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Toxicological information

Genetic toxicity: in vitro

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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:
2005

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
Name:
Unnamed
Type:
Constituent

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.