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EC number: 600-809-4 | CAS number: 1072-53-3
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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:
- Study initiation: 22 November 2010, Final report: 22 February 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Korea
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3,2λ⁶-dioxathiolane-2,2-dione
- EC Number:
- 600-809-4
- Cas Number:
- 1072-53-3
- Molecular formula:
- C2H4O4S
- IUPAC Name:
- 1,3,2λ⁶-dioxathiolane-2,2-dione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Chemical name : 1,3,2-Dioxathiolane, 2,2-dioxide
Product name: ESA
Lot No. : Not available
Received date : 18 November, 2010
Appearance : Lemon yellow solid
Purity : 99.1 %
Stability : Stable in recommended storage condition
Method
- Target gene:
- histidine and tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver of Sprague-Dawley male rat induced by Aroclor-1254, 500 mg/kg i.p.
- Test concentrations with justification for top dose:
- •In the absence of metabolic activation system (S9 mix(-))
TA100, TA1537, WP2uvrA
0, 5, 10, 20, 39, 78, 156, 313 µg/plate
TA1535
0, 39, 78, 156, 313, 625, 1250, 2500 µg/plate
TA98
0, 0.6, 1.25, 2.5, 5, 10, 20, 39 µg/plate
•In the presence of metabolic activation system (S9 mix(+))
0, 5, 10, 20, 39, 78, 156, 313 µg/plate - Vehicle / solvent:
- The test substance showed high solubility in DMSO but crystals were formed after. DMSO was not suitable for use in the test. The test substance showed high solubility in 1,4-Dioxane and did not react with the 1,4-Dioxane. Therefore, 1,4-Dioxane was selected to negative control.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1,4-Dioxane
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5 µg/plate for strain TA1535
- Positive control substance:
- sodium azide
- Remarks:
- Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1,4-Dioxane
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 80 µg/plate for strain TA1537
- Positive control substance:
- other: 9-Aminoacridine hydrochloride hydrate
- Remarks:
- Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1,4-Dioxane
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.01 µg/plate for strains TA100 and WP2uvrA, 0.1 µg/plate for strain TA98
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1,4-Dioxane
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5 µg/plate for strain TA98, 1.0 µg/plate for strain TA100, 2.0 µg/plate for strains TA1535 and TA1537, 10 µg/plate for strain WP2uvrA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 mix
- Details on test system and experimental conditions:
- Condition of pre-cultivation
Nutrient broth: No. 2, Oxoid, 588285
Cultivation time: 10 hours (Stop incubation in the early stationary phase)
Shaking incubator: Model: SHKE-5000-1CE
Incubation method: Shaking type: rotation (RPM: 180 /min) Rotation diameter: 2.54 cm
Culture vessel: Erlenmeyer flask Capacity: 50 ml
Volume of culture medium: 15 ml
Volume of inoculum: 30 ml
Preparation of test substance
The test substance was dissolved in 1,4-dioxane and then, serially diluted (two-fold) from highest concentration.
Method
This study was conducted using preincubation method with and without metabolic activation system (S9).
Test condition
Preincubation: 37 ºC, 20 min
Incubation: 37 ºC, 48 hours
Experiments with test item and controls were performed in triplicate
Method of observation, measurement and analysis
Colony counting
The number of revertants were counted only inside area of plate (diameter : 90 mm) by manual measurement using electronic register (Model 570, SUNTEX, Taiwan).
Test method of growth inhibition
All plate was observed with the naked eye.
Measurement of bacterial concentration
It was performed by step-dilution method according to the Standard Operation Procedure, KCL.
Sterility test
0.1 ml of S9 mix and test substance were mixed with top agar respectively, and then, it was added onto minimum glucose agar plate. The plate was incubated at 37ºC for 48 hours. Since the bacteria did not grow after incubation, it was confirmed that the test was performed aseptically. - Evaluation criteria:
- The test result was recorded experimental value, average value and standard deviation for the number of revertant colonies per plate. The result was judged as ‘Positive’, if there is a dose-dependent increase and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system. Also, the number of revertant colony should increase more than 2 times than the negative control group.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Increase in the number of revertant colonies was seen in TA100, TA1535 and WP2uvrA strains compared with negative control groups in the absence of metabolic activation system. Increase in the number of revertant colonies was seen in TA100, TA1535, WP2uvrA and TA1537 strains compared with negative control groups in the presence of metabolic activation system.
Preliminary range-finding test was performed to determine dose levels at the main test.
Preliminary range-finding test was carried out on 313, 625, 1250, 2500, 5000 µg/plate (two-fold serial dilutions). As a result of preliminary range-finding test, cytotoxicity was observed in TA98, TA100, TA1537 and WP2uvrA strains more than 313 µg/plate dose levels regardless metabolic activation system. In the case of TA1535 strain, cytotoxicity was observed at a concentration of 2500 µg/plate or higher in the absence of metabolic activation system, and cytotoxicity was observed at a concentration of 313 µg/plate or higher in the presence of metabolic activation system. In the case of TA98 strain, main test (II) was performed on 0~39 µg/plate because cytotoxicity was observed at TA98 strain more than 39 µg/plate dose levels in absence of metabolic activation system.
As a result of main test, cytotoxicity was observed in TA100, TA1537 strains more than 156 µg/plate dose levels at absence of metabolic activation system. At the concentration of 2500 µg/plate for TA1535, 313 µg/plate for WP2uvrA and 39 µg/plate and above for TA98, cytotoxicity was observed in the absence of metabolic activation system. At the concentration of 156 µg/plate and above for TA100, 313 µg/plate for TA98, TA1535, TA1537 and WP2uvrA, cytotoxicity was observed in the presence of metabolic activation system.
When compared to the negative control, significant increases in the number of revertant colonies were observed in TA100, TA1535 and WP2uvrA strains regardless presence of metabolic activation system. In the case of TA1537 strain, significant increases in the number of revertant colonies were observed in presence of metabolic activation system.
Sterility of the solvent and S9 mix were certified by the sterility test. It was counted that the number of revertant colonies of positive control groups and negative control groups were within or close to the range of the historical data. Therefore, this test was performed properly.
As the results, ESA did induce reverse mutation in this test condition.
Any other information on results incl. tables
Test results (Main study)
Metabolic activation |
Dose (µg/plate) |
Number of colony/plate |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
Dose (µg/plate) |
TA1535 |
Dose (µg/plate) |
WP2uvrA |
Dose (µg/plate) |
TA98 |
Dose (µg/plate) |
TA1537 |
|||
S9 Mix (-) |
0 |
70 64 61 |
0 |
9 6 4 |
0 |
45 43 46 |
0 |
13 13 15 |
0 |
3 6 5 |
|
Mean ± SD |
66 ± 4.6 |
Mean ± SD |
6 ± 2.5 |
Mean ± SD |
45 ± 1.5 |
Mean ± SD |
14 ± 1.2 |
Mean ± SD |
5 ± 1.5 |
||
5 |
107 138 89 |
39 |
315 286 272 |
5 |
750 636 688 |
5 |
11 14 5 |
5 |
3 8 7 |
||
Mean ± SD |
111 ± 24.8 |
Mean ± SD |
291 ± 21.9 |
Mean ± SD |
691 ± 57.1 |
Mean ± SD |
10 ± 4.6 |
Mean ± SD |
6 ± 2.6 |
||
10 |
73 76 109 |
78 |
418 456 350 |
10 |
854 938 1104 |
10 |
6 14 9 |
10 |
5 5 3 |
||
Mean ± SD |
86 ± 20.0 |
Mean ± SD |
408 ± 53.7 |
Mean ± SD |
965 ± 127.2 |
Mean ± SD |
10 ± 4.0 |
Mean ± SD |
4 ± 1.2 |
||
20 |
144 126 150 |
156 |
764 794 752 |
20 |
1824 1680 1542 |
20* |
8 13 7 |
20 |
3 5 2 |
||
Mean ± SD |
140 ± 12.5 |
Mean ± SD |
770 ± 21.6 |
Mean ± SD |
1682 ± 141.0 |
Mean ± SD |
9 ± 3.2 |
Mean ± SD |
3 ± 1.5 |
||
39 |
175 200 232 |
313 |
924 996 984 |
39 |
2200 1836 2068 |
39* |
P/C P/C P/C |
39 |
8 2 7 |
||
Mean ± SD |
202 ± 28.6 |
Mean ± SD |
968 ± 38.6 |
Mean ± SD |
2035 ±184.3 |
Mean ± SD |
- ± - |
Mean ± SD |
6 ± 3.2 |
||
78 |
150 107 134 |
625 |
870 1176 1300 |
78 |
2306 2280 2784 |
78* |
P/C P/C P/C |
78 |
5 6 4 |
||
Mean ± SD |
130 ± 21.7 |
Mean ± SD |
1115 ± 221.3 |
Mean ± SD |
2457 ± 283.8 |
Mean ± SD |
- ± - |
Mean ± SD |
5 ± 1.0 |
||
156* |
P/C P/C P/C |
1250 |
788 1332 996 |
156 |
2894 2502 2778 |
156* |
P/C P/C P/C |
156* |
P/C P/C P/C |
||
Mean ± SD |
- ± - |
Mean ± SD |
1039 ± 274.5 |
Mean ± SD |
2725 ± 201.4 |
Mean ± SD |
- ± - |
Mean ± SD |
- ± - |
||
313* |
P/C P/C P/C |
2500* |
0 0 0 |
313* |
P/C P/C P/C |
313* |
0 0 0 |
313* |
P/C P/C P/C |
||
Mean ± SD |
- ± - |
Mean ± SD |
0 ± 0 |
Mean ± SD |
- ± - |
Mean ± SD |
0 ± 0 |
Mean ± SD |
- ± - |
||
S9 Mix (+) |
0 |
100 124 137 |
0 |
8 7 8 |
0 |
75 85 70 |
0 |
27 22 38 |
0 |
4 7 3 |
|
Mean ± SD |
120 ± 18.8 |
Mean ± SD |
8 ± 0.6 |
Mean ± SD |
77 ± 7.6 |
Mean ± SD |
29 ± 8.2 |
Mean ± SD |
5 ± 2.1 |
||
5 |
324 354 370 |
5 |
812 930 960 |
5 |
326 327 328 |
5 |
26 33 38 |
5 |
5 7 7 |
||
Mean ± SD |
349 ± 23.4 |
Mean ± SD |
901 ± 78.2 |
Mean ± SD |
327 ± 1.0 |
Mean ± SD |
32 ± 6.0 |
Mean ± SD |
6 ± 1.2 |
||
10 |
620 498 712 |
10 |
1106 1118 1110 |
10 |
1308 1340 1284 |
10 |
37 41 45 |
10 |
3 6 3 |
||
Mean ± SD |
610 ± 107.3 |
Mean ± SD |
1111 ± 6.1 |
Mean ± SD |
1311 ± 28.1 |
Mean ± SD |
41 ± 4.0 |
Mean ± SD |
4 ± 1.7 |
||
20 |
888 734 688 |
20 |
1792 1728 1420 |
20 |
1960 2272 2040 |
20 |
48 61 71 |
20 |
7 4 7 |
||
Mean ± SD |
770 ± 104.7 |
Mean ± SD |
1647 ± 198.9 |
Mean ± SD |
2091 ± 162.1 |
Mean ± SD |
60 ± 11.5 |
Mean ± SD |
6 ± 1.7 |
||
39 |
852 860 854 |
39 |
2104 2000 1740 |
39 |
3044 3624 3048 |
39 |
45 58 62 |
39 |
15 15 10 |
||
Mean ± SD |
855 ± 4.2 |
Mean ± SD |
1948 ±187.5 |
Mean ± SD |
3238 ± 333.7 |
Mean ± SD |
55 ± 8.9 |
Mean ± SD |
13 ± 2.9 |
||
78 |
407 329 443 |
78 |
1680 1792 1816 |
78 |
2576 3112 2880 |
78 |
43 56 47 |
78 |
18 13 20 |
||
Mean ± SD |
393 ± 58.3 |
Mean ± SD |
1763 ± 72.6 |
Mean ± SD |
2856 ± 268.8 |
Mean ± SD |
49 ± 6.7 |
Mean ± SD |
17 ± 3.6 |
||
156* |
P/C P/C P/C |
156 |
644 1116 1324 |
156 |
3144 2884 3196 |
156* |
5 5 7 |
156 |
5 3 6 |
||
Mean ± SD |
- ± - |
Mean ± SD |
1028 ± 348.4 |
Mean ± SD |
3075 ±167.2 |
Mean ± SD |
6 ± 1.2 |
Mean ± SD |
5 ± 1.5 |
||
313* |
P/C P/C P/C |
313* |
P/C P/C P/C |
313* |
P/C P/C P/C |
313* |
P/C P/C P/C |
313* |
0 0 0 |
||
Mean ± SD |
- ± - |
Mean ± SD |
- ± - |
Mean ± SD |
- ± - |
Mean ± SD |
- ± - |
Mean ± SD |
0 ± 0 |
||
Positive controls |
S9 Mix (-) |
Positive controls |
AF-2 |
Positive controls |
NaN3 |
Positive controls |
AF-2 |
Positive controls |
AF-2 |
Positive controls |
9-AA |
Dose (µg/plate) |
0.01 |
Dose (µg/plate) |
0.5 |
Dose (µg/plate) |
0.01 |
Dose (µg/plate) |
0.1 |
Dose (µg/plate) |
80 |
||
Number of colony |
499 401 410 |
Number of colony |
237 198 225 |
Number of colony |
280 228 223 |
Number of colony |
501 345 396 |
Number of colony |
2464 2260 2584 |
||
Mean ± SD |
437 ± 54.2 |
Mean ± SD |
220 ±20.0 |
Mean ± SD |
244 ± 31.6 |
Mean ± SD |
414 ± 79.5 |
Mean ± SD |
2436 ± 163.8 |
||
S9 Mix (+) |
Positive controls |
2-AA |
Positive controls |
2-AA |
Positive controls |
2-AA |
Positive controls |
2-AA |
Positive controls |
2-AA |
|
Dose (µg/plate) |
1 |
Dose (µg/plate) |
2 |
Dose (µg/plate) |
10 |
Dose (µg/plate) |
1 |
Dose (µg/plate) |
2 |
||
Number of colony |
448 592 626 |
Number of colony |
207 201 251 |
Number of colony |
280 261 264 |
Number of colony |
246 234 259 |
Number of colony |
191 155 167 |
||
Mean ± SD |
555 ± 94.5 |
Mean ± SD |
220 ± 27.3 |
Mean ± SD |
268 ± 10.2 |
Mean ± SD |
246 ± 12.5 |
Mean ± SD |
171 ± 18.3 |
* cytotoxicity
Test results (Main study Ⅱ)
Metabolic activation |
Dose (µg/plate) |
|
||||||
|
||||||||
Number of colony/plate |
||||||||
Base-pair substitution type |
Frameshift type |
|
||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
|||
S9 Mix (-) |
0 |
|
|
|
28 22 24 |
|
|
|
Mean ± SD |
|
|
|
25 ± 3.1 |
|
|
||
0.6 |
|
|
|
26 27 24 |
|
|
||
Mean ± SD |
|
|
|
26 ± 1.5 |
|
|
||
1.25 |
|
|
|
23 29 22 |
|
|
||
Mean ± SD |
|
|
|
25 ± 3.8 |
|
|
||
2.5 |
|
|
|
27 24 30 |
|
|
||
Mean ± SD |
|
|
|
27 ± 3.0 |
|
|
||
5 |
|
|
|
28 28 34 |
|
|
||
Mean ± SD |
|
|
|
30 ± 3.5 |
|
|
||
10 |
|
|
|
30 33 33 |
|
|
||
Mean ± SD |
|
|
|
32 ± 1.7 |
|
|
||
20 |
|
|
|
21 25 30 |
|
|
||
Mean ± SD |
|
|
|
25 ± 4.5 |
|
|
||
39* |
|
|
|
08 9 8 |
|
|
||
Mean ± SD |
|
|
|
8 ± 0.6 |
|
|
||
S9 Mix (+) |
0 |
|
|
|
24 27 21 |
|
|
|
Mean ± SD |
|
|
|
24 ± 3.0 |
|
|
||
5 |
|
|
|
28 27 37 |
|
|
||
Mean ± SD |
|
|
|
31 ± 5.5 |
|
|
||
10 |
|
|
|
25 32 33 |
|
|
||
Mean ± SD |
|
|
|
30 ± 4.4 |
|
|
||
20 |
|
|
|
40 43 33 |
|
|
||
Mean ± SD |
|
|
|
36 ± 5.1 |
|
|
||
39 |
|
|
|
45 37 46 |
|
|
||
Mean ± SD |
|
|
|
43 ± 4.9 |
|
|
||
78 |
|
|
|
46 36 57 |
|
|
||
Mean ± SD |
|
|
|
46 ± 10.5 |
|
|
||
156 |
|
|
|
30 22 20 |
|
|
||
Mean ± SD |
|
|
|
24 ± 5.3 |
|
|
||
313* |
|
|
|
P/C P/C P/C |
|
|
||
Mean ± SD |
|
|
|
- ± - |
|
|
||
Positive controls |
S9 Mix (-) |
Positive controls |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
9-AA |
|
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
||
Number of colony |
|
|
|
490 466 452 |
|
|
||
Mean ± SD |
|
|
|
469 ± 19.2 |
|
|
||
S9 Mix (+) |
Positive controls |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
|
Dose (µg/plate) |
1 |
2 |
10 |
1 |
2 |
|
||
Number of colony |
|
|
|
564 540 572 |
|
|
||
Mean ± SD |
|
|
|
559 ± 16.7 |
|
|
* cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- When compared to the negative control, significant increases in the number of revertant colonies were observed in TA100, TA1535 and WP2uvrA strains regardless of presence of metabolic activation system. In the case of TA1537 strain, significant increases in the number of revertant colonies were observed in presence of metabolic activation system.
ESA did induce reverse mutation in under the conditions of this test. - Executive summary:
Summary
To evaluate mutagenic potential of ESA in bacteria, bacterial reverse mutation study was performed with preincubation method using four histidine-requiring strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and one tryptophan-requiring strain of Escherichia coli (WP2uvrA) in the presence and absence of metabolic activation system (S9 mix). The test substance was dissolved 1,4-dioxane and then it was applied to the test strains at the dose levels of followings.
•In the absence of metabolic activation system (S9 mix(-))
TA100, TA1537, WP2uvrA: 0, 5, 10, 20, 39, 78, 156, 313 ㎍/plate
TA1535: 0, 39, 78, 156, 313, 625, 1250, 2500 ㎍/plate
TA98: 0, 0.6, 1.25, 2.5, 5, 10, 20, 39 ㎍/plate
•In the presence of metabolic activation system (S9 mix(+))
0, 5, 10, 20, 39, 78, 156, 313 ㎍/plate
Increase in the number of revertant colonies was seen in TA100, TA1535 and WP2uvrA strains compared with negative control groups in the absence of metabolic activation system. Increase in the number of revertant colonies was seen in TA100, TA1535, WP2uvrA and TA1537 strains compared with negative control groups in the presence of metabolic activation system.
Considering these findings, it is concluded that the test substance ESA does induce reverse mutation in TA100, TA1535, WP2uvrA and TA1537 strains which were used in this study.
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