Registration Dossier
Registration Dossier
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EC number: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th January 1986 to 27th June 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Internal method in accordance with standard operating procedures
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- Ammonium 7-(2,6-dimethyl-8-(2,2-dimethylbutyryloxy)-1,2,6,7,8,8a-hexahydro-1-naphthyl)-3,5-dihydroxyheptanoate
- EC Number:
- 404-520-2
- EC Name:
- Ammonium 7-(2,6-dimethyl-8-(2,2-dimethylbutyryloxy)-1,2,6,7,8,8a-hexahydro-1-naphthyl)-3,5-dihydroxyheptanoate
- Cas Number:
- 139893-43-9
- Molecular formula:
- C25 H43 O6 N
- IUPAC Name:
- ammonium 7-{8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl}-3,5-dihydroxyheptanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Mice were sourced from Charles River Breeding Farms, weight range 14 - 27.1 The mice were housed 4-12 per cage. Each animal was identified by a metal ear tag.
Food: Purina Certified Rodent Chow
Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqueous Methylcellulose
- Duration of treatment / exposure:
- 6, 24 and 48 hours
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 000 mg/kg bw/day
- Dose / conc.:
- 1 667 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control(s):
- Mitomycin C
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- Bone marrow was harvested in pre-warmed Hank's Balanced Salt Solution. Bone marrow cells were treated with a hypotonic solution of potassium chloride in water and is fixed in freshly prepared absolute methanol : glacial acetic acid (3:1).
Fixed cells were dropped onto clean wet slides and allowed to dry. All slides were stained with Giemsa and coverslips applied. - Evaluation criteria:
- For each mouse the following quantities were calculated:
% mitotic cells
Total aberrant cells
% aberrant cells
Total aberrants
frequency of aberrant/cell - Statistics:
- Adjusted trend P-value
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- There was no evidence for induction of chromosome aberrations in MK-0733 under the conditions of this test
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