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EC number: 807-124-1 | CAS number: 1519029-23-2
- 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:
- 48h
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals Part 471, adopted 21. Jul. 1997 "Bacterial Reverse Mutation Test"
EU-Guideline B. 13/14 adopted 31. May 2008 "Mutagenicity - Reverse mutation test using bacteria" - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(methylamino)pentane-2-ol dibenzoate
- EC Number:
- 807-124-1
- Cas Number:
- 1519029-23-2
- Molecular formula:
- C20H23NO3
- IUPAC Name:
- 4-(methylamino)pentane-2-ol dibenzoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- 4-8methylamino)pentan-2-ol dibenzoate, CAS-No.: 15 19029-23-2, monoconstituent substance, stable at room temperature, solid, soluble in DMSO
batch No. STCB/226/14, purity: 96.06%, production date: Jun. 2014
Method
- Target gene:
- Histidine deficiency: hisD6610 (frame shift), present in TA97a / hisD3052 (frame shift) present in TA98 / hisG46 (base pair substitutrion) present in TA100 and TA1535 / hisG428 (base pair substitution) present in TA102
UV sensitivity, biotine deficiency: uvrB (deletion) present in TA97a, TA98, TA100 and TA1535
lipopolysaccharide side chain deficiency: rfa (deletion) present in TA97a, TA98, TA100, TA102 and TA1535
ampicillin resistance: pKM101 (plasmide) present in TA97a, TA98, TA100 and TA102
tetracyclin resistance: pAQ1 (plasmide) present in TA102
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, rfa, pKM101, pAQ1
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (from livers of male Sprague-Dawley rats treated with Aroclor), obtained by Trinova BioChem, Gießen
- Test concentrations with justification for top dose:
- first experiment (plate incorporation method): 1500 / 500 / 150 / 50 / 15 µg/plate
second experiment (pre-incubation method): 1500 / 750 / 375 / 188 / 94 / 47 µg/plate
top dose is not cytotoxic - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent: DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- A genotype confirmation was performed. Also a toxicity control (maximal dose on maximal agar) ans sterility control (without bacteria) were perfomed too.
- Details on test system and experimental conditions:
- 2 experiments were perfomed. Per strain and dose, 4 plates with and without S9-mix were used.
Spontaneous revertants were detected in 4 replicates (with or without S9 mix) for each solvent used in the test.
In the first experiment the plate incorporation method was used: All materials (100µl test solution at each dose level, negative or positive control + 500 µl S9 mix or phosphate buffer + 100 µl bacteria suspension + 2000 µl overlay agar) were gently vortexed in a test tube and then poured onto the selective agar plates.
The second experiment was performed in the pre-incubation method. All test materials (100 µl test solutions, 500 µl S9 mix or phosphate buffer and 100 µl bacteria suspension) were vortexed and incubated for 20 minutes in selective test tubes. Then the test tubes were poured onto agar plates and 2000 µl overlay agar was added.
Then all the agar plates were closed and placed in the dark incubator at 37°C for 48h. The colonies were counted visually. - Rationale for test conditions:
- according to guideline
- Evaluation criteria:
- The genotype of the bacteria was confirmed. The highest dose of the test item showed no signs of toxicity towards the bacteria. The sterility controls and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation. The second experiment confirmed result of the first experiment. So the study was considered valid.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor =/> 2) in one strain can be observed. Also a concentration-related increase can be taken as a sign for mutagenicity. - Statistics:
- The colonies were counted visually and the numbers were recorded. A spreadsheet software (Microsoft Excel) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The increase factor (f) of revertant induction (mean revertants divided by mean spontaneous revertants) and the absolute number of revertants were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- not mutagenic under the conditions of this test
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