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Diss Factsheets
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EC number: - | 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
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:
- September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Solubility and stability of the test substance in the solvent/vehicle: According to ICH Draft Consensus Guideline M7, formulations were prepared freshly prior to start of treatment. Thus, no stability test in the solvent was performed.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation: clear colorless solution (only used at the same day) - The purity of the test item was not taken into account for the calculation of the dosages.
Method
- Target gene:
- Histidine gene 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:
- Aroclor 1254 induced male Sprague Dawley rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 16, 50, 160, 500, 1600, 5000 µg/plate (+/-S9 mix, all strains)
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA 1535, TA 100), 4-nitro-1,2-phenylene diamine (TA 1537), 2-Nitrofluoren (TA 98), Cumene hydroperoxide (TA 102), 2-aminoanthracene (all strains).
- Details on test system and experimental conditions:
- METHOD: each concentration including the controls was tested in triplicate.
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100, TA1537 and TA98 this increase should be about twofold as compared to the solvent controls. For TA102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these criteria may be overruled by good scientific judgment. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA98 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- test item precipitation was not observed.
Any other information on results incl. tables
Table 1: Summary of results from the Salmonella mutagenicity assay with FMA (mean values of revertants per plate)
Dose (µg per plate) | Without metabolic activation | ||||
| TA 1535 | TA 100 | TA 1537 | TA 98 | TA 102 |
solvent control | 8 | 109 | 6 | 14 | 233 |
16 | 6 | 107 | 6 | 17 | 233 |
50 | 7 | 112 | 7 | 16 | 200 |
160 | 7 | 116 | 7 | 14 | 215 |
500 | 6 | 101 | 6 | 15 | 197 |
1600 | 7 | 118 | 8 | 13 | 205 |
5000 | 7 | 122 | 7 | 16 | 209 |
Positive control | 643 | 780 | 43 | 1250 | 638 |
Dose ( µg per plate ) | With metabolic activation (liver S9 mix) | ||||
| TA 1535 | TA 100 | TA 1537 | TA 98 | TA 102 |
solvent control | 11 | 133 | 8 | 18 | 336 |
16 | 10 | 139 | 5 | 20 | 332 |
50 | 11 | 134 | 6 | 17 | 302 |
160 | 9 | 144 | 7 | 22 | 340 |
500 | 9 | 121 | 7 | 19 | 322 |
1600 | 9 | 129 | 7 | 20 | 311 |
5000 | 10 | 130 | 7 | 14 | 300 |
Positive control | 127 | 2293 | 129 | 2474 | 2133 |
Historical negative control data demonstrated that no deleterious or mutagenic effects were induced by the chosen solvent. The positive controls sodium azide, 4-nitro-1,2 -phenylene diamine, 2-nitrofluoren, cumene hydroperoxide and 2-aminoanthracene increased mutant counts to well over those of the solvent controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.
None of the five strains used showed a dose-related and biologically relevant increase in mutant counts over those of the solvent controls in the preincubation test. This applied both to the tests with and without S9 mix.
Applicant's summary and conclusion
- Conclusions:
- No evidence of mutagenic activity.
- Executive summary:
The test item, dissolved in DMSO, was administered in doses of up to and including 5000 μg per plate without and with S9 mix on five Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA1535, TA100, TA1537, TA98 and TA102.
Doses up to and including 5000 μg per plate did not cause any bacteriotoxic effects. Test item precipitation occurred at the dose of 1600 μg per plate and above.
Evidence of mutagenic activity of the test item was not seen. In the preincubation modification, no biologically relevant increase in the mutant count, in comparison to the solvent controls, was observed in any of the strains tested, without and with S9 mix, under the experimental conditions applied.
The employed positive controls induced a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding solvent controls.
Therefore, the test item is considered to be non-mutagenic in the preincubation modification of the Salmonella/microsome test.
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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