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EC number: 909-701-4 | CAS number: -
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD TG 474-compliant study, using a main constituent of the reaction mass for a read-across purpose
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus 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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle France
- Age at study initiation: 5 weeks old
- Weight on day of dosing: 30 - 34 g (males) / 23 - 29 g (females)
- Housing: by groups of 5 of the same sex in polycarbonate cages with stainless steel lid
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): filtered and non-recycled fresh air
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: 1% carboxymethylcellulose solution
- Justification for choice of solvent/vehicle: appropriate to oral suspensions
- Concentration of test material in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg bw
- Lot/batch no. (if required): Sigma 58C-0156 - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Immediately before use, by putting the test substance in suspension
- Duration of treatment / exposure:
- Single administration
- Frequency of treatment:
- Single administration
- Post exposure period:
- 24 hours (test substance, negative control, positive control) and 48 hours (test substance, negative control)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
other: nominal
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Nature: cyclophosphamide
- Justification for choice of positive control: not provided
- Route of administration: Oral (gavage)
- Dose: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Femur bone marrow erythrocytes
- Details of tissue and slide preparation:
- - Femur bone marrow eluted out with fetal calf serum and cell suspension centrifuged
- Supernatant removed and cells in sediment resuspended by shaking
- One drop of cell suspension spread on a coded slide
- Slides air-dried and stained by May-Grünwald Giemsa
- Two slides prepared per animal but only one used for scoring - Evaluation criteria:
- - 2000 polychromatic erythrocytes scored for micronuclei per animal
- Ratio between polychromatic and normochromatic erythrocytes (PE/NE ratio) calculated by scoring 1000 erythrocytes per animal
- Substance considered clastogenic if statistical increase in mean number of micronucleated polychromatic erythrocytes for at least one of the sampling time compared to negative controls and this increase doubles the number of micronucleated polychromatic erythrocytes in the test facility's historical data (1.4 +/- 0.6 per thousand) - Statistics:
- - Intergroup comparison of mean numbers of micronucleated polychromatic erythrocytes using Kastenbaum and Bowman's test (5% significance level)
- Intergroup comparison of PE/NE ratios using Student's t test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- at 2000 mg/kg bw (nominal)
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
No clinical signs in 3 males and 3 females given a single oral dose of 2000 mg/kg bw.
RESULTS OF DEFINITIVE STUDY
See summary table below.
Any other information on results incl. tables
Mean number of micronucleated polychromatic erythrocytes and PE/NE ratio:
Time of sacrifice (hours post dosing) | Group | Number of polychromatic erytrocytes / 1000 polychromatic erythrocytes(mean +/- standard deviation) | PE/NE ratio(mean +/- standard deviation) |
24 | Vehicle | 1.9 +/- 1.0 | 1.0 +/- 0.2 |
Test substance | 2.4 +/- 1.3 | 1.1 +/- 0.2 | |
Cyclophosphamide | 56.6 +/- 10.4 *** | 0.8 +/- 0.1 * | |
48 | Vehicle | 1.7 +/- 1.6 | 1.0 +/- 0.2 |
Test substance | 2.9 +/- 1.3 | 1.1 +/- 0.3 |
*** p < 0.001 * p < 0.05
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative at 2000 mg/kg bw
No evidence of clastogenicity in this mouse bone marrow micronucleus assay at the limit dose of 2000 mg/kg - Executive summary:
The clastogenic potential of Cerium Oxide was tested in an oral mouse bone marrow micronucleus assay. Swiss OF1 5-week old mice (5/sex per group) were given a single oral administration of 2000 mg/kg Cerium Oxide by gavage. Two test substance-treated groups, two vehicle (1% carboxymethylcellulose)-treated control groups and one positive control (cyclophosphamide) group were used. Euthanasia was performed 24 and 48 hours after dosing for substance-treated and negative control groups. Positive controls were euthanasied 24 hours after dosing. For each animal, 2000 polychromatic erythrocytes from femur bone marrow were microscopically examined for micronuclei. The polychromatic to normochromatic erythrocytes (PE/NE) ratio was determined from 1000 erythrocytes per mouse.
At both sampling times, there were no statistical differences from negative control values in the number of micronucleated polychromatic erythrocytes and the PE/NE ratio from substance-treated animals.
An appropriate reference mutagen used as positive control showed a significant increase in micronucleated polychromatic erythrocytes together with a significant decrease in the PE/NE ratio, indicating that the test was sensitive and valid.
Therefore, Cerium Oxide did not induce cytogenetic damage in this micronucleus test in mice treated by the oral route at the limit dose of 2000 mg/kg.
This study is classified as acceptable. It satisfies the OECD 474 guideline requirements on Mammalian Erythrocyte Micronucleus Test.
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