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EC number: 237-262-2 | CAS number: 13709-94-9
- 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
- Remarks:
- reported in a publication
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- esting protocol based on the publications by Ames (1975), modified acc. Yahagi (1975), performed on strains TA100, TA98 only
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Absence of mutagenic activity of sodium borate (borax) and boric acid in the Salmonella pre-incubation test.
- Author:
- Benson W H, Birge W J, Dorough H W
- Year:
- 1 984
- Bibliographic source:
- Environmental Toxicology and Chemistry 3: 209-214.
- Reference Type:
- publication
- Title:
- Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test.
- Author:
- Ames, B.N.; et al.
- Year:
- 1 975
- Bibliographic source:
- Mutation Research 31, 347-364
- Reference Type:
- publication
- Title:
- Mutagenicity of carcinogenic azo dyes and their derivatives
- Author:
- Yahagi T, Degawa M, Seino Y, Matsushima T, Nagao M, Sugimura T, Hashimoto Y
- Year:
- 1 975
- Bibliographic source:
- Cancer Letters, 1 (1975) 91-96
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983 / only 2 strains tested
- Principles of method if other than guideline:
- The mutagenicity of borax and boric acid was examined in Salmonella typhimurium strains TA98 and TA100 by the preincubation method.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
- Reference substance name:
- 1303-96-4
- EC Number:
- 603-411-9
- Cas Number:
- 1303-96-4
- IUPAC Name:
- 1303-96-4
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Sodium tetraborate (borax) (Na2B407- 10 H20) and boric acid (H3B03) were certified ACS-grade (Fisher Scientific, Fair Lawn, NJ).
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- The bacterial strains (TA98 and TA 100) were acquired from Dr. B. N. Ames (Biochemistry Department, University of California, Berkeley, CA). They are histidine-requiring mutants that lack an excision repair system and the lipopolysaccharide barrier, making them more sensitive and permeable to foreign compounds. These two strains contain the R-factor plasmid pKm 101 that codes for an error-prone DNA repair system, which increases their sensitivity for mutagenic expression. Strain TA98 is a frameshift mutant, whereas TA100 is a base-pair substitution mutant.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- In preliminary assays, borax and boric acid showed mutagenic activity at a level of 1 µg/plate; therefore, a range of doses from 0.01 to 100 µg/plate was chosen for study.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
The liquid preincubation procedures used to determine mutagenesis were similar to those described by Yahagi et al. Some mutagens that cannot be detected efficiently in the standard plate incorporation assay can be tested using a slight modification of the standard assay, wherein the test chemical is incubated with the S-9 mixture and bacterial culture before incorporation into the soft agar overlay. The modified procedure involved mixing 0.1 ml of the test solution(s), 0.5 ml of S-9 mixture or 0.2 M sodium phosphate buffer, and 0.1 ml of bacterial test strain culture (10E9 bacteria/ml), in the order given, to sterile glass tubes placed in an ice bath. The tubes were then incubated for 30 min at 37°C in an incubator-shaker. Following incubation, the tubes were again placed on ice.
Top agar containing just enough histidine to support several cell divisions was dispensed into each tube, in 2-ml aliquots, from a Fisher lsotemp Dry Bath (model 145) maintained at 37°C. Cellular toxicity was determined using 0.1 ml of a diluted nutrient broth culture (10E3 bacteria/ml) and top agar containing an excess of histidine (3 µmol/tube). The contents were mixed and poured on minimal glucose bottom agar previously added to a 15 x 100 mm petri plate. The plates were incubated for 48 h at 37°C and the mutagenicity was assayed by counting the number of histidine-revertant colonies per plate using a Biotran II Automated Colony Counter.
The S-9 fraction (9,000 x g supernatant of rat liver) used in the mutagenesis assays was obtained from male Sprague-Dawley rats (200-250 g body weight). Induction of the liver enzyme system was accomplished by injecting the animals intraperitoneally with Aroclor 1254 (500 mg/kg) 5 d before sacrifice. The resulting S-9 liver preparation was stored at -70°C prior to use. All the components of the Salmonella mutagenicity test were prepared as described by Ames et al.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- 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:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The study was performed equivalent to OECD TG 471 with minor deficiencies in documentation and performance, positive and negative controls gave the appropriate response, but only 2 strains were tested. The results were negative, and the test item is so considered not to induce gene mutations in bacteria, and the results may be used as supporting information.
- Executive summary:
In a reverse gene mutation assay in bacteria (similar to OECD 471 of 1983), strains TA98 and TA100, of S. typhimurium were exposed to Borax and Boric acid at concentrations of up to 100 µg/plate in the presence and absence of mammalian metabolic activation (induced rat liver S9) via pre-incubation.
The positive controls induced the appropriate responses in the corresponding strains. There was no clear evidence of induced mutant colonies over background.
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