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EC number: 939-487-8 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-02-06 - 1995-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD not actually specified but mentioned in 'Statement of Compliance'.
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
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 pKM 101
- Species / strain / cell type:
- E. coli, other: WP2 pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3333 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Sponsor's request and compatibility with the target cells.
NOTE: the solvent is described as acetone in the method section but in most of the tables of results it is reported to be DMSO. It is thought by the reviewer that this is a typographical error: if DMSO was used rather than acetone the study would still be valid.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 1.0 µg/plate
- Remarks:
- TA98, TA100, TA1535, TA1537 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 10 µg/plate
- Remarks:
- WP2 uvrA (pKM101) with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sterigmatocystin 100 µg/plate
- Remarks:
- WP2 (pKM101) with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation 75 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA (pKM101), WP2 (pKM101) without metabolic activation 1,000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors. Concentration of S9 in the mix was 10%. 0.5mlk of S9 mix were added to a total volume of 2.65ml, giving a final concentration of approximately 2% S9.
DURATION
- Preincubation period: 60 minutes +/- 2 minutes at 37ºC
- Exposure duration: 48 - 72 hours at 37ºC
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- For the test to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. TA1535 and TA1537 were judged positive if the increase in mean revertants is equal to or greater than three times the mean vehicle control value. TA98, TA100, WP2 uvrA (pKM101) and WP2 (pKM101) were judged positive in the increase in mean revertants is equal to or greater than two times the mean vehicle control value.
- Statistics:
- None stated in report
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli, other: WP2 (pKM101)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed at 333 µg/plate and above
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity was not evident at any concentration - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Summary of results – Experiment B1 revertants per plate (mean of 3 plates)
Dose µg/plate |
+/- metabolic activation |
Average revertants per plate |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA (pKM101) |
WP2 (pKM101) |
||
Solvent control |
- |
21 |
143 |
11 |
7 |
210 |
44 |
100 |
- |
19 |
158 |
11 |
6 |
212 |
52 |
333 |
- |
24 |
141 |
11 |
7 |
199 |
50 |
1000 |
- |
20 |
136 |
15 |
6 |
232 |
48 |
3333 |
- |
20 |
142 |
14 |
4 |
163 |
53 |
5000 |
- |
22 |
153 |
14 |
6 |
169 |
46 |
Positive control |
- |
804 |
675 |
467 |
156 |
1963 |
205 |
Solvent control |
+ |
28 |
157 |
15 |
9 |
276 |
58 |
100 |
+ |
27 |
159 |
15 |
9 |
294 |
61 |
333 |
+ |
29 |
188 |
10 |
8 |
242 |
50 |
1000 |
+ |
30 |
182 |
12 |
8 |
254 |
52 |
3333 |
+ |
30 |
157 |
14 |
7 |
287 |
55 |
5000 |
+ |
28 |
180 |
12 |
7 |
270 |
58 |
Positive control |
+ |
1363 |
1241 |
94 |
179 |
1395 |
2018 |
NOTE: the solvent is described as acetone in the method section but in most of the tables of results it is reported to be DMSO. It is thought by the reviewer that this is a typographical error, however if DMSO was used rather than acetone the study would still be valid.
Applicant's summary and conclusion
- Conclusions:
- Silsesquioxanes, phenyl has been tested for mutagenicity to bacteria, in a study which was conducted according to a protocol that was similar to OECD 471, and in compliance with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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