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EC number: 402-140-1 | CAS number: 17865-32-6 CHMMS; CHMS; DYNASYLAN 9407; Z-6187
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:
- 3 June to 16 June 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (only 2 replicate plates/concentration)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cyclohexyldimethoxymethylsilane
- EC Number:
- 402-140-1
- EC Name:
- Cyclohexyldimethoxymethylsilane
- Cas Number:
- 17865-32-6
- Molecular formula:
- C9H20O2Si
- IUPAC Name:
- cyclohexyldimethoxymethylsilane
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- histidine locus (S. typhimurium)
tryptophan locus (E. coli)
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, Escherichia coli WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 microsomal fraction prepared from rat liver induced by phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- S. typhimurium TA100, TA98 and TA1537 were treated at 0, 10, 20, 39, 78 or 156 µg/plate without S9; TA1535 and E. coli WP2 uvrA were exposed at 20-313 µg/plate. With S9, all S. typhimurium strains were tested at 20, 39, 78, 156 or 313 µg/plate, apart from TA1537 which was tested at 10-156 µg/plate. E. coli WP2 uvrA was tested at 313, 625, 1250, 2500 or 5000 µg/plate with S9.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test material reacts with water, soluble in DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: without S9 - 3 µg/plate TA100; 5 µg/plate TA1535; 2 µg/plate WP2 uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: without S9 - 1 µg/plate TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: without S9 - 80 µg/plate TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: with S9 - 5 µg/plate TA100, TA98, TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; with S9 - 2 µg/plate TA1535; 20 µg/plate WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: plates incubated for 48 h
SELECTION AGENT (mutation assays): depleted histidine or tryptophan levels in medium for selection of heterotrophs
NUMBER OF REPLICATIONS: 2 plates/concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
OTHER:
- type and composition of metabolic activation system:
- species and cell type: rat, S9 fraction
- quantity: 0.5 ml of S9 mix/culture
- induced or not induced: induced
- chemicals used for induction: phenobarbital and 5,6-benzoflavone
- co-factors used: MgCl2 8 µmol, KCl 33 µmol, G6P 5 µmol, NADPH 4 µmol, NADP 4 µmol, Na-phosphate buffer (pH 7.4) 100 µmol, - Evaluation criteria:
- no data
- Statistics:
- not applicable, results negative
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 156 µg/plate in TA98, TA100, TA1537 -S9, TA1537 +S9; 313 µg/plate in TA1535, WP2 uvrA -S9, TA98, TA100, TA1535 +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes with concentrations of 10-5000 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: Inhibition of the background lawn was seen without S9 at 156 µg/plate with TA100, TA98 and TA1537 and at 313 µg/plate with TA1535 and WP2 uvrA. Inhibition was seen with S9 at 156 µg/plate with TA1537 and at 313 µg/plate with TA100, TA1535 and TA98. No inhibition was observed in WP2 uvrA with S9 at levels of up to 5000 µg/plate.
Revertant numbers were reduced without S9 at 78 µg/plate for TA1535 and TA98 and at 156 µg/plate for TA100, TA1537 and WP2 uvrA. With S9, revertant frequency was reduced at 156 µg/plate with TA100, TA98, TA1535 and TA1537. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 1:Number of revertants per plate (1 plate) – Preliminary test
Bacterial strain |
TA100 |
TA1535 |
WP2 uvrA |
||||||
Concentration of test material, |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
105 |
96 |
no |
5 |
6 |
no |
20 |
13 |
no |
10 |
77 |
88 |
no |
12 |
13 |
no |
7 |
11 |
no |
50 |
111 |
97 |
no |
6 |
10 |
no |
10 |
14 |
no |
100 |
75 |
77 |
yes –MA no +MA |
6 |
10 |
no |
8 |
17 |
no |
500 |
0 |
0 |
yes |
0 |
5 |
yes |
8 |
13 |
yes –MA no +MA |
1000 |
0 |
0 |
yes |
0 |
5 |
yes |
1 |
13 |
yes –MA no +MA |
5000 |
0 |
0 |
yes |
0 |
3 |
yes |
0 |
18 |
yes –MA no +MA |
Positive control |
ENNG 3.0 µg/plate |
B[a]P 5.0 µg/plate |
ENNG 5.0 µg/plate |
2AA 2.0 µg/plate |
ENNG 2.0 µg/plate |
2AA 20.0 µg/plate |
|||
328 |
823 |
130 |
87 |
361 |
419 |
||||
Table 1. (cont’d)
TA98 |
TA1537 |
|||||
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
|
0* |
16 |
21 |
no |
6 |
8 |
no |
10 |
17 |
27 |
no |
3 |
4 |
no |
50 |
18 |
23 |
no |
4 |
3 |
no |
100 |
5 |
16 |
yes –MA no +MA |
4 |
2 |
yes –MA no +MA |
500 |
0 |
0 |
yes |
0 |
0 |
yes |
1000 |
0 |
0 |
yes |
0 |
0 |
yes |
5000 |
0 |
0 |
yes |
0 |
0 |
yes |
Positive control |
4NQO 1.0 µg/plate |
B[a]P 5.0 µg/plate |
9AA 80.0 µg/plate |
B[a]P 5.0 µg/plate |
||
458 |
343 |
1117 |
63 |
|||
*solvent control (DMSO)
2AA, 2-aminoanthracene; 9AA, 9-aminoacridine; B[a]P,benzo(a)pyrene; ENNG, N-ethyl-N'-nitro-N-nitrosoguanidine; MA, metabolic activation; 4NQO, 4-nitroquinoline-N-oxide
Table 2:Number of revertants per plate (mean of 2 or 3 plates) – Main test
Bacterial strain |
TA100 |
TA1535 |
WP2 uvrA |
||||||
Concentration of test material, |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
127 108 99 (111) |
116 114 126 (119) |
no |
18 16 6 (13) |
14 18 13 (15) |
no |
16 17 26 (20) |
25 19 14 (19) |
no |
10 |
78 118 (98) |
no |
|||||||
20 |
112 92 (102) |
122 118 (120) |
no |
12 7 (10) |
8 14 (11) |
no |
22 24 (23) |
no |
|
39 |
103 104 (104) |
127 120 (124) |
no |
10 7 (9) |
10 11 (11) |
no |
17 20 (19) |
no |
|
78 |
108 95 (102) |
89 110 (100) |
no |
10 3 (7) |
10 11 (11) |
no |
16 17 (17) |
no |
|
156 |
56 66 (61) |
83 81 (82) |
yes –MA no +MA |
7 4 (6) |
6 7 (7) |
no |
11 17 (14) |
no |
|
313 |
0 0 (0) |
yes |
0 0 (0) |
0 0 (0) |
yes |
0 8 (4) |
19 18 (19) |
yes –MA no +MA |
|
625 |
11 13 (12) |
no |
|||||||
1250 |
12 13 (13) |
no |
|||||||
2500 |
9 16 (13) |
no |
|||||||
5000 |
10 13 (12) |
no |
|||||||
Positive control |
ENNG 3.0 µg/plate |
B[a]P 5.0 µg/plate |
ENNG 5.0 µg/plate |
2AA 2.0 µg/plate |
ENNG 2.0 µg/plate |
2AA 20.0 µg/plate |
|||
230 239 (235) |
913 1006 (960) |
66 42 (54) |
176 158 (167) |
298 177 (238) |
530 496 (513) |
||||
Table 2. (cont’d)
TA98 |
TA1537 |
|||||
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
|
0* |
44 47 30 (40) |
49 52 53 (51) |
no |
4 9 9 (7) |
8 12 14 (11) |
no |
10 |
42 39 (41) |
no |
14 6 (10) |
8 14 (11) |
no |
|
20 |
40 50 (45) |
47 47 (47) |
no |
9 6 (8) |
12 7 (10) |
no |
39 |
39 40 (40) |
45 45 (45) |
no |
4 8 (6) |
13 9 (11) |
no |
78 |
18 23 (21) |
46 40 (43) |
no |
6 4 (5) |
7 6 (7) |
no |
156 |
10 14 (12) |
18 10 (14) |
yes –MA no +MA |
0 1 (1) |
1 11 (6) |
yes |
313 |
0 0 (0) |
yes |
||||
Positive control |
4NQO 1.0 µg/plate |
B[a]P 5.0 µg/plate |
9AA 80.0 µg/plate |
B[a]P 5.0 µg/plate |
||
595 601 (598) |
416 458 (437) |
712 545 (629) |
88 99 (94) |
|||
*solvent control (DMSO)
2AA, 2-aminoanthracene; 9AA, 9-aminoacridine; B[a]P,benzo(a)pyrene; ENNG, N-ethyl-N'-nitro-N-nitrosoguanidine; MA, metabolic activation; 4NQO, 4-nitroquinoline-N-oxide
Applicant's summary and conclusion
- Conclusions:
- In a key study conducted according to Japanese guidelines and in compliance with GLP, cyclohexyldimethoxymethylsilane showed no mutagenic potential in a bacterial reverse mutation (Ames) assay with four strains of Salmonella typhimurium and Escherichia coli WP2 uvrA, with or without S9.
- Executive summary:
In a GLP study, conducted according to Japanese guidelines, CHMS was assessed for its ability to induce reverse mutation in bacteria in an Ames test.
A range-finding study was first conducted using the pre-incubation method in which the test material was tested at concentrations of up to 5000 µg/plate, with and without a rat metabolic activation fraction (S9), to determine the concentrations for the main study. In the main study, again using a pre-incubation method, Salmonella typhimurium strains TA100, TA98 and TA1537 were tested at up to 156 µg/plate and TA 1535 and Escherchia coli WP2 uvrA were tested at up to 313 µg/plate without S9. In the presence of S9, TA1537 was tested at up to 156 µg/plate, TA100, TA98 and TA1535 at up to 313 µg/plate and WP2 uvrA at up to 5000 µg/plate. The S9 was prepared from microsomes obtained from phenobarbital- and 5,6-benzoflavone-induced rat liver and the pre-incubation period was 20 min, after which top agar was added to the pre-incubation mix and poured onto the surface of agar plates. After incubation at 37 oC for 2 days the revertant colonies were counted. Vehicle controls were similarly prepared together with positive controls using known mutagens.
No increase in mutant frequency was observed with the test material when compared to the vehicle controls in either the range-finding or main study. The positive controls gave the expected increase in mutant frequency demonstrating the validity of the assay. With the test material, cytotoxicity was observed for each of the strains (apart from WP2 uvrA with S9) at the highest concentration tested as shown by inhibition of the background lawn and the number of mutants present.
Under the conditions of this assay, CHMS showed no mutagenic potential in a reverse bacterial mutation test with four strains of S. typhimurium and E. coli WP uvrA.
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