Registration Dossier
Registration Dossier
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EC number: 616-212-7 | CAS number: 75330-75-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Type of information:
- other: Mevacor Tablets
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Mevacor Tablets
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: Mevacor Tablets
- Principles of method if other than guideline:
- Mevacor Tablets
- GLP compliance:
- no
- Type of assay:
- other: Mevacor Tablets
Test material
- Reference substance name:
- (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate
- EC Number:
- 616-212-7
- Cas Number:
- 75330-75-5
- Molecular formula:
- C24-H36-O5
- IUPAC Name:
- (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate
Constituent 1
Results and discussion
Any other information on results incl. tables
Lovastatin did not demonstrate genotoxic potential in the Ames
bacterial mutagenicity assay, an alkaline elution assay using rat or mouse
hepatocytes, a mutation assay in Chinese hamster cells, a chromosomal aberration
assay in hamster cells and an in vivo mouse micronucleus assay.
Applicant's summary and conclusion
- Conclusions:
- Lovastatin did not demonstrate genotoxic potential in the Ames
bacterial mutagenicity assay, an alkaline elution assay using rat or mouse
hepatocytes, a mutation assay in Chinese hamster cells, a chromosomal aberration
assay in hamster cells and an in vivo mouse micronucleus assay. - Executive summary:
Lovastatin did not demonstrate genotoxic potential in the Ames
bacterial mutagenicity assay, an alkaline elution assay using rat or mouse
hepatocytes, a mutation assay in Chinese hamster cells, a chromosomal aberration
assay in hamster cells and an in vivo mouse micronucleus assay.
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