Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 240-040-8 | CAS number: 15901-40-3
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:
- 1989-05-10 to 1989-12-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The restrictions were that the range of strains tested does not comply with the current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- the range of strains tested does not include a strain to detect cross-linking mutations
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N',N''-tricyclohexyl-1-methylsilanetriamine
- EC Number:
- 240-040-8
- EC Name:
- N,N',N''-tricyclohexyl-1-methylsilanetriamine
- Cas Number:
- 15901-40-3
- Molecular formula:
- C19H39N3Si
- IUPAC Name:
- N,N',N''-tricyclohexyl-1-methylsilanetriamine
- Reference substance name:
- Tricyclohexyl-1-methylsilanetriamine
- IUPAC Name:
- Tricyclohexyl-1-methylsilanetriamine
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- biphenyl polychlorides-activated rat liver S9
- Test concentrations with justification for top dose:
- 0.1, 0.5, 1.0, 2.5, 5.0 μl/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: amino-2-anthracene
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537, TA 1538, with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- TA 1535, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 100, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98, without metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: Cofactors were added to the S9 mix to reach the following concentrations: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 4 mM NADP in 100 mM potassium-phosphate-buffer pH 7.4. The concentration of S9 in the mix was 5%, and 0.5 ml of S9 mix were added to test substance, overlay agar and bacterial suspension giving a final concentration of approximately 1% S9 in the plates.
METHOD OF APPLICATION: Vigel-Bonner agar medium, plate incorporation
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): no data
SELECTION AGENT (mutation assays): agar medium
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: reduction in number of revertants; condition of background lawn. - Evaluation criteria:
- If the number of colonies apparent in presence of test article is greater than or equal to twice the number of colonies apparent in the negative control group, the result is considered to be positive.
- Statistics:
- Relevant statistics (st.dev, mean) were calculated
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Results for main study no 1, mean revertants, with and without metabolic activation
Concentration μl/dish |
TA 1535 |
TA 1537 |
TA 1538 |
TA 100 |
TA 98 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
0 |
10.7 |
8.3 |
10.3 |
10.0 |
43.0 |
41.3 |
101.0 |
95.3 |
28.0 |
24.0 |
0.1 |
9.3 |
9.0 |
12.7 |
10.3 |
39.3 |
38.7 |
120.3 |
86.7 |
34.0 |
23.7 |
0.5 |
7.3 |
9.7 |
8.0 |
10.7 |
39.3 |
34.7 |
93.0 |
103.0 |
38.0 |
20.3 |
1.0 |
12.3 |
8.0 |
9.7 |
13.0 |
33.0 |
32.7 |
87.3 |
88.3 |
35.0 |
21.3 |
2.5 |
8.7 |
6.7 |
9.0 |
11.7 |
37.7 |
21.0 |
110.7 |
87.3 |
31.7 |
22.7 |
5.0 |
7.7 |
1.0 |
9.7 |
1.3 |
27.0 |
2.3 |
112.7 |
86.0 |
32.7 |
22.0 |
SR |
11.0 |
8.3 |
8.7 |
9.3 |
44.0 |
39.0 |
102.0 |
|
27.3 |
25.7 |
2 NF 0.001 |
|
|
|
|
|
|
|
|
|
551.5 |
2A |
185.0 |
|
93.5 |
|
1258.0 |
|
1538.0 |
|
1135.5 |
|
MMS 0.1 |
|
|
|
|
|
|
|
308.5 |
|
|
EMS 10 |
|
1002.5 |
|
|
|
|
|
|
|
|
9 AA 0.05 |
|
|
|
331.9 |
|
|
|
|
|
|
2 NF 0.001 |
|
|
|
|
|
240.0 |
|
|
|
|
Table 2. Results for main study no 2, mean revertants, with and without metabolic activation
Concentration μl/dish |
TA 1535 |
TA 1537 |
TA 1538 |
TA 100 |
TA 98 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
0 |
11.7 |
11.3 |
7.7 |
11.3 |
45.7 |
31.3 |
107.0 |
109.0 |
24.3 |
30.0 |
0.1 |
12.0 |
8.3 |
11.0 |
8.7 |
43.3 |
28.7 |
95.0 |
90.7 |
27.3 |
21.3 |
0.5 |
9.7 |
13.3 |
7.7 |
9.0 |
35.0 |
30.7 |
105.3 |
115.3 |
28.3 |
32.7 |
1.0 |
12.0 |
11.0 |
8.7 |
6.7 |
37.0 |
30.0 |
119.7 |
129.7 |
30.0 |
22.3 |
2.5 |
11.0 |
17.0 |
10.3 |
6.0 |
32.0 |
0.7 |
128.0 |
96.7 |
19.0 |
10.0 |
5.0 |
6.0 |
7.0 |
6.3 |
0.7 |
16.3 |
0.0 |
101.7 |
52.0 |
8.0 |
0.0 |
SR |
11.3 |
10.0 |
6.3 |
11.0 |
40.3 |
27.7 |
110.0 |
83.3 |
30.0 |
23.0 |
2 NF 0.001 |
|
|
|
|
|
|
|
|
|
408.5 |
2A |
133.0 |
|
62.5 |
|
1193.0 |
|
1118.5 |
|
1106.6 |
|
MMS 0.1 |
|
|
|
|
|
|
|
293.5 |
|
|
EMS 10 |
|
1295.5 |
|
|
|
|
|
|
|
|
9 AA 0.05 |
|
|
|
216.5 |
|
|
|
|
|
|
2 NF 0.001 |
|
|
|
|
|
291.0 |
|
|
|
|
SR: spontaneous revertants
2 NF: 2 -nitrofluorene (mg/dish)
2A: 2 -aminoanthracene (mg/dish)
MMS: methyl metanesulphonate (mg/dish)
EMS: ethyl metanesulphonate (mg/dish)
9 -AA: 9 -aminoacridine (mg/dish)
Applicant's summary and conclusion
- Conclusions:
- N,N’,N’’-Tricyclohexyl-1-methylsilanetriamine has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471 (1989), compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 3538 in the initial or the repeat experiments using the plate incorporation method up to limit concentrations. Appropriate positive and solvent (acetone) and controls were included and gave the expected results. 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.
