Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The 48 h acute toxicity test with D. magna was conducted following OECD guideline 202 (1984). The 48 h D. magna EC50 value for paracetamol (acetaminophen) determined in the present study was 11.85 mg/L on the basis of mortality effect. Based on this EC50 value, the substance may qualify for the aquatic classification in the chronic 3 category. But paracetamol was found to be rapidly degradable and the BCF value was not >= 500. Also the partition coefficient the Log Kow was not >= 4. Thus considering the CLP Criteria for aquatic classification of the substance, it is concluded that Paracetamol shall not exhibit short term toxicity to aquatic invertebrate (Daphnia magna) i.e. it is non hazardous to the aquatic environment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
11.85 mg/L

Additional information

Kim,P. et.al (2012) studied the 48 h acute toxicity test with D. magna and Moina macrocopa following OECD guideline 202 (1984).EC50 value determined in the present study was 11.85 mg/L and 56.34 mg/L on the basis of mortality effect.  

Based on the short term toxicity test conducted by Ministry of the Environment in Japan/J-CHECK database.The tests are conducted based on OECD-GLP standard and OECD test guidelines.The median effective concentration (EC50) in Daphnia magna was found to be 3.5 mg/L in a 48 hour study. 

In another study conducted by Guk h. Han et.al (2006),the lethal concentration (LC50) reported as 20.1 mg/L on the basis of mortality effects in a 48 hour study. 

In the study reported by K.-P. Henschel et.al ((1997)), A Daphnia magna chemical toxicity test was performed: “according to OECD Guideline 202”. The resulting dose-response curve was used to evaluate the level of toxicity to D. magna after 48 hours. The effect concentration (EC50) after 48 hours was reported as 50 mg/L. 

Similarly Henrik Lilius et.al (1995) conducted the study on daphnia pulex for 24 hrs indicate the effective concentration (EC50) value of Paracetamol as 136 mg/L; based on intoxication effect . 

In the study of Calleja, M. C. et.al (1994) ,the lethal concentration (LC50) in aquatic invertebrate (Daphnia magna) in a 24 hr study on the basis of immobility effects was found to be 269.153 mg/L. 

As determined by the Etox database, the lethal concentration (LC50) in aquatic invertebrate (Artemia salina) in a 24 hr study on the basis of mobility effect was found to be 578 mg/L.

 

Based on the above studies available for the substance Paracetamol (acetaminophen), the EC50 is ranging from 3.5 to 136 mg/L and LC50 is ranging from 20.1 to 578 mg/L in aquatic invertebrates in a 24 to 48 hours study on the basis of various effects such as mortality, intoxication, immobility etc. Based on some of this EC50 and LC50 value, the substance may qualify for the aquatic classification in the chronic 2 category and chronic 3 category. But Paracetamol was found to be rapidly degradable and the BCF value was not >= 500. Also the partition coefficient the Log Kow was not >= 4. Thus, it is concluded that Paracetamol shall not exhibit short term toxicity to aquatic invertebrate i.e. it is non-hazardous to the aquatic environment for the purpose of classification of the substance as per the new CLP guidelines.