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EC number: 272-599-9 | CAS number: 68892-13-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19-JAN-1995 (preliminary test-treatment) to 14-FEB-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 471 (Bacterial Reverse Mutation Assay: Salmonella typhimurium) and OECD guideline 472 (Bacterial Reverse mutation Assay: Escherichia coli)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-phenyldecane-1,3-dione
- EC Number:
- 272-599-9
- EC Name:
- 1-phenyldecane-1,3-dione
- Cas Number:
- 68892-13-7
- Molecular formula:
- C16H22O2
- IUPAC Name:
- 1-phenyldecane-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): RHODIASTAB X2
- Substance type: no data
- Physical state: opaque dark amber liquid and gold solid
- Analytical purity: the analytical purity was the responsibility of the Sponsor
- Purity test date: the purity test date was the responsibility of the Sponsor
- Lot/batch No.: 9330912
- Expiration date of the lot/batch: no data
- Stability under test conditions: the stability under the storage conditions below was the responsibility of the Sponsor
- Storage condition of test material: the test substance was stored at ambient temperature in the Sponsor original container
- Other: the test substance was received at the facility on 30 December 1994.
Rhodiastab X2 is the previous name of the same test substance currently commercialised as Rhodiastab 92.
Constituent 1
Method
- Target gene:
- Histidine auxotrophy in S. typhimurium
Tryptophan auxotrophy in E.coli
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal preparation from 1254-aroclor induced rat (S9-mix).
- Test concentrations with justification for top dose:
- Preliminary toxicity test (S. typhimurium TA 98 and E. coli WP2 uvrA in the absence of S9-mix):
- 0 (DMSO) and 0 (top-agar and culture alone),
- 2.5, 25, 250, 2500 µg/plate (first test),
- 5, 50, 500 5000 µg/plate (second test)
Main test:
- 0, 50, 158, 500, 1580, 5000 µg/plate with and without metabolic activation in all bacteria strains (two independent tests) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO ( batch 04047HZ, Aldrich) for test substance dilution and all positive control compounds except sodium azide which was dissolved in purified water
- Justification for choice of solvent/vehicle: no data
- Volume of vehicle/solvent in the medium: 0.1 mL of DMSO (as vehicle negative control) or 0.1 mL of test substance concentrations (in DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see "any other information on materials and methods"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: no
- Exposure duration: 48 hours at 37°C
SELECTION AGENT (mutation assays): histidine auxotrophy for S. typhymurium strains and tryptophan auxotrophy for E. coli
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: observation of the visible thinning of the background lawn of non-revertant cells in following exposure to test substance
OTHER: no data - Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS: no data
RANGE-FINDING/SCREENING STUDIES: no visible thinning of the background lawn of non-revertant cells was obtained following exposure to RHODIASTAB X2 up to the highest tested concentrations in the preliminary range-finding test. Therefore,a top exposure level of 5000 µg/plate was selected for use in the main test.
COMPARISON WITH HISTORICAL CONTROL DATA: no
ADDITIONAL INFORMATION ON CYTOTOXICITY: no
Any other information on results incl. tables
Table 7.6.1/1: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (test 1)
Conc. |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA/pKM101 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
23 |
1 |
114 |
5 |
16 |
1 |
17 |
4 |
45 |
8 |
50** |
23 |
3 |
93 |
6 |
17 |
4 |
15 |
2 |
38 |
12 |
158** |
21 |
5 |
99 |
2 |
16 |
1 |
16 |
2 |
48 |
1 |
500** |
19 |
3 |
111 |
1 |
15 |
5 |
16 |
4 |
38 |
7 |
1580** |
20 |
2 |
111 |
23 |
17 |
4 |
13 |
2 |
33 |
8 |
5000** |
21 |
6 |
117 |
22 |
14 |
1 |
15 |
2 |
32 |
4 |
Positive controls*** |
143 |
10 |
851 |
47 |
561 |
45 |
588 |
66 |
846 |
47 |
34 |
6 |
110 |
10 |
24 |
4 |
15 |
2 |
42 |
3 |
Table 7.6.1/2: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (test 2)
Conc. |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA/pKM101 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
28 |
2 |
98 |
10 |
16 |
4 |
12 |
3 |
50 |
7 |
50** |
26 |
9 |
106 |
9 |
12 |
3 |
9 |
2 |
45 |
6 |
158** |
31 |
0 |
90 |
6 |
11 |
2 |
9 |
1 |
42 |
0 |
500** |
27 |
5 |
104 |
11 |
9 |
3 |
12 |
2 |
45 |
6 |
1580** |
21 |
7 |
86 |
7 |
12 |
5 |
11 |
1 |
42 |
11 |
5000** |
21 |
8 |
74 |
5 |
9 |
3 |
13 |
2 |
29 |
6 |
Positive controls*** |
123 |
6 |
834 |
72 |
502 |
14 |
540 |
11 |
698 |
19 |
22 |
4 |
104 |
5 |
9 |
1 |
14 |
2 |
53 |
3 |
* Solvent control = negative control: 100 µL DMSO/plate
** Test substance solution volume: 100 µL/plate
*** Mutagens positive controls:
-Sodium azide (2 µg/plate) in TA1535 and TA 100 strains
-2-Aminoanthracene in TA1535 (2 µg/plate) and WP2 uvrA (10 µg/plate)
-9-aminoacridine (80 µg/plate) in TA1537 strain
-2-nitrofluorene (1 µg/plate) in TA 98 strain
-Benzo[a]pyrene (5 µg/plate) in TA1537, TA 100, TA 98 strains
-N-Ethyl-N’-Nitro-N-nitrosoguanidine (2 µg/plate) in WP2 uvrA
Table 7.6.1/3: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (test 1)
Conc. |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA/pKM101 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
27 |
1 |
125 |
11 |
21 |
4 |
18 |
1 |
43 |
3 |
50** |
21 |
6 |
104 |
3 |
20 |
1 |
19 |
3 |
47 |
4 |
158** |
23 |
2 |
109 |
4 |
18 |
2 |
18 |
3 |
43 |
8 |
500** |
21 |
4 |
80 |
10 |
17 |
1 |
14 |
5 |
46 |
2 |
1580** |
21 |
1 |
103 |
23 |
17 |
1 |
13 |
1 |
56 |
9 |
5000** |
24 |
4 |
95 |
11 |
18 |
2 |
17 |
4 |
41 |
13 |
Positive controls*** |
478 |
34 |
598 |
43 |
486 |
78 |
114 |
1 |
553 |
18 |
Table 7.6.1/4: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (test 2)
Conc. |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA/pKM101 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
29 |
3 |
103 |
10 |
16 |
3 |
12 |
2 |
47 |
6 |
50** |
33 |
7 |
113 |
16 |
11 |
4 |
12 |
3 |
52 |
7 |
158** |
40 |
2 |
110 |
16 |
10 |
4 |
11 |
2 |
45 |
13 |
500** |
29 |
2 |
100 |
12 |
8 |
2 |
11 |
1 |
49 |
7 |
1580** |
35 |
7 |
89 |
9 |
11 |
7 |
8 |
3 |
51 |
4 |
5000** |
24 |
2 |
82 |
3 |
7 |
1 |
8 |
1 |
50 |
2 |
Positive controls*** |
482 |
13 |
338 |
4 |
237 |
11 |
202 |
8 |
500 |
33 |
* Solvent control = negative control: 100 µL DMSO/plate
** Test substance solution volume: 100 µL/plate
*** Mutagens positive controls:
-2-Aminoanthracene in TA1535 (2 µg/plate) and WP2 uvrA (10 µg/plate)
-Benzo[a]pyrene (5 µg/plate) in TA1537, TA 100, TA 98 strains
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of mutagenic activity in the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2 uvrA at any dose level of Rhodiastab X2 in the presence and the absence od S9 -mix. Hence, Rhodiastab X2 was not mutagenic in these bacterial test systems.
- Executive summary:
The mutagenic potential of Rhodiastab X2 (former commercial name of the registered substance) was assessed in the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2 uvrA, according to OECD guidelines 471-472, Japan MITI/MHW and US/EPA-TSCA 798.5265 and in compliance with Good Laboratory Practices. Tests were carried out in presence and in absence of liver preparations from Aroclor 1254-induced rats (S9-mix). Rhodiastab X2 was dissolved in dimethyl sulphoxide (DMSO) and tested at concentrations up to 5000 µg/plate without S9 -mix in a range-finding preliminary test to determine dose-level cytotoxicity. In the absence of cytotoxicity at the highest RHODIASTAB X2 concentrations, dose levels used in the main assays were: 50, 158, 500, 1580 and 5000 µg/plate with and without metabolic activation system. Two independent tests were performed .
Under conditions of both tests, no evidence of mutagenic activity was observed at any dose level of Rhodiastab X2 in the presence and the absence od S9 -mix. Hence, Rhodiastab X2 was not mutagenic in these bacterial test systems.
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