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EC number: 226-827-9 | CAS number: 5495-84-1
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 June 2003 to 15 October 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- not indicated
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-isopropyl-9H-thioxanthen-9-one
- EC Number:
- 226-827-9
- EC Name:
- 2-isopropyl-9H-thioxanthen-9-one
- Cas Number:
- 5495-84-1
- Molecular formula:
- C16H14OS
- IUPAC Name:
- 2-isopropyl-9H-thioxanthen-9-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: CHL/IU
- Metabolic activation:
- with and without
- Metabolic activation system:
- Induced rat liver microsomal fraction
- Test concentrations with justification for top dose:
- Test 1 (With activation): 37.5, 70 and 150 µg/mL
Test 1 (Without activation): 15, 30 and 60 µg/mL
Test 2 (Without activation): 10, 20 and 40 µg/mL
Test 3 (Without activation): 2.5, 5 and 10 µg/mL - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- WITH METABOLIC ACTIVATION
Test 1- Exposure time: 6 hours and Harvest time: 24 hours
WITHOUT METABOLIC ACTIVATION
Test 1- Exposure time: 6 hours and Harvest time: 24 hours
WITHOUT METABOLIC ACTIVATION
Test 2- Exposure time: 24 hours and Harvest time: 24 hours
WITHOUT METABOLIC ACTIVATION
Test 3- Exposure time: 48 hours and Harvest time: 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity was determined with or without metabolic activation using viable cell counts.
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - In the cytotoxicity measurement, it was determined that concentrations of the test material at 60 µg/mL, 40 µg/mL and 10 µg/ml respectively for 6 hours, 24 hours and 48 hours without metabolic activator and at 150 µg/mL with metabolic activator could result in a significant inhibition of cell growth by 50 percent.
- Without metabolic activator, the test material did not cause structural chromosome aberration in CHL cells exposed for 6 hours, 24 hours and 48 hours respectively, but it could induce the increase of gap in CHL cells treated for 48 hour. The test material didn't induce structural chromosome aberration in CHL cells with metabolic activator.
- The test material caused a significant increase of polyploidy in CHL cells at 60 µg/mL in the case of CHL cells exposed for 6 hours without metabolic activation (P<0.05). No other abnormality was observed.
- In this study, it was observed that without metabolic activation, polyploidy of CHL cells increased significantly exposed for 6 hours at 60 µg/mL of test material, while this case didn't occur when exposed for 24 hours and 48 hours. Since the polyploidy ratio is as low as 2.5 % and there was no obvious dose-response relationship, it is therefore concluded that the 6 hours result may be not related to action of the test material.
Any other information on results incl. tables
Table 1: Effect of the Test Material on Structural Chromosome Aberration in CHL Cells
Metabolic activation |
Exposure period |
Dose (µg/mL) |
Cell no. scored |
Gaps |
No. of structural aberrations |
Ratio of aberration (%) |
Result |
+ |
6 hours |
0 |
200 |
3 |
2 |
1.0 |
- |
37.5 |
200 |
6 |
3 |
1.5 |
- |
||
75 |
200 |
12 |
1 |
0.5 |
- |
||
150 |
200 |
8 |
8 |
4.0 |
- |
||
CP (20) |
200 |
28 |
118 |
59.0 |
+ |
||
- |
6 hours |
0 |
200 |
0 |
3 |
1.5 |
- |
15 |
200 |
6 |
3 |
1.5 |
- |
||
30 |
200 |
2 |
1 |
0.5 |
- |
||
60 |
200 |
3 |
6 |
3.0 |
- |
||
MMC (0.2) |
200 |
5 |
73 |
36.5 |
+ |
||
- |
24 hours |
0 |
200 |
3 |
3 |
1.5 |
- |
10 |
200 |
2 |
4 |
2.0 |
- |
||
20 |
200 |
5 |
2 |
1.0 |
- |
||
40 |
200 |
2 |
2 |
1.0 |
- |
||
MMC (0.1) |
200 |
30 |
106 |
53.0 |
+ |
||
- |
48 hours |
0 |
200 |
0 |
2 |
1.0 |
- |
2.5 |
200 |
14 |
2 |
1.0 |
- |
||
5 |
200 |
10 |
7 |
3.5 |
- |
||
10 |
200 |
18 |
8 |
4.0 |
- |
||
MMC (0.05) |
200 |
4 |
41 |
20.5 |
+ |
Table 2: Effect of the Test Material on Polyploidy in CHL Cells
Metabolic activation |
Exposure period |
Dose (µg/mL) |
Cell no. scored |
Number of polyploid |
Ratio of polyploidy (%) |
X^2 |
+ |
6 hours |
0 |
200 |
4 |
2.0 |
5.44 P > 0.05 |
37.5 |
200 |
5 |
2.5 |
|||
75 |
200 |
2 |
1.0 |
|||
150 |
200 |
0 |
0.0 |
|||
CP (20) |
200 |
0 |
0.0 |
|||
- |
6 hours |
0 |
200 |
0 |
0.0 |
9.09 P > 0.05 |
15 |
200 |
3 |
1.5 |
|||
30 |
200 |
0 |
0.0 |
|||
60 |
200 |
5 |
2.5* |
|||
MMC (0.2) |
200 |
0 |
0.0 |
|||
- |
24 hours |
0 |
200 |
2 |
1.0 |
2.74 P > 0.05 |
10 |
200 |
3 |
1.5 |
|||
20 |
200 |
2 |
1.0 |
|||
40 |
200 |
0 |
0.0 |
|||
MMC (0.1) |
200 |
0 |
0.0 |
|||
- |
48 hours |
0 |
200 |
0 |
0.0 |
3.0 P > 0.05 |
2.5 |
200 |
1 |
0.5 |
|||
5 |
200 |
0 |
0.0 |
|||
10 |
200 |
0 |
0.0 |
|||
MMC (0.05) |
200 |
0 |
0.0 |
Compared with Negative Control:*, P<0.05
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material is not clastogenic in either the presence or absence of metabolic activation.
- Executive summary:
The potential of the test material to cause chromosome aberrations in cultured mammalian cells was investigated in accordance with the standardised guideline OECD 473.
CHL/IU cells were treated with the test material according to the following:
Test 1 (with metabolic activation) for exposure time 6 hours and harvest time 24 hours at 37.5, 70 and 150 µg/mL;
Test 1 (without metabolic activation) for exposure time 6 hours and harvest time 24 hours at 15, 30 and 60 µg/mL;
Test 2 (without metabolic activation) for exposure time of 24 hours and harvest time 24 hours; and
Test 3 (without metabolic activation) for exposure time 48 hours and harvest time 48 hours.
Metabolic activation was provided in the form of Induced rat liver microsomal fraction. The test material was prepared in DMSO and this was used as the solvent control. Mitomycin C was used as a positive control in the absence of exogenous metabolic activation and Cyclophosphamide was used for the presence of exogenous metabolic activation. Cytotoxicity was determined with or without metabolic activation using viable cell counts.
In the cytotoxicity measurement, it was determined that concentrations of the test material at 60 µg/mL, 40 µg/mL and 10 µg/mL respectively for 6 hours, 24 hours and 48 hours without metabolic activation and at 150 µg/mL with metabolic activator could result in a significant inhibition of cell growth by 50 percent.
Without metabolic activation, the test material did not cause structural chromosome aberration in CHL cells exposed for 6 hours, 24 hours and 48 hours respectively, but it could induce the increase of gaps in CHL cells treated for 48 hours. The test material didn't induce structural chromosome aberration in CHL cells with metabolic activator.
The test material caused a significant increase of polyploidy in CHL cells at 60 µg/mL in the case of CHL cells exposed for 6 hours without metabolic activation (P<0.05). No other abnormality was observed.
In this study, it was observed that without metabolic activation, polyploidy of CHL cells increased significantly when exposed for 6 hours at 60 µg/ml of test material, while this case didn't occur when exposed for 24 hours and 48 hours, respectively. Since the polyploidy ratio is as low as 2.5 % and there was no obvious dose-response relationship it is therefore concluded that the 6 hours results may not be related to action of the test material.
Under the conditions of this study, the test material is not clastogenic in either the presence or absence of metabolic activation.
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