Registration Dossier
Registration Dossier
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EC number: 614-478-9 | CAS number: 684269-94-1
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
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).
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