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EC number: 939-154-7 | 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
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- 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:
- From October 10 to November 14, 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- pentasodium 4-hydroxybenzene-1,3-disulfonate 4-hydroxybenzene-1-sulfonate sulfate
- EC Number:
- 939-154-7
- Cas Number:
- not available
- Molecular formula:
- C6H5NaO4S - C6H4Na2O7S2 - Na2SO4
- IUPAC Name:
- pentasodium 4-hydroxybenzene-1,3-disulfonate 4-hydroxybenzene-1-sulfonate sulfate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Dr. G.P. Meshram genotox services
- method of preparation of S9 mix: from wistar male rats induced with Aroclor 1254 in corn oil
- concentration or volume of S9 mix and S9 in the final culture medium: 0.1 mL of S9 mix (5% v/v S9 mix for initial toxicity-mutation test and 10% v/v S9 mix for confirmatory mutation test) prepared for treatment was added aseptically to 2 mL of the top agar
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): performed - Test concentrations with justification for top dose:
- Toxicity test at 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the absence and presence of S9
Confirmatory mutation test at 156.25, 312.5, 625, 1250, 2500, 5000 µg/plate in the absence and presence of S9 - Vehicle / solvent:
- distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- In presence of S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- In absence of S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): duplicate in the toxicity test and triplicate in the main test
- Number of independent experiments: 1 toxicity test and 1 main study
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; plate incorporation method
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h incubation period at 37 ± 1 ºC - Evaluation criteria:
- Cytotoxicity Evaluation Criteria
Six analysable doses were available to evaluate assay data. Cytotoxicity was not detectable as a decrease in the number of revertant colonies per plate and/or by a thinning of the bacterial background lawn was not observed.
Assay Evaluation Criteria
A result was considered positive if concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without any metabolic activation system.
Strains TA1535 and TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose-response was equal to or greater than 3.0 times the mean negative control value.
Strains TA98, TA100, and TA102
Data sets were judged positive if the increase in mean revertants at the peak of the dose-response was equal to or greater than 2.0 times the mean negative control value.
Statistical analysis was used as an aid in the evaluation of dose-response.
As the response did not meet all three of the above criteria (magnitude, concentration-responsiveness, reproducibility) and so was not evaluated as positive.
Negative results obtained in the initial toxicity-mutation test were confirmed by a second trial, using the same method as specified above, with an alteration in concentration spacing. - Statistics:
- Simple linear regression analysis was performed for tester strains TA1537, TA1535, TA98, TA100, and TA102, separately, to assess the dose-dependent nature of any increase in revertant colonies.
Results and discussion
Test results
- Species / strain:
- other: TA1537, TA1535, TA98, TA100, and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Negative Control
Results of this study indicate that values of the negative control in all strains were within the historical range for respective strains.
Positive Controls
2-Aminoanthracene was used as a positive control in the presence of the metabolic activation system for tester strains during the initial toxicity test and the confirmatory mutation test. Large historical control data of this laboratory proved the efficiency and suitability of 2-aminoanthracene as a positive control in the presence of the metabolic activation system. The batch of S9 used in this study, characterised by the supplier with benzo(a)pyrene, required a metabolic activation system by microsomal enzymes.
Positive controls exhibited a clear increase in the number of revertants when compared with that of the concurrent negative controls. This demonstrated the efficiency of the test system and the suitability of procedures employed in this assay.
Any increase in revertants was not observed in TA100 (initial toxicity-mutation test and confirmatory mutation test) treated with 2-aminoanthracene, in the absence of the metabolic activation, but a clear increase was observed in the presence of the metabolic activation. This demonstrated the efficiency of the S9 fraction used in this assay.
Initial Toxicity-Mutation Test
A normal bacterial background lawn was observed up to the tested concentration of 5000 µg/plate, in all tester strains (TA1537, TA1535, TA98, TA100, and TA102) in the absence and presence of the metabolic activation system (5% v/v S9 mix).
No reduction in the number of revertant colonies was observed at a tested concentration up to 5000 µg/plate in the absence and presence of the metabolic activation (5% v/v S9 mix) in all tester strains.
Results revealed that there was no positive mutagenic effect in any tester strain, up to the tested concentration of 5000 µg/plate in the absence and presence of the metabolic activation (5% v/v S9 mix), when compared with that of the negative control.
Statistical analysis did not reveal any significant effect in tester strains TA1537, TA1535, TA98, TA100, and TA102 in the absence of the metabolic activation and tester strains TA1535, TA98, TA100 and TA102 in the presence of the metabolic activation (5% v/v S9 mix).
In tester strain TA1537 (in the presence of the metabolic activation), the statistical analysis showed correlation at 5%, however the mean value was within the historical control data, hence it was biologically non-significant.
Based on the results of the initial toxicity mutation test, six concentrations (156.25, 312.5, 625, 1250, 2500, 5000 µg/plate) of SELLASOL HH-F were selected for the confirmatory mutation test, in the absence and presence of the metabolic activation system (10% v/v S9 mix) for all tester strains.
Confirmatory Mutation Test
As recommended by the OECD guideline, the confirmatory experiment was conducted with a modification in study parameters to confirm the negative results obtained in the initial toxicity mutation test. In the confirmatory mutation test, the concentration spacing was modified, using a factor of 2 and the concentration of S9 mix was increased to 10% v/v.
A normal bacterial background lawn was observed up to the tested concentration of 5000 µg/plate, in all tester strains (TA1537, TA1535, TA98, TA100, and TA102) in the absence and presence of the metabolic activation system (10% v/v S9 mix).
No reduction in the number of the revertant colonies was observed up to the tested concentration of 5000 µg/plate, in the absence and presence of the metabolic activation (10% v/v S9 mix) in all tester strains.
Results revealed that there was no positive mutagenic effect in the tester strains TA1537, TA1535, TA98, TA100, and TA102, up to the tested concentration of 5000 µg/plate, in the absence and presence of the metabolic activation (10% v/v S9 mix), when compared with that of the negative control.
Statistical analysis did not reveal any significant effect in any tester strains.
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic
- Executive summary:
This study was performed to evaluate the mutagenic activity of the test substance using the bacterial reverse mutation test on five histidine deficient mutant tester strains of Salmonella typhimurium (i.e., TA1537, TA1535, TA98, TA100, and TA102).
The test item was tested in two independent experiments in the absence and presence of metabolic activation. Bacterial cultures were exposed to the test item at 8 concentration levels (two plates/concentration) ranging from 1.5 to 5000 µg/plate in the initial toxicity-mutation test, using the plate incorporation method.
Normal bacterial background lawn was observed up to the concentration of 5000 µg/plate, in all tester strains (TA1537, TA1535, TA98, TA100, and TA102) in the absence and presence of the metabolic activation system (5% v/v S9 mix).
No increase in the number of revertant colonies (no mutagenic effect) was observed in the absence and presence of the metabolic activation system (5% v/v S9 mix) in any tester strain. To confirm the negative results obtained in the initial toxicity mutation test, the confirmatory mutation test was conducted, using the plate incorporation method with an increased S9 concentration, i.e., 10% v/v S9 mix and concentration spacing modification.
Bacterial cultures were exposed to the test substance at 6 concentration levels (three plates/concentration) ranging from 156.25 to 5000 µg/plate for tester strains TA1537, TA1535, TA98, TA100, and TA102 in the absence and presence (10 % v/v S9 mix) of the metabolic activation. The revertant colonies were scored after 48 hours of incubation at 37 ± 1 °C.
The test item did not induce any significant increase in the number of revertants, in trials with and without S9 mix, in any tester strain. Values for the negative control were within the historical control ranges of the laboratory. Positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system.
All criteria for a valid study were met. Based on the results of this study, under specified experimental conditions, the test substance is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.
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