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Diss Factsheets
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EC number: 433-930-4 | CAS number: 247089-62-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline conform study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his
trp
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:
- S9-mixture
- Test concentrations with justification for top dose:
- first assay: 3, 10, 33, 100, 333, 1000, 3330 and 5000 pg/plate in the absence and presence of 5% (v/v) S9-mix
second assay: Based on the results of the first mutation assay, TKP 50048 was tested up to concentrations of 100 pg/plate. - Vehicle / solvent:
- The test substance was suspended ethanol absolute pro analyse (Labscan Ltd, Dublin, Ireland). The stock solution was treated with ultra-sonication to obtain a homogeneous suspension. Test substance concentrations were prepared directly prior to use.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- TA1535, 1µg/plate
Migrated to IUCLID6: in physiological saline
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TAl537, 60 µg/plate
Migrated to IUCLID6: in physiological saline
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: daunomycine, in physiological saline
- Remarks:
- TA98, 4 µg/plate
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA100, 650 µg/plate
Migrated to IUCLID6: in DMSO
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2UvrA, 10 µg/plate
Migrated to IUCLID6: in DMSO
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene in DMSO
- Remarks:
- TAl537, TA1535,TA98 2,5 µg/plate
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene in DMSO
- Remarks:
- TA100 2,5 µg/plate
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene in DMSO
- Remarks:
- WP2UvrA, 5 µg/plate
- Details on test system and experimental conditions:
- The test substance was tested both in the absence and presence of S9-mix in each strain, in two independent experiments. Top agar in top agar tubes was molten and heated to 45°C. The following solutions were successively added to 3 ml molten top agar: 0.1 ml of a fresh bacterial culture (10°cells/ml) of one of the tester strains, 0.1 ml of a dilution of the test substance in ethanol and either 0.5 ml S9-mix (in case of activation assays) or 0.5 ml
0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were turned and incubated in the dark at 37°C for 48 h. After this period revertant colonies (histidine independent for Salmonella typhimurium bacteria and tryptophan independent for Escherichia coli) were counted. - Evaluation criteria:
- The revertant colonies (histidine independent cq. tryptophan independent) were counted
automatically with a Protos model 50000 colony counter or manually, if less than 40 colonies
per plate were present. Plates with sufficient test article precipitate to interfere with automated
colony counting were counted manually. - Statistics:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment. A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated
experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final
evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitate
The test substance precipitated in the top agar at concentrations of 33 pg/plate and upwards. Precipitation of TKP 50048 on the plates was observed at the start of the incubation period at concentrations of 33 pg/plate and upwards. Precipitation on the plates was observed at concentrations of 100 pg/plate and upwards at the end of the incubation period.
Toxicity
To determine the toxicity of TKP 50048, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed. The definitions are stated in Appendix 1. No reduction of the bacterial background lawn and no decrease in the number of revertants was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that TKP 50048 is not mutagenic in the
Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation
assay. - Executive summary:
In the first mutation assay, TKP 50048 was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix. TKP 50048 precipitated on the plates at dose levels of 100 µg/plate and upwards. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
In the second mutation assay, TKP 50048 was tested up to concentrations of 100 µg/plate in the absence and presence of S9-mix. TKP 50048 precipitated on the plates at this dose level. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
TKP 50048 did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TAl 00) and in the number of revertant (Trp+) colonies in tester strain WP2UvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that TKP 50048 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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