Registration Dossier
Registration Dossier
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EC number: 203-157-5 | CAS number: 103-90-2
Endpoint summary
Administrative data
Description of key information
Biodegradation in water: screening tests
Biodegradation in water and sediment: simulation tests
Half-life period of Paracetamol in water is observed to be 15 days (360 hrs.) while in sediment it is 140 days (3360 hrs).Based on these half-life values of Paracetamol, it is concluded that the chemical is readily biodegradable in water medium as the half-life does not exceed the threshold of 60 days where as it is persistent in sediment medium as the half-life exceeds the threshold of >120 days.However, since there is no diffusion of the substance in the sediment as evident from the reported data (0% in sediment) and hence persistence in the sediment compartment is not likely to be critical.
Biodegradation in soil
The PBT Profiler & EPI Suite has estimated that Paracetamol is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 30 days (720 hrs). does not exceeds the threshold of 120 days as per Annex XIII of REACH regulation.Therefore, Paracetamol is estimated to be not persistent in the soil environment.
Additional information
Biodegradation in water
No. of studies were reviewed for Biodegradation in water from reliable sources having Klimisch rating 2.
The summary of the results are presented below
Based on prediction by PBT profiler, Office of Chemical Safety and Pollution Prevention , U.S. Environmental Protection Agency; version 1.301 the half life period of Paracetamol in water is 15 days and based on this value it can be concluded that the chemical is not persistent in water medium since the half life is less than the threshold of 60 days (to qualify the chemical as persistent). Also the diffusion percentage of Paracetamol in water medium is 22%. This coupled with the dilution of water shall result in ready biodegradability of the chemical.
QSAR version3.1 estimated the biodegradtion to be 67.355 % in 28 days.
Study conducted by Lili Zhang et.al (Appl Microbiol Biotechnol (2013) 97:3687–3698) on three strains ofStenotrophomonas sp.Found paracetamol to be readily biodegradable considering Toc values as well as oxygen consumption values. Individual stranis f1, f2, and fg-2 as well as the coculture could perform complete degradation of paracetamol at concentrations of different concentrations in a over all duration of 7.5 days.
Another publication by Tsung-Hsien et.al,presenting abatch experiment results, acetaminophen was characterized by significant biodegradability, weak desorption and strong sorption. Therefore resulting in 100% removal after 8 days via sorption and >25% removal by biodegradation after 2 days. Moreover, the half-life via bio-sorption/degradation for acetaminophen was 0.6 days. Based on the kinetic rate constants for degradation of acetaminophen, the substance is most probably readily biodegradable.
Based on the weight of evidences used for the target chemical Paracetamol it was found that the degradation percentage of Paracetamol in water medium is ranging between 50 to 67.355%.This leads to the conclusion that the substance is readily biodegradable in water.
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Biodegradation in water and sediment
Based on the PBT Profiler, the half-life period of the Paracetamol was estimated. The half-life period of Paracetamol in water is 15 days (360 hrs.) therefore it is considered that the substance will qualify as not persistent as the half-life does not exceed the threshold of 60 days. So, it can be confirmed that the substance is readily biodegradable in water medium. While in sediment the half-life is 140 days (3360 hrs.) therefore it is considered that the substance will qualify as persistent as the half-life exceeds the threshold of >120 days. However, it can be observed that Paracetamol does not diffuse in the sediment medium since it's percentage in the sediment medium is reported to be 0% and hence persistence in the sediment compartment is not likely to be critical.
Media |
Half-Life |
Percent in |
Water |
15 |
22% |
Sediment |
140 |
0% |
Biodegradation in soil
The PBT Profiler & EPI Suite has estimated that Paracetamol is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 30 days (720 hrs). does not exceeds the threshold of 120 days as per Annex XIII of REACH.Therefore, paracetamol is estimated to be not persistent in the soil environment.
PBT profiler estimate
Media |
Half-Life |
Percent in |
Soil |
30 |
78% |
EPI Suite
|
Mass Amount (percent) |
Half-Life (hr) |
Emissions (kg/hr) |
Soil |
77.6 |
720 |
1000 |
|
Fugacity (atm) |
Reaction (kg/hr) |
Advection (kg/hr) |
Reaction (percent) |
Advection (percent) |
soil |
2.84e-016 |
1.6e+003 |
0 |
53.3 |
0 |
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