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EC number: 212-110-8 | CAS number: 763-32-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
It can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Isoprenol is considered to be non-mutagenic in this HPRT assay.
According to the results of the present study, the test substance 3-Methylbuten-3-ol-1 is not mutagenic in the Ames test under the experimental conditions chosen here.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.03.2010 - 17.05.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- HPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian liver microsome preparations (S9 mix)
- Test concentrations with justification for top dose:
- concentrations in μg/mL
Experiment I
without S9 mix: 55.0 110 220 440 880
with S9 mix: 55.0 110 220 440 880
Experiment II
without S9 mix: 55.0 110 220 330 440
with S9 mix: 55.0 110 220 440 880 - Vehicle / solvent:
- Culture medium
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Remarks:
- As solvent/vehicle is culture medium, untreated negative controls and negative solvent/vehicle controls are the same.
- Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
- Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent
increase of mutant frequencies using SYSTAT11 (SYSTAT Software, Inc., 501, Canal
Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological and statistical significance were considered together. - Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
Therefore, Isoprenol is considered to be non-mutagenic in this HPRT assay. - Executive summary:
The study was performed to investigate the potential of Isoprenol to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster.
The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a
treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation.
The highest concentration of the test item (880 μg/mL) was equal to a molar concentration of about 10 mM.
The tested concentrations are described in Table 2 (page 19). The evaluated experimental points and the results are summarised in Table 1 (page 13).
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.
Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test item and the activity of the metabolic activation system.
- 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:
- 1989-03-03 and 1989-03-09 (testing days)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP, four strains only.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate
- Remarks:
- positive control substance depending on tester strain and activation condition
- Details on test system and experimental conditions:
- Two independent experiments were carried out.
1st Experiment:
METHOD OF APPLICATION: in agar (plate incorporation)
Standard plate incorporation test with and without metabolic activation with S-9 mix prepared from liver homogenate of Aroclor 1254-pretreated Sprague-Dawley rats.
TEST CONCENTRATION: 0, 20, 100, 500, 2500 and 5000 µg/plate
SOLVENT: DMSO
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants
2nd Experiment
METHOD OF APPLICATION: preincubation;
Preincubation test with and without metabolic activation with S-9 mix prepared from liver homogenate of Aroclor 1254-pretreated Sprague-Dawley rats.
TEST CONCENTRATION: 0, 20, 100, 500, 2500 and 5000 µg/plate
SOLVENT: DMSO
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants - 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:
- cytotoxicity
- Remarks:
- >= 2500 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system. Positive control experiments gave the expected increase in the number of revertants.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Complete solubility of the test substance in DMSO.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect was observed only in the preincubation test without S-9 mix using TA 1537 and TA 98 at doses >= 2500 µg/plate . - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
According to the results of the present study, the test substance 3-Methylbuten-3-ol-1 is not mutagenic in the Ames test under the experimental conditions chosen here.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
It can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow
cells of the mouse. Therefore, Isoprenol is considered to be non-mutagenic in this micronucleus assay.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.04.2010 - 17.05.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- Since no gender specific differences concerning signs of toxicity in the pre-experiment were observed, the main study was performed using males only.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Age at start of experiment: 8-9 weeks
Mean inital body weight: 39.3 g (SD +/- 2.3 g)
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: single
Cage Type: Makrolon Type 111111, with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany)
Bedding: granulated soft wood bedding (Rettenmaier & Sohne GmbH + Co. KG, 73494 Rosenberg, Germany)
Feed: pelleted standard diet, ad libitum (Hartan Laboratories B.V. Postbus 6174,5960 AD Horst,The Netherlands)
Water: tap water, ad libitum, (Gemeindewerke, 64380 Rossdorf, Germany)
Environment: temperature 22 +/- 2 GC
relative humidity 45 - 65 %
artificial light 6.00 a.m. - 6.00 p.m. - Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- Details on exposure:
- At the beginning of the treatment the animals (including the controls) were weighed and the individual volume to be administered was adjusted to the animal's body weight. The animals received the test item, the vehicle or the positive control substance once orally.
- Frequency of treatment:
- Once
- Post exposure period:
- 24 h
Additional sample for the highest dose level at 48 h after treatment. - Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 7 males per group (5 for contol groups)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 5 males, 40 mg/kg b.w. cyclophosphamide administered orally was used as positive control.
- Tissues and cell types examined:
- Polychromatic erythrocytes
- Details of tissue and slide preparation:
- The animals were sacrificed using CO2 followed by bleeding. The femora were removed, the epiphyses were cut off and the marrow was flushed out with foetal calf serum using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant was discarded. A small drop of the re-suspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald.
At least one slide was made from each bone marrow sample. - Evaluation criteria:
- A test item is classified as mutagenic if it induces either a dose-related increase or a clear increase in the number of micronucleated polychromatic erythrocytes in a single dose group. A test item that fails to produce a biological relevant increase in the number of micronucleated polychromatic erythrocytes is considered non-mutagenic in this system.
- Statistics:
- Statistical significance at the five per ceAt level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
Therefore, Isoprenol is considered to be non-mutagenic in this micronucleus assay. - Executive summary:
This study was performed to investigate the potential of Isoprenol to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test item was formulated in corn oil, which was also used as vehicle control. The volume administered orally was 10 mLlkg b.w.. 24 hand 48 h after a single administration of the test item the bone marrow cells were collected for micronuclei analysis.
Seven males per test group (except the vehicle and positive control groups with 5 males each) were evaluated for the occurrence of micronuclei. Per animal 2000 polychromatic erythrocytes (PCEs) were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test item the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and reported as the number of PCEs per 2000 erythrocytes.
After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control thus indicating that Isoprenol
did not exert any cytotoxic effects in the bone marrow. In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used. Cyclophosphamide as positive control showed a substantial increase of induced micronucleus frequency.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The available information is conclusive but not sufficient for classification.
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.
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