Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: micronucleus test by oral route in mice
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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Materials and methods

Principles of method if other than guideline:
no data available
Type of assay:
micronucleus assay

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

Test animals

Species:
mouse

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Clopidogrel was not genotoxic in in vivo test (micronucleus test by oral route in mice).
Executive summary:

Clopidogrel was not genotoxic in one in vivotest (micronucleus test by oral route in mice).