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EC number: 277-962-5 | CAS number: 74665-14-8
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 18, 2022 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:
- June 26, 2020
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenol, sulfonated
- EC Number:
- 277-962-5
- EC Name:
- Phenol, sulfonated
- Cas Number:
- 74665-14-8
- Molecular formula:
- The substance is an UVCB, therefore the molecular formula is not available
- IUPAC Name:
- Reaction products of phenol and fuming sulphuric acid
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine
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 (Nagpur, Maharashtra) - Test concentrations with justification for top dose:
- Initial Toxicity-Mutation Test: 0.0015, 0.005, 0.015, 0.05, 0.15, 0.5, 1.5 and 5 μL/plate.
Confirmatory Mutation Test: 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 μL/plate
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled Water
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 9-Aminoacridine hydrochloride monohydrate
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation) - 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 resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative 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 5 μL/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 5 μL/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 5 μL/plate of Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P 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 any tester strains.
Based on the results of the initial toxicity mutation test, six concentrations (0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 μL/plate) of Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P 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 concentration of 5 μL/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 5 μL/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 5 μL/plate of Phenol Sulphonated (EC: 277- 962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P, 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:
- Not mutagenic
- Executive summary:
This study was performed to evaluate the mutagenic activity of Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P 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 0.0015 to 5 μL/plate in the initial toxicity-mutation test, using the plate incorporation method.
Normal bacterial background lawn was observed up to the concentration of 5 μL/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 Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P at 6 concentration levels (three plates/concentration) ranging from 0.15625
to 5 μL/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, Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.
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