Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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).