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EC number: 915-673-4 | CAS number: 211519-85-6
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan ministry of labour notifications 67
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- EC Number:
- 915-673-4
- Cas Number:
- 211519-85-6
- Molecular formula:
- For the substance, C18H42O6SnSi2 (n = 2 – 4) Constituent 1 (S2): C18H42O6S2Si2 Constituent 2 (S3): C18H42O6S3Si2 Constituent 3 (S4): C18H42O6S4Si2
- IUPAC Name:
- Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
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:
- phenobarbitol and 5,6 benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 4.88-5000 µg/plate (range finding expt), 156-5000 µg/plate main tests (pre-incubation)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance is insoluble in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2(2-furyl)-3-(5-mitro-2-furyl)acrylamide
- Remarks:
- TA 100, TA 98 and E coli WP2 uvrA without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino] acridine
- Remarks:
- TA 1537 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoacridine
- Remarks:
- all strains with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h
NUMBER OF REPLICATIONS: test concentrations plated in triplicate, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: inhibition of bacterial growth
ACTIVATION: 1 ML of S9 mix contained 8 µmol MgCL2, 33 µmol of KCl, 5 µmol of glucose-6-phosphate, 4 µmol of NADPH, 100 µmol of sodium phosphate buffer and 0.1 ml S9. 0.5 ml S9 was added to 0.1 ml test substance and 0.1 ml of bacterial culture medium was added to 2 ml of top agar, resulting in a final concentration of approximately 2% S9. - Evaluation criteria:
- An increase in the number of revertants above twice that of the negative (solvent) control was judged to be a positive result.
- Statistics:
- No statistical treatment was done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: hydrolyses in water
- Effects of osmolality: no information
- Evaporation from medium: no information
- Water solubility: hydrolyses in water
- Precipitation: observed at highest concentration
- Other confounding effects: none reported
RANGE-FINDING/SCREENING STUDIES: no cytotoxicity or genotoxicity observed
COMPARISON WITH HISTORICAL CONTROL DATA: comparable with historical data
ADDITIONAL INFORMATION ON CYTOTOXICITY: no inhibition of bacterial growth was observed
Any other information on results incl. tables
Table 2: Dose range-finding study. Number of revertants per plate (mean of 3 plates)
|
TA100 |
TA1535 |
E coli WP2 uvrA |
||||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
110 |
119 |
no |
8 |
11 |
no |
22 |
25 |
no |
4.88 |
111 |
112 |
no |
10 |
11 |
no |
20 |
24 |
no |
19.5 |
111 |
104 |
no |
8 |
11 |
no |
19 |
25 |
no |
78.1 |
100 |
120 |
no |
12 |
8 |
no |
21 |
30 |
no |
313 |
114 |
126 |
no |
13 |
9 |
no |
19 |
27 |
no |
1250 |
116 |
114 |
no |
10 |
14 |
no |
23 |
31 |
no |
+5000 |
117 |
122 |
no |
9 |
7 |
no |
24 |
29 |
no |
Positive control |
329 |
992 |
- |
349 |
153 |
- |
111 |
692 |
- |
*solvent control with DMSO
Table 3: Dose range-finding study. Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA1537 |
||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
19 |
32 |
no |
8 |
16 |
no |
4.88 |
18 |
29 |
no |
9 |
19 |
no |
19.5 |
18 |
34 |
no |
8 |
20 |
no |
78.1 |
21 |
26 |
no |
9 |
20 |
no |
313 |
24 |
27 |
no |
10 |
17 |
no |
1250 |
16 |
31 |
no |
12 |
19 |
no |
+5000 |
24 |
29 |
no |
12 |
15 |
no |
Positive control |
398 |
264 |
- |
22296 |
198 |
- |
*solvent control with DMSO
Table 4: Experiment 1 Preincubation. Number of revertants per plate (mean of 3 plates)
|
TA100 |
TA1535 |
E coli WP2 uvrA |
||||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
110 |
124 |
no |
15 |
12 |
no |
17 |
28 |
no |
156 |
109 |
101 |
no |
17 |
11 |
no |
19 |
23 |
no |
313 |
102 |
95 |
no |
18 |
13 |
no |
22 |
29 |
no |
625 |
118 |
104 |
no |
18 |
14 |
no |
19 |
28 |
no |
1250 |
104 |
91 |
no |
13 |
12 |
no |
21 |
24 |
no |
+2500 |
134 |
132 |
no |
19 |
16 |
no |
23 |
30 |
no |
+5000 |
114 |
131 |
no |
16 |
17 |
no |
26 |
32 |
no |
Positive control |
422 |
912 |
- |
447 |
115 |
- |
121 |
887 |
- |
*solvent control with DMSO
Table 5: Experiment 1 Preincubation. Number of revertants per plate (mean of 3 plates)
- |
TA 98 |
TA1537 |
||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
15 |
29 |
no |
9 |
15 |
no |
156 |
18 |
34 |
no |
5 |
16 |
no |
313 |
21 |
34 |
no |
6 |
17 |
no |
625 |
19 |
30 |
no |
8 |
10 |
no |
1250 |
20 |
32 |
no |
7 |
15 |
no |
+2500 |
16 |
35 |
no |
8 |
15 |
no |
+5000 |
22 |
35 |
no |
15 |
16 |
no |
Positive control |
384 |
273 |
- |
2814 |
173 |
- |
*solvent control with DMSO
Table 6: Experiment 2 Preincubation. Number of revertants per plate (mean of 3 plates)
- |
TA100 |
TA1535 |
E coli WP2 uvrA |
||||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
112 |
108 |
no |
8 |
6 |
no |
17 |
23 |
no |
156 |
102 |
111 |
no |
11 |
7 |
no |
18 |
21 |
no |
313 |
108 |
101 |
no |
7 |
8 |
no |
18 |
21 |
no |
625 |
100 |
105 |
no |
10 |
8 |
no |
17 |
25 |
no |
1250 |
110 |
114 |
no |
7 |
11 |
no |
14 |
18 |
no |
+2500 |
100 |
110 |
no |
8 |
7 |
no |
18 |
23 |
no |
+5000 |
105 |
109 |
no |
7 |
9 |
no |
23 |
26 |
no |
Positive control |
360 |
908 |
- |
200 |
125 |
- |
111 |
570 |
- |
*solvent control with DMSO
Table 7: Experiment 2 Preincubation. Number of revertants per plate (mean of 3 plates)
- |
TA 98 |
TA1537 |
||||
Conc. |
-MA |
+ MA |
Cytotoxic |
-MA |
+ MA |
Cytotoxic |
0* |
15 |
22 |
no |
4 |
12 |
no |
156 |
15 |
21 |
no |
5 |
11 |
no |
313 |
13 |
28 |
no |
6 |
10 |
no |
625 |
15 |
23 |
no |
5 |
10 |
no |
1250 |
17 |
20 |
no |
4 |
11 |
no |
+2500 |
17 |
23 |
no |
6 |
13 |
no |
+5000 |
18 |
24 |
no |
7 |
12 |
no |
Positive control |
354 |
249 |
- |
2665 |
173 |
- |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Polysulfides (CAS 211519 -85 -9; EC 606-716-5) has been testing according to OECD Test Guideline 471 and in compliance with GLP. No increase in the number of reversions was observed in S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 or E. coli WP2 uvrA, with or without metabolic activation, when tested up to limit concentrations. The initial and the repeat study used the preincubation method and the results were in agreement. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not mutagenic to bacteria under the conditions of the test.
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