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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-644-4 | CAS number: 17671-26-0
- 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:
- 15 Mar - 24 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Departement of Health of the Government of the United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecyl nonan-1-oate
- EC Number:
- 241-644-4
- EC Name:
- Dodecyl nonan-1-oate
- Cas Number:
- 17671-26-0
- Molecular formula:
- C21H42O2
- IUPAC Name:
- dodecyl nonanoate
Constituent 1
Method
- Target gene:
- his operon, trp operon
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:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats
- Test concentrations with justification for top dose:
- Following concentrations were used in the main experiments:
First experiment (plate ioncorporation, all strains): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation (tested up to the limit concentration)
Second experiment (pre-incubation, all strains): 15, 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation (based on results of first experiment, tested up to the limit concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in ditilled water and DMSO, acetone was selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) (first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 20 min
- Exposure duration: approx. 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of bacterial background lawn - Evaluation criteria:
- Acceptance criteria
The study was considered valid if:
- the bacterial strains demonstrate the required strain characteristics
- the number of revertant colonies of the negative (solvent) and positive controls are in the historical control range in all strains of the main tests
- all tester strain cultures should be in the range of 0.9 - 9 x 10^9 bacteria/mL.
- diagnostic mutagens (positive control chemicals) must be included to demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure and the integrity of the S9-mix
- a minimum of four non-toxic test item dose levels
- no evidence of excessive contamination
Evaluation criteria
A positive result is determined by any, one or all of the following:
- dose-related increase in mutant frequency over the dose range tested
- a reproducible increase at one or more concentrations
- biological relevance against in-house historical control ranges
- statistical analysis of data as determined by UKEMS
- at least 2-fold increase compared to the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response)
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
In some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: started at a concentration of 1500 μg/plate in all strains in both experiments
RANGE-FINDING/SCREENING STUDIES: first main test was used to detremine concentrations of secon main test
Any other information on results incl. tables
Table 1: Summary of test results (main experiment 1 (Plate Incorporation Method)
With or without S9 Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 98 |
TA 1537 |
TA 100 |
TA 1535 |
WP2 uvrA |
||
– |
Solvent control (Acetone) |
22 ± 7.1 |
10 ± 2.3 |
101 ± 11.0 |
16 ± 5.0 |
39 ± 12.0 |
1.5 |
19 ± 2.5 |
12 ± 3.0 |
103 ± 10.6 |
20 ± 5.0 |
44 ± 3.5 |
|
5 |
22 ± 1.2 |
11 ± 0.6 |
*122 ± 12.3 |
18 ± 1.5 |
38 ± 3.8 |
|
15 |
19 ± 7.0 |
11 ± 4.7 |
114 ± 13.9 |
18 ± 2.5 |
36 ± 4.2 |
|
50 |
18 ± 2.6 |
10 ± 0.0 |
108 ± 5.2 |
19 ± 2.1 |
41 ± 4.0 |
|
150 |
18 ± 4.7 |
12 ± 3.2 |
116 ± 14.2 |
19 ± 2.9 |
37 ± 4.2 |
|
500 |
15 ± 4.2 |
13 ± 1.7 |
*125 ± 3.8 |
18 ± 0.6 |
38 ± 8.4 |
|
1500 |
20 ± 3.2 P |
15 ± 4.0 P |
*127 ± 6.8 P |
17 ± 1.0 P |
43 ± 10.5 P |
|
500 |
19 ± 2.1 P |
12 ± 4.6 P |
**129 ± 6.1 P |
21 ± 3.8 P |
38 ± 2.5 P |
|
Positive controls (µg/plate) |
4NQO (0.2) |
9AA (80) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
|
Mean (No. of colonies/plate) |
202 ± 3.8 |
232 ± 30.5 |
496 ± 25.1 |
437 ± 56.9 |
724 ± 33.0 |
|
+ |
Solvent control (Acetone) |
35 ± 3.2 |
10 ± 1.2 |
121 ± 5.6 |
11 ± 2.0 |
47 ± 6.0 |
1.5 |
30 ± 7.0 |
11 ± 4.5 |
107 ± 8.7 |
10 ± 3.2 |
43 ± 6.5 |
|
5 |
30 ± 6.8 |
11 ± 2.3 |
122 ± 6.8 |
11 ± 0.6 |
50 ± 4.5 |
|
15 |
23 ± 3.5 |
15 ± 1.5 |
121 ± 8.5 |
13 ± 0.0 |
42 ± 6.0 |
|
50 |
28 ± 6.7 |
13 ± 1.2 |
107 ± 13.3 |
10 ± 1.2 |
49 ± 1.2 |
|
150 |
26 ± 3.6 |
14 ± 2.5 |
122 ± 16.5 |
11 ± 1.2 |
46 ± 4.0 |
|
500 |
24 ± 8.2 |
11 ± 0.6 |
123 ± 8.5 |
14 ± 4.6 |
45 ± 8.2 |
|
1500 |
25 ± 5.5 P |
15 ± 4.2 P |
97 ± 15.4 P |
11 ± 2.0 P |
48 ± 7.0 P |
|
500 |
19 ± 3.1 P |
12 ± 3.5 P |
100 ± 4.9 P |
9 ± 2.1 P |
41 ± 1.5 P |
|
Positive controls (µg/plate) |
B(a)P (5) |
2AA (2) |
2AA (1) |
2AA (2) |
2AA |
|
Mean (No. of colonies/plate) |
316 ± 22.5 |
394 ± 64.0 |
1215 ± 120.6 |
261 ± 3.1 |
374 ± 23.1 |
2AA = 2-aminoanthracene
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
B(a)P = benzo(a)pyrene
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
P = precipitate
* = p ≤ 0.05
** = p ≤ 0.01
Table 2: Summary of test results (main experiment 2 (Pre-Incubation Method))
With or without S9 Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 98 |
TA 1537 |
TA 100 |
TA 1535 |
WP2 uvrA |
||
– |
Solvent control (Acetone) |
19 ± 2.3 |
9 ± 1.2 |
107 ± 21.9 |
13 ± 3.0 |
31 ± 3.0 |
15 |
21 ± 0.6 |
8 ± 2.3 |
115 ± 9.7 |
8 ± 0.0 |
34 ± 3.2 |
|
50 |
20 ± 6.8 |
10 ± 3.5 |
110 ± 5.5 |
9 ± 1.7 |
36 ± 1.2 |
|
150 |
25 ± 4.7 |
8 ± 2.1 |
111 ± 16.0 |
13 ± 5.0 |
30 ± 7.6 |
|
500 |
22 ± 1.2 |
10 ± 2.5 |
120 ± 8.2 |
12 ± 1.0 |
30 ± 3.8 |
|
1500 |
24 ± 5.8 P |
9 ± 2.1 P |
102 ± 5.0 P |
13 ± 1.7 P |
32 ± 2.1 P |
|
500 |
18 ± 2.6 P |
10 ± 4.4 P |
104 ± 3.1 P |
10 ± 0.0 P |
35 ± 4.0 P |
|
Positive controls (µg/plate) |
4NQO (0.2) |
9AA (80) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
|
Mean (No. of colonies/plate) |
235 ± 33.6 |
261 ± 57.0 |
840 ± 44.8 |
557 ± 25.6 |
811 ± 64.8 |
|
+ |
Solvent control (Acetone) |
28 ± 1.7 |
10 ± 2.5 |
109 ± 17.5 |
12 ± 3.2 |
42 ± 5.5 |
15 |
29 ± 8.4 |
11 ± 1.2 |
102 ± 5.2 |
11 ± 3.1 |
43 ± 5.9 |
|
50 |
24 ± 4.9 |
13 ± 1.2 |
121 ± 5.8 |
12 ± 3.8 |
35 ± 11.7 |
|
150 |
30 ± 1.5 |
13 ± 1.5 |
116 ± 13.1 |
10 ± 2.0 |
41 ± 0.6 |
|
500 |
22 ± 4.4 |
12 ± 1.5 |
127 ± 2.6 |
13 ± 4.9 |
44 ± 6.6 |
|
1500 |
27 ± 7.8 P |
12 ± 1.5 P |
119 ± 13.2 P |
10 ± 2.6 P |
40 ± 4.7 P |
|
500 |
25 ± 0.6 P |
9 ± 0.6 P |
125 ± 13.6 P |
14 ± 0.6 P |
42 ± 2.0 P |
|
Positive controls (µg/plate) |
B(a)P (5) |
2AA (2) |
2AA (1) |
2AA (2) |
2AA |
|
Mean (No. of colonies/plate) |
135 ± 14.4 |
301 ± 26.2 |
1296 ± 155.1 |
206 ± 15.8 |
200 ± 24.3 |
2AA = 2-aminoanthracene
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
B(a)P = benzo(a)pyrene
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
P = precipitate
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study the test substance did not exhibit mutagenic properties in bacterial cells.
CLP/EU GHS criteria not met, no classification required according to 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.