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EC number: 278-140-9 | CAS number: 75214-72-1
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 5 March to 14 March, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
- Justification for type of information:
- The read across justification is detailed in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: his G base-pair substitution Additional mutations: Δ uvr B, rfa
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: his C frameshift Additional mutations: Δ uvr B, rfa
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: his D frameshift Additional mutations: Δ uvr B, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: his D frameshift Additional mutations: Δ uvr B, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: his G base-pair substitution Additional mutations: Δ uvr B, rfa, pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 Mix
- Test concentrations with justification for top dose:
- -Experiment concentrations: 1.0, 10.0, 100.0, 500.0, 1000.0, 2500.0, 5000.0, 10000.0 µg/plate
Doses for the actual assay were selected from a preliminary study conducted on the test material at 14 doses: 1.22, 2.44, 4.88, 9.77, 19.53, 39.06, 78.13, 156.25, 312.50, 625.00, 1250, 2500.00, 5000.00, 10000.00 µg per plate using the strain TA-100. In this preliminary study, the test material did not exhibit toxicity to the indicator strain at any of the doses tested, as evidenced by the appearance of the background lawn on the minimal plates. - Vehicle / solvent:
- sterile deionized water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- MICROORGANISM
The Salmonella typhimurium strains used in this assay were obtained from Dr. Bruce Ames, University of California at Berkeley.
All indicator strains were kept at 4 °C on minimal medium plates supplemented with a trace of biotin and an excess of histidine. The plates with plasmid-carrying strains contain in addition ampicillin (25 µg/ml) to ensure stable maintenance of plasmid pKM101. New stock culture plates are made as often as necessary from frozen master cultures or from single colony reisolates that were checked for their genotypic characteristics (his, rfa, uvrB, big) and for the presence of plasmid.
For each experiment, an inoculum from the stock culture plates is grown overnight at 37 °C in nutrient broth (Oxoid CM67).
MEDIA
The bacterial strains were cultured in Oxoid Media #2 (nutrient Broth). The selective medium was Vogel Bonner Medium E with 2 % glucose. The overlay agar consisted of 0.6 % purified agar with 0.05 mM histidine, 0.05 mM biotin and 0.1 M NaCl.
ACTIVATION SYSTEM
- S9 Homogenate: A 9,000 x g supernatant prepared from Sprague Dawley adult male rat liver induced by Aroclor 1254 was purchased commercially and used in this assay.
- S9 Mix composition: 4 µmol/ml of NADP (sodium salt), 5 µmol/ml D-glucose-6-phosphate, 8 µmol/ml MgCl2, 33 µmol/ml KCl, 100 µmol/ml sodium phosphate buffer pH 7.4, organ homogenate from rat liver (S9 fraction) 100 µl/ml - Rationale for test conditions:
- The Salmonella typhimurium strains used are all histidine auxotrophs by virtue of mutations in the histidine operon. when these histidine-dependent cells are grown in a minimal media petri plate containing a trace of histidine, only those cells that revert to histidine independence (his+) are able to form colonies. The trace amount of histidine allows all the plated bacteria to undergo a few divisions; this growth is essential for mutagenesis to occur. The his+ revertants are easily scored as colonies against the slight background growth. The spontaneous mutation frequency of each strain is relatively constant, but when a mutagen is added to the agar the mutation frequency is increased 2- to 100-fold. Cells which grow to form colonies on the minimal media petri plates are therefore assumed to have reverted, either spontaneously or by the action of a test substance to his+ genotype.
- Evaluation criteria:
- Because the procedures used to evaluate the mutagenicity of the test material were semiquantitative, the criteria used to determine positive effects are inherently subjective and are based primarily on a historical data base. Most data sets are evaluated using the following criteria:
(1) Strains TA-1535, TA-1537 and TA-1538
If the solvent control value is within the normal range, a test material producing a positive response equal to three times the solvent control value is considered mutagenic.
(2) Strains TA-98 and TA-100
If the solvent control value is within the normal range, a test material producing a positive response equal to twice the solvent control value for TA-98 and TA-100 is considered mutagenic.
The following normal range of revertants for solvent controls are generally considered acceptable:
TA-1535: 8-30
TA-1537: 4-30
TA-1538: 10-35
TA-98: 20-75
TA-100 : 80-250
(3) Pattern
Because TA-1535 and TA-100 are both derived from the same parental strain (G-46) and because TA-1538 and TA-98 are both derived from the same parental strain (D3052), to some extent there is a built-in redundancy in the microbial assay. In general, the two strains of a set respond to the same mutagen and such a pattern is sought. Generally, if a strain responds to a mutagen in nonactivation tests, it will do so in activation tests. Occasionally, exception to this pattern may also be seen.
The demonstration of dose-related increases in mutant counts is an important criterion in establishing mutagenicity. Since, several doses were employed in the actual assay, a dose response would normally be seen with a mutagenic test material. Additional tests may be performed at narrower dose, if the mutagenic test material fails to exhibit a dose-response in the initial assay. However, occasionally it is difficult to generate a dose-response and the test material will be evaluated based on the available data. - Statistics:
- Statistical methods were not used.
Plate test data consisted of direct revertant colony counts obtained from a set of selective agar plates seeded with populations of mutant cells suspended in a semisolid overlay. Because the test material and the cells were incubated in the overlay for approximately 2 days and a few cell divisions occurred during the incubation period, the test is semiquantitative in nature. Although these features of the assay reduce the quantitation of result, they provide certain advantages not contained in a quantitative suspension test:
- The small number of cell divisions permits potential mutagens to act in replicating DNA, which is often more sensitive than nonreplicating DNA.
- The combined incubation of the test material and the cells in the overlay permits constant exposure of the indicator cells for approximately 2 days.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA-1535, TA-1537,TA-1538, TA-98 and TA-100 bacteria
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Any other information on results incl. tables
The test with the strain TA-1537 was repeated because the activation system was not added to the positive control plates during the first trial. The repeat test was also negative.
Applicant's summary and conclusion
- Conclusions:
- The test item tested negative to bacterial mutagenicity in the Ames test both with and without metabolic activation
- Executive summary:
The test item was evaluated for its potential to induce mutagenic effects in an in vitro bacterial inverse mutation assay, according to a method similar to the OECD 471 guideline. Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100 were used. The test material showed no toxicity to the TA-100 indicator strain during the preliminary test. Therefore, mutagenicity tests were performed at eight doses in the range of 1.0 to 10000.0 μg / plate with and without S9 metabolic activation.
The test item showed no genetic activity in any of the tests conducted and was considered non-mutagenic in these test conditions. The high concentrations used counterbalance the shortcomings that could result from the use of a test material with a low purity used suggesting that the use of the experimental results for the evaluation of mutagenicity is acceptable.
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