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EC number: 236-109-7 | CAS number: 13170-05-3
- 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:
- 2009-09-14 - 2009-10-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Guideline no. 471: "Genetic Toxicology: Salmonella typhimurium Reverse Mutation Assay". (adopted May 26, 1983)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium
- EC Number:
- 236-109-7
- EC Name:
- Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium
- Cas Number:
- 13170-05-3
- Molecular formula:
- C22H27AlO5
- IUPAC Name:
- aluminum hydroxide bis(4-tert-butylbenzoate)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At normal room temperature and dry in the sample storeroom.
Method
- Target gene:
- his (S. typhimurium)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% or 5% liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- According to the result of the preliminary test, tetrahydrofuran was selected as the vehicle for the test. The maximum dose was 5mg/plate, followed by 2 mg/plate, 0.5 mg/plate, 0.2 mg/plate and 0.05 mg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylenediamine for strain TA98 (200 µg/plate) -S9,
- Remarks:
- 2-aminofluorene for strain TA97, TA98, TA100 (10 µg/plate) + S9, Danthron for strain TA102 (50 µg/plate) + S9, 2-aminoanthracene for strain TA1335 (3 µg/plate) + S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 1.1 - 1.6 E9 / ml
A frozen permanent was thawn from liquid nitrogen, a master plate was made, a well-isolated colony was selected and suspended it in 15 ml nutrient cultures, incubated for 12h in a 37°C dark incubator shaken at 120 rpm (at the time, the bacteria in the growing cultures was still at the logarithmic grow phase)
Preparation of medium and culture suspension: All the operations were performed according to SOP of in vitro mutagenicity test (Ames test) of Shanghai Institute for Preventive Medicine.
Dose selection:
Solubility in the plate: 100mg of the sample was weighed and added appropriated vehicle to 2ml, mixed extensively to form a 50 mg/ml solution. 400 µl, 100 µl, 40µl and 10 µl of the upper liquid were imbibed respectively, and appropriated vehicle was added to 1.0 ml to form solution of 20 mg/ml, 5 mg/ml, 2.0mg/ml and 0.5 mg/ml. 2 ml top agar was warmed in 45°C, added 100 µl above five different concentration sample solutions, mixed quickly and decanted onto the minimal glucose plates to make them evenly distributed and solidified on the horizontal table top. These plates were cultured in 37°C for 48h. Then dissolve condition was checked under 100x microscope
DETERMINATION OF CYTOTOXICITY
To determine the toxicity 100 mg of the test sample was weighed and added appropriated vehicle to 2ml, mixed extensively to form a 50 mg/ml solution. 400µl, 100 µl, 40 µl and 10 µl of the solution were imbibed and added appropriated vehicle to 1.0 ml to be a solution of 20 mg/ml, 5 mg/ml, 2.0 mg/ml and 0.5 mg/ml. 2 ml top agar was warmed in 45°C, 0.5 ml 0.1 mol/l PBS, 0.1 ml of the sample of five concentration, 0.1 ml enrichment solution of TA100 strain were added in turn, mixed quickly and decanted onto the minimal glucose plates. Plates were inverted, two plates per dosage group. A vehicle control was set at the same time. All the plates were cultured in 37°C for 48h. Number of bacterium colony of reversion per plate was recorded. And the bacterium colonies of background were observed, compared and described under 100* microscope to offer the evidence of determining the maximum dose of the formal test. - Rationale for test conditions:
- Recommended test system in international guidelines (e.g. EPA, OECD, EEC).
- Statistics:
- no details given
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- 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:
- not specified
- 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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: consistent in Formal Test 1 and 2
Applicant's summary and conclusion
- Conclusions:
- The result of this Ames Test was Negative. The substance Bis(4-(tert-butyl)benzoate-0) hydroxyaluminium (CAS No.: 13170-05-3) was considered not mutagenic.
- Executive summary:
The Reverse Mutation Assay ("Ames") using Salmonella typhimurium was performed according to OECD TG 471. The plate incorporation method was applied.
Positive and negative controls gave the appropriate results. Hence, the results can be considered to be sufficiently reliable to assess the potential of Bis(4-(tert-butyl)benzoate-0) hydroxyaluminium to induce gene mutations in bacteria. Dissolving extent and reasonable dosage of solvent and medium were studied. 5 dosage groups of 0.05, 0.2, 0.5, 2 and 5 mg/plate were selected, with or without 2 concentrations (5% and 10%) of S9 mixture. The numbers of revertant colonies of 5 different strains of TA97, TA98, TA100, TA102 and TA1535 were tested.
Based on the results of this study it is concluded that Bis(4-(tert-butyl)benzoate-0) hydroxyaluminium is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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