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EC number: 500-057-6 | CAS number: 27104-30-9
- 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
- Study period:
- 14 April 2014 - 10 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2013-01-10
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Tetrakis(hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea
- Physical state: colorless to pale yellow liquid
- Lot/batch No.: PCCP28G1
- Active ingredient content: 66.7% w/w
- Water content: 31.1% w/w
- Correction factor applied: 1.5
- Expiry date: 31 July 2014
- Storage condition: at room temperature.
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- Experiments without S9 mix
The selected treatment-levels were:
- 3.91, 7.81, 15.6, 31.3, 62.5 and 125 µg/plate for the TA 1535 and TA 100 strains in the first and second experiments as well as for the TA 1537 strain in the second experiment,
- 7.81, 15.6, 31.3, 62.5, 125 and 250 µg/plate for the TA 102 strain in the first and second experiments as well as for the TA 98 strain in the first experiment,
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1537 strain in the first experiment,
- 15.6, 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 98 strain in the second experiment, as well as for the TA 1535, TA 98, TA 100 and TA 102 strains in the third experiment.
Experiments with S9 mix
The selected treatment-levels were:
- 3.91, 7.81, 15.6, 31.3, 62.5 and 125 µg/plate for the TA 1535 in the first and second experiments as well as for the TA 1537 strain in the second experiment,
- 7.81, 15.6, 31.3, 62.5, 125 and 250 µg/plate for the TA 98, TA 100 and TA 102 strains in the first experiment,
-7.81, 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 100 strain in the second experiment,
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1537 strain in the first experiment,
- 15.6, 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 98 and TA 102 strains in the second experiment, as well as for the TA 98 strain in the third experiment using the direct incorporation method.
- 7.81, 15.6, 31.3, 62.5, 93.75, 125 and 250 µg/plate for the TA 98 strain in the third experiment using the pre-incubation method. - Vehicle / solvent:
- - Vehicle used: water for injections
- Justification for choice: Since the test item was found to be cytotoxic in the preliminary test, the selection of the highest dose-level to be used in the main experiments was based on the level of cytotoxicity.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-aminoacridine, 2-nitrofluorene, mitomycin C (-S9 mix); 2-anthramine, benzo(a)pyrene (+S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 to 72 hours.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn. - Evaluation criteria:
- In all case, biological relevance (such as reproducibility and reference to historical data) was taken into consideration when evaluating the results.
The test item is considered to have shown mutagenic activity in this study if:
- 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 mean number of revertants compared with the vehicle controls is observed, in any strain, at any dose-level,
- and/or a reproducible dose-response relationship is evidenced.
The test item is considered to have shown no mutagenic activity in this study if:
- neither an increase in the mean number of revertants, reaching 2-fold (for the TA 98, TA 100 and TA 102 strains) or 3-fold (for the TA 1535 and TA 1537 strains) the vehicle controls value, is observed at any of the tested dose-levels,
- nor any evidence of a dose-response relationship is noted.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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
Under the experimental conditions of this study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, either in the presence or absence of a rat liver metabolizing system. - Executive summary:
The objective of this study was to evaluate the potential of the test item to induce reverse mutations in Salmonella typhimurium.
Methods
A preliminary toxicity test was performed to define the dose-levels of the test item to be used for the mutagenicity experiments. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Five strains of bacteria Salmonella typhimurium were used: TA 1535, TA 1537, TA 98, TA 100 and TA 102. 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 at 37°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 cytotoxicity was not shown with the selected dose-levels in each of the tested conditions of the main experiments, a third experiment was undertaken for some strains and conditions, using higher ranges of dose-levels. In order to check the reliability of slight increases in the number of revertants noted in the TA 98 strain in the second experiment with S9 mix, a third experiment was also undertaken with this strain under the same experimental conditions but using a narrower range of dose-levels.
All experiments were performed according to the direct plate incorporation method, except for the second experiment with S9 mix as well as a part of the third experiment with S9 mix, which were performed according to the pre-incubation method (60 minutes, 37°C).
The test item was dissolved in water for injections.
Results
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were at least five analysable dose-levels for each strain and test condition. The study was therefore considered to be valid.
Since the test item was found to be cytotoxic in the preliminary test, the selection of the highest dose-level to be used in the main experiments was based on the level of cytotoxicity, according to the criteria specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were ranged from 3.91 to 1000 µg/plate.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose-levels >= 62.5 µg/plate in the TA 1537 strain, >= 125 µg/plate in the TA 1535 and TA 100 strains and >= 250 µg/plate in the TA 98 and TA 102 strains.
Slight increases in the number of revertants were noted in the TA 98 strain in the first experiment. These increases seemed dose-related and exceeded the positive threshold of 2-fold the vehicle control value. Nevertheless the mean number of revertants remained within the vehicle control historical range (up to 39 revertants/plate versus [12-39] for the vehicle control historical data). Furthermore, no similar results were noted either in the second or in the third experiment. The slight increases noted in the first experiment were therefore considered to be not biologically relevant.
The test item did not induce any other noteworthy increase in the number of revertants, in any other strains or test conditions.
Experiments with S9 mix
The selected treatment-levels were ranged from 3.91 to 1000 µg/plate.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose-levels >= 125 µg/plate in the TA 1535, TA 1537, TA 98 and TA 100 strains and >= 250 µg/plate in the TA 102 strain.
Slight increases in the number of revertants were noted in the TA 98 strain in the second experiment (pre‑incubation method). These increases seemed dose-related, they exceeded the positive threshold of 2-fold the vehicle control value and the mean number of revertants exceeded the vehicle control historical range (up to 67 revertants/plate versus [16-44] for the vehicle control historical data). Nevertheless, no similar effect was observed either in the third experiment using the pre-incubation method, despite the use of a narrower range of dose-levels, or in the first and third experiments using the direct plate incorporation method. Since the slight increases noted in the second experiment were not reproducible they were considered to be not biologically relevant.
The test item did not induce any other noteworthy increase in the number of revertants, in any other strains or test conditions.
Conclusion
Under the experimental conditions of this study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium either in the presence or absence of a rat liver metabolizing system.
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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