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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity:
- in vitro: negative (OECD 471, OECD 476)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.10.1980 - 16.10.1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Method: in compliance with Ames B.N.et al., Proc. Nat. Acad. Sci., USA, 70, 2281-2285, (1973) and Mut. Res. 31, 347 -364, (1975)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- 4, 20, 100, 500, 2500 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 500 µg/plate dissolved in water; for TA100, TA 1535 - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 10µg/plate dissolved in DMSO; for TA100, TA98, TA1538, TA1537, TA1535
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 5 µg/plate dissolved in DMSO; for TA98, TA100, TA1535 - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylendiamin, 10µg/plate dissolved in DMSO; for TA1538
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-Aminoaeridiniumchloride monohydrate, 100 µg/plate dissolved in DMSO; for TA1537
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h, 37°C
NUMBER OF REPLICATIONS: 4 - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HPRT-locus
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 1st Experiment
without S9 mix (4-hour exposure period)
0; 6.25; 12.5; 25.0; 50.0; 100.0; 150.0; 200.0 µg/mL
with S9 mix (4-hour exposure period)
0; 1.25; 2.5; 5.0; 10.0; 15.0; 20.0; 30.0 µg/mL
2nd Experiment (requirements of the OECD Guideline 476 were failed)
without S9 mix (24-hour exposure period)
0; 6.25; 12.5; 25.0; 50.0; 100.0; 150.0; 200.0 µg/mL
with S9 mix (4-hour exposure period)
0; 1.25; 2.5; 5.0; 10.0; 15.0; 17.5; 25.0 µg/mL
3rd Experiment
without S9 mix (24-hour exposure period)
0; 12.5; 25.0; 50.0; 100.0; 200.0; 300.0; 400.0 µg/mL
with S9 mix (4-hour exposure period)
0; 0.63; 1.25; 2.5; 5.0; 10.0; 15.0; 17.5; 20.0 µg/mL - Vehicle / solvent:
- culture medium (Ham's F12)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Details on test system and experimental conditions:
- After an attachment period of 20 - 24 hours and a treatment period of 4 hours both with and without metabolic activation and 24 hours without metabolic activation, an expression phase of about 6 - 8 days and a selection period of about 1 week followed. The colonies of each test group were fixed with methanol, stained with Giemsa and counted.
- Statistics:
- Due to the clearly negative findings, a statistical evaluation was not carried out.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions chosen, the conclusion is drawn that Propargyl alcohol highly conc. is not a mutagenic substance in the HPRT locus assay using CHO cells in the absence and the presence of metabolic activation. - Executive summary:
The substance Propargyl alcohol highly conc. was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro. Three independent experiments were carried out, with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). The vehicle controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, EMS and MCA, led to the expected increase in the frequencies of forward mutations.
In this study, in the 1st and 3rd Experiment in the absence and presence of metabolic activation the highest concentrations tested for gene mutations were clearly cytotoxic.
On the basis from the results of the present study, the test substance did not cause any relevant increase in the mutant frequencies both either without S9 mix or after adding a metabolizing system in two valid experiments performed independently of each other.
Thus, under the experimental conditions of this study, the test substance Propargyl alcohol highly conc. is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.
Referenceopen allclose all
Results:
Dose µg/plate | metabolic activation | TA98 | TA100 | TA1535 | TA1537 | TA1538 | |||||||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 1 | Trial 2 | Trial 3 | Trial 4 | ||
0 | + | 34 | 40 | 31 | 38 | 117 | 112 | 128 | 121 | 10 | 12 | 13 | 12 | 5 | 5 | 6 | 6 | 20 | 18 | 23 | 16 |
4 | + | 32 | 34 | 38 | 35 | 115 | 127 | 127 | 113 | 14 | 11 | 13 | 10 | 2 | 5 | 7 | 4 | 24 | 23 | - | 21 |
20 | + | 38 | 28 | 35 | 32 | 119 | 129 | 114 | 116 | 10 | 15 | 13 | 8 | 3 | 5 | - | 4 | 18 | 24 | 17 | 23 |
100 | + | 41 | 29 | 43 | 37 | 107 | 125 | 121 | 107 | 13 | 12 | 12 | 13 | 5 | 6 | 6 | 7 | 16 | 11 | 22 | 14 |
500 | + | 42 | 33 | 44 | 40 | 111 | 124 | 114 | 117 | 11 | 12 | 13 | 18 | 4 | 4 | 6 | 5 | 20 | 16 | 20 | 19 |
2500 | + | 28 | 30 | 41 | 45 | 143 | 98 | 129 | 113 | 18 | 13 | 7 | 11 | 7 | 4 | 7 | 5 | 18 | 25 | 25 | 24 |
10 2-Aminoanthracene | + | 870 | 910 | 830 | 925 | 1740 | 1830 | 1650 | 1550 | 225 | 197 | 194 | 203 | 149 | 128 | 140 | 157 | 230 | 269 | 177 | 165 |
500 Cyclophosphamid | + | 221 | 219 | 213 | 218 | 132 | 122 | 126 | 106 | ||||||||||||
0 | - | 25 | 24 | 20 | 28 | 122 | 149 | 133 | 114 | 13 | 9 | 13 | 11 | 6 | 7 | 4 | 5 | 12 | 10 | 14 | 15 |
4 | - | 23 | 28 | 29 | 24 | 126 | 122 | 138 | 114 | 13 | 8 | 10 | 10 | 6 | 7 | 5 | 4 | 11 | 12 | 11 | 10 |
20 | - | 28 | 27 | 24 | 26 | 129 | 115 | 124 | 120 | 8 | 13 | 9 | 10 | 7 | 5 | 8 | 4 | 14 | 12 | 9 | 12 |
100 | - | 22 | 33 | 21 | 27 | 123 | 127 | 108 | 141 | 11 | 11 | 14 | 14 | 5 | 5 | 4 | 5 | 13 | 11 | 12 | 17 |
500 | - | 22 | 31 | 25 | 25 | 120 | 134 | 103 | 117 | 10 | 16 | 14 | 18 | 7 | 5 | 7 | 4 | 11 | 13 | 11 | 11 |
2500 | - | 25 | 23 | 20 | 23 | 107 | - | 138 | 135 | 15 | 14 | 13 | 15 | 4 | 3 | 6 | 3 | 11 | 12 | 12 | 13 |
5 MNNG | - | 1640 | 1770 | 1350 | 1480 | 2800 | 3200 | 2300 | 2700 | 2800 | 2750 | 2650 | 2450 | ||||||||
10 4-Nitro-o-phenylendiamin | - | 263 | 278 | 246 | 250 | ||||||||||||||||
100 9-Aminoacridiniumchloride monohydrate | - | 287 | 258 | 263 | 309 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Genetic toxicity:
- in vivo: negative (OECD 474)
Link to relevant study records
- 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)
- 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
- 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. - 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
- 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 - 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 .
- 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 - 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.
Reference
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 .
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro was analyzed in a study performed in large part equivalent to OECD guideline 471 (BASF, 1980). Bacteria S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538 were treated with concentrations of 4, 20, 100, 500, 2500 ug/plate with and without metabolic activation by a rat liver S9 mix. As result, no genetic toxicity was observed.
The same negative result was found in a similar study, where bacteria S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538 were treated with a saturated vapor containing 51721 ppm 2-methylbut-3-yn-2-ol with and without metabolic activation by Aroclor 1254-induced rat liver S9 mix (Dow Chemical, 1980).
The substance Propargyl alcohol highly conc. (read across; CAS 107 -19 -7) was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro (BASF SE; 2010). A detailed read across justification is added in chapter 13. Three independent experiments were carried out, with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation).The vehicle controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, EMS and MCA, led to the expected increase in the frequencies of forward mutations.
In this study, in the 1st and 3rd Experiment in the absence and presence of metabolic activation the highest concentrations tested for gene mutations were clearly cytotoxic. The test substance did not cause any relevant increase in the mutant frequencies both either without S9 mix or after adding a metabolizing system in two valid experiments performed independently of each other.
To evaluate the genetic toxicity in vivo, a micronucleus test conducted according OECD guideline 474 was taken into account (BASF, 1995). In this study, NMRI mice received a single intraperitoneal injection of 300, 600 1200 mg/kg bw. After the preparation and scoring of the polychromatic and normochromatic erythrocytes of bone marrow, no clastogenic effect nor any impairment of chromosome distribution in the course of mitosis were found (BASF, 1995).
Justification for classification or non-classification
Classification for genetic toxicity is not warranted according to the criteria of Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.