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Description of key information

There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma exposures >25 times that in humans at the recommended daily dose of 75 mg.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
77 mg/kg bw/day
Study duration:
subacute
Species:
other: mice and rats
Quality of whole database:
Read-across from supporting substance (structural analogue or surrogate).
The assessment is based on results of toxicological tests supplied by Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
Bridgewater, NJ 08807 to U.S. Food and Drug Administration for clopidogrel hydrogen sulphate (CAS 120202-66-6) which is salt of similar structure.

Justification for classification or non-classification

The results show no carcinogenic potential of similar salt.

Additional information

Presented results are read-across from supporting substance (structural analogue or surrogate).

The assessment is based on results of toxicological tests supplied by Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership

Bridgewater, NJ 08807 to U.S. Food and Drug Administration for clopidogrel hydrogen sulphate (CAS 120202-66-6) which is salt of similar structure.

This results are available via internet: http://products.sanofi.us/plavix/plavix.html#section-13.1

Justification for selection of carcinogenicity via oral route endpoint:

Literature report for structural analogue:

There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma exposures >25 times that in humans at the recommended daily dose of 75 mg.