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EC number: 215-150-4 | CAS number: 1306-38-3
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:
- January 2007 - March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- (without concentration, stability and homogeneity analytical determinations based on the high stability of the test substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no concentration, stability and homogeneity analytical determinations included based on the high stability of the test substance
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cerium dioxide
- EC Number:
- 215-150-4
- EC Name:
- Cerium dioxide
- Cas Number:
- 1306-38-3
- Molecular formula:
- CeO2
- IUPAC Name:
- cerium dioxide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Cerium Oxide
- Physical state: Beige powder
- Analytical purity: 99.5% (CeO2/LnO)
- Impurities (identity and concentrations):
Fe2O3 --> 0.003%
Na2O --> 0.05%
PbO --> 0.0002%
MnO --> <0.001%
F --> 0.01%
Cl --> 0.17%
SO4 --> 0.02%
La2O3 --> 0.1%
Nd2O3 --> 0.1%
Pr6O11 --> 0.1%
- Purity test date: Not specified
- Lot/batch No.: 5310-3-1009-1
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Considered stable over the experimental phase
- Storage condition of test material: At room temperature in ambient light
- Other:
Particle size = 7.8 µ
Supplier: McDaniel Lambert Inc.
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/5,6-benzoflavone-pretreated male Sprague-Dawley rat liver S9 fraction
- Test concentrations with justification for top dose:
- 0 (vehicle), 1.58, 5, 15.8, 50, 158, 500, 1581 or 5000 µg/plate (5 highest concentrations were analyzed)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: aqueous 1% w/v methylcellulose (suspension)
- Justification for choice of solvent/vehicle: limited solubility in water and dimethyl formamide
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) + preincubation
DURATION
- Preincubation period: 30 minutes
- Selection time (if incubation with a selection agent): 48 to 72 hours
SELECTION AGENT: tryptophan
NUMBER OF REPLICATIONS: 3 per concentration and per condition (+/-S9) - Evaluation criteria:
- - Positive: if treatment produced a dose-related increase in revertant colony numbers of at least 2-fold (1.5-fold for strain TA100) the concurrent vehicle control either in the presence or absence of S9 mix
- Negative: if treatment did not produce a dose-related increase in revertant colony numbers of at least 2-fold (1.5-fold for strain TA100) the concurrent vehicle control either in the presence or absence of S9 mix
- Equivocal: if results obtained failed to satisfy the criteria for a clear "positive" or "negative" response - Statistics:
- Mean comparison of numbers of revertant colonies between treatment groups and concurrent vehicle control group
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Positive controls validity:
- valid
Any other information on results incl. tables
Summary tables of mutagenicity assay results:
Plate incorporation assay:
|
|
Dose (µg/plate) |
Number of revertant colonies per plate (Mean ± SD) |
|
|
|
|
|
|
|
|
|
|
|
|
TA1535 |
|
TA1537 |
|
TA98 |
|
TA100 |
|
WP2 uvrA |
|
|
|
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Negative controls |
1% methylcellulose |
0 |
22 ± 5 |
23 ± 6 |
9 ± 2 |
20 ± 5 |
25 ± 1 |
39 ± 2 |
159 ± 18 |
161 ± 5 |
52 ± 9 |
64 ± 12 |
Positive controls |
NaAZ 9AC 2NF NQO 2AA BaP |
0.5 50 1 0.5 5 5 |
311 ± 17 nt nt nt nt nt |
nt nt nt nt 385 ± 9 nt |
nt 574 ± 119 nt nt nt nt |
nt nt nt nt nt 117 ± 9 |
nt nt 147 ± 20 nt nt nt |
nt nt nt nt nt 451 ± 37 |
546 ± 26 nt nt nt nt nt |
nt nt nt nt nt 1145 ± 25 |
nt nt nt 222 ± 8 nt nt |
nt nt nt nt 294 ± 19 nt |
Test substance
|
Cerium Oxide |
50 158 500 1581 5000 |
21 ± 3 19 ± 1 17 ± 3 25 ± 2 22 ± 3 |
26 ± 1 19 ± 3 17 ± 7 24 ± 5 19 ± 6 |
17 ± 6 16 ± 2 14 ± 6 19* ± 2 14 ± 3 |
16 ± 6 17 ± 2 13 ± 2 17 ± 2 11 ± 4 |
28 ± 7 28 ± 2 23 ± 6 27 ± 2 25 ± 7 |
37 ± 4 39 ± 6 30 ± 3 35 ± 8 42 ± 7 |
140 ± 6 166 ± 4 182 ± 11 148 ± 12 135 ± 4 |
151 ± 16 172 ± 11 148 ± 9 166 ± 9 150 ± 11 |
41 ± 2 45 ± 6 55 ± 1 47 ± 11 45 ± 10 |
44 ± 4 69 ± 17 54 ± 5 49 ± 8 57 ± 4 |
NaAZ: Sodium azide
9AC: 9-aminoacridine
2NF: 2-nitrofluorene
NQO: 4-nitroquinoline N-oxide
2AA: 2-aminoanthracene
BaP: Benzo[a]pyrene
nt: not tested
* Apparent increase considered to be normal variation since colony counts were within historical control range
Pre-incubation assay:
|
|
Dose (µg/plate) |
Number of revertant colonies per plate (Mean ± SD) |
|
|
|
|
|
|
|
|
|
|
|
|
TA1535 |
|
TA1537 |
|
TA98 |
|
TA100 |
|
WP2 uvrA |
|
|
|
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Negative controls |
1% methylcellulose |
0 |
18 ± 2 |
21 ± 7 |
12 ± 3 |
15 ± 5 |
20 ± 4 |
38 ± 11 |
133 ± 7 |
173 ± 13 |
52 ± 7 |
52 ± 7 |
Positive controls |
NaAZ 9AC 2NF NQO 2AA BaP |
0.5 50 1 0.5 5 5 |
280 ± 19 nt nt nt nt nt |
nt nt nt nt 321 ± 17 nt |
nt 778 ± 111 nt nt nt nt |
nt nt nt nt nt 103 ± 6 |
nt nt 80 ± 15 nt nt nt |
nt nt nt nt nt 353 ± 23 |
511 ± 39 nt nt nt nt nt |
nt nt nt nt nt 991 ± 58 |
nt nt nt 1458 ± 51 nt nt |
nt nt nt nt 560 ± 53 nt |
Test substance
|
Cerium Oxide |
50 158 500 1581 5000 |
17 ± 1 23 ± 2 18 ± 7 19 ± 2 23 ± 2 |
18 ± 4 16 ± 4 25 ± 7 17 ± 1 23 ± 4 |
14 ± 4 17 ± 2 13 ± 3 16 ± 8 16 ± 2 |
19 ± 8 14 ± 6 15 ± 1 18 ± 4 15 ± 3 |
25 ± 3 31 ± 3 28 ± 3 30 ± 11 27 ± 11 |
46 ± 8 39 ± 3 37 ± 2 42 ± 10 42 ± 5 |
136 ± 14 120 ± 19 123 ± 38 147 ± 13 125 ± 4 |
159 ± 18 167 ± 26 165 ± 14 172 ± 6 175 ± 17 |
41 ± 1 43 ± 3 42 ± 7 56 ± 4 45 ± 6 |
50 ± 9 59 ± 9 60 ± 2 55 ± 5 61 ± 8 |
NaAZ: Sodium azide
9AC: 9-aminoacridine
2NF: 2-nitrofluorene
NQO: 4-nitroquinoline N-oxide
2AA: 2-aminoanthracene
BaP: Benzo[a]pyrene
nt: not tested
Applicant's summary and conclusion
- Conclusions:
- No mutagenic activity was observed with the test substance in this Ames test up to the limit concentration of 5000 µg/plate with or without metabolic activation.
- Executive summary:
The mutagenic potential of Cerium Oxide was tested in a bacterial reverse mutation (Ames) test. The test substance was applied on four strains ofSalmonella typhimurium(TA1535, TA1537, TA98 and TA100) and one strain ofEscherichia coli(WP2uvrA), using both plate incorpoation and preincubation methods, at concentrations of 0 (1% aqueous methylcellulose), 1.58, 5, 15.8, 50, 158, 500, 1581 or 5000 µg/plate, with or without metabolic activation. The appropriate positive controls were included and responded adequately.
Whatever the test concentration and the presence or absence or metabolic activation, no significant increase in the number of revertant colonies per plate over controls occurred.
Therefore Cerium Oxide showed no mutagenic activity in this bacterial reverse mutation (Ames) test using the plate incorporation and preincubation methods up to the limit concentration of 5000 µg/plate with or without metabolic activation.
This study is classified as acceptable. It is compliant with the OECD 471 guideline requirements on bacterial reverse mutation test.
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