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EC number: 267-029-0 | CAS number: 67762-64-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 06 May - 29 Aug 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- September 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- September 1995
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- EC Number:
- 234-392-1
- EC Name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- Cas Number:
- 11138-60-6
- IUPAC Name:
- 2,2-bis[(octanoyloxy)methyl]butyl decanoate
- Details on test material:
- - Physical state: Yellow , clear liquid
- Expiration date: 01.01.2006
- Storage condition of test material: room temperature, protected from light
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon ( E. coli strains)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (Spraque Dawley rats, male, Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- 0, 10, 33, 100, 333 and 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide (SA; 1 μg/plate, TA1535 and TA100); 9-Aminoacridine (9AA; 75 µg/plate, TA 1537); 2-Nitrofluorene (2NF; 1 µg/plate, TA98 and TA 1538); Methylmethanesulfonate (MMS; 1000 µg/plate, WP2 uvrA) with S9: 2-Amino-anthracene (2-AA; 1 μg/pl
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 h
- Expression time (cells in growth medium): 48 to 72 h
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial backgroung lawn wit a dissecting microscope - Evaluation criteria:
- Revertant colonies were counted and the mean and standard deviation were calculated and compared to the controls.
All Salmonella tester strains must demonstrate the presence of the deep rough mutation and the deletion of the uvrA gene. Cultures of the TA98 and TA100 strains must demonstrate the presence of the pKM101 plasmid R-factor. All WP2 uvrA cultures must demonstrate the deletion of the uvrA gene. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. Tester strain titers must be above 30.000.000 cells/ml. The mean of each positive control must be at least three-fold increased to the controlls. A minimum of three non-toxic dose levels are recquired to evaluate assay data. - Statistics:
- Mean and standard deviation were calculated
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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- other: An unacceptable vehicle control value with the tester strain TA1537, contamination of tester strain TA98, experiments were repeated
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: >100 µg/plate
RANGE-FINDING/SCREENING STUDIES: Yes
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1:
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||||
Base-pair substitution type |
Frameshift type |
||||||
TA 1535 |
TA1537 |
TA98 |
TA100
|
TA 1538 |
WP2uvrA |
||
- |
Vehicle |
12 |
4 |
17 |
111 |
5 |
21 |
|
10 |
3 |
4 |
15 |
115 |
6 |
16 |
|
33 |
5 |
5 |
19 |
113 |
6 |
11 |
- |
100 |
9 |
4 |
19 |
98 |
7 |
12 |
- |
333 |
7 |
5 |
11 |
116 |
4 |
10 |
- |
1000 |
8 |
6 |
21 |
120 |
7 |
13 |
Positive controls - S9 |
Name |
SA |
9AA |
2NF |
SA |
2NF |
MMS |
Concentrations (μg/plate) |
1.0 |
75 |
1.0 |
1.0 |
1.0 |
1000 |
|
Number of colonies/plate |
241 |
40 |
105 |
377 |
179 |
143 |
|
+ |
Vehicle |
14 |
5 |
18 |
133 |
7 |
11 |
|
10 |
9 |
5 |
27 |
114 |
12 |
16 |
+ |
33 |
9 |
3 |
21 |
113 |
8 |
13 |
+ |
100 |
8 |
7 |
26 |
108 |
9 |
13 |
+ |
333 |
9 |
4 |
27 |
115 |
6 |
8 |
+ |
1000 |
10 |
5 |
17 |
111 |
9 |
13 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
10 |
|
Number of colonies/plate |
72 |
127 |
888 |
904 |
783 |
57 |
SA: Sodium azide
9AA : 9-Aminoacridine
MMS: Methylmethanesulfonate
2-AA: 2-Aminoanthracene
2NF: 2-Nitrofluorene
Experiment 2/3:
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||||
Base-pair substitution type |
Frameshift type |
||||||
TA 1535 |
TA1537 |
TA98 |
TA100
|
TA 1538 |
WP2uvrA |
||
- |
Vehicle |
14 |
10 |
23 |
126 |
11 |
27 |
|
10 |
7 |
13 |
16 |
117 |
7 |
27 |
|
33 |
9 |
15 |
23 |
124 |
8 |
19 |
- |
100 |
5 |
13 |
22 |
120 |
6 |
18 |
- |
333 |
12 |
9 |
17 |
110 |
11 |
16 |
- |
1000 |
8 |
14 |
17 |
125 |
5 |
21 |
Positive controls - S9 |
Name |
SA |
9AA |
2NF |
SA |
2NF |
MMS |
Concentrations (μg/plate) |
1.0 |
75 |
1.0 |
1.0 |
1.0 |
1000 |
|
Number of colonies/plate |
429 |
757 |
125 |
601 |
221 |
195 |
|
+ |
Vehicle |
8 |
5 |
19 |
147 |
14 |
24 |
|
10 |
9 |
7 |
17 |
142 |
16 |
30 |
+ |
33 |
10 |
5 |
19 |
136 |
18 |
25 |
+ |
100 |
10 |
5 |
20 |
132 |
13 |
31 |
+ |
333 |
10 |
4 |
17 |
138 |
12 |
19 |
+ |
1000 |
10 |
7 |
19 |
125 |
12 |
19 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
10 |
|
Number of colonies/plate |
85 |
97 |
530 |
647 |
1041 |
88 |
SA: Sodium azide
9AA : 9-Aminoacridine
MMS: Methylmethanesulfonate
2-AA: 2-Aminoanthracene
2NF: 2-Nitrofluorene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Under the tested experimental conditions the test substance did not induce gene mutations in S. typhimurium strains and in an E. coli strain up to the maximum of solubility. Therefore it is not considered to be mutagenic in this bacterial mutagenicity tes
Under the tested experimental conditions the test substance did not induce gene mutations in S. typhimurium strains and in an E. coli strain up to the maximum of solubility. Therefore it is not considered to be mutagenic in this bacterial mutagenicity test. - Executive summary:
Under the tested experimental conditions the read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)- 1,3-propanediol octanoate did not induce gene mutations in S. typhimurium strains and in an E. coli strain up to the maximum of solubility. Therefore it is not considered to be mutagenic in this bacterial mutagenicity test.
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