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EC number: 274-936-5 | CAS number: 70851-50-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenicity in bacteria (OECD 471, Ames): S. typhimurium strains: TA 98, TA 100, TA 102, TA 1535 and TA 1537: Negative with and without metabolic activation
Mutagenicity in mammalian cells: no data
Clastogenicity in mammalian cells: no data
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-13 to 2002-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns SozialesFreie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 3.16, 10, 31.6, 100 and 316 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- - S9: 10 µg/plate in water for strains TA 1535 and TA 100.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9: 10 µg/plate in DMSO for strain TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -S9: 100 µg/plate in ethanol for strain TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- -S9: 1300 µg/plate in DMSO for strain TA 102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- +S9: 2 µg/plate in DMSO for strains TA 98, TA 102, TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- +S9: 1500 µg/plate in aqua ad iniectabilia for stains TA 100 and TA 1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts - Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
In a reliable test, conducted under OECD 471, with GLP, no mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
Reference
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
148 |
140 |
No |
0.316 |
160 |
151 |
No |
1 |
148 |
141 |
No |
3.16 |
153 |
149 |
No |
10 |
138 |
141 |
No |
31.6 |
162 |
149 |
No |
100 |
132 |
162 |
No |
316 |
171 |
157 |
Yes |
1000 |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
30.3 |
39 |
No |
152.3 |
164.7 |
No |
273.7 |
275.7 |
No |
3.16 |
34.7 |
38.3 |
No |
152 |
159.7 |
No |
275.7 |
278 |
No |
10 |
26.3 |
33.3 |
No |
155 |
164.3 |
No |
274.3 |
266 |
No |
31.6 |
26.7 |
39 |
No |
149 |
169 |
No |
270 |
273 |
No |
100 |
22.7 |
36.3 |
No |
152 |
162 |
No |
270.7 |
262.7 |
No |
316 |
31.7 |
36 |
Yes |
150 |
164.7 |
Yes |
272.3 |
260.7 |
Yes |
Positive control |
726.3 |
736.3 |
No |
1091.7 |
1093.3 |
No |
1105.3 |
1115 |
No |
*solvent control with acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
17.3 |
17.7 |
No |
4 |
5 |
No |
3.16 |
16 |
15 |
No |
4 |
3.7 |
No |
10 |
17.3 |
18 |
No |
2.7 |
4 |
No |
31.6 |
15.7 |
12 |
No |
3 |
3.3 |
No |
100 |
16 |
17 |
No |
3.7 |
4.7 |
No |
316 |
15.3 |
18.3 |
Yes |
3 |
4.3 |
Yes |
Positive control |
529.3 |
530.7 |
No |
518.3 |
528.3 |
No |
*solvent control with acetone
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
32 |
35.3 |
No |
151.3 |
176.7 |
No |
271.7 |
287.7 |
No |
3.16 |
31 |
35 |
No |
136.3 |
162.3 |
No |
285 |
260.3 |
No |
10 |
30.7 |
36 |
No |
146.7 |
165 |
No |
278 |
269.3 |
No |
31.6 |
25.3 |
26.7 |
No |
161 |
171 |
No |
278 |
268.3 |
No |
100 |
25 |
27 |
No |
152 |
170.7 |
No |
274 |
271.3 |
No |
316 |
26.7 |
32.7 |
Yes |
157 |
173.3 |
Yes |
277 |
292 |
Yes |
Positive control |
876.7 |
1062.3 |
No |
1300.3 |
1264 |
No |
1294.3 |
1267.3 |
No |
*solvent control with acetone
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15.3 |
14.7 |
No |
4 |
3.3 |
No |
3.16 |
15 |
12.3 |
No |
3 |
4 |
No |
10 |
11.3 |
12.3 |
No |
2.3 |
4 |
No |
31.6 |
12 |
14.3 |
No |
3.3 |
4.7 |
No |
100 |
13.7 |
12.7 |
No |
3 |
4 |
No |
316 |
12 |
12 |
Yes |
3 |
4 |
Yes |
Positive control |
491.7 |
451 |
No |
443.3 |
446.7 |
No |
*solvent control with acetone
MA - Metabolic activation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An Ames test is available with dimethoxymethyloctadecylsilane (CAS 70851-50-2).
The mutagenicity of dimethoxymethyloctadecylsilane in bacteria was assessed in a study performed according to OECD Guideline 471 with Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 (LPT, 2002). The tester strains were treated using the plate incorporation and the preincubation method both with and without S9-mix. The concentrations tested were 3.16 – 316 µg/plate for the plate incorporation and preincubation test, respectively. Results achieved with vehicle (acetone) and positive controls were valid. No genotoxicity was observed in the presence and absence of metabolic activation. No precipitation was observed up to the highest dose tested. Cytotoxicity (defined as reduction of colonies by more than 50% and/or by a scarce background lawn) was observed in all strains at 316 µg/plate. In conclusion, dimethoxymethyloctadecylsilane did not induce mutations in bacteria under the test conditions applied.
Justification for classification or non-classification
The available in vitro data are reliable and suitable for classification and fulfil the standard requirements given in Annex VII of Regulation (EC) 1272/2008. Based on the available data, there is no indication that the substance induces genetic toxicity. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 or Directive 67/548/EEC can be made, as no information on mutagenicity and clastogenicity in mammalian cells/in vivo is available.
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