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EC number: 233-117-2 | CAS number: 10039-33-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- May 17th 2012 to July 3rd, 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study is 1
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: guidelines published by the Japanese Regulatory Authorities, including METI, MHLW and MAFF.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: USA, EPA (TSCA) OPPTS harmonised guidelines.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- Ethyl-9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Test material form:
- liquid
Constituent 1
Method
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:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Mutation Test - Experiments 1 and 2: 0, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: the test material was insoluble in dimethyl sulphoxide at 50 mg/ml; it was soluble in dimethyl formamide and acetonitrile at 50 mg/ml, acetone at 100 mg/ml and tetrahydrofuran at 200 mg/ml. Acetone was selected as the most appropriate vehicle.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene: TA100 (1 μg/plate), TA1535 (2 μg/plate), TA1537 (2 μg/plate), WP2 (10 μg/plate)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- - EXPERIMENT 1
METHOD OF APPLICATION: in agar (plate incorporation)
2 ml molten top agar (0.6 % agar, 0.5 % NaCl with 5 ml of 1.0 mM histidine and 1.0mM biotin for Salmonella typhimurium or 1.0 mM tryptophan solution for E. coli), 0.1 ml of culture of the appropriate strain, 0.1 ml of the appropriate test material solution or the vehicle or positive control substance and 0.5 ml S9-mix (for the plates with metabolic activation) or 0.5 ml phosphate buffer (for the plates without metabolic activation) were thoroughly mixed and the mix was immediately poured onto the surface of Vogel-Bonner Minimal agar plates.
DURATION
- Exposure duration: 48 hours at 37 °C.
NUMBER OF REPLICATIONS: the tests were performed in triplicate.
- EXPERIMENT 2
METHOD OF APPLICATION: pre-incubation
0.1 ml of the appropriate bacterial culture was dispensed into a test tube followed by 0.5 ml of S9 mix or phosphate buffer and 0.05 ml of the vehicle or test material formulation and incubated for 20 minutes at 37 °C with shaking at approximately 130 rpm prior to the addition of 2 ml of molten, trace histidine or tryptophan supplemented top agar. The contents of the tube were then mixed and equally distributed on the surface of Vogel-Bonner Minimal agar plates.
DURATION
- Exposure duration: 48 hours at 37 °C
NUMBER OF REPLICATIONS: the tests were performed in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: cytotoxicity was assessed as a reduction in the number of revertant colonies and/or a clearing of the background lawn of bacterial growth.
S9-Mix: the metabolic activation system was prepared from rats induced with phenobarbitone/ß-naphthoflavone at 80/100 mg/kg/day, orally, for 3 days prior to preparation on day 4. The S9 homogenate was produced by homogenising the liver in a 0.15 M KCl solution followed by centrifugation at 9000 g. The protein content of the resultant supernatant was adjusted to 20 mg/ml. The S9 mix was prepared immediately before use using sterilised co-factors and maintained on ice for the duration of the test.
S9: 5.0 ml, 1.65 M KCl / 0.4 M MgCl2: 1.0 ml, 0.1 M glucose-6 -phosphate: 2.5 ml, 0.1 M NADP: 2.0 ml, 0.2 M sodium phosphate buffer (pH 7.4): 25.0 ml, sterile distilled water: 14.5 ml.
Additional strain characteristics: S. typhimurium: all strains possess rfa- and uvrB-; TA98 and TA100 also possess the R-factor plasmid pKM101. E. coli strain possesses the uvrA- mutation. Stock cultures were prepared in Oxoid nutrient broth. Stored at -196 °C in a liquid nitrogen freezer. Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory) - Evaluation criteria:
- The mutagenicity study was considered valid if the mean colony counts of the control plates were within acceptable ranges and if the results of the positive controls met the criteria for a positive response. Furthermore, all tester strains must have demonstrated the required characteristics as determined by their respective strain checks. There should be a minimum of four non-toxic test material dose levels and no evidence of excessive contamination.
A test material was considered to be positive if the increase in the mean number of revertant colonies on the test plates was concentration-related or if a reproducible two-fold or more increase was observed compared to that of negative control plates.
A test substance was considered to be negative in the bacterial gene mutation test if it produced neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRE-STUDY CHECKS: the amino acid supplemented top agar and S9-mix used in both experiments was shown to be sterile. The culture density for each bacterial strain was also checked and considered acceptable.
PRELIMINARY TOXICITY TEST: the test material was non-toxic to the strains of bacteria used (TA 100 and WP2uvrA). The test material formulation and S9-mix used in the experiment were both shown to be sterile.
MUTATION TEST: the test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was therefore tested up to the maximum recommended dose level of 5000 µg/plate. A precipitate (creamy and particulate in appearance) was noted at and above 1500 µg/plate, this observation did not prevent the scoring of revertant colonies.
No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method. Small statistically significant increases in WP2uvrA revertant colony frequency were observed in the presence of S9-mix at 50 and 5000 µg/plate in Experiment 2. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at 50 and 5000 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.3 times the concurrent vehicle control.
Results for the negative controls were considered to be acceptable. Furthermore, all of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Any other information on results incl. tables
Table: experiment 1 - Mean Number of Revertants
Dose (µg/plate) |
|
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
||
0 |
Mean |
115 |
118 |
24 |
12 |
38 |
51 |
35 |
36 |
13 |
12 |
SD |
13.3 |
14.6 |
4.5 |
0.0 |
4.6 |
6.4 |
5.3 |
6.1 |
4.4 |
3.5 |
|
50 |
Mean |
103 |
103 |
20 |
9 |
42 |
47 |
32 |
31 |
9 |
12 |
SD |
6.1 |
8.1 |
1.0 |
2.0 |
1.7 |
6.2 |
7.5 |
2.0 |
5.9 |
1.2 |
|
150 |
Mean |
112 |
113 |
22 |
10 |
43 |
45 |
24 |
27 |
8 |
12 |
SD |
0.6 |
2.1 |
1.7 |
4.2 |
4.6 |
5.5 |
1.2 |
6.7 |
1.0 |
0.6 |
|
500 |
Mean |
99 |
99 |
22 |
12 |
31 |
36 |
35 |
28 |
13 |
8 |
SD |
4.5 |
4.5 |
2.6 |
1.0 |
5.2 |
8.5 |
3.8 |
10.3 |
6.0 |
5.0 |
|
1500 |
Mean |
108 P |
107 P |
23 P |
11 P |
42 P |
41 P |
30 P |
30 P |
12 P |
8 P |
SD |
1.7 |
4.0 |
3.5 |
1.7 |
5.6 |
10.5 |
10.5 |
4.0 |
8.0 |
6.4 |
|
5000 |
Mean |
96 P |
75 P |
22 P |
11 P |
35 P |
41 P |
30 P |
34 P |
10 P |
11 P |
SD |
8.1 |
6.2 |
1.5 |
2.0 |
3.6 |
6.1 |
3.2 |
2.5 |
1.2 |
4.5 |
|
Positive Control |
Substance (µg/plate) |
ENNG 3 |
2AA 1 |
ENNG 5 |
2AA 2 |
ENNG 2 |
2AA 10 |
4NQO 0.2 |
BP 5 |
9AA 80 |
2AA 2 |
Mean |
409 |
1513 |
141 |
288 |
550 |
427 |
137 |
195 |
561 |
278 |
|
SD |
82.4 |
77.9 |
9.9 |
24.1 |
28.1 |
19.4 |
12.7 |
3.1 |
202.6 |
3.1 |
Table: experiment 2 - Mean Number of Revertants
Dose (µg/plate) |
|
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
-S9 Mix |
+S9 Mix |
||
0 |
Mean |
110 |
99 |
22 |
11 |
40 |
39 |
19 |
31 |
12 |
10 |
SD |
10.6 |
20.1 |
4.9 |
3.8 |
9.0 |
6.7 |
4.0 |
10.2 |
4.0 |
5.2 |
|
50 |
Mean |
97 |
106 |
23 |
12 |
45 |
50* |
19 |
32 |
8 |
12 |
SD |
2.9 |
10.1 |
0.6 |
3.1 |
0.0 |
4.6 |
4.0 |
7.0 |
4.6 |
7.2 |
|
150 |
Mean |
100 |
112 |
20 |
10 |
35 |
46 |
30 |
31 |
13 |
8 |
SD |
12.9 |
11.6 |
4.6 |
1.2 |
4.0 |
4.2 |
7.6 |
6.8 |
5.5 |
1.0 |
|
500 |
Mean |
108 |
103 |
21 |
15 |
43 |
48 |
16 |
28 |
10 |
11 |
SD |
20.3 |
5.0 |
2.0 |
4.6 |
11.6 |
7.0 |
4.6 |
4.5 |
4.0 |
3.2 |
|
1500 |
Mean |
104 P |
105 P |
14 P |
12 P |
33 P |
46 P |
20 P |
20 P |
12 P |
14 P |
SD |
3.8 |
11.7 |
6.6 |
0.0 |
2.1 |
2.1 |
2.3 |
1.2 |
0.0 |
2.1 |
|
5000 |
Mean |
103 P |
91 P |
20 P |
9 P |
32 P |
52 P* |
15 P |
24 P |
17 P |
8 P |
SD |
14.2 |
0.6 |
3.6 |
2.6 |
3.0 |
4.0 |
8.5 |
7.8 |
1.7 |
3.1 |
|
Positive Control |
Substance (µg/plate) |
ENNG 3 |
2AA 1 |
ENNG 5 |
2AA 2 |
ENNG 2 |
2AA 10 |
4NQO 0.2 |
BP 5 |
9AA 80 |
2AA 2 |
Mean |
466 |
1474 |
180 |
280 |
596 |
341 |
129 |
669 |
463 |
236 |
|
SD |
24.9 |
187.6 |
48.6 |
29.3 |
47.4 |
31.9 |
17.1 |
41.4 |
87.2 |
19.7 |
ENNG = N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO = 4 -nitroquinoline-1 -oxide
9AA = 9 -aminoacridine
2AA = 2 -aminoanthracene
BP = benzo(a)pyrene
P = precipitate
* = p ≤ 0.05
SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- negative with and without metabolic activation
- Executive summary:
The mutagenicity of the test material was assessed in a bacterial reverse mutation assay (Ames Test) in accordance with OECD guideline 471 and EU Method B.13/14. During the study, Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with the test material using both the plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without metabolic activation. The dose range for the study was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate.
Τhe vehicle control plates gave counts of revertant colonies generally within the normal range. All positive controls used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. A test material precipitate (creamy and particulate in appearance) was noted at and above 1500 µg/plate, though this observation did not prevent the scoring of revertant colonies. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method. Small, statistically significant increases in WP2uvrA revertant colony frequency were observed in the presence of S9-mix at 50 and 5000 µg/plate in Experiment 2. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at 50 and 5000 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.3 times the concurrent vehicle control.
The test material was concluded to be non-mutagenic under the conditions of the test.
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