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EC number: 915-316-2 | CAS number: -
- 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:
- from 31 May 2011 to 14 October 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
- EC Number:
- 915-316-2
- Molecular formula:
- C50H80O4
- IUPAC Name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the liver of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Concentration tested in Experiments 1 and 2 (plate incorporation, with and without metabolic activation): 12.3, 37, 111.1, 333.3 and 1000 µg/plate (A strong precipitate was observed in the Petri plates at dose levels > or = at 1000 µg/plate).
Due to a severe toxicity observed with S9 mix using the pre-incubation method, a third experiment was undertaken using a lower range of dose levels. The selected dose-levels for this third experiment were:
- 0.137, 0.412, 1.23, 3.7, 11.1 and 33.3 µg/plate for the TA 102 strain,
- 0.412, 1.23, 3.7, 11.1, 33.3 and 100 µg/plate for the TA 1537 strain,
- 0.8, 2.5, 7.4, 22.2, 66.7 and 200 µg/plate for the TA 98 strain,
- 1.23, 3.7, 11.1, 33.3, 100 and 300 µg/plate for the TA 100 strain. - Vehicle / solvent:
- - Solvent used: Tetrahydrofuran (THF)
- Justification for choice of solvent: THF was chosen because of its solubility properties.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see details below
- Details on test system and experimental conditions:
- Positive controls:
Without S9 mix:
- sodium azide for strains TA 1535 and TA 100 (1 µg/plate),
- 9-Aminoacridine for strain TA 1537 (50 µg/plate),
- 2-Nitrofluorene for strain TA 98 (0.5 µg/plate),
- Mitomycin C for strain TA 102 (0.5 µg/plate).
With S9 mix:
- 2-Anthramine for strains TA 1535, TA 1537, TA 98 (2 µg/plate) and TA102 (10 µg/plate),
- Benzo(a)pyrene for strain TA 100 (5 µg/plate). - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result.
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of Results Experiment I
Direct plate incorporation method
Metabolic activation |
Test group |
Dose level per plate |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
THF |
15 |
11 |
18 |
108 |
272 |
|
Rhodiastab 55P |
12.3 µg |
17 |
14 |
23 |
113 |
312 |
|
37 µg |
23 |
7 |
22 |
112 |
304 |
||
111.1 µg |
31 |
12 |
22 |
115 |
311 |
||
333.3 µg |
39 |
16 |
32 |
111 |
307 |
||
1000 µg |
29 |
14 |
27 |
101 |
366 |
||
NAN3 |
1 µg |
669 |
|
|
452 |
|
|
9AA |
50 µg |
|
337 |
|
|
|
|
2NF |
0.5 µg |
|
|
163 |
|
|
|
MMC |
0.5 µg |
|
|
|
|
1872 |
|
With activation |
THF |
10 |
5 |
23 |
147 |
438 |
|
Rhodiastab 55P |
12.3 µg |
14 |
8 |
28 |
123 |
411 |
|
37 µg |
10 |
15 |
28 |
114 |
483 |
||
111.1 µg |
14 |
8 |
29 |
116 |
485 |
||
333.3 µg |
16 |
9 |
27 |
164 |
429 |
||
1000 µg |
29 |
7 |
23 |
150 |
500 |
||
2AM |
2 µg |
241 |
57 |
895 |
|
|
|
10 µg |
|
|
|
|
3065 |
||
BAP |
5 µg |
|
|
|
565 |
|
Summary of Results Experiment II
Direct plate incorporation method (without S9 mix) and Pre-incubation method (with S9 mix)
Metabolic activation |
Test group |
Dose level per plate |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
THF |
17 |
7 |
24 |
110 |
410 |
|
Rhodiastab 55P |
12.3 µg |
19 |
10 |
26 |
93 |
370 |
|
37 µg |
17 |
12 |
26 |
93 |
345 |
||
111.1 µg |
19 |
6 |
26 |
88 |
405 |
||
333.3 µg |
30 |
12 |
19 |
102 |
318 |
||
1000 µg |
33 |
2 |
21 |
86 |
347 |
||
NAN3 |
1 µg |
443 |
|
|
516 |
|
|
9AA |
50 µg |
|
132 |
|
|
|
|
2NF |
0.5 µg |
|
|
128 |
|
|
|
MMC |
0.5 µg |
|
|
|
|
2089 |
|
With activation |
THF |
14 |
10 |
32 |
139 |
387 |
|
Rhodiastab 55P |
12.3 µg |
10 |
6 |
24 |
137 |
215 |
|
37 µg |
23 |
13 |
31 |
137 |
186 |
||
111.1 µg |
18 |
2 |
26 |
126 |
110 |
||
333.3 µg |
19 |
14 |
22 |
97 |
55 |
||
1000 µg |
27 |
13 |
51 |
41 |
37 |
||
2AM |
2 µg |
170 |
203 |
1659 |
|
|
|
10 µg |
|
|
|
|
2085 |
||
BAP |
5 µg |
|
|
|
541 |
|
Summary of Results Experiment III
With metabolic activation, Pre-incubation method
Metabolic activation |
Test group |
Dose level per plate |
Mean revertant colony counts |
TA 102 |
THF |
483 |
|
Rhodiastab 55P |
0.137 µg |
359 |
|
0.412 µg |
349 |
||
1.23µg |
378 |
||
3.7 µg |
319 |
||
11.1 µg |
357 |
||
33.3 µg |
206 |
||
2AM |
10 µg |
1570 |
|
TA 1537 |
THF |
7 |
|
Rhodiastab 55P |
0.412 µg |
9 |
|
1.23µg |
4 |
||
3.7 µg |
2 |
||
11.1 µg |
5 |
||
33.3 µg |
4 |
||
100 µg |
3 |
||
2AM |
2 µg |
99 |
|
TA 98 |
THF |
31 |
|
Rhodiastab 55P |
0.8 µg |
30 |
|
2.5 µg |
29 |
||
7.4 µg |
22 |
||
22.2 µg |
17 |
||
66.7 µg |
21 |
||
200 µg |
16 |
||
2AM |
2 µg |
1572 |
|
TA 100 |
THF |
109 |
|
Rhodiastab 55P |
1.23µg |
141 |
|
3.7 µg |
112 |
||
11.1 µg |
100 |
||
33.3 µg |
120 |
||
100 µg |
142 |
||
300 µg |
117 |
||
BAP |
5 µg |
590 |
Vehicle:
THF: Tetrahydrofuran
Positive Controls:
NAN3: sodium azide
9-AA: 9-aminoacridine
2NF: 2-Nitrofluorene
MMC: Mitomycin C
2AM: 2-Anthramine
BAP: Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is considered to be non-mutagenic in Ames test, with and without metabolic activation. - Executive summary:
This study was performed to investigate the potential of the test item, RHODIASTAB 55 P, to induce reverse mutation in Salmonella typhimurium. The study was performed according to OECD guideline no. 471 and EC guideline n° B13/14 and in compliance with the Principles of Good Laboratory Practice.
A preliminary toxicity test was performed to define the dose-levels of RHODIASTAB 55 P to be used for the mutagenicity study. The test item was then tested in three independent experiments, with and/or without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254. The negative control was the vehicle (Tetrahydrofuran).
The preliminary test, both experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate incorporation method. The second and third experiments with S9 mix were performed according to the preincubation method (60 minutes,37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
Since the test item was found poorly soluble in the preliminary test, the choice of the highest dose-level was based on the level of precipitate, according to the criteria specified in the international guidelines.
The selected treatment-levels were 12.3, 37, 111.1, 333.3 and 1000 µg/plate for the first and second experiments with and without S9 mix. Due to a severe toxicity observed with S9 mix using the preincubation method, a third experiment was undertaken using a lower range of dose-levels. The selected dose-levels for this third experiment were:
. 0.137, 0.412,1.23,3.7, 11.1 and 33.3 µg/plate for the TA 102 strain,
. 0.412,1.23,3.7, 11.1, 33.3 and 100 µg/plate for the TA 1537 strain,
. 0.8, 2.5, 7.4, 22.2, 66.7 and 200 µg/plate for the TA 98 strain,
. 1.23,3.7, 11.1, 33.3, 100 and 300 µg/plate for the TA 100 strain.
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered to be valid.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains and in either experiment.
In conclusion, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in the absence or in the presence of a rat metabolising system therefore RHODIASTAB 55 P is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
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