Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-818-1 | CAS number: 13497-18-2
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:
- 08 Sep - 02 Nov 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997
- Deviations:
- yes
- Remarks:
- 2-AA was used as sole positive control in the presence of S9-mix, which is in conflict with the OECD guideline 471 (adopted 1997). No further information on S9 characterisation was given from the supplier.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(triethoxysilylpropyl)amine
- EC Number:
- 236-818-1
- EC Name:
- Bis(triethoxysilylpropyl)amine
- Cas Number:
- 13497-18-2
- Molecular formula:
- C18H43NO6Si2
- IUPAC Name:
- bis(triethoxysilylpropyl)amine
Constituent 1
Method
- Target gene:
- S. typhimurium strains: his operon
E. coli strain: trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Dose Range Finder: 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate (±S9)
Main test:
-S9: 9.78, 19.6, 39.1, 78.3, 157, 313 µg/plate (TA 100); 39.1, 78.1, 156, 313, 625, 1250 µg/plate (TA 98, TA 1535, TA 1537, E. coli)
+S9: 39.1, 78.1, 156, 313, 625, 1250 µg/plate - Vehicle / solvent:
- DMSO (Lot No: K40982531)
- Justification for choice of solvent/vehicle: Based on sponsor information and the result of a preliminary solubility test.
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
- other: 2-aminoanthracene (2-AA), 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF2)
- Remarks:
- +S9: 2-AA (TA 98, TA 100, TA 1535, TA 1537, WP2uvrA; 1, 2, 3, 3, 2 µg/plate); -S9: 2-NF (TA 98; 5 µg/plate); SA (TA 100, TA 1535; 1.5 µg/plate); 9-AA (TA 1537; 80 µg/plate); AF2 (WP2uvrA; 0.005 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 independent experiments with 3 plates/concentration.
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition - Evaluation criteria:
- The results were considered positive when the following conditions are met:
- The number of revertant colonies in the test substance groups was increased at least twice as compared to the negative control group at one or more doses per plate in at least one strain.
- The numer of revertant colonies was increased dose dependently.
- The results were reproducible. - Statistics:
- Mean values and standard deviation were calculated
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 625 µg/plate (without S9); 1250 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 313 µg/plate (without S9); 1250 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1250 µg/plate (with and without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1250 µg/plate (with and without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1250 µg/plate (with and without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Deposition was observed at 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: In the preliminary test growth inhibition was observed in all strains at 1250 µg/plate in the absence and presence of S9-mix. In addition growth inhibition was observed at 313 µg/plate in TA 100 in the absence of S9-mix.
Any other information on results incl. tables
Table 1: Test results of main test
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 |
WP2 uvrA (pKM101) |
TA98 |
TA1537 |
||
– |
Solvent control |
73±2 |
12±2 |
104±7 |
10±1 |
5±1 |
|
– |
9.78 |
69±1 |
- |
- |
- |
- |
|
– |
19.6 |
71±1 |
- |
- |
- |
- |
|
– |
39.1 |
64±7 |
7±5 |
106±1 |
12±1 |
5±1 |
|
– |
78.1 (78.3, TA 100) |
68±4 |
9±1 |
114±4 |
11±2 |
4±2 |
|
– |
156 (157, TA 100) |
66±4 |
8±1 |
132±3 |
11±3 |
5±0 |
|
– |
313 |
15±15 |
9±2 |
99±15 |
11±3 |
6±4 |
|
– |
625 |
- |
7±3 |
124±16 |
9±2 |
3±2 |
|
– |
1250 |
- |
4±1 |
90±12 |
7±3 |
5±2 |
|
Positive controls, –S9 |
Name |
sodium azide |
sodium azide |
AF2 |
2-nitrofluorene |
9-amino-acridine |
|
Concentrations (μg/plate) |
1.5 |
1.5 |
0.005 |
5 |
80 |
||
Average of 3 plates±sd |
294±36 |
425±8 |
905±250 |
550±79 |
642±90 |
||
+ |
Solvent control |
81±5 |
8±3 |
128±13 |
17±4 |
12± |
|
+ |
39.1 |
85±12 |
7±1 |
130±33 |
19±1 |
10±3 |
|
+ |
78.1 |
91±9 |
5±1 |
54±6 |
21±0 |
9±2 |
|
+ |
156 |
81±6 |
6±1 |
127±42 |
21±2 |
10±4 |
|
+ |
313 |
82±13 |
7±1 |
142±48 |
19±1 |
10±4 |
|
+ |
625 |
80±7 |
7±1 |
148±1 |
18±1 |
14±2 |
|
+ |
1250 |
59±8 |
5±1 |
107±18 |
12±3 |
8±3 |
|
Positive controls, +S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (μg/plate) |
2 |
3 |
2 |
1 |
3 |
||
Average of 3 plates±sd |
194±27 |
118±21 |
544±28 |
191±30 |
239±39 |
||
Table 2: Test results of main test 2.
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 |
WP2 uvrA (pKM101) |
TA98 |
TA1537 |
||
– |
Solvent control |
72±5 |
8±2 |
114±8 |
12±3 |
5±3 |
|
– |
9.78 |
69±15 |
- |
- |
- |
- |
|
– |
19.6 |
70±1 |
- |
- |
- |
- |
|
– |
39.1 |
65±3 |
10±2 |
119±2 |
10±4 |
4±2 |
|
– |
78.1 (78.3, TA 100) |
65±9 |
9±0 |
117±8 |
10±3 |
6±2 |
|
– |
156 (157, TA 100) |
66±8 |
10±2 |
102±1 |
12±4 |
5±3 |
|
– |
313 |
49±8 |
8±3 |
137±7 |
10±3 |
4±1 |
|
– |
625 |
- |
6±2 |
130±8 |
10±5 |
4±1 |
|
– |
1250 |
- |
7±4 |
121±13 |
6±1 |
3±1 |
|
Positive controls, –S9 |
Name |
sodium azide |
sodium azide |
AF2 |
2-nitrofluorene |
9-amino-acridine |
|
Concentrations (μg/plate) |
1.5 |
1.5 |
0.005 |
5 |
80 |
||
Average of 3 plates±sd |
349±38 |
420±15 |
917±15 |
376±34 |
313±20 |
||
+ |
Solvent control |
85±11 |
8±3 |
149±19 |
16±7 |
11±4 |
|
+ |
39.1 |
69±3 |
8±2 |
136±8 |
14±6 |
10± |
|
+ |
78.1 |
71±10 |
6±2 |
148±9 |
16±4 |
12±4 |
|
+ |
156 |
70±11 |
7±2 |
154±18 |
14±3 |
9±5 |
|
+ |
313 |
79±4 |
11±4 |
149±11 |
16± |
13±1 |
|
+ |
625 |
79±3 |
7±2 |
156±10 |
20±7 |
11±6 |
|
+ |
1250 |
62±7 |
7±3 |
155±10 |
17±2 |
7±3 |
|
Positive controls, +S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (μg/plate) |
2 |
3 |
2 |
1 |
3 |
||
Average of 3 plates±sd |
298±25 |
99±7 |
482±31 |
150±13 |
171±3 |
||
Applicant's summary and conclusion
- Conclusions:
- negative
3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine 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 a preincubation experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
