Registration Dossier
Registration Dossier
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EC number: 614-478-9 | CAS number: 684269-94-1
Carcinogenicity
Administrative data
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.
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