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Diss Factsheets
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EC number: 935-211-5 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010.06.01 - 2010-07-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted on July 21, 1997
- Deviations:
- yes
- Remarks:
- Only 2-AA used as positive control in the presence of S9 mix
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF SE
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol
- EC Number:
- 935-211-5
- Cas Number:
- 1305113-15-8
- Molecular formula:
- C30H28O10P2
- IUPAC Name:
- 1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol
- Reference substance name:
- phosphoric acid 6-(diphenoxy-phosphoryloxy)-hexahydro-furo[3,2-b]furan-3-yl ester diphenyl ester
- IUPAC Name:
- phosphoric acid 6-(diphenoxy-phosphoryloxy)-hexahydro-furo[3,2-b]furan-3-yl ester diphenyl ester
- Details on test material:
- Test substance: Isosorbid-O,O’-bis(diphenylphosphorsäureester); Lab test substance number: 10/0230-1
Physical state, appearance: solid, white
Batch identification: 9731/09/009 V1
Purity/composition: > 99% (w/w)
The test substance was homogen and stable throughout the study period
- Storage condition of test material: room temperature.
Constituent 1
Constituent 2
Method
- Target gene:
- his (salmonella strains), trp (e. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix of phenobarbital (i.p.) and β-naphthoflavone (orally) induced rats
- Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1 000; 2 500 and 5 000 μg/plate
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA), dissolved in DMSO, 2.5 μg/plate for the strains TA100, TA98, TA1357, TA1535, 60 μg/plate for E. coli WP2 uvrA
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 5 μg/plate dissolved in DMSO for strains TA 1535, TA 100
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD), 10 μg/plate dissolved in DMSO for strain TA 98
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 100 μg/plate dissolved in DMSO for strain TA 1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 5 μg/plate dissolved in DMSO for E. coli WP2 uvrA
- Details on test system and experimental conditions:
- Standard plate test and preincubation Test. 3 test plates per dose or per control.
Standard plate test (plate incorporation method) based on the method of Ames et al.
Preincubation Test procedure is based on the method described by Yahagi et al. and Matsushima et al.
After incubation at 37°C for 48 – 72 hours in the dark, the bacterial colonies (his+/trp+ revertants) are counted.
Determination of rate of induced back mutations of several bacteria mutants from histidine auxotrophy (his-/trp-) to histidine prototrophy (his+/trp+). - Evaluation criteria:
- Toxicity detected by a
• decrease in the number of revertants
• clearing or diminution of the background lawn (= reduced his- or trp- background growth)
• reduction in the titer
The experiment is considered valid if:
• The number of revertant colonies in the negative controls was within or nearby the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• The titer of viable bacteria was ≥ 10exp8/ml
The test substance is considered positive if:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Weak bacteriotoxic effect (slight decrease in the number of his+ revertants) at 5000 μg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No relevant increase in the number of his+ or trp+ revertants was ovserved with or without metabolic activation in non of the tested strains.
No test substance precipitation was found. - 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
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