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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 216-509-8 | CAS number: 1604-34-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology BASF AG
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6,10-dimethylundecan-2-one
- EC Number:
- 216-509-8
- EC Name:
- 6,10-dimethylundecan-2-one
- Cas Number:
- 1604-34-8
- Molecular formula:
- C13H26O
- IUPAC Name:
- 6,10-dimethylundecan-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tetrahydrogeranylaceton
- Substance No.: 01/0275-1
- Batch-Nr.: B 633
- Purity: 97.5 area% (GC)
- Date of production: 17 Oct 2000
- Substance type: Liquid / colourless - clear
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF, Batch No. B 633
- Purity: 97.5 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Appearance, consistency: colorless liquid
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Method
- Target gene:
- his, trp
Species / strainopen allclose all
- 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:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9-mix
- Test concentrations with justification for top dose:
- SPT: 20, 100, 500, 2500 and 5000 µg/plate;
PIT: 4, 20, 100, 500 and 2500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the Iimited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 4-nitro-o-phenylendiamine (NOPD)
- Remarks:
- Positive control substance with S9-mix: 2-aminoanthracene (2-AA); 2.5 µg/plate, dissolved in DMSO, strains: TA1535, TA100, TA1537, TA98; 60 µg/plate, dissolved in DMSO, strain: E.coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 - 72 h, 37°C
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontanous mutation rate in at least one tester strain eitherwithout S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out
independently of each other
Generally, the experiment is considered valid if the following criteria are met:
- The number of revertant colonies in the negative controls was within the normal range of the historical data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control articles both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical control data.
- The titer of viable bacteria was >= 10^9/mL.
Results and discussion
Test resultsopen allclose all
- 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:
- other: SPT: >= 500 µg/plate, PIT >= 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- PIT >=2 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weak bacteriotoxic effect (slight decrease in the number of revertants and/or reduction in the titer) was observed in the standard plate test depending on the strain and test conditions from about 500 µg - 2500 µg/plate onward.
In the preincubation assay bacteriotoxicity (reduced background growth, slight decrease in the number of revertants, slight reduction in the titer) was observed depending on the strain and test conditions at doses of about >= 500 µg/plate.
Solubility:
No test substance precipitation was found.
Any other information on results incl. tables
Results:
Standard plate test:
Dose µg/plate | metabolic activation | TA98 | TA100 | TA1535 | TA1537 | E.coli WP2 uvr A | ||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||
0 | + | 35 | 40 | 36 | 141 | 123 | 139 | 17 | 19 | 22 | 11 | 12 | 10 | 27 | 29 | 27 |
20 | + | 30 | 27 | 32 | 113 | 119 | 120 | 17 | 16 | 19 | 13 | 11 | 7 | 24 | 27 | 28 |
100 | + | 26 | 24 | 23 | 124 | 103 | 114 | 16 | 14 | 16 | 10 | 8 | 7 | 26 | 22 | 33 |
500 | + | 24 | 20 | 20 | 109 | 98 | 93 | 15 | 15 | 15 | 10 | 8 | 7 | 27 | 28 | 23 |
2500 | + | 16 | 21 | 18 | 57 | 43 | 73 | 16 | 20 | 12 | 6 | 7 | 5 | 17 | 21 | 20 |
5000 | + | 16 | 10 | 19 | 32 | 53 | 36 | 14 | 12 | 10 | 5 | 4 | 5 | 18 | 20 | 17 |
2.5 µg 2-Aminoanthracene | + | 651 | 570 | 570 | 649 | 638 | 636 | 202 | 213 | 207 | 99 | 89 | 103 | |||
60 µg 2-Aminoanthracene | + | 200 | 216 | 222 | ||||||||||||
0 | - | 24 | 28 | 29 | 102 | 104 | 111 | 19 | 16 | 17 | 7 | 10 | 10 | 30 | 25 | 27 |
20 | - | 25 | 22 | 18 | 107 | 111 | 106 | 17 | 15 | 19 | 7 | 3 | 9 | 26 | 21 | 26 |
100 | - | 23 | 24 | 19 | 110 | 122 | 111 | 18 | 14 | 19 | 6 | 9 | 5 | 21 | 19 | 22 |
500 | - | 19 | 21 | 20 | 93 | 88 | 97 | 16 | 13 | 16 | 7 | 7 | 8 | 25 | 21 | 26 |
2500 | - | 14 | 17 | 15 | 98 | 81 | 71 | 14 | 16 | 14 | 7 | 9 | 5 | 21 | 20 | 19 |
5000 | - | 14 | 13 | 11 | 54 | 44 | 59 | 10 | 13 | 11 | 5 | 5 | 4 | 19 | 21 | 20 |
5 µg MNNG | - | 683 | 633 | 513 | 632 | 572 | 652 | |||||||||
10 µg 4-Nitro-o-phenylendiamin | - | 722 | 682 | 703 | ||||||||||||
100 µg 9-amninoacridine | - | 411 | 420 | 463 | ||||||||||||
5 µg 4-nitroquinoline-N-oxide | - | 460 | 473 | 409 |
Preincubation test:
Dose µg/plate | metabolic activation | TA98 | TA100 | TA1535 | TA1537 | E.coli WP2 uvra | ||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||
0 | + | 32 | 34 | 44 | 103 | 108 | 104 | 16 | 18 | 20 | 10 | 10 | 11 | 25 | 33 | 31 |
4 | + | 30 | 36 | 33 | 107 | 107 | 104 | 13 | 19 | 17 | 11 | 12 | 11 | 24 | 30 | 22 |
20 | + | 39 | 29 | 33 | 125 | 109 | 100 | 15 | 16 | 13 | 10 | 11 | 9 | 30 | 27 | 22 |
100 | + | 32 | 30 | 31 | 78 | 66 | 94 | 15 | 10 | 10 | 11 | 14 | 9 | 24 | 31 | 27 |
500 | + | 24 | 31 | 30 | 90 | 96 | 72 | 12 | 10 | 14 | 10B | 8B | 6B | 39 | 31 | 22 |
2500 | + | 22B | 19B | 21B | 69B | 54B | 47B | 11B | 9B | 12B | 8B | 6B | 4B | 24B | 17B | 16B |
2.5 µg 2-Aminoanthracene | + | 736 | 822 | 804 | 739 | 682 | 622 | 109 | 117 | 122 | 113 | 147 | 128 | |||
60 µg 2-Aminoanthracene | + | 287 | 244 | 261 | ||||||||||||
0 | - | 36 | 38 | 36 | 116 | 105 | 128 | 20 | 16 | 19 | 12 | 12 | 7 | 26 | 27 | 31 |
4 | - | 33 | 46 | 34 | 102 | 105 | 110 | 16 | 15 | 16 | 16 | 9 | 13 | 28 | 29 | 26 |
20 | - | 27 | 29 | 29 | 98 | 97 | 125 | 15 | 20 | 16 | 8 | 7 | 9 | 21 | 27 | 29 |
100 | - | 28 | 31 | 24 | 79 | 89 | 74 | 20 | 18 | 15 | 6 | 8 | 6 | 24 | 27 | 22 |
500 | - | 24 | 29 | 24 | 90 | 66 | 66 | 16 | 13 | 15 | 2B | 4B | 7B | 23 | 26 | 20 |
2500 | - | 10B | 21B | 20B | 66B | 67B | 64B | 10B | 10B | 14B | 0B | 0B | 0B | 22B | 23B | 17B |
5 µg MNNG | - | 557 | 687 | 637 | 991 | 873 | 962 | |||||||||
10 µg 4-Nitro-o-phenylendiamin | - | 936 | 956 | 982 | ||||||||||||
100 µg 9-amninoacridine | - | 413 | 460 | 449 | ||||||||||||
5 µg 4-nitroquinoline-N-oxide | - | 425 | 557 | 529 |
B: reduced backround growth
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions chosen in this study, it is concluded that the test substance is not a mutagenic agent in a bacterial reverse mutation test.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.
- Strains: TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA
- Dose range: 20 µg - 5.000 µg/plate (SPT), 4 µg - 2.500 µg/plate (PIT)
- Test conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S9 mix)
- Solubility: No precipitation of the test substance was found.
- Toxicity: A bacteriotoxic effect was observed under all test conditions
- Mutagenicity: An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system
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.