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EC number: 255-350-9 | CAS number: 41395-83-9
- 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:
- 14 Sep 2017- 15 Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Propylene dinonanoate
- EC Number:
- 255-350-9
- EC Name:
- Propylene dinonanoate
- Cas Number:
- 41395-83-9
- Molecular formula:
- C21H40O4
- IUPAC Name:
- propylene dinonanoate
- Test material form:
- liquid
1
Method
- Target gene:
- Histidin (Salmonella), tryptophan (E. coli)
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:
- Phenobarbital/P-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes at 5000 μg/plate . Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 μg/plate. The undissolved particles had no influence on the data recording. The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol;
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
All formulations were prepared freshly before treatment and used within 2 hours of preparation.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
- Cell density at seeding (if applicable):
Precultures of bacteria were grown in Erlenmeyer flasks and harvested at the late exponential or early stationary phase (10.0E+08 to 10.0E+09 cells/mL).
Experiment I (Plate Incorporation)
The following materials were mixed in a test tube and poured onto the selective agar plates:
100 μL Test solution at each dose level (solvent or reference mutagen solution (positive control)),
500 μL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation),
100 μL Bacteria suspension,
2000 μL Overlay agar
Experiment II (Pre-Incubation)
In the pre-incubation assay 50 μL test solution (or solvent) or 100 μL reference mutagen solution (positive control), 500 μL S9 mix / S9 mix substitution buffer and 100 μL bacterial suspension were mixed in a test tube and incubated at 37°C for 60 minutes. After preincubation 2.0 mL overlay agar ( 45°C) was added to each tube.
The mixture was poured on minimal agar plates. After solidification the plates were incubated upside down for at least 48 hours at 37°C in the dark.
In parallel to each test a sterile control of the test item was performed and documented in the raw data. Therefore, 100 μL ( experiment I) or 100 μL ( experiment II) of the stock solution,
500 μl S9 mix/ S9 mix substitution buffer were mixed with 2.0 mL overlay agar and poured on minimal agar plates.
SELECTION AGENT (mutation assays): Plates with selective agar (without histidine/tryptophan) were used.
NUMBER OF REPLICATIONS: Triplicates
DETERMINATION OF CYTOTOXICITY
- Method: regular background growth
OTHER EXAMINATIONS:
Regular checking of the properties of the Salmonella typhimurium and Escherichia coli strains was done regarding the membrane permeability, ampicillin resistance; UV sensitivity, and amino acid requirement as well as normal spontaneous mutation rates.
- OTHER:
Experimental period: 14 September 2017 - 23 October 2017 - Rationale for test conditions:
- Acceptability criteria:
- regular background growth in the negative and solvent control;
- the spontaneous reversion rates in the negative and solvent control in the range of laboratory's historical data;
- the positive control substances should produce an increase above the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control;
- a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5; - Evaluation criteria:
- - mutagen if biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice
(strains TA 1535 and TA 1537) the colony count of the corresponding solvent control;
- dose dependent increase considered biologically relevant if the threshold was exceeded at more than one concentration;
- increase exceeding the threshold at only one concentration was judged as biologically relevant if reproduced in an independent second experiment;
- dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment.
Whenever the colony counts remain within the historical range of negative and solvent controls such an increase was not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
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
- Remarks:
- Precipitation at 5000 µg/plate
- 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
- Remarks:
- Precipitation at 5000 µg/plate
- 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
- Remarks:
- Precipitation at 5000 µg/plate
- 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
- Remarks:
- Precipitation at 5000 µg/plate
- 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
- Remarks:
- Precipitation at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- All values were within the acceptable ranges of historicol control data of the laboratory.
Any other information on results incl. tables
Revertant Colony Counts (Mean of triplicates ±standard deviation)
Experiment I |
without S9 |
|
|
|
|
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
Vehicle (ethanol) |
10±4 |
8±2 |
33±6 |
158±8 |
31±8 |
0 |
13±5 |
7±2 |
33±5 |
162±13 |
43±3 |
3 |
8±3 |
9±4 |
37±11 |
158±6 |
33±2 |
10 |
11±3 |
6±1 |
30±5 |
151±28 |
33±9 |
33 |
12±4 |
10±2 |
29±6 |
142±23 |
27±5 |
100 |
11±3 |
6±1 |
31±6 |
152±10 |
29±9 |
333 |
10±6 |
12±4 |
28±4 |
158±23 |
33±7 |
1000 |
11±0 |
9±3 |
35±2 |
145±10 |
35±5 |
2500 |
8±3 |
10±3 |
34±4 |
145±9 |
34±7 |
5000 |
8±1P |
8±4P |
24±4P |
167±5P |
42±2P |
sodium azide (10 µg) |
1161±66 |
|
|
2439±49 |
|
4-nitro-o-phenylene-diamine (10 µg) |
|
|
846±43 |
|
|
4-nitro-o-phenylene-diamine (50 µg) |
|
77±9 |
|
|
|
methyl methane sulfonate (2 µL) |
|
|
|
|
966±48 |
P = precipitation |
Experiment I |
with S9 |
|
|
|
|
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
Vehicle (ethanol) |
15±1 |
17±3 |
48±8 |
172±17 |
42±5 |
0 |
12±2 |
18±2 |
43±10 |
159±22 |
40±9 |
3 |
14±3 |
19±6 |
44±3 |
132±23 |
52±3 |
10 |
10±2 |
18±3 |
42±6 |
152±6 |
42±10 |
33 |
14±4 |
15±6 |
42±12 |
146±9 |
46±7 |
100 |
11±4 |
17±6 |
44±8 |
142±11 |
47±6 |
333 |
10±3 |
16±6 |
36±4 |
135±9 |
40±7 |
1000 |
12±4 |
12±4 |
47±6 |
137±1 |
48±6 |
2500 |
12±3 |
16±2 |
42±1 |
137±15 |
55±9 |
5000 |
11±2P |
9±3P |
48±16P |
120±10P |
51±8P |
2-aminoanthracene (2.5 µg) |
388±32 |
176±21 |
5251±462 |
2924±370 |
|
2-aminoanthracene (10 µg) |
|
|
|
|
427±16 |
P = precipitation |
Experiment II |
without S9 |
|
|
|
|
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
Vehicle (ethanol) |
9±3 |
8±3 |
31±6 |
183±11 |
42±1 |
0 |
13±5 |
9±2 |
25±8 |
196±13 |
45±8 |
33 |
10±1 |
8±3 |
38±6 |
181±21 |
50±3 |
100 |
12±3 |
10±3 |
29±4 |
168±21 |
48±3 |
333 |
10±4 |
8±3 |
29±8 |
187±23 |
45±4 |
1000 |
11±3 |
7±3 |
26±6 |
186±13 |
47±2 |
2500 |
12±2 |
8±3 |
42±5 |
193±15 |
43±5 |
5000 |
7±2P |
9±2P |
41±3P |
193±14P |
51±7P |
sodium azide (10 µg) |
1321±129 |
|
|
2200±65 |
|
4-nitro-o-phenylene-diamine (10 µg) |
|
|
330±22 |
|
|
4-nitro-o-phenylene-diamine (50 µg) |
|
157±3 |
|
|
|
methyl methane sulfonate (2 µL) |
|
|
|
|
843±42 |
P = precipitation |
Experiment II |
with S9 |
|
|
|
|
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
Vehicle (ethanol) |
18±6 |
13±2 |
48±9 |
172±8 |
61±7 |
0 |
12±3 |
9±2 |
43±15 |
203±23 |
54±3 |
33 |
15±6 |
12±2 |
45±4 |
160±11 |
62±10 |
100 |
17±4 |
13±5 |
46±5 |
152±6 |
52±4 |
333 |
16±4 |
9±2 |
39±12 |
171±18 |
53±10 |
1000 |
16±6 |
10±4 |
39±5 |
165±11 |
57±2 |
2500 |
13±3 |
13±5 |
35±12 |
169±13 |
45±7 |
5000 |
16±6P |
11±2P |
40±12P |
163±12P |
59±5P |
2-aminoanthracene (2.5 µg) |
499±25 |
138±29 |
4428±281 |
4575±143 |
|
2-aminoanthracene (10 µg) |
|
|
|
|
524±19 |
P = precipitation |
Applicant's summary and conclusion
- Conclusions:
- No biologically relevant increase in revertant colony numbers of any of the five tester strains was observed at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).
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