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EC number: 217-496-1 | CAS number: 1873-88-7
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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
- Study period:
- 2008-01-28 - 2008-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
- EC Number:
- 217-496-1
- EC Name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
- Cas Number:
- 1873-88-7
- Molecular formula:
- C7H22O2Si3
- IUPAC Name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
Constituent 1
Method
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent: the solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100 without metabolic activation 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- TA98 - 10 µg/plate, TA1537 - 50 µg/plate without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 3 µl/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- TA1535, TA1537, TA98, TA100 - 2.5 µg/plate and WP2 uvrA - 10 µg/plate with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: S9 mix contained glucose-6-phophate and NADP as co-factors, the S9 supernatant was 10% v/v in the S9 mix of which 0.5 ml were added to 2 ml top agar, giving a final concentration of approximately 2% S9.
DURATION
- Preincubation period: 60 minutes at 37ºC
- Exposure duration: Experiment 1 - 72 hours at 37ºC, experiment II - 72 hours at 37ºC + a further 72 hours at 4ºC
SELECTION AGENT: histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- A result is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and WP2 uvrA) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- Statistics:
- No statistical analysis was performed.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
COMPARISON WITH HISTORICAL CONTROL DATA: yes, included in report and all within limits
Any other information on results incl. tables
Results of plate incorporation assay Experiment I; revertants per plate (mean of 3 plates)
[Note, the pre-experiment is reported as Experiment 1, as there were evaluable plates at all concentrations in all strains used.]
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
Solvent control** |
- |
16 |
13 |
22 |
130 |
54 |
Negative control*** |
- |
14 |
12 |
24 |
130 |
47 |
3 |
- |
11 |
14 |
21 |
138 |
50 |
10 |
- |
11 |
14 |
29 |
130 |
46 |
33 |
- |
11 |
12 |
21 |
122 |
51 |
100 |
- |
9 |
14 |
25 |
120 |
45 |
333 |
- |
16 |
18 |
21 |
136 |
52 |
1000 |
- |
15 |
10 |
24 |
138 |
52 |
2500 |
- |
15 |
13 |
22 |
137 |
59 |
5000 |
- |
13 |
8 |
26 |
158 |
62 |
Positive control |
- |
1935 |
78 |
281 |
2196 |
1314 |
Solvent control** |
+ |
15 |
16 |
33 |
172 |
64 |
Negative control*** |
+ |
18 |
13 |
37 |
154 |
49 |
3 |
+ |
17 |
16 |
33 |
149 |
64 |
10 |
+ |
17 |
15 |
35 |
165 |
57 |
33 |
+ |
17 |
16 |
34 |
177 |
65 |
100 |
+ |
18 |
17 |
38 |
165 |
61 |
333 |
+ |
18 |
18 |
35 |
161 |
64 |
1000 |
+ |
12* |
15* |
29* |
157* |
55* |
2500 |
+ |
11* |
13* |
25* |
156* |
55* |
5000 |
+ |
12* |
11* |
26* |
148* |
55* |
Positive control |
+ |
234 |
123 |
998 |
1334 |
231 |
* non-interfering precipitate
** with acetone
*** Untreated
Results of preincubation assay, Experiment 2; revertants per plate (mean of 3 plates)
Dose level µg/plate |
Metabolic activation |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
Solvent control** |
- |
12 |
12 |
30 |
133 |
37 |
Negative control*** |
- |
14 |
17 |
30 |
120 |
44 |
33 |
- |
13 |
13 |
23 |
136 |
42 |
100 |
- |
14 |
11 |
23 |
135 |
45 |
333 |
- |
15 |
13 |
31 |
125 |
46 |
1000 |
- |
15 |
12 |
26 |
133 |
43 |
2500 |
- |
15 |
11 |
21 |
118 |
39 |
5000 |
- |
14 |
10 |
31 |
125 |
38 |
Positive control |
- |
2143 |
99 |
335 |
1941 |
901 |
Solvent control** |
+ |
19 |
15 |
34 |
121 |
60 |
Negative control*** |
+ |
16 |
18 |
33 |
156 |
49 |
33 |
+ |
18 |
17 |
31 |
142 |
52 |
100 |
+ |
15 |
19 |
33 |
142 |
52 |
333 |
+ |
16 |
19 |
36 |
137 |
60 |
1000 |
+ |
18* |
16* |
30* |
129 |
60 |
2500 |
+ |
15* |
16* |
30* |
135* |
56* |
5000 |
+ |
17* |
14* |
30* |
154* |
49* |
Positive control |
+ |
307 |
195 |
1206 |
863 |
349 |
* non-interfering precipitate
** with acetone
*** Untreated
Applicant's summary and conclusion
- Conclusions:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane has been tested for mutagenicity to 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 activation in the initial plate incorporation assay or the repeat experiment using the preincubation method. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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