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EC number: 700-486-0 | CAS number: 102687-65-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- gas under pressure: liquefied gas
- Details on test material:
- - Storage Conditions: Room temperature, upright in the dark without desiccant
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- - Preliminary toxicity assay: 1, 3, 6, 8, 11, 21 and 37 mmoles/L (24,500; 73,400; 147,000; 196,000, 269,000; 513,000 and 905,000 ppm, respectively)
- Mutagenicity and confirmatory assay: 3, 6, 8, 11, 21 and 37 mmoles/L (73,400; 147,000; 196,000, 269,000; 513,000 and 905,000 ppm, respectively).
- Confirmatory retest: 0.7, 1, 3, 6, 8, 11, 21 and 37 mmoles/L (17,200; 24,500; 73,400; 147,000; 196,000, 269,000; 513,000 and 905,000 ppm, respectively)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: test system was exposed to the test article via the desiccator methodology, a modification of the plate incorporation methodology originally described by Ames et al. (1975) and updated by Maron and Ames (1983). This test system has been shown to detect a wide range of classes of chemical mutagens (McCann et al., 1975; McCann and Ames, 1976). The desiccator methodology has been shown to be an effective method for detecting the genotoxic activity of volatile and gaseous test articles (Wagner et al., 1992). Briefly, once agar had solidified, the plates were inverted in 9 liter dessicators and an appropriate quantity of test material was introduced into each dessicator by withdrawing the appropriate amount of air and replacing with test material.
DURATION
- Original assay: following 24 hour exposure to test article, the plates were removed from the dessicators and allowed to inclubate at 37 °C for an additional 24 hours.
- Confirmatory assay: exposure duration 48 hours in dessicator.
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; number of revertants - Evaluation criteria:
- - Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value.
- Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value.
- An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited.
- A response will be evaluated as negative, if it is neither positive nor equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY TOXICITY ASSAY
- No background lawn toxicity was observed however a reduction in revertant counts was observed beginning at 11, 21 or at 37 mmoles/L with some test conditions.
MUTAGENICITY ASSAY: No positive mutagenic responses were observed with any of the tester strains in the presence or absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 11, 21 or at 37 mmoles/L.
CONFIRMATORY MUTAGENICITY ASSAY
No positive mutagenic response was observed with tester strains TA100, TA1535 and WP2 uvrA in the absence of S9 activation and with tester strains TA100, TA1535 and TA1537 in the presence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 21 or 37 mmoles/L. Tester strain TA98 in the presence and absence of S9 was not evaluated due to confluent growth but was retested. Due to excessive toxicity, as a result of a drop in the revertant counts beginning at 8 mmoles/L, tester strain TA 1537 in the absence of S9 was retested. Due to an unacceptable vehicle control value, tester strain WP2 uvrA in the absence of S9 activation was not evaluated but was retested. In the retest of the confirmatory mutagenicity assay, no positive responses were observed with tester strains TA98 and TA1537 in the absence of S9 activation and with tester strains TA98 and WP2 uvrA in the presence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 21 or 37 mmoles/L. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
|
| -S9
| +S9
| ||
Strain | Test conc (mmol/L) | Average reverants original | Average revertants – confirmatory | Average reverants – original | Average revertants – confirmatory |
|
|
|
|
|
|
TA98 | Vehicle | 35 | 30 | 24 | 12 |
| 0.7 | NA | 31 | NA | 9 |
| 1 | NA | 34 | NA | 9 |
| 3 | 27 | 29 | 15 | 10 |
| 6 | 28 | 24 | 25 | 9 |
| 8 | 22 | 27 | 18 | 11 |
| 11 | 19 | 22 | 13 | 10 |
| 21 | 4 | 15 | 3 | 10 |
| 37 | 0 | 0 | 0 | 0 |
| Positive control | 129 | 351 | 442 | 408 |
TA100 | Vehicle | 179 | 96 | 209 | 106 |
| 3 | 214 | 108 | 216 | 88 |
| 6 | 179 | 113 | 203 | 83 |
| 8 | 184 | 130 | 236 | 72 |
| 11 | 216 | 88 | 214 | 63 |
| 21 | 205 | 40 | 267 | 40 |
| 37 | 0 | 0 | 0 | 0 |
| Positive control |
| 772 |
| 407 |
TA1535 | Vehicle | 10 | 11 | 7 | 9 |
| 3 | 10 | 8 | 7 | 10 |
| 6 | 9 | 9 | 6 | 5 |
| 8 | 11 | 11 | 10 | 12 |
| 11 | 8 | 7 | 8 | 7 |
| 21 | 6 | 11 | 5 | 7 |
| 37 | 0 | 0 | 0 | 0 |
| Positive control | 293 | 666 | 73 | 140 |
TA1537 | Vehicle | 7 | 10 | 7 | 7 |
| 0.7 | NA | 6 | NA | NA |
| 1 | NA | 6 | NA | NA |
| 3 | 3 | 10 | 4 | 6 |
| 6 | 3 | 11 | 3 | 6 |
| 8 | 5 | 7 | 4 | 4 |
| 11 | 0 | 6 | 7 | 5 |
| 21 | 1 | 4 | 0 | 5 |
| 37 | 0 | 0 | 0 | 0 |
| Positive control | 992 | 633 | 36 | 473 |
WP2 uvrA | Vehicle | 14 | 45 | 19 | 42 |
| 0.7 | NA | NA | NA | 39 |
| 1.0 | NA | NA | NA | 42 |
| 3 | 13 | 56 | 23 | 43 |
| 6 | 12 | 55 | 16 | 28 |
| 8 | 11 | 39 | 13 | 35 |
| 11 | 4 | 33 | 6 | 32 |
| 21 | 2 | 15 | 5 | 34 |
| 37 | 0 | 8 | 0 | 4 |
| Positive control | 168 | 372 | 181 | 198 |
Applicant's summary and conclusion
- Conclusions:
- The results of the bacterial reverse mutation test using gas-phase exposure indicate that, under the conditions of this study, the test article did not cause a positive mutagenic response in either the presence or absence of Aroclor induced rat liver S9.
- Executive summary:
In a reverse mutation assay, performed according to OECD Guideline 471 and GLP, Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test material using the desiccator methodology, a modification of the Ames plate incorporation methodology, in the presence and absence of S9 -mix. The assay was performed in three phases: a preliminary toxicity assay, a mutagenicity assay and a confirmatory mutagenicity assay. Based on the findings of the preliminary toxicity assay, the maximum dose plated in the confirmatory mutagenicity assay was 37 mmoles/L (905,000 ppm). In the mutagenicity and confirmation assay, no precipitation was observed and toxicity was observed beginning at 11, 21 or at 37 mmoles/L. In the mutagenicity and confirmation assay, no positive mutagenic response was observed. In conclusion, under the conditions of this study, the test article did not cause a positive mutagenic response in either the presence or absence of Aroclor-induced rat liver S9.
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