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EC number: 944-574-9 | 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:
- 2 July 1993 - 28 July 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study using some noncurrent practices
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The study used the concurrent control, 2-anthramine, as the sole indicator of the efficacy of the S9 mix. The concentration of the post-mitochondrial fraction in the S9 mix was 6% which boarders on the very lower limit of acceptability (5%).
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- All Salmonella strains contain a uvrB deletion mutation (affecting DNA excision repair), as well as an rfa mutation (affecting membrane permeability). In addition, strains TA98 and TA100 contain the plasmid pKM101, which enhances the error-prone DNA repair system normally present in this organism. Strains TA1535 and TA100 detect base pair substitution mutations affecting the hisG locus. Strains TA1538 and TA98 detect frameshift mutations affecting the hisD locus, while TA1537 detects frameshift mutations at the hisC locus. E. coli strain WP2 uvrA contains a uvrA deletion mutation (affecting DNA excision repair) and can detect base pair substitution mutations affecting the trp locus.
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA 98, TA100 and Escherichia coli strain WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- The exogenous metabolic activation (S9) mixture contained 8 mM MgCl2, 33 mM KCl, 4 mM NADP, 5 mM glucose-6-phosphate, 100 mM Na2HP04 (pH 7.4) and 6% (v/v) Aroclor 1254-induced male Sprague-Dawley rat liver homogenate.
- Test concentrations with justification for top dose:
- 1.67, 5.00, 16.7, 50.0, 167, 500, 1670 and 5000 mg/plate for the original assay with and without S9; 16.7, 50.0, 167, 500, 1670 and 5000 mg/plate for the confirmatory assay and the retest with and without S9; and 1.67, 5.00, 16.7, 50.0, 167, 500, 1670 and 5000 mg/plate for thesecond retest without S9
- Vehicle / solvent:
- dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Concurrent positive controls without S9: sodium azide, 9-aminoacridine, 2-nitrofluorene, N-ethyl-N-nitro-N-nitroguanidine; Concurrent positive controls with S9: 2-anthramine
- Remarks:
- The report notes that according to SOP, the concentration of liver homogenate in the metabolic activation mixture is optimized for each lot of S9 prepared, using three positive control articles (2-acetylaminofluorene, 2-anthramine, and benzo[a]pyrene.
- Details on test system and experimental conditions:
- Fresh cultures for mutagenesis testing were prepared by quickly thawing a vial of frozen working stock cultures of each tester strain and transferring the culture to 25 mL of Oxoid Nutrient Broth #2. After growth for approximately 6 hours at 37°C in an orbital shaking incubator, samples of each culture were diluted 1:4 in de-ionized water (di-H20) and optical densities were determined at 650 nm. Cultures with optical densities of 0.40 to 0.60, representative of cells in late exponential or early stationary phase (approximately 1-2 x 109 cellsfmL), were utilized for this study. Triplicate cultures of each strain were evaluated with the appropriate solvent and positive controls.
- Evaluation criteria:
- A positive result is defined as a statistically significant, dose-dependent increase in the number of histidine- or tryptophan-independent revertants with at least one dose level inducing a revertant frequency that is two-fold the spontaneous solvent control value. If the test article does not induce a statistically significant, dose-dependent increase in revertant frequency, but induces a revertant frequency at one dose level that is two-fold the spontaneous control value, the result is considered equivocal. A negative result is defined as the absence of a statistically significant or dose-dependent increase in the number of histidine- or tryptophan independent revertants. Statistical analyses are performed only when a 50% increase in revertant frequency, relative to the concurrent negative controls, is observed. This 50% "trigger" was selected based upon the normal, spontaneous variation observed among replicate negative control cultures (see next page), as well as spontaneous fluctuation observed in this laboratory among groups of cultures treated with a variety of test articles judged to be negative in this assay.
- Statistics:
- Statistical analyses were performed using the program developed by Snee and Irr (1981), with significance established at the 95% confidence limit. [Snee, R.D. and J.D. Irr (1981) Design of a statistical method for the analysis of mutagenesis at the hypoxanthine guanine phosphoribosyl transferase locus of cultured Chinese hamster ovary cells, Mutation Res., 85:77-93.]
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA 98, TA100 and Escherichia coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- other: The positive controls overall are considered valid recognizing that the S9 mix was checked with 2-acetylaminofluorene, 2-anthramine, and benzo[a]pyrene prior to testing but that only 2-anthramine was used as the positive control in the tests.
- Additional information on results:
- Prescreen: the test material was not toxic to any strain at a dose of 50 ug/plate, or to strain WP2 uvrA at doses of 167 and 500 u/g/plate. Inhibited growth was observed in strains TA1538 and TA100 at doses of ≥167 ug/plate and in strain WP2 uvrA at doses ≥1670 ug/plate. The test article was incompletely soluble at doses ≥500 ug/plate. First test: The test material again was found to be incompletely soluble at doses ≥1670 ug/plate, but normal growth was observed in all tester strains at all doses evaluated with and without S9. Second test: In the confirmatory the test article again was found to be incompletely soluble at doses ≥500 ug/plate. Inhibited growth was observed in tester strains TA1537 and TA1538 at doses of 1670 and/or 5000 ug/plate with and/or without S9. Third test: The test article again was found to be incompletely soluble at doses ≥1670 g/plate, and inhibited growth again was observed in tester strains TA1537 and TA100 at a dose of 5000 ug/plate with or without S9. Fourth test: The test material was incompletely soluble at doses ≥1670 ug/plate, and inhibited growth was observed at doses of 167, 500, 1670 and 5000 ug/plate. Analysis: The authors concluded that the apparent discrepancy in toxicity between the prescreen and the mutation assays likely was related to interference resulting from test article insolubility.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
First test: The test material was evaluated in triplicate cultures in all five Salmonella tester strains at doses of 1.67, 5.00, 16.7, 50.0, 167 and 500 ug/plate, and in E. coli strain WP2 uvrA at doses of 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9. Revertant frequencies for all doses in all tester strains with and without S9 approximated or were less than those observed in the concurrent negative solvent controls.
Second test: A confirmatory assay was conducted in all Salmonella and E. coli strains at doses of 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9. Revertant frequencies for all doses of the test material in all tester strains with and without S9 again approximated or were less than in the negative solvent controls.
Third test: The test material again was re-evaluated under identical conditions in all five Salmonella tester strains (16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9) to confirm the results observed at the higher dose levels evaluated in the second assay where cytotoxicity was observed (5000 ug/plate with and without S9 for TA 1537 and 1670 and 5000 ug/plate without S9 for TA1538). Revertant frequencies for all doses in all tester strains with S9, and in tester strains TA1535, TA1537, TA98 and TA100 without S9, approximated or were less than negative solvent control values. Statistically significant increases in revertant frequencies, approximately 2.4- to 2.7-fold negative solvent control values, were observed in strain TA1538 at doses of 16.7, 50, and 500 g/plate without S9. However, these increases were not dose related.
Fourth test: The test material was re-evaluated in strain TA1538 doses of 1.67, 5.00, 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate without S9. Revertant frequencies for all doses of the test material approximated or were less than control values, thus not confirming the response observed in test three and indicating that the slight increases observed in strain TA1538 in previous trial were statistical aberrations due to random fluctuation of the spontaneous revertant frequency.
Controls: All positive and negative control values in all assays were within acceptable limits.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was not mutagenic in the Ames/Salmonella-E. coli Liquid Pre-incubation Assay under
the conditions and the criteria of the test protocol. - Executive summary:
The in vitro genetic toxicity potential of this substance was evaluated in the Ames/Salmonella-E. coli Liquid Pre-incubation Assay using Salmonella typhimurium strains TA1535, TA1537, TA1538, TA 98, TA100 and Escherichia coli strain WP2 uvrA. An apparent difference in toxicity was observed between the prescreen and the mutation assays, which likely was related to interference resulting from test article insolubility. In the first, test the test material was evaluated in triplicate cultures in all five Salmonella tester strains at doses of 1.67, 5.00, 16.7, 50.0, 167 and 500 ug/plate, and in E. coli strain WP2 uvrA at doses of 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9. Revertant frequencies for all doses in all tester strains with and without S9 approximated or were less than those observed in the concurrent negative solvent controls. In the second, confirmatory assay that was conducted in all Salmonella and E. coli strains at doses of 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9, revertant frequencies for all doses of the test material in all tester strains with and without S9 again approximated or were less than in the negative solvent controls. In the third, test the test material again was evaluated under identical conditions in all five Salmonella tester strains (16.7, 50.0, 167, 500, 1670 and 5000 ug/plate with and without S9) to confirm the results observed at the higher dose levels evaluated in the second assay where cytotoxicity was observed (5000 ug/plate with and without S9 for TA 1537 and 1670 and 5000 ug/plate without S9 for TA1538). Revertant frequencies for all doses in all tester strains with S9, and in tester strains TA1535, TA1537, TA98 and TA100 without S9, approximated or were less than negative solvent control values. Statistically significant increases in revertant frequencies, approximately 2.4- to 2.7-fold negative solvent control values, were observed in strain TA1538 at doses of 16.7, 50, and 500 g/plate without S9. However, these increases were not dose related. In the fourth test, the test material was re-evaluated in strain TA1538 doses of 1.67, 5.00, 16.7, 50.0, 167, 500, 1670 and 5000 ug/plate without S9. Revertant frequencies for all doses of the test material approximated or were less than control values, thus not confirming the response observed in test three and indicating that the slight increases observed in strain TA1538 in previous trial were statistical aberrations due to random fluctuation of the spontaneous revertant frequency. All positive and negative control values in all assays were within acceptable limits. Based on these results, the test material was not mutagenic in the Ames/Salmonella-E. coli Liquid Pre-incubation Assay under the conditions and the criteria of the test protocol.
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