Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study has been made with structural analogue. Study presented to US Food and Drug Administration. No details available.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Materials and methods

Principles of method if other than guideline:
no data available

Test material

Constituent 1
Chemical structure
Reference substance name:
(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate hydrogen sulfate
EC Number:
601-679-1
Cas Number:
120202-66-6
Molecular formula:
C16 H16 Cl N O2 S . H2 O4 S
IUPAC Name:
(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate hydrogen sulfate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
no details available

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes).
Executive summary:

Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes).