 1500 mg/kg body weight was selected as the highest dose in the present cytogenetic study. 1000 mg/kg and 500 mg/kg body weight were administered as further doses.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields):
The animals of the negative control were sacrificed 24 hours after administration of the solvent. The control animals were treated at different times so that it was always possible to prepare control animals simultaneously for all the different sacrifice intervals of the test animals.
DETAILS OF SLIDE PREPARATION:
The two femora were prepared from the animals, and all soft tissues were removed. After cutting off the epiphyses, the bone marrow was flushed out of the diaphysis into a centrifuge tube using a cannula filled with fetal calf serum which was at 37°C (about 2 ml/ femur). The suspension was mixed thoroughly with a pipette, centrifuged at 1500 rpm for 5 minutes, the supernatant was removed except for a few drops, and the precipitate was resuspended. 1 drop of this suspension was dropped onto clean microscopic slides, using a Pasteur pipette. Smears were prepared using slides with ground edges, the preparations were dried in the air and subsequently stained.
Staining: The slides were stained in eosin and methylene blue solution for 5 minutes, rinsed in aqua dest . and then placed in fresh aqua dest. for 2 or 3 minutes. They were finally stained in Giemsa solution for 12 minutes. After being rinsed twice in aqua dest. and clarified in xylene, the preparations were embedded in Corbit-Balsam.
METHOD OF ANALYSIS:
In general, 1000 polychromatic erythrocytes from each of the male and female animals of every test group are evaluated and investigated for micronuclei by microscopic evaluation. - Statistics:
- A statistical evaluation was not necessary to perform. The number of polychromatic micronucleated erythrocytes after test substance treatment was nearly the range of the actual control value and within the historical values.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- irregular respiration, staggering, piloerection in all treatment groups
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Clinical signs of toxicity in test animals: Mortality was observed down to a dose of 1750 mg/kg body weight whereas 1500 mg/kg body weight was survived by all animals.
RESULTS OF DEFINITIVE STUDY
- Clinical signs of toxicity in test animals:
1500 mg/kg and 1000 mg/kg groups:
<15 minutes: irregular respiration, staggering, piloerection, in few cases abdominal position
30 min. up to 4 hours: abdominal position, narcotic like stage, shallow respiration, poor general state
1st day after administration: piloerection, in few cases apathy
2nd day after administration: in few cases piloerection
500 mg/kg group:
< 15 minutes: irregular respiration, piloerection
15 min. up to 4 hours: irregular respiration, piloerection, staggering, squatting posture
1st day after treatment: no signs or symptoms
- Ratio of PCE/NCE (for Micronucleus assay): the ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups
Any other information on results incl. tables
Results:
Test group | Interval: 16 h | |||
Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (‰) | ||
Dose (mg/kg bw) | polychromatic | normochromatic | ||
1500 | 10000 | 3565 | 2.0 | 1.4 |
Test group | Interval: 24 h | |||
Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (‰) | ||
Dose (mg/kg bw) | polychromatic | normochromatic | ||
vehicle control | 10000 | 3426 | 2.7 | 0.88 |
1500 | 10000 | 4945 | 2.7 | 1.82 |
1000 | 10000 | 4901 | 2 | 3.06 |
500 | 10000 | 5240 | 2 | 1.15 |
20; cyclophosphamide | 5000 | 2834 | 10.6 | 2.12 |
0.15; vincristine | 5000 | 3932 | 77.8 | 4.07 |
Test group | Interval: 48 h | |||
Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (‰) | ||
Dose (mg/kg bw) | polychromatic | normochromatic | ||
1500 | 10000 | 3124 | 3.1 | 1.92 |
Test substance preparation analysis:
Depending on the dose, about 90 - 97% of the theoretical values could be determined analytically.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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