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EC number: 221-336-6 | CAS number: 3069-29-2
- 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
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- Nanomaterial pour density
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- 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:
- 2002-04-10 to 2002-06-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-336-6
- EC Name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-29-2
- Molecular formula:
- C8H22N2O2Si
- IUPAC Name:
- N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- 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 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000 and 3160 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without metabolic activation): 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without metabolic activation): 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without metabolic activation): 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 (without metabolic activation): 1300 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide 2 µg/plate
- Remarks:
- TA 98, TA 102, TA 1537 (with metabolic activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100, TA 1535 (with metabolic activation): 1500 µg/plate
- 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 x 2
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
METHOD OF APPLICATION in agar (plate incorporation)
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors. 0.5 ml S9 mix was added to 2 ml top agar, 0.1 ml test solution, 0.1 ml salmonella cell suspension giving a final concentration of 0.9% S9.
DURATION
- Preincubation period: 1 hour (second experiment)
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 replicates per concentration, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - 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.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- background lawn reduced in preincubation experiment at 100 µg/plate without metabolic activation and at 316 µg/plate with metabolic activation. Top dose limited to 3160 µg/plate based on cytotoxicity observed in preliminary test test.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- background lawn reduced in preincubation experiment at 316 µg/plate without metabolic activation and at 1000 µg/plate with metabolic activation. Top dose limited to 3160 µg/plate based on cytotoxicity observed in preliminary test.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- background lawn reduced in preincubation experiment at 3160 µg/plate without metabolic activation and at 316 µg/plate with metabolic activation. Top dose limited to 3160 µg/plate based on cytoxicity observed in preliminary test.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- background lawn reduced at 3160 µg/plate in plate incorporation assay and at 316 µg/plate in preincubation experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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:
- background lawn reduced in preincubation experiment at 316 µg/plate without metabolic activation and at 31.6 µg/plate with metabolic activation. Top dose limited to 3160 µg/plate based on cytotoxicity observed in preliminary test.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Controls were within range of historical controls.
Cytotoxicity: In the plate incorporation test slight cytotoxicity was noted in the test substance in TA 100, with and without metabolic activation.
In the preincubation test without metabolic activation pronounced cytotoxicity was noted at 3160 µg/plate in TA98, from 316 µg/plate to 3160 µg/plate in TA 100, TA 102 and TA 1537, and from 100 µg/plate up to 3160 µg/plate in TA 1535.
With metabolic activation, pronounced cytotoxicity was noted at concentrations 316 µg/plate – 3160 µg/plate in TA 98 and TA 1535, at 1000 µg/plate and 3160 µg/plate in TA 100 and TA 1537 and from 100 µg/plate – 3160 µg/plate in TA 102.
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
145 |
138 |
No |
0.316 |
145 |
141 |
No |
1 |
128 |
148 |
No |
3.16 |
145 |
135 |
No |
10 |
174 |
139 |
No |
31.6 |
137 |
141 |
No |
100 |
148 |
146 |
No |
316 |
163 |
140 |
No |
1000 |
156 |
150 |
No |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with ethylene glycol dimethyl ether
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* |
22.7 |
27.7 |
No |
133.3 |
138.7 |
No |
264.7 |
268 |
No |
31.6 |
25 |
21.7 |
No |
117 |
156 |
No |
296.3 |
285.7 |
No |
100 |
23.3 |
30.7 |
No |
123.7 |
136.7 |
No |
268 |
269.7 |
No |
316 |
28.7 |
33.3 |
No |
110.3 |
141.7 |
No |
267 |
274.7 |
No |
1000 |
26.3 |
29 |
No |
125 |
124.3 |
No |
275 |
264 |
No |
3160 |
25 |
27.3 |
No |
114.7 |
150.3 |
Yes** |
249 |
244 |
No |
Positive control |
1026.3 |
1066 |
No |
1161 |
1175.3 |
No |
1191 |
1170.7 |
No |
*solvent control with ethylene glycol dimethyl ether
** scarce background bacterial lawn
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* |
16.3 |
411.7 |
No |
11.3 |
13.3 |
No |
31.6 |
14 |
18 |
No |
12 |
14.3 |
No |
100 |
15.3 |
21.7 |
No |
13.7 |
17.3 |
No |
316 |
17.3 |
22.7 |
No |
12.7 |
16.3 |
No |
1000 |
17.3 |
19.7 |
No |
14.7 |
12.3 |
No |
3160 |
17.7 |
18.7 |
No |
14.7 |
11.7 |
No |
Positive control |
401 |
411.7 |
No |
974.3 |
945.7 |
No |
*solvent control with ethylene glycol dimethyl ether
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* |
42.7 |
38.7 |
No |
128.3 |
155.7 |
No |
291.7 |
287.3 |
No |
3.16 |
27.3 |
32 |
No |
119 |
147.3 |
No |
254.7 |
300 |
No |
10 |
29 |
34.3 |
No |
128.7 |
151 |
No |
258.3 |
277.3 |
No |
31.6 |
34 |
30.3 |
No |
120.7 |
140.7 |
No |
252.7 |
290.3 |
No |
100 |
22.7 |
27 |
No |
126 |
153.7 |
No |
257 |
0 |
Yes |
316 |
24.7 |
0 |
Yes |
0 |
170.7 |
Yes |
0 |
0 |
Yes |
1000 |
24.3 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
983.3 |
1085.3 |
No |
1471 |
1443.3 |
No |
1488.3 |
1445.3 |
No |
*solvent control with ethylene glycol dimethyl ether
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 |
15.3 |
No |
9.7 |
14 |
No |
3.16 |
13 |
17 |
No |
8.3 |
9 |
No |
10 |
13.3 |
15 |
No |
8 |
11.7 |
No |
31.6 |
13 |
16.3 |
No |
8.7 |
10.7 |
No |
100 |
0 |
13 |
Yes |
9 |
10.7 |
No |
316 |
0 |
0 |
Yes |
0 |
10.3 |
Yes |
1000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
684.3 |
680.3 |
No |
529.3 |
540.3 |
No |
*solvent control with ethylene glycol dimethyl ether
Applicant's summary and conclusion
- Conclusions:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine has been tested in a reliable bacterial mutagenicity study conducted according to OECD 471, and in compliance with GLP conditions. No increase in revertant frequency was observed with or without metabolic activation when the substance was tested up to a concentration of 3160 µg/plate in Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in either the initial plate incorporation assay or the repeat experiment using the pre-incubation method. Cytotoxicity was observed at the highest concentration tested in strain TA 100 in the plate incorporation test, and in all strains in the pre-incubation assay. Appropriate solvent and positive 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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