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Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
EC number: 947-257-3 | 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
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March the 14th to the 15th, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline ISO 10993 "Biological Evaluation of Medical Device" Part 5: "Tests for cytotoxicityz In vitro methods“
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
Test material
Results and discussion
- Details on results:
- Toxic effects were observed following incubation with the test item from 312.5 µg/ml up to the highest tested concentration (5000 µg/ml). The calculated XTT50 value is 289.5 µg/ml. Even after stringent washing not all of the test item could be removed from the cells in the higher concentrations leading to high chemical blank values and therewith freak high viability values.
CONTROLS
The negative control and the solvent control showed no reduction in cell viability. The positive control (SDS) induced a distinct dose-related reduction in cell viability.
Any other information on results incl. tables
Results with test item
Test group | Absorbance* | SD | Chem. Blanks | Absorbance of solvent control (%)** |
Negative control | 0.730 | 0.024 | 0.113 | 106.4 |
Solvent control | 0.690 | 0.018 | 0.109 | 100.0 |
Test item 39.1 µg/ml | 0.693 | 0.021 | 0.115 | 99.5 |
Test item 78.1 µg/ml | 0.675 | 0.017 | 0.115 | 96.4 |
Test item 156.3 µg/ml | 0.620 | 0.017 | 0.122 | 85.8 |
Test item 312.5 µg/ml | 0.391 | 0.012 | 0.137 | 43.7 |
Test item 625 µg/ml | 0.262 | 0.007 | 0.148 | 19.7 |
Test item 1250 µg/ml | 0.340 | 0.016 | 0.180 | 27.6 |
Test item 2500 µg/ml | 0.393 | 0.021 | 0.235 | 27.4 |
Test item 5000 µg/ml | 0.615 | 0.022 | 0.331 | 49.1 |
*Mean absorbance (absolute) of 7 wells
**Relative absorbance (rounded values)
Positive control
Test group | Absorbance* | SD | Chem. Blanks | Absorbance of solvent control (%)** |
Negative control | 1.085 | 0.132 | 0.116 | 112.4 |
Solvent control | 0.974 | 0.059 | 0.112 | 100.0 |
SDS 3.125 µg/ml | 1.062 | 0.075 | 0.109 | 110.6 |
SDS 6.25 µg/ml | 1.012 | 0.092 | 0.110 | 104.7 |
SDS 12.5 µg/ml | 0.973 | 0.070 | 0.110 | 100.2 |
SDS 25 µg/ml | 0.940 | 0.066 | 0.106 | 96.7 |
SDS 50 µg/ml | 0.722 | 0.014 | 0.104 | 71.8 |
SDS 100 µg/ml | 0.117 | 0.003 | 0.103 | 1.7 |
SDS 125 µg/ml | 0.118 | 0.003 | 0.106 | 1.5 |
SDS 250 µg/ml | 0.126 | 0.003 | 0.102 | 2.8 |
*Mean absorbance (absolute) of 7 wells
**Relative absorbance (rounded values)
Applicant's summary and conclusion
- Conclusions:
- The test item possesses a cytotoxic potential.
- Executive summary:
The in vitro study was performed to assess the cytotoxic potential of test item by means of the XTT test using the mouse cell line L929.
The following concentrations of the test item were tested: 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000 µg/ml.
Complete medium (RPMI containing 10 % (v/v) FCS) was used as negative control. The solvent control for the positive control was also RPMI medium containing 10 % (v/v) FCS and 10.0 % (v/v) deion. water.
SDS was used as positive control. The following concentrations were applied: 3.125, 6.25, 12.5, 25, 50, 100, 125, 250 µg/ml.
The incubation time was 24 hours at 37 ± 1.5 °C.
The negative control and the solvent control showed no reduction in cell viability. The positive control (SDS) induced a distinct dose~re|ated reduction in cell viability.
Toxic effects were observed following incubation with the test item from 312.5 µg/ml up to the highest tested concentration (5000 µg/ml). The calculated XTT50 value is 289.5 µg/ml. Even after stringent washing not all of the test item could be removed from the cells in the higher concentrations leading to high chemical blank values and therewith freak high viability values.
Conclusion
It can be stated that under the experimental conditions reported, the test item possesses a cytotoxic potential.
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