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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 263-218-7 | CAS number: 61792-31-2
- 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:
- 13 Jan - 06 Feb 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- EC Number:
- 263-218-7
- EC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- Cas Number:
- 61792-31-2
- Molecular formula:
- C17H36N2O2
- IUPAC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains) and trp operon (E. coli strains)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system: Cofactor supplemented post-mitochondrial fraction (S9 mix).
- source of S9: Trinova Biochem GmbH, Giessen, Germany
- method of preparation of S9 mix: S9 mix was prepared from the livers of rats treated with Aroclor 1254.
- quality controls of S9 mix: Each S9 batch was characterized with the mutagens benzo-(a)-pyrene and 2-aminoanthracene in S. typhimurium strain TA100 at concentrations of 5 and 2.5 µg/plate, respectively. - Test concentrations with justification for top dose:
- First experiment: 5.4, 17, 52, 164, 512 and 1600 µg/plate with and without metabolic activation in strains TA 98, TA 1535 and TA 1537 and 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate in strains TA 100 and WP2 uvrA.
Second experiment: 5.4, 17, 52, 164, 512 and 1600 µg/plate with and without metabolic activation in strains TA 98, TA 100, TA 1535 and TA 1537 and 17, 52, 164, 512, 1600 and 5000 µg/plate in strain WP2 uvrA
The highest concentration was selected based on a preliminary toxicity test in strains TA 100 and WP2 uvrA, in which cytotoxicity was observed at 1600 µg/ plate in strain TA 100 and at 5000 µg/plate in strain WP2 uvrA in the presence and absence of S9 mix. The preliminary toxicity test was reported as part of the direct plate assay (first experiment). - Vehicle / solvent:
- - Vehicle/solvent used: Milli-Q water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191, 2.5 µg/plate in DMSO (- S9) for TA 1537 (plate incorporation assay); 2-aminoanthracene (2AA), 2.5 µg/plate in DMSO (+ S9) for TA 1535 and TA 1537, 1 µg/plate in DMSO (+ S9) for TA 98 and TA 100, 15 µg/plate in DMSO (+ S9) for WP2 uvrA
- Remarks:
- Each S9 batch was characterized with the mutagens benzo-(a)-pyrene and 2-aminoanthracene, which require metabolic activation, in tester strain TA100 at concentrations of 5 μg/plate and 2.5 μg/plate, respectively.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, preliminary toxicity test/Experiment 1); preincubation (Experiment 2)
DURATION
- Preincubation period: 30 ± 2 min (Experiment 2)
- Exposure duration: 48 ± 4 h (Experiment 1 and 2)
NUMBER OF REPLICATIONS: triplicates each in 2 independant experiments
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed. - Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at ≥ 1600 µg/plate with and without S9 mix in the first experiment and at ≥ 512 µg/plate with and without S9 mix in the second experiment
- Vehicle controls validity:
- not valid
- Remarks:
- in the first experiment, please refer to "Additional information on results"
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at ≥ 1600 µg/plate with and without S9 mix in the first experiment and at ≥ 512 µg/plate with and without S9 mix in the second experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at ≥ 1600 µg/plate with and without S9 mix in the first and in the second experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at ≥ 1600 µg/plate with and without S9 mix in the first experiment and at ≥ 512 µg/plate with and without S9 mix in the second experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate with and without S9 mix in the first and in the second experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: There was no precipitation at any test item concentration in any experiment, neither with or without S9 mix.
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity test was performed in strains TA 100 and WP2 uvrA at concentrations in the range of 1.7 to 5000 µg/plate with and without metabolic activation. The preliminary toxicity test was reported as part of the first experiment (plate-incorporation assay).
CYTOTOXICITY:
Cytotoxicity, evident as a reduced or absent bacterial background lawn was observed:
- at ≥ 1600 µg/plate with and without S9 mix for strains TA 98, TA 100, TA 1535 and TA 1537 and at 5000 µg/plate with and without S9 mix for strain WP2 uvrA in the first experiment.
- at ≥ 512 µg/plate with and without S9 mix for strains TA 98, TA 100 and TA 1537, at 1600 µg/plate for strain TA 1535, and at 5000 µg/plate for WP2 uvrA in the second experiment.
STUDY RESULTS
- All bacterial strains showed negative responses over the entire dose-range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
HISTORICAL CONTROL DATA: please refer to Tables 3 and 4 under "Any other information on results incl. tables".
- Positive historical control data: The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
- Negative (solvent/vehicle) historical control data: The negative control values were within the laboratory historical control data ranges, except the response for TA98 in the absence of S9-mix in the first experiment. However, since the mean number of revertant colonies showed a characteristic number of revertant colonies (5 revertant colonies) when compared against relevant historical control data (6 revertant colonies), the validity of the test was considered not to be affected.
Any other information on results incl. tables
Table 1: Results of the preliminary toxicity test (plate incorporation test with strains TA 100 and WP2 uvrA) and the first experiment (plate incorporation test with strains TA 98, TA 1535 and TA 1537)
Experiment 1: Plate incorporation test | ||||||||||
Strain | TA 1535 | TA 1537 | TA 98 | TA 100# | WP2uvrA# | |||||
Metabolic activation | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 |
Vehicle control | ||||||||||
Water mean | 3 | 5 | 2 | 4 | 5 | 12 | 116 | 80 | 18 | 25 |
± SD | ± 1 | ± 4 | ± 1 | ± 1 | ± 1 | ± 2 | ± 2 | ± 9 | ± 6 | ± 8 |
Test item [µg/plate] | ||||||||||
1.7 mean | - | - | - | - | - | - | 110 | 95 | 15 | 17 |
± SD | - | - | - | - | - | - | ± 15 | ± 5 | ± 0 | ± 10 |
5.4 mean | 5 | 9 | 3 | 1 | 11 | 13 | 107 | 93 | 15 | 13 |
± SD | ± 1 | ± 1 | ± 1 | ± 1 | ± 4 | ± 3 | ± 2 | ± 8 | ± 1 | ± 4 |
17 mean | 7 | 5 | 4 | 2 | 9 | 12 | 104 | 101 | 22 | 19 |
± SD | ± 2 | ± 3 | ± 4 | ± 2 | ± 2 | ± 4 | ± 6 | ± 12 | ± 7 | ± 6 |
52 mean | 7 | 5 | 4 | 0 | 5 | 11 | 104 | 119 | 18 | 15 |
± SD | ± 1 | ± 3 | ± 1 | ± 1 | ± 2 | ± 2 | ± 10 | ± 10 | ± 9 | ± 8 |
164 mean | 5 | 5 | 3 | 2 | 9 | 12 | 106 | 86 | 20 | 23 |
± SD | ± 3 | ± 1 | ± 1 | ± 1 | ± 5 | ± 4 | ± 13 | ± 6 | ± 11 | ± 7 |
512 mean | 4s | 3 | 4 | 3 | 5 | 10 | 62s | 71 | 21 | 24 |
± SD | ± 2 | ± 2 | ± 2 | ± 2 | ± 3 | ± 2 | ± 10 | ± 6 | ± 4 | ± 4 |
1600 mean | eMC | eMC | eMC | eMC | eMC | 1m | eMC | eMC | 11 | 11 |
± SD | - | - | - | - | - | ± 1 | - | - | ± 7 | ± 5 |
5000 mean | - | - | - | - | - | - | 0a | 0a | eMC | eMC |
± SD | - | - | - | - | - | - | ± 0 | ± 0 | - | - |
Positive control | ||||||||||
§mean | 676 | 243 | 1092 | 254 | 1102 | 1117 | 788 | 1616 | 1397 | 349 |
± SD | ± 35 | ± 18 | ± 328 | ± 62 | ± 128 | ± 92 | ± 59 | ± 422 | ± 57 | ± 19 |
#: results of the preliminary toxicity test | ||||||||||
MC: Microcolonies; a: bacterial background lawn absent, e: bacterial background lawn extremely reduced, s: bacterial background lawn slighly reduced, m: bacterial background lawn moderately reduced |
Table 2: Results of the second experiment (pre-incubation test with all strains)
Experiment 2: Pre-incubation Test | ||||||||||
Strain | TA 1535 | TA 1537 | TA 98 | TA 100 | WP2uvrA | |||||
Metabolic activation | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 |
Vehicle control | ||||||||||
Water mean | 6 | 23 | 5 | 5 | 9 | 17 | 107 | 88 | 13 | 17 |
± SD | ± 3 | ± 18 | ± 2 | ± 2 | ± 6 | ± 2 | ± 17 | ± 2 | ± 2 | ± 4 |
Test item | ||||||||||
5.4 mean | 8 | 9 | 1 | 5 | 15 | 13 | 92 | 90 | - | - |
± SD | ± 2 | ± 1 | ± 0 | ± 3 | ± 6 | ± 5 | ± 6 | ± 13 | - | - |
17 mean | 7 | 6 | 5 | 5 | 16 | 13 | 104 | 76 | 19 | 21 |
± SD | ± 3 | ± 2 | ± 2 | ± 3 | ± 6 | ± 1 | ± 8 | ± 10 | ± 4 | ± 9 |
52 mean | 4 | 6 | 3 | 6 | 14 | 22 | 83 | 68 | 14 | 25 |
± SD | ± 1 | ± 1 | ± 0 | ± 3 | ± 2 | ± 3 | ± 8 | ± 9 | ± 2 | ± 5 |
164 mean | 5s | 6s | 1m | 4s | 5m | 14s | 39m | 59s | 13 | 16 |
± SD | ± 3 | ± 2 | ± 2 | ± 0 | ± 3 | ± 3 | ± 6 | ± 7 | ± 2 | ± 5 |
512 mean | 4m | 8m | eMC | eMC | eMC | eMC | eMC | eMC | 18 | 17 |
± SD | ± 3 | ± 4 | - | - | - | - | - | - | ± 6 | ± 5 |
1600 mean | eMC | eMC | eMC | eMC | eMC | eMC | eMC | eMC | 12 | 15 |
± SD | - | - | - | - | - | - | - | - | ± 1 | ± 4 |
5000 mean | - | - | - | - | - | - | - | - | a | a |
± SD | - | - | - | - | - | - | - | - | - | - |
Positive control | ||||||||||
§mean | 956 | 227 | 150 | 119 | 1422 | 418 | 654 | 1395 | 1446 | 497 |
± SD | ± 58 | ± 34 | ± 17 | ± 3 | ± 12 | ± 19 | ± 68 | ± 161 | ± 139 | ± 19 |
MC: Microcolonies; a: bacterial background lawn absent, e: bacterial background lawn extremely reduced, s: bacterial background lawn slighly reduced |
Table 3: Historical control data for the solvent control generated in the testing laboratory from Nov 2016 - Nov 2019
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2uvrA | ||||||
S9-mix | - | + | - | + | - | + | - | + | - | + |
Range | 3 – 29 | 3 – 27 | 2 – 15 | 2 – 19 | 6 – 61 | 8 – 60 | 61 – 176 | 60 - 176 | 11 – 61 | 13 - 68 |
Mean | 10 | 11 | 5 | 6 | 15 | 21 | 114 | 108 | 27 | 33 |
SD | 3 | 3 | 2 | 2 | 5 | 7 | 18 | 21 | 8 | 9 |
n | 2992 | 2960 | 2965 | 2960 | 2958 | 3025 | 3037 | 2946 | 2790 | 2753 |
Table 4: Historical control data for the positive control generated in the testing laboratory from Nov 2016 - Nov 2019
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|||||
S9-mix |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Range |
107 – 1530 |
73 – 1481 |
58 – 1422 |
48 – 1239 |
365 – 1978 |
250 – 2033 |
439 – 1993 |
424 – 2666 |
93 – 1999 |
109 - 1968 |
Mean |
932 |
269 |
812 |
314 |
1259 |
910 |
900 |
1354 |
1117 |
431 |
SD |
177 |
116 |
360 |
148 |
228 |
353 |
167 |
401 |
529 |
158 |
n |
2879 |
2810 |
2497 |
2893 |
2920 | 2895 | 2917 | 2864 | 2689 | 2729 |
Applicant's summary and conclusion
- Conclusions:
- Under the tested conditions, the test compound was not mutagenic in any of the S. typhimurium strains (TA 98, TA 100, TA 1535 and TA1537) and in E. coli strain WP2 uvrA with and without metabolic activation.
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.