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EC number: 212-985-6 | CAS number: 901-44-0
- 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:
- weight of evidence
- Study period:
- 26 June 2015 - 17 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
- EC Number:
- 212-985-6
- EC Name:
- 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
- Cas Number:
- 901-44-0
- Molecular formula:
- C19H24O4
- IUPAC Name:
- 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
- Test material form:
- liquid: viscous
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:
- The selected dose-levels were the following:Without S9 mix: 125, 250, 500, 1000, 2000 and 4000 µg/plate in all strains for both mutagenicity experiments.With S9 mix:- 125, 250, 500, 1000, 2000 and 4000 µg/plate for the first experiment, and in the TA 98, TA 100 and TA 102 strain for the second experiment,- 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 1535 and TA 1537 strains in the second experiment.
- Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide- Justification for choice: test item was found to be soluble in the vehicle at 100 mg/mL
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 agarDURATION- Preincubation period: 60 minutes- Incubation time: 48 to 72 hours.DETERMINATION OF TOXICITY- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn
- Evaluation criteria:
- In all cases, 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
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- For all strains, a moderate to strong toxicity (thinning of the bacterial lawn and/or decrease in the number of revertants) was noted in both experiments without S9 mix, at dose-levels = 2000 µg/plate. A moderate to strong toxicity (thinning of bacterial lawn) was noted in both experiments with S9 mix, at dose-levels from 500 to 4000 µg/plate, depending on the strain.
Applicant's summary and conclusion
- Conclusions:
- egative under the experimental conditions of the study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium strains, 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.
The study was performed according to the international guidelines (OECD No. 471 and Council Regulation No. B.13/14).
Methods
A preliminary toxicity test was performed to define the dose-levels of the test item dissolved in dimethylsulfoxide (DMSO), to be used for the mutagenicity experiments. The test item was then tested in two independent experiments, both 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.
Treatments were performed according to the direct plate incorporation method except for the second experiment with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium were used: TA 1535, TA 1537, TA 98, TA 100 and TA 102. Each strain was exposed to six 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.
Results
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were six analysable dose-levels for each strain and test condition. The study was therefore considered to be valid.
The test item was found toxic and not freely soluble in the preliminary test. The selection of the highest dose-level to be used in the main experiments was based on the first limiting factor (i.e. level of toxicity in this case), according to the criteria specified in the international guidelines.
The selected dose-levels were the following:
Without S9 mix: 125, 250, 500, 1000, 2000 and 4000 µg/plate in all strains for both mutagenicity experiments.
With S9 mix:
. 125, 250, 500, 1000, 2000 and 4000 µg/plate for the first experiment, and in the TA 98, TA 100 and TA 102 strain for the second experiment,
. 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 1535 and TA 1537 strains in the second experiment.
A strong precipitate (preventing the scoring of revertants) was observed in the Petri plates at dose-level of 4000 µg/plate in the five strains, both with and without S9 mix.
A moderate to strong toxicity (thinning of the bacterial lawn and/or decrease in the number of revertants) was noted in the five strains tested in both experiments without S9 mix, at dose-levels = 2000 µg/plate.
A moderate to strong toxicity (thinning of bacterial lawn) was noted in the five tested strains tested in both experiments with S9 mix, at dose-levels from 500 to 4000 µg/plate, depending on the strain.
No noteworthy increase in the number of revertants was noted in any of the five tested strains, either with or without S9 mix. These results met thus the criteria of a negative response.
Conclusion
Under the experimental conditions of the study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium strains, either in the presence or absence of a rat liver metabolizing system.
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