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Description of key information

The value of Daphnia Acute toxicity (EC50 or median effective concentration) after 48 hours is 8.3 mg/l and No Observed Effect Concentration (NOEC) is 6.2 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
8.3 mg/L

Additional information

EC50 and NOEC values for Daphnia and degradiation study have been reported in USA in Review of Environmental Assesment for NDA 20 -839/S-019 for Plavix tablets prepared by Division of Cardio-Renal Drug Products (HFD-110), Center for Drug Evaluation and Research from Feb. 11, 2002.

The reported substance is a salt with INNm Clopidogrel hydrogen sulphate, CAS No. 120202 -66 -6, and is a close analogue of CLI.

The results disclosed in the report show that this substance is not a rapidly degradable substance with EC50 in 48 h for Dahnia is 8.3 mg/L. As there is no data on long term aquatic hazards, the substance is classified in Category Chronic 2 as EC50 is in the range >1 and =<10 mg/L from the Table 4.1.0/(b)/(iii).