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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
fertility, other
Remarks:
based on test type (migrated information)
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 performed on th structuraly 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:
details not 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:
not available

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Clopidogrel was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg per day.
Executive summary:

Clopidogrel was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg per day.