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EC number: 932-019-3 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 13, 1997 to August 08, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-Keto-gluonic acid
- IUPAC Name:
- 2-Keto-gluonic acid
- Reference substance name:
- L-xylo-hex-2-ulosonic acid
- EC Number:
- 208-403-5
- EC Name:
- L-xylo-hex-2-ulosonic acid
- Cas Number:
- 526-98-7
- Molecular formula:
- C6H10O7
- IUPAC Name:
- L-sorbosonic acid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium, other: TA1535, TA1537, TA98, TA100, and TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat Liver S9-Mix
- Test concentrations with justification for top dose:
- 1st series: 5, 15.8, 50, 158, 500, 1580, and 5000 µg/plate
2nd series: 50, 158, 500, 1580, and 5000 µg/plate - Vehicle / solvent:
- DMSO or acetone and ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Aqua bidest (H2O)
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9-aminoacridine, Cumene hydroperoixide, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 37 degrees C for days - Evaluation criteria:
- Dose-related response with significant increase over negative controls. Test is valid if there is a significant increase in mutation frequency in positive controls as compared to negative controls.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Any other information on results incl. tables
Results for Experiment I (Mean Revertants/plate (SD)) – Without S9
Strain |
S9 Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
WP2 |
Solvent |
- |
16 (2) |
99 (9) |
218 (19) |
9 (3) |
5 (3) |
82 (16) |
5 |
- |
5 (3) |
117 (22) |
233 (16) |
13 (3) |
8 (3) |
99 (3) |
15.8 |
- |
7 (3) |
114 (7) |
215 (25) |
7 (2) |
5 (2) |
91 (6) |
50 |
- |
7 (2) |
99 (10) |
242 (12) |
11 (3) |
6 (3) |
95 (4) |
158 |
- |
6 (3) |
104 (3) |
233 (10) |
10 (3) |
5 (1) |
87 (15) |
500 |
- |
6 (2) |
94 (15) |
219 (14) |
10 (3) |
7 (1) |
73 (18) |
1580 |
- |
12 (5) |
102 (34) |
231 (42) |
10 (1) |
7 (4) |
76 (10) |
5000 |
- |
11 (3) |
112 (10) |
215 (11) |
6 (2) |
7 (3) |
82 (12) |
Results for Experiment I (Mean Revertants/plate (SD)) – With S9
Strain |
S9 Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
WP2 |
Solvent |
+ |
18 (4) |
116 (16) |
309 (12) |
11 (6) |
6 (1) |
86 (13) |
5 |
+ |
14 (1) |
127 (18) |
283 (3) |
13 (3) |
5 (2) |
116 (9) |
15.8 |
+ |
14 (4) |
128 (18) |
294 (5) |
9 (2) |
6 (3) |
88 (10) |
50 |
+ |
15 (3) |
127 (8) |
288 (16) |
12 (5) |
6 (2) |
102 (15) |
158 |
+ |
16 (1) |
128 (7) |
293 (29) |
12 (3) |
4 (2) |
103 (20) |
500 |
+ |
20 (1) |
118 (6) |
287 (6) |
15 (5) |
5 (2) |
106 (7) |
1580 |
+ |
14 (1) |
118 (3) |
297 (14) |
13 (2) |
8 (1) |
104 (19) |
5000 |
+ |
15 (5) |
116 (38) |
280 (22) |
12 (5) |
8 (2) |
112 (19) |
Results for Experiment II (Mean Revertants/plate (SD)) – Without S9
Strain |
S9 Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
WP2 |
Solvent |
- |
16 (3) |
84 (9) |
208 (36) |
7 (3) |
6 (1) |
82 (5) |
50 |
- |
12 (3) |
82 (9) |
163 (2) |
8 (3) |
3 (2) |
92 (6) |
158 |
- |
13 (3) |
84 (11) |
182 (12) |
7 (4) |
4 (1) |
92 (5) |
500 |
- |
13 (2) |
86 (13) |
177 (26) |
6 (3) |
4 (3) |
76 (4) |
1580 |
- |
8 (2) |
93 (17) |
202 (6) |
6 (4) |
2 (1) |
81 (9) |
5000 |
- |
8 (3) |
89 (5) |
185 (11) |
5 (3) |
4 (2) |
90 (5) |
Results for Experiment II (Mean Revertants/plate (SD)) – With S9
Strain |
S9 Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
WP2 |
Solvent |
+ |
20 (3) |
115 (7) |
209 (32) |
10 (3) |
6 (1) |
99 (12) |
50 |
+ |
22 (4) |
112 (5) |
182 (16) |
10 (2) |
8 (1) |
97 (16) |
158 |
+ |
15 (4) |
107 (5) |
197 (14) |
10 (2) |
10 (3) |
102 (5) |
500 |
+ |
20 (2) |
121 (15) |
201 (3) |
9 (3) |
6 (2) |
108 (16) |
1580 |
+ |
21 (7) |
105 (13) |
195 (7) |
9 (7) |
8 (1) |
101 (3) |
5000 |
+ |
17 (1) |
109 (5) |
184 (13) |
10 (1) |
6 (1) |
85 (10) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
This study examined the mutagenic potential of the test substance. Salmonella typhimuirum strains TA1537, TA1535, TA102, TA98, and TA100, were exposed to concentrations ranging from 5 to 5000 ug/plate of test substance in DMSO (or other organic solvent) in both the presence and absence of S9. Positive control substances were Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9 -aminoacridine and cumene hydroperoxide. Cultures were tested in triplicate for mutation frequency. No treatment cultures showed mutation frequencies significantly greater than negative controls. Positive controls showed significantly greater mutation frequencies over negative controls, therefore the test was valid. The test substance is not mutagenic in either the presence or absence of metabolic activation.
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