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EC number: 241-881-3 | CAS number: 17955-88-3
- 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:
- 2001-06-20 to 2001-07-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 2000/32/EEC Method B. 13/14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- EC Number:
- 241-881-3
- EC Name:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- Cas Number:
- 17955-88-3
- Molecular formula:
- C15H38O2Si3
- IUPAC Name:
- 2,2,4,6,6-pentamethyl-4-octyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 97s, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β-naphtoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 5, 1.6, 0.5, 0.16, 0.05 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol 95 %
- Justification for choice of solvent/vehicle:
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191
- Remarks:
- TA 97a, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylen-diamine
- Remarks:
- TA 98, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: nitrofurantione
- Remarks:
- TA 100, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- TA 102, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracen
- Remarks:
- TA97a, TA 98, TA 100, TA 1535, with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: danthron
- Remarks:
- TA 102, with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: no data
DURATION
- Exposure duration:
Experiment 1: 48 hours, all test strains with and without metabolic activation
Experiment 2: 48 hours, all test strains with and without metabolic activation; 48 hours, TA 98 and TA 1535, without metabolic activation
SELECTION AGENT (mutation assays): no data
NUMBER OF REPLICATIONS: triplicate cultures
NUMBER OF CELLS EVALUATED: 150 cells
DETERMINATION OF CYTOTOXICITY
- Method: number of revertants, background lawn, induction rates - Evaluation criteria:
- The test item was considered mutagen when there was a concentration effect relationship and the induction rate was >= 2.
- Statistics:
- The arithmetic mean value and the standard deviation were calculated out of the three replicates of the revertant colony plates.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 97s, TA 98, TA 100, TA 102 and TA 1535
- 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
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Experiement 1, mean number of revertants and induction rates of positive controls
Concentration μL/plate |
TA 97a |
TA 98 |
TA 1535 |
TA 100 |
TA 102 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
5 |
215 |
417 |
45 |
44 |
29 |
31 |
116 |
133 |
710 |
537 |
1.6 |
232 |
344 |
41 |
38 |
28 |
36 |
111 |
134 |
730 |
533 |
0.5 |
227 |
324 |
48 |
41 |
26 |
45 |
113 |
121 |
557 |
490 |
0.16 |
254 |
307 |
36 |
40 |
29 |
32 |
115 |
127 |
688 |
531 |
0.05 |
213 |
264 |
28 |
35 |
28 |
36 |
108 |
120 |
659 |
484 |
ICR 191 0.5 μg/plate |
|
>4.2 |
|
|
|
|
|
|
|
|
4-nitro-o-phenylen-diamine 0.5 μg/plate |
|
|
|
3.0 |
|
|
|
|
|
|
2-aminoanthracen 2.0 μg/plate |
>5.1 |
|
>34 |
|
4.5 |
|
>12.8 |
|
|
|
nitrofurantione 0.2 μg/plate |
|
2.7 |
|
|
|
|
|
2.7 |
|
|
cumene hydroperoxide 100 μg/plate |
|
|
|
|
|
|
|
|
|
>2.8 |
Danthron 30.0 μg/plate |
|
|
|
|
|
|
|
|
>2.4 |
|
sodium azide 0.25 μg/plate |
|
|
|
|
|
7.0 |
|
|
|
|
Table 2: Experiement 2, mean number of revertants and induction rates of positive controls
Concentration μg/plate |
TA 97a |
TA 98 |
TA 1535 |
TA 100 |
TA 102 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
5 |
282 |
282 |
37 |
39 |
40 |
37 |
109 |
163 |
631 |
499 |
1.6 |
255 |
382 |
48 |
49 |
33 |
32 |
116 |
133 |
563 |
485 |
0.5 |
190 |
291 |
31 |
40 |
31 |
33 |
122 |
183 |
675 |
509 |
0.16 |
210 |
350 |
33 |
36 |
35 |
30 |
113 |
134 |
629 |
469 |
0.05 |
242 |
327 |
36 |
41 |
26 |
32 |
94 |
117 |
631 |
479 |
ICR 191 2.0 μg/plate |
|
>4.1 |
|
|
|
|
|
|
|
|
4-nitro-o-phenylen-diamine 0.5 μg/plate |
|
|
|
5.1 |
|
|
|
|
|
|
2-aminoanthracen 2.0 μg/plate |
>4.9 |
|
>33 |
|
4.1 |
|
>11.5 |
|
|
|
nitrofurantione 0.2 μg/plate |
|
|
|
|
|
|
|
2.9 |
|
|
cumene hydroperoxide 100 μg/plate |
|
|
|
|
|
|
|
|
|
>2.3 |
Danthron 30.0 μg/plate |
|
|
|
|
|
|
|
|
>2.2 |
|
sodium azide 0.25 μg/plate |
|
|
|
|
|
5.4 |
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 97a, TA 98, TA 100, TA 1535, or TA 102 in the initial or the repeat experiments up to limit concentrations. Appropriate positive, and solvent controls were included and gave the 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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