Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-070-5 | CAS number: 115-19-5
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-04 - 1995-12-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol
- Author:
- BASG AG
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Remarks:
- Dept. of Toxicology, BASF AG
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-methylbut-3-yn-2-ol
- EC Number:
- 204-070-5
- EC Name:
- 2-methylbut-3-yn-2-ol
- Cas Number:
- 115-19-5
- Molecular formula:
- C5H8O
- IUPAC Name:
- 2-methylbut-3-yn-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Methyl-1-butyn-3-ol
- Date of manufacturing : February 8, 1994
- Test substance No.: 93/231
- Physical state: colorless to yellowish liquid
- Analytical purity: 99 .7 area%
- Lot/batch No.: Tank 7 + 8
- Storage condition of test material: room temperature
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, Germany
- Weight at study initiation: about 28 g
- Assigned to test groups randomly: yes, acc. randomization plan prepared with an appropriate computer program
- Housing:individually in Makrolon cages, type M I
- Diet (e.g. ad libitum): ad libitum, standardized pelleted feed (Kliba Haltungsdiät, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: about one week in Makrolon cages, type M III, in groups of 5 separately according to sex
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
ANALYSIS
- The feed used in the study was assayed for chemical and microbiological contaminants.
- The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and by the Technical Services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 10 ml
- Concentration of test material in vehicle: 30, 60, 120 mg/ml - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- 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:
- single intraperitoneal application
- Frequency of treatment:
- once
- Post exposure period:
- 24 - 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
300, 600 1200 mg/kg bw
Basis:
analytical conc.
- No. of animals per sex per dose:
- 5 for all test groups and negative controls;
2 male and 3 female for cyclophosphamide;
3 male and 2 female for vincristine - Control animals:
- yes
- Positive control(s):
- cyclophosphamide
- Route of administration: intraperitoneally
- Doses / concentrations: 20 mg/kg bw
vincristine
- Route of administration: intraperitoneally
- Doses / concentrations: 0.15 mg/kg bw
Examinations
- Tissues and cell types examined:
- polychromatic and normochromatic erythrocytes of bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In a pretest for the determination of the acute oral toxicity deaths were observed down to a dose of 1250 mg/kg body weight. Therefore, a dose of 1200 mg/kg body weight was selected as the highest dose in the present cytogenetic study. 600 mg/kg and 300 mg/kg body weight were administered as further doses.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Test Group - Sampling time - Dose
1 - 24 h - vehicle control
2 - 48 h - vehicle control
3 - 24 h - 300 mg/kg bw
4 - 24 h - 600 mg/kg bw
5 - 24 h - 1200 mg/kg bw
6 - 48 h - 1200 mg/kg bw
7 - 24 h - 20 mg/kg bw cyclophosphamide
8 - 24 h - 0.15 mg/kg bw vincristine
DETAILS OF SLIDE PREPARATION:
The bone marrow was prepared according to the method described by SCHMID, W . (1976, 1977):
- 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.
- 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. The normochromatic erythrocytes (= normocytes), which occur, are also scored.
- Evaluation criteria:
- - The increase in the number of micronuclei in polychromatic erythrocytes of treated animals as compared with the solvent control group provides an index of a chromosome-breaking (clastogenic) effect or of a spindle activity of the substance tested.
- The number of micronuclei in normochromatic erythrocytes at the early sacrifice intervals represents the situation before test substance administration and may serve as a control value.
- A substance-induced increase in the number of micronuclei in normocytes may be found with an increase in the duration of the sacrifice intervals.
- Ratio of polychromatic to normochromatic erythrocytes indicates an influence of the test substance specifically on the bone marrow . - Statistics:
- 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:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: down to a dose of 1,250 mg/kg bw
- Clinical signs of toxicity in test animals: 1/4 animals died
Any other information on results incl. tables
SUMMARY TABLE (MALES + FEMALES) : Polychromatic and normochromatic erythrocytes
Test group | Interval: 24 h | Interval: 48 h | ||||||
Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (%) | Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (%) | |||
Dose (mg/kg bw) | polychromatic | normochromatic | polychromatic | normochromatic | ||||
vehicle control | 10000 | 3833 | 1.5 | 0 | 10000 | 5140 | 1.5 | 0 |
300 | 10000 | 4351 | 0.9 | 1.4 | ||||
600 | 10000 | 3731 | 1.8 | 1.1 | ||||
1200 | 10000 | 3794 | 1.6 | 0.8 | 10000 | 4672 | 1.1 | 0.6 |
20, cyclophosphamide | 5000 | 2918 | 18.2** | 1.4 | ||||
0.15, vincristine | 5000 | 3332 | 82.8** | 3.6 |
Thus, the test substance 3-Methyl-l-butyn-3-ol did not lead to any increase in the rate of micronuclei. The number of normochromatic or polychromatic erythrocytes containing small micronuclei (d <= D/4) did not deviate from the solvent control value at any of the sacrifice intervals. Nor were large micronuclei (d > D/4) observed either in the negative control group or in the three dose groups of 3-Methyl-l-butyn-3-ol. No inhibition of erythropoiesis induced by the treatment of mice with 3-Methyl-l-butyn-3-ol was detected; the ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups.
CLINICAL EXAMINATIONS
- The single intraperitoneal administration of the vehicle in a volume of 10 ml/kg body weight was tolerated by all animals without any signs or symptoms.
- Doses of 300 mg/kg or 600 mg/kg body weight led to staggering about 30 minutes - 1 hour after 'test substance administration.
- In the 1,200 mg/kg group abdominal position, shallow respiration and a narcotic-like state were observed after about 30 minutes - 6 hours after treatment of the animals.
- Neither the single administration of the positive control substance cyclophosphamide in a dose of 20 mg/kg bw nor that of vincristine in a dose of 0 .15 mg/kg body weight caused any evident signs of toxicity .
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the experimental conditions chosen here, the test substance 3-Methyl-1-butyn-3-ol has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.