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EC number: 939-621-5 | CAS number: -
- 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 vitro
Administrative data
- 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:
- June 21 to 22, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study performed according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alcohols, C16-20-branched
- EC Number:
- 274-758-8
- EC Name:
- Alcohols, C16-20-branched
- Cas Number:
- 70693-04-8
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Alcohols, C16-20-branched
- Details on test material:
- - Name of test material (as cited in study report): ISOFOL 18T
- Substance type: pure active substance
- Physical state: colourless liquid
- Lot/batch No.: 0183/MA
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver homogenate from Arochlor-1254 induced rats
- Test concentrations with justification for top dose:
- 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (50 µg/ml) for Salmonella typhimurium TA100 and TA 1535; 2-Nitrofluorene (50 µg/ml) for Salmonella typhimurium TA98; 9-Aminoacridine (1000 µg/ml) for Salmonella typhimurium TA1537; Methyl methanesulfonate (1% v/v) for E. coli WP2 uvrA
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (10 µg/ml) for Salmonella typhimurium TA 100, TA98, TA1535 and TA1537; 2-Aminoanthracene (100 µg/ml) for E. coli strain WP2 uvrA)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- test on cytotoxicity only on Salmonella thyphimurium strain TA 100 and E. Coli WP2 uvrA in a preliminary test at concentrations of 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate; evaluation of toxicity based on 1. revesion frequency, 2. viability and 3. integrity of the background
OTHER EXAMINATIONS:
Other:
- verification of genetic markers of test strains; histidine requirement, crystal violet sensitivity, ampicillin resistence, ultraviolet sensitivity and spontaneous reversion rates for Salmonella typhimurium; tryptophan requirment and sensitivity to Mitomycin C and ampicillin resistance for E. coli strain
- Determination of the exact cell concentration at the initiation of the test by a % transmittance reading at 650 nm and verification by plate count determination - Evaluation criteria:
- A positive response is considered if there is a statistically significant difference (at p ¿ 0.05) in the number of revertants between the solvent control and the test article; and either strain TA98 or TA100 responds to a dose that produces a mean reversion frequency of the corresponding solvent control plates, or if strains TA 1535, TA1537, WP2 uvrA respond to a dose producing a threefold increase in the mean reversion frequency. In addition, the response must be dose-dependent or increasing concentrations of the test article must show increasing mean reversion frequencies. In evaluating the results, consideration is given to the degree of toxicity exhibited by the dose causing the twofold/threefold or greater increase in reversion frequency and the magnitude of the increase in reversion frequency.
A negative response is considered if there is no statistically significant difference (at p=0.05) in the number of revertants between the solvent control and the test article. A response is considered negative if strains TA98 and TA100 respond to a dose that produces mean reversion frequencies that are less than twice that of the mean reversion frequencies of the corresponding solvent control plates; strains TA1535, TA1537, WP2 uvrA respond to a dose producing reversion frequencies that are less than three times that of the corresponding solvent control plates, and there is no evidence of a dose-dependent response.
A response is considered equivocal if it does not fulfil the criteria of either a negative or a positive response and/or the Study Director does not consider the response to be either positive or negative. - Statistics:
- One Way Analysis of Variance
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
preliminary screening test with 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate on tester strains Salmonella typhimurium TA100 and E. coli WP2 uvra. The test article was found to be non cytotoxic at these dose levels for both stains.
Any other information on results incl. tables
Table 1: No. of revertants (mean values and standard deviations; MA = metabolic activation) | |||||
S. typhimurium TA98 | |||||
- MA | + MA | ||||
Concentration (mg/plate) | 1. experiment | 2. experiment | 1. experiment | 2. experiment | |
ethanol | 45 ± 3.5 | 41 ± 2.1 | 47 ± 1.7 | 49 ± 4.2 | |
0.05 | 47 ± 1.0 | 42 ± 1.5 | 46 ± 0.6 | 49 ± 7.2 | |
0.1 | 44 ± 3.8 | 41 ± 6.7 | 43 ± 1.5 | 49 ± 6.4 | |
0.5 | 40 ± 2.0 | 41 ± 4.5 | 46 ± 1.0 | 48 ± 7.5 | |
1.0 | 44 ± 3.5 | 41 ± 0.0 | 44 ± 1.7 | 51 ± 3.8 | |
5.0 | 47 ± 1.2 | 38 ± 2.6 | 44 ± 1.2 | 51 ± 5.5 | |
positive control | 1092 ± 42.1 | 1056 ± 48.0 | 831 ± 25.7 | 816 ± 96.0 | |
S. typhimurium TA100 | |||||
- MA | + MA | ||||
Concentration (mg/plate) | 1. experiment | 2. experiment | 1. experiment | 2. experiment | |
ethanol | 131 ± 6.1 | 124 ± 6.7 | 124 ± 4.0 | 127 ± 10.1 | |
0.05 | 129 ± 0.6 | 125 ± 5.0 | 122 ± 2.1 | 123 ± 9.5 | |
0.1 | 128 ± 1.7 | 129 ± 0.6 | 125 ± 1.2 | 121 ± 11.0 | |
0.5 | 131 ± 6.4 | 125 ± 6.4 | 124 ± 4.0 | 126 ± 9.2 | |
1.0 | 131 ± 4.6 | 127 ± 1.0 | 123 ± 4.9 | 124 ± 3.8 | |
5.0 | 123 ± 4.4 | 117 ± 10.1 | 123 ± 6.1 | 121 ± 19.2 | |
positive control | 1287 ± 77.7 | 1125 ± 82.1 | 943 ± 26.6 | 961 ± 12.2 | |
S. typhimurium TA1535 | |||||
- MA | + MA | ||||
Concentration (mg/plate) | 1. experiment | 2. experiment | 1. experiment | 2. experiment | |
ethanol | 19 ± 2.1 | 23 ± 3.2 | 17 ± 2.1 | 14 ± 3.8 | |
0.05 | 21 ± 8.5 | 22 ± 2.9 | 22 ± 4.0 | 13 ± 1.7 | |
0.1 | 13 ± 1.2 | 25 ± 3.8 | 12 ± 0.6 | 15 ± 1.7 | |
0.5 | 16 ± 0.6 | 26 ± 3.6 | 17 ± 3.2 | 16 ± 3.1 | |
1.0 | 13 ± 3.2 | 25 ± 4.9 | 18 ± 3.8 | 15 ± 3.0 | |
5.0 | 19 ± 4.0 | 23 ± 1.7 | 22 ± 1.7 | 21 ± 1.0 | |
positive control | 1205 ± 56.2 | 1190 ± 76.8 | 82 ± 5.7 | 88 ± 1.5 | |
S. typhimurium TA1537 | |||||
- MA | + MA | ||||
Concentration (mg/plate) | 1. experiment | 2. experiment | 1. experiment | 2. experiment | |
ethanol | 16 ± 1.2 | 16 ± 3.5 | 14 ± 2.0 | 18 ± 1.0 | |
0.05 | 16 ± 2.9 | 19 ± 3.1 | 14 ± 3.1 | 18 ± 2.3 | |
0.1 | 18 ± 1.0 | 16 ± 3.5 | 13 ± 2.5 | 18 ± 4.0 | |
0.5 | 14 ± 4.0 | 15 ± 1.0 | 15 ± 2.0 | 17 ± 2.9 | |
1.0 | 16 ± 2.6 | 19 ± 4.2 | 15 ± 2.1 | 16 ± 4.0 | |
5.0 | 15 ± 3.0 | 15 ± 1.7 | 14 ± 1.5 | 13 ± 4.9 | |
positive control | 1291 ± 33.3 | 1257 ± 26.6 | 33 ± 3.5 | 34 ± 4.4 | |
E. coli WP2 uvrA | |||||
- MA | + MA | ||||
Concentration (mg/plate) | 1. experiment | 2. experiment | 1. experiment | 2. experiment | |
ethanol | 30 ± 5.6 | 28 ± 3.5 | 32 ± 8.4 | 34 ± 11.9 | |
0.05 | 27 ± 2.1 | 28 ± 1.7 | 34 ± 5.1 | 35 ± 8.7 | |
0.1 | 27 ± 3.8 | 29 ± 3.5 | 31 ± 2.1 | 33 ± 4.5 | |
0.5 | 28 ± 8.7 | 29 ± 6.2 | 41 ± 5.5 | 35 ± 7.2 | |
1.0 | 23 ± 3.0 | 28 ± 1.5 | 33 ± 6.4 | 32 ± 2.9 | |
5.0 | 25 ± 3.8 | 25 ± 7.6 | 34 ± 4.0 | 31 ± 9.5 | |
positive control | 477 ± 16.7 | 530 ± 62.0 | 96 ± 7.6 | 103 ± 2.6 | |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study under the experimental conditions alcohols 16-20, branched do not induce gene mutations by base pair
changes or frameshifts in the genome and are therefore not mutagenic. - Executive summary:
Based on the results of this study under the experimental conditions alcohols 16-20, branched do not induce gene mutations by base pair
changes or frameshifts in the genome and are therefore not mutagenic.
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