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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

Based on the nominal concentrations, experimental median lethal concentration [LC-50 (96 h)] for Paracetamol (CAS No. -103-90-2) in Danio rerio was found to be  > 100 mg/L on the basis of mortality effects in a 96 hour study. Thus based on this LC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the substance Paracetamol does not exhibit toxicity to aquatic fish (Danio rerio).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

Based on the short term toxicity test conducted in compliance with the OECD guideline 203 by UERL(FT-/103-90-2/2016), the median lethal concentration [LC-50 (96 h)] was found to be > 100 mg/L. The study was carried out on zebra fish for 96 hrs. on the basis of mortality effects. 

In another study reported by Kim et.al (Environ. Int.33(3): 370-375),the LC50 was found to be >160mg/L after exposure to Oryzias latipes for 96 hrs.on the basis of mortality effect. 

Broderius et.al (Environ. Toxicol. Chem.14(9): 1591-1605) presented a 96hr short term study in Pimephales promelas indicating the LC50 to be 814mg/L. 

Similarly Brooke et.al (Superior, WI: Center for Lake Superior Environmental Studies Univ. of Wisconsin Superior, 1984. p.291) along with the other reliable database sources indicated the LC50 to be 814 mg/L. 

As determined by the prediction model Danish QSAR and Etox database the LC50 values were found to be found to be 334.15 mg/l and >1000mg/l respectively. 

A fish early-life stage test was used to assess the toxicity of paracetamol by K.-P. Henschel(1997). Based on mortality induced in embryos of the zebrafish after exposure, the EC50 was estimated to be 378 mg/L based on Probit analysis of the dose-response curve.

 

Thus from the above studies available for the the target substance Paracetamol, the LC50 values was found to be ranging between >100 mg/L to >1000 mg/L in a 96 hrs. study on the basis of mortality effect. Thus, it is concluded that Paracetamol does not exhibit short term toxicity to aquatic fish i.e. it is non-hazardous to the aquatic environment for the purpose of classification of the substance as per the new CLP guidelines.