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EC number: 232-122-7 | CAS number: 7787-59-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- / AT reversion site not covered, no historical data provided, no concentrations of positive controls provided, no data on dose-finding study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bismuth oxide salicylate
- EC Number:
- 238-953-1
- EC Name:
- Bismuth oxide salicylate
- Cas Number:
- 14882-18-9
- Molecular formula:
- C7H5BiO4
- IUPAC Name:
- 2-hydroxy-4H-1,3,2-benzodioxabismin-4-one
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats and male hamsters, treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- main experiment: 3.3, 10, 33, 100, 333, 666 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (4-NPD), 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: The dose-finding assay and main assay were carried out in triplicates.
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number his+ colonies, clearing of the bacterial background lawn - Evaluation criteria:
- The test article is judged to be mutagenic or weakly mutagenic, if it produced a reproducible dose-related increase in his+ revertants compared to the corresponding solvent control.
- Statistics:
- Mean values and standard error of means were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- other: no data on historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no data on historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- other: no data on historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no data on historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control at 333.3 and 666.6 μg/ plate without S9 mix (93 and 100%, respectively) and with S9 mix (hamster) and with S9 mix (rat) (60, 100, 91 and 100%, respectively)
- Vehicle controls validity:
- other: no data on historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no data on historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control at 333.3 and 666.6 μg/ plate without S9 mix (67 and 100%, respectively) and at 666.6 μg/ plate with S9 mix (hamster) and S9 mix (rat) (84 and 100%, respectively)
- Vehicle controls validity:
- other: no data on historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no data on historical control data given
Any other information on results incl. tables
Table 1: Summary of test results (main assay)
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair |
||||
TA1537 |
TA98 |
TA100 |
TA1535 |
||
– S9 |
Solvent control (DMSO) |
6 ± 0.3 |
17 ± 1.2 |
130 ± 4.6 |
27 ± 5.1 |
3.3 |
- |
- |
105 ± 2.1 |
- |
|
10 |
6 ± 0.9 |
14 ± 2.7 |
132 ± 9.3 |
26 ± 4.8 |
|
33.3 |
7 ± 3.5 |
17 ± 1.2 |
111 ± 5.8 |
21 ± 2.8 |
|
100 |
4 ± 1.2 |
13 ± 2.1 |
123 ± 9.0 |
18 ± 2.3 |
|
333.3 |
2 ± 0.3 |
12 ± 3.5 |
84 ± 2.9 |
2 ± 1.0 |
|
666.6 |
0 ± 0.0 |
9 ± 0.9 |
- |
0 ± 0.0 |
|
Positive controls |
9AA |
4-NPD |
SAZ |
SAZ |
|
Mean No. of colonies/plate (average of 3 plates) |
614 ± 162.9 |
1085 ± 2.6 |
1615 ± 43.6 |
1320 ± 45.1 |
|
+ 10% S9 (hamster) |
Solvent control (DMSO) |
6 ± 0.9 |
24 ± 6.8 |
108 ± 4.4 |
10 ± 2.7 |
3.3 |
- |
- |
96 ± 2.4 |
- |
|
10 |
6 ± 0.9 |
27 ± 3.5 |
92 ± 2.0 |
31 ± 1.2 |
|
33.3 |
6 ± 0.7 |
28 ± 2.1 |
113 ± 5.8 |
30 ± 1.2 |
|
100 |
6 ± 0.7 |
22 ± 2.1 |
101 ± 8.3 |
5 ± 0.9 |
|
333.3 |
3 ± 0.9 |
20 ± 4.0 |
90 ± 2.0 |
4 ± 1.3 |
|
666.6 |
1 ± 0.3 |
21 ± 1.9 |
- |
0 ± 0.0 |
|
Positive control |
2AA |
||||
Mean No. of colonies/plate (average of 3 plates) |
120 ± 18.2 |
1449 ± 83.9 |
1382 ± 127.5 |
184 ± 8.4 |
|
+ 10% S9 (rat) |
Solvent control (DMSO) |
8 ± 0.7 |
30 ± 3.7 |
107 ± 4.8 |
11 ± 1.0 |
3.3 |
- |
- |
103 ± 2.7 |
- |
|
10 |
7 ± 1.5 |
24 ± 1.9 |
100 ± 0.6 |
9 ± 2.0 |
|
33.3 |
8 ± 1.7 |
23 ± 1.8 |
108 ± 4.5 |
7 ± 1.8 |
|
100 |
8 ± 0.9 |
24 ± 0.6 |
100 ± 8.4 |
7 ± 2.6 |
|
333.3 |
4 ± 1.2 |
18 ± 2.7 |
83 ± 4.3 |
1 ± 0.6 |
|
666.6 |
0 ± 0.0 |
18 ± 3.8 |
- |
0 ± 0.0 |
|
Positive control |
2AA |
||||
Mean No. of colonies/plate (average of 3 plates) |
133 ± 2.7 |
1503 ± 9.5 |
1700 ± 55.2 |
182 ± 6.4 |
|
2AA = 2-aminoanthracene
4-NPD = 4-nitro-o-phenylenediamine
SAZ = sodium azide
9AA = 9-aminoacridine
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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