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EC number: 438-930-8 | CAS number: 2550-52-9
- 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:
- 03 Mar - 06 Apr 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Directive 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 438-930-8
- EC Name:
- -
- Cas Number:
- 2550-52-9
- Molecular formula:
- C16H30O
- IUPAC Name:
- cyclohexadecanone
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon (E. coli strain)
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:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phenobarbital and ß-Naphthoflavone
- Test concentrations with justification for top dose:
- Range-finding study:
10, 50, 100, 500, 1000 and 5000 µg/plate with and without metabolic activation in TA 100 and WP2 uvr A
Experiment 1:
10, 50, 100, 500, 1000 and 5000 µg/plate with and without metabolic activation in TA 1537, TA 1535 and TA 98
Experiment 2:
10, 50, 100, 500, 1000 and 5000 µg/plate with and without metabolic activation in all strains
Top dose in experiment 1 and 2 was selected based on the precipitation of the test substance at 5000 µg/plate, which interfered with the scoring in the range-finding study. - Vehicle / solvent:
- - Vehicle/Solvent used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: in agar (plate incorporation); experiment 2: preincubation
DURATION
- Preincubation period: 20 min (experiment 2)
- Exposure duration: 48 h (experiment 1 and 2)
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: determination of bacterial background lawn - Evaluation criteria:
- A test is considered to be positive if the test item induces dose related increases in numbers of revertants scored in two separate experiments and these increases are deemed to be of biological relevance. Reproducible increases at one experimental point may also indicate a positive response. For a biologically relevant response the number of revertants is expected to be at least double the spontaneous reversion rate in the S. typhimurium strains TA 98, TA 100 and the E. coli strain. In the S. typhimurium strains TA 1535 and TA 1537 the number of revertants is expected to be at least the triple of the spontaneous reversion rate. A test item producing neither a dose related and reproducible increase in the number of revertants nor a reproducible positive response at any experimental point is considered to be non-mutagenic in this test system.
- Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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:
- (at 5000 µg/plate in range-finding study, reported as experiment 1)
- 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:
- (at 5000 µg/plate in range-finding study, reported as experiment 1)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the toxicity range-finding study at a concentration of 5 mg/mL the test material precipitated in the cell culture medium.
RANGE-FINDING/SCREENING STUDIES: A toxicity range-finding study was carried out to determine the maximum concentration of the test substance in the main experiments. Therefore, S. typhimurium strain TA 100 and E. coli WP2 uvr A were tested at concentrations of 10, 50, 100, 500, 1000 and 5000 µg/plate with and without metabolic activation. A precipitation of the test substance, which interfered with the scoring, was observerd at 5000 µg/plate. Based on this result concentrations of 10, 50, 100, 500 and 1000 µg/plate were chosen for the main experiments. The results of the range-finding study for TA 100 and WP2 uvr A are used for experiment 1.
HISTORICAL CONTROL DATA
In both independent experiments controls gave counts of spontaneous revertants within the normal ranges obtained in this laboratory, except of one untreated control of WP2 uvr A. However, these value is in the normal range of spontaneous revertants of WP2 uvr A (30 - 60) according to literature*. The spontaneous revertants of the vehicle control was within the normal range. *(Green and Muriel (1976), Mutation Res. 38, 3-32)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Bacterial background lawn indicated sufficient growth conditions in all experiments.
Any other information on results incl. tables
Table 1: Test Results of Experiment 1
EXPERIMENT 1 (plate incubation method) |
|||||
S9-Mix |
Without
|
||||
Test item (mg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
NC |
16.0±5.3 |
11.3±3.2 |
22.0±3.0 |
239.0±31.4 |
39.0±4.2 |
SC |
16.0±6.6 |
13.7±4.2 |
22.0±5.6 |
207.0±12.0 |
23.0±1.0 |
0.01 |
12.7±4.9 |
13.3±2.3 |
16.3±3.2 |
251.0±11.3 |
27.3±5.7 |
0.05 |
13.0±1.7 |
11.0±4.4 |
18.0±4.6 |
213.0±8.9 |
25.3±5.7 |
0.1 |
8.7±2.5 |
13.0±1.7 |
20.3±3.5 |
191.0±6.2 |
26.7±4.9 |
0.5 |
10.3±3.1 |
8.0±1.7 |
15.0±1.7 |
221.7±25.2 |
31.7±6.5 |
1 |
10.0±3.5 |
8.3±2.5 |
13.7±3.2 |
209.0±10.4 |
26.3±9.1 |
5 |
|
|
|
226.0±28.7 |
21.7±5.7 |
NaN3 |
1818.7±546.0 |
|
|
2490.7±187.5 |
|
9-AA |
|
676.0±511.6 |
|
|
|
2-NF |
|
|
585.3±102.1 |
|
|
MMS |
|
|
|
|
118.0±23.3 |
S9-Mix |
With
|
||||
Test item (mg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
NC |
16.3±5.5 |
13.0±7.0 |
22.3±5.7 |
255.0±18.7 |
36.7±2.5 |
SC |
16.0±2.6 |
14.0±1.0 |
20.7±8.1 |
221.3±22.5 |
31.3±4.0 |
0.01 |
14.7±9.0 |
15.7±5.9 |
16.3±2.1 |
234.0±19.3 |
29.7±11.6 |
0.05 |
14.3±3.2 |
11.7±3.5 |
21.7±2.1 |
246.0±9.2 |
34.7±2.5 |
0.1 |
12.3±4.0 |
12.7±3.2 |
16.7±5.5 |
222.3±27.1 |
33.0±3.5 |
0.5 |
13.0±4.4 |
10.3±2.3 |
16.0±8.2 |
257.7±34.0 |
30.0±5.3 |
1 |
9.3±1.5 |
12.0±3.6 |
17.7±3.2 |
226.7±16.5 |
30.00±5.3 |
5 |
|
|
|
212.0±16.5 |
44.7±10.6 |
2-AA |
127.0±18.2 |
210.3±53.3 |
1736.0±138.8 |
1560.0±52.5 |
77.3±8.0 |
NC = Negative Control (untreated) SC = Solvent Control (DMSO) NaN3: sodium acide; 9-AA: 9-aminoacridine; 2-NF: 2-nitrofluorene; MMS: methyl methanesulphonate; 2-AA: 2-aminoanthracene |
Table 2: Test Results of Experiment 2
EXPERIMENT 2 (pre-incubation method) |
|||||
S9-Mix |
Without
|
||||
Test item (mg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
NC |
12.0±3.0 |
17.7±2.1 |
20.7±8.6 |
229.3±32.3 |
22.0±2.6 |
SC |
11.7±2.5 |
15.7±2.1 |
15.3±7.8 |
199.0±39.0 |
27.7±4.6 |
0.01 |
10.3±5.7 |
6.0±1.7 |
14.7±3.5 |
225.3±9.6 |
24.0±5.0 |
0.05 |
8.7±0.6 |
7.7±3.2 |
17.7±6.5 |
201.0±36.6 |
18.0±4.0 |
0.1 |
10.0±1.0 |
6.3±1.2 |
25.0±1.7 |
218.0±28.0 |
20.3±7.0 |
0.5 |
11.0±4.4 |
3.3±1.5 |
14.3±3.8 |
185.3±21.1 |
22.0±4.0 |
1 |
10.7±2.1 |
2.7±1.5 |
15.3±5.1 |
203.3±10.0 |
23.7±5.7 |
NaN3 |
1712.0±40.0 |
|
|
1400.0±172.1 |
|
9-AA |
|
1164.0±1.4 |
|
|
|
2-NF |
|
|
1400.0±172.1 |
|
|
MMS |
|
|
|
|
256.3±37.7 |
S9-Mix |
With
|
||||
Test item (mg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
NC |
14.7±9.2 |
7.3±0.6 |
46.3±6.0 |
214.3±9.0 |
15.3±4.5 |
SC |
14.0±3.5 |
7.3±4.5 |
47.3±3.1 |
216.7±25.2 |
20.7±1.5 |
0.01 |
14.0±3.0 |
8.3±1.2 |
44.0±5.6 |
206.3±25.5 |
17.0±3.6 |
0.05 |
13.7±5.5 |
11.7±4.2 |
49.7±8.4 |
199.3±15.6 |
16.7±5.1 |
0.1 |
12.3±4.9 |
4.7±0.6 |
39.7±9.0 |
193.0±14.0 |
22.3±4.5 |
0.5 |
14.7±3.2 |
6.3±1.5 |
41.3±2.9 |
188.3±4.7 |
19.0±4.0 |
1 |
14.3±2.5 |
4.7±1.5 |
32.7±3.8 |
180.3±6.7 |
13.3±1.2 |
2-AA |
118.3±14.4 |
188.3±7.8 |
1501.3±287.4 |
1464.0±68.4 |
206.3±29.7 |
NC = Negative Control (untreated) SC = Solvent Control (DMSO) NaN3: sodium acide; 9-AA: 9-aminoacridine; 2-NF: 2-nitrofluorene; MMS: methyl methanesulphonate; 2-AA: 2-aminoanthracene |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames test the test substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation.
- Executive summary:
A bacterial gene mutation assay (2001) with the test substance was performed in accordance with OECD Guideline 471 and in compliance with GLP. In two independent experiments, the S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and the E. coli strain WP2 uvr A were exposed to the test substance using the plate incorporation method (experiment 1) and pre-incubation method (experiment 2). In a toxicity range-finding study, in which 6 concentrations up to 5000 µg/plate were tested in TA 100 and E. coli WP2 uvr A, precipitation of the test substance, which interfered with scoring, was observed at 5000 µg/plate. Therefore concentrations of 10, 50, 100, 500 and 1000 µg/plate were selected for the main experiments. The test substance showed no bacterial toxicity at any dose in both experiments with or without metabolic activation. No biologically relevant increase in revertant numbers was observed after treatment with the test substance in any bacterial strain and at any concentration tested in the presence and absence of metabolic activation. The revertant frequencies of the vehicle control were within the expected range and the positive control chemicals induced marked increases in revertant colonies, demonstrating the effective performance of the experiments. Under the conditions of this experiment, the test substance is considered non-mutagenic in the selected S. typhimurium and E. coli strains in the presence and absence of metabolic activation.
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