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EC number: 221-337-1 | CAS number: 3069-33-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
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)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-337-1
- EC Name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-33-8
- Molecular formula:
- C8H22N2OSi
- IUPAC Name:
- (2-aminoethyl)[3-(methoxydimethylsilyl)propyl]amine
- Details on test material:
- - Name of test material (as cited in study report): VP 50991
- Physical state: colourless liquid
- Stability under test conditions: > 1 day (4°C, in the dark) if vehicle is free of water
- Storage condition of test material: at room temperature, dry, tightly closed, dark
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- plate incorporation test: 10, 31.6, 100, 316, 1000 µg/plate
preincubation test: 3.16, 10, 31.6, 100, 316 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cyclophosphamide
- methylmethanesulfonate
- other: 2-anthracene amide
- Remarks:
- +S9: CP (TA 100, TA 1535; 1500 µg/plate); 2-anthracene amide (TA 98, TA 102, TA 1537; 2 µg/plate); -S9: Sodium azide (TA 100, TA 1535; 10 µg/plate); MMS (TA 102; 1300 µg/plate); 2-NF (TA 98; 10 µg/plate); amino acridine (TA 1537; 100 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min (only in preincubation test)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 independent experiments with 3 plates/concentration.
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of colonies and/or scarce background lawn - Evaluation criteria:
- Cytotoxicity: reduction of colonies by more than 50%
Mutagenicity:
No significant effects: number of colonies after treatment with test substance is less than 2-fold the number of colonies of the solvent control.
Significant effects:
- number of colonies after treatment with test substance is at least 2-fold (TA 98, TA 100, TA 102) or 3-fold (TA 1535, TA 1537) the number of colonies of the solvent control (with statistical significance),
- and a significant concentration-releated effect is observed,
- positive results were reproducible and histidine independence of the revertants was confirmed. - Statistics:
- Number of revertants: U-test according to MANN and WHITNEY
Trend test: Spearman´s rank correlation coefficient
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: In the preliminary test cytotoxicity was observed from 1000 µg/plate onwards.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Plate incorporation test:
Without S9: Cytotoxicity was observed at 1000 µg/plate in all strains, from 100 µg/plate onwards in test strain TA 102 and at concentrations of 316 and 1000µg/plate in test strains TA 1535 and TA 1537.
With S9: Cytotoxicity was observed at 1000 µg/plate in all strains and at 316 and 1000 µg/plate in test strains TA 102 and TA 1537.
Preincubation test:
Without S9: Cytotoxicity was observed at 316 µg/plate in all strains, but in the test strains TA 98, TA 102 and TA 1535 it was noticed at 100 and 316 µg/plate.
With S9: Cytotoxicity was observed at 316 µg/plate in strains TA 102, TA 1537, and TA 1535. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Test results of main test 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the plate incorporation test |
|||||
(μg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
TA 102 |
TA98 |
TA1537 |
||
– |
Solvent control |
118.3±2.9 |
9.0±3.0 |
288.7±52.8 |
20.3±4.5 |
9.0±3.0 |
|
– |
10 |
140.7±40.5 |
11.0±1.0 |
268.3±3.2 |
22.3±4.0 |
11.0±1.0 |
|
– |
31.6 |
104.3±3.2 |
6.7±2.1 |
277.3±17.3 |
22.3±3.1 |
6.7±2.1 |
|
– |
100 |
112.7±12.6 |
9.7±4.5 |
200.0±18.7# |
20.7±0.6 |
9.7±4.5 |
|
– |
316 |
122.3±2.5 |
15.3±5.5 |
207.7±56.5# |
27.7±6.0 |
4.3±2.1 |
|
– |
1000 |
96.3±11.0# |
# |
154.0±49.0# |
# |
1.0±1.0# |
|
Positive controls, –S9 |
Name |
sodium azide |
sodium azide |
methyl methane sulfonate (MMS) |
2-nitrofluorene (2 -NF) |
amino-acridine |
|
Concentrations (μg/plate) |
10 |
10 |
1300 |
10 |
100 |
||
Average of 3 plates±sd |
1123.0±61.3 |
291.7±74.4 |
983±35 |
755.3±22.9 |
246.7±12.7 |
||
+ |
Solvent control |
143.0±7.8 |
14.3±0.6 |
299.3±13.0 |
35.3±3.8 |
15.0±7.0 |
|
+ |
10 |
139.7±15.9 |
10.0±3.0 |
274.0±22.6 |
39.3±1.5 |
8.0±2.0 |
|
+ |
31.6 |
180.7±48.9 |
12.0±2.0 |
278.3±10.1 |
39.0±6.0 |
6.3±3.1 |
|
+ |
100 |
133.3±17.6 |
14.7±6.0 |
159.0±14.2 |
41.3±4.0 |
8.0±2.6 |
|
+ |
316 |
146.0±33.8 |
16.0±3.5 |
113.3±47.6# |
27.0±7.9 |
9.0±1.7# |
|
+ |
1000 |
110.7±35.2# |
5.3±5.0# |
# |
5.7±1.5# |
# |
|
Positive controls, +S9 |
Name |
cyclophosphamide (CP) |
cyclophosphamide (CP) |
2-anthracene amide |
2-anthracene amide |
2-anthracene amide |
|
Concentrations (μg/plate) |
1500 |
1500 |
2 |
2 |
2 |
||
Average of 3 plates±sd |
413.3±27.3 |
240.0±27.6 |
1061.0±49.3 |
758.7±31.8 |
254.3±10 |
#: scarce background lawn
Table 2: Test results of main test 2 (preincubation test).
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the preincubation test |
|||||
(μg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
TA 102 |
TA98 |
TA1537 |
||
– |
Solvent control |
110.3±8.4 |
12.3±6.4 |
259.0±32.5 |
24.0±3.6 |
9.0±2.6 |
|
– |
316 |
42.0±22.9# |
0# |
0# |
5.0±5.0# |
1.0±1.7# |
|
– |
100 |
97.3±7.1 |
18.7±4.9# |
90.7±39.3# |
14.0±5.6# |
5.0±1.7 |
|
– |
31.6 |
96.7±6.0 |
15.7±3.2 |
228.0±52.9 |
22.3±3.8 |
5.7±1.5 |
|
– |
10 |
103.0±6.1 |
19.0±5.3 |
258.7±13.7 |
27.0±7.8 |
5.7±1.5 |
|
– |
3.16 |
94.7±112.9 |
20.0±2.6 |
270.3±8.3 |
24.3±6.0 |
8.7±2.3 |
|
Positive controls, –S9 |
Name |
2-nitrofluorene (2 -NF) |
sodium azide (2 -NF) |
methylmethane sulfonate (MMS) |
2-nitrofluorene |
amino-acridine |
|
Concentrations (μg/plate) |
10 |
10 |
1300 |
10 |
100 |
||
Average of 3 plates±sd |
683.7±48.0 |
237.0±17.3 |
1076.3±97.2 |
683.7±48.0 |
287.3±48.2 |
||
+ |
Solvent control |
102.3±13.1 |
12.7±2.5 |
336.0±67.1 |
49.0±10.1 |
11.3±3.5 |
|
+ |
316 |
106.0±5.3 |
12.0±4.4# |
0# |
28.3±1.2 |
0.3±0.6# |
|
+ |
100 |
104.7±30.6 |
14.3±2.5 |
272.3±7.6 |
37.0±1.7 |
8.3±3.8 |
|
+ |
31.6 |
118.3±21.7 |
11.7±3.8 |
273.3±48.7 |
38.3±3.5 |
9.3±2.1 |
|
+ |
10 |
104.3±16.0 |
14.3±3.8 |
343.3±20.4 |
40.3±2.1 |
6.0±1.7 |
|
+ |
3.16 |
90.3±5.5 |
19.7±3.8 |
331.3±42.0 |
40.0±6.1 |
8.7±1.5 |
|
Positive controls, +S9 |
Name |
cyclophosphamide (CP) |
cyclophosphamide (CP) |
2-anthracene amide |
2-anthracene amide |
2-anthracene amide |
|
Concentrations (μg/plate) |
1500 |
1500 |
2 |
2 |
2 |
||
Average of 3 plates±sd |
1092.0±53.7 |
318±45.4 |
1101.0±94.0 |
676.0±252.0 |
283.3±58.5 |
#: scarce background lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
N-[3-(methoxydimethylsilyl)propyl]ethylenediamine has been tested for mutagenicity in bacteria, in a study which was conducted according 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 metabolic activation in the plate incorporation and preincubation experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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