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EC number: 250-437-8 | CAS number: 31024-56-3
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- 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
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- Toxicological Summary
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- (no strain was included for detection of oxidising or cross-linking substances)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- EC Number:
- 250-437-8
- EC Name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- Cas Number:
- 31024-56-3
- Molecular formula:
- C10H25NO3Si
- IUPAC Name:
- butyl[3-(trimethoxysilyl)propyl]amine
- Details on test material:
- - Name of test material (as cited in study report): BRD 1155; 07651 J8 003
- Substance type: alkoxysilane
- Physical state: liquid
- Lot/batch No.: 1
- Storage condition of test material: at 4°C, in the dark under dry conditions
Constituent 1
Method
- Target gene:
- his 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 1538
- 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:
- 0.05-5 mg/plate
- Vehicle / solvent:
- - Solvent: ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-anthramine (TA 98, TA 100, TA 1535, TA 1537, TA 1538); -S9: 2-nitrofluorene (TA98); methyl methanesulfonate (TA 100); ethyl methanesulfonate (TA 1535); 9-aminoacridine (TA 1537); 2-nitrofluorene (TA 1538)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Cytotoxicity was determined in a preliminary study using strain TA 98 and also within the main study cytotoxicity was determined. No further information was given about the method applied.
POSITIVE CONTROLS:
+S9: 2-anthramine (TA 98, TA 100, TA 1535, TA 1537, TA 1538: 0.002 mg/plate)
-S9: 2-nitrofluorene (TA98: 0.001 mg/plate); methyl methanesulfonate (TA 100: 0.1 mg/plate); ethyl methanesulfonate (TA 1535: 10 mg/plate); 9-aminoacridine (TA 1537: 0.05 mg/plate); 2-nitrofluorene (TA 1538: 0.001 mg/plate) - Evaluation criteria:
- 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 the number of colonies of the solvent control.
Results and discussion
Test results
- 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:
- -S9: TA 98, TA 1535 (5 mg/plate), TA 100, TA 1537, TA 1538 (1 and 5 mg/plate); +S9: TA 1537 (5 mg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In a preliminary study the test substance was applied to bacteria (TA 98) from 0.5 to 100 mg/plate. Cytotoxicity was observed from 5 mg/plate upwards.
Any other information on results incl. tables
Table 1: Test results of experiment 1.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±4 |
83±4 |
9±3 |
5±1 |
22±1 |
|
– |
50 |
25±1 |
91±5 |
9±4 |
4±1 |
26±1 |
|
– |
100 |
26±8 |
90±11 |
6±2 |
5±0 |
23±4 |
|
– |
500 |
21±5 |
101±9 |
7±0 |
6±2 |
19±5 |
|
– |
1000 |
21±2 |
78±6 |
11±4 |
8±5 |
26±4 |
|
– |
5000 |
T |
53±8 |
5±1 |
T |
5±2 |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
472 |
299 |
1035 |
131 |
248 |
||
+ |
0 |
39±4 |
112±12 |
13±5 |
5±2 |
34±9 |
|
+ |
50 |
35±5 |
107±2 |
8±2 |
7±4 |
40±4 |
|
+ |
100 |
36±5 |
107±20 |
8±2 |
5±2 |
35±13 |
|
+ |
500 |
37±1 |
108±6 |
12±3 |
7±2 |
33±3 |
|
+ |
1000 |
34±7 |
102±8 |
10±3 |
4 |
33±8 |
|
+ |
5000 |
36±3 |
111±4 |
9±4 |
4±2 |
38±7 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
554 |
1528 |
239 |
63 |
298 |
Table 2: Test results of experiment 2.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±5 |
78±7 |
7±2 |
6±2 |
32±6 |
|
– |
50 |
28±3 |
81±16 |
7±3 |
5±2 |
32±4 |
|
– |
100 |
29±2 |
73±17 |
7±3 |
4±1 |
30±3 |
|
– |
500 |
27±6 |
73±8 |
7±3 |
5±1 |
25±3 |
|
– |
1000 |
28±6 |
T |
5±3 |
2±1 |
7±6 |
|
– |
5000 |
T |
T |
7±1 |
T |
T |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
573 |
270 |
835 |
116 |
548 |
||
+ |
0 |
43±10 |
118±4 |
9±5 |
6±1 |
38±3 |
|
+ |
50 |
41±5 |
107±13 |
11±2 |
5±3 |
47±11 |
|
+ |
100 |
43±2 |
101±14 |
8±2 |
5±1 |
38±10 |
|
+ |
500 |
44±14 |
101±11 |
9±5 |
5±3 |
42±9 |
|
+ |
1000 |
46±11 |
98±17 |
9±1 |
6±2 |
49±4 |
|
+ |
5000 |
43±8 |
109±5 |
11±2 |
6±1 |
41±12 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
673 |
1337 |
185 |
35 |
579 |
MMS = methyl methanesulfonate
EMS = ethyl methanesulfonate
9AA = 9-aminoacridine
2-A = 2-anthramine
T = cytotoxic
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In a bacterial mutagenicity assay similar to OECD 471 and GLP, no mutagenic effect was observed for the test substance tested up to the top dose of 5000 µg/plate in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic under the applied conditions.
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