Registration Dossier
Registration Dossier
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EC number: 248-003-8 | CAS number: 26787-78-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Weight of evidence. Multiple studies were available (no guideline, no GLP, fulfilling basic scientific principles). Amoxicillin has a rapid absorption, with a saturable mechanism and a bioavailability around 77%. It distributes well into tissues and extravascular fluids, preferentially the liver and kidney, it has a fast elimination (urinary excretion of unchanged amoxicillin is 60-75% after 24h) and it does not accumulate. The main degradation products found were amoxicilloic acid and amoxicillin diketopiperazine-2,5-dione.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The oral bioavailability in humans was 77.4% (Arancibia et al., 1980) and was not affected by the presence of food in the stomach (Eshelman et al., 1978). Regarding the protein binding in plasma, the drug was quickly eliminated with an elimination half-life of 0.22 h in mice (Woodnutt et al., 1999) and 1.5 h in dogs (Küng et al., 1994), with no bioaccumulation. Moreover, similar to the laboratory animals, amoxicillin absorption in humans has a saturable mechanism (Sjövall et al., 1985). The urinary recovery of amoxicillin in humans was 76.5% (Arancibia et al. 1980) and ranged from 48% to 75% in rats (Sakamoto et al., 1985; Fujiwara et al., 2011). Although most absorbed amoxicillin is excreted unchanged, it should be taken into account that metabolites constitute almost 20% of the total drug excreted in urine of rats, dogs and humans (Haginaka et al., 1987; WHO, 2012). Nägele et al. (2005) identified amoxicilloic acid, amoxicillin piperazine-2’,5’-dione, and two minor other inactive metabolites as possible degradation products. The pharmacokinetics of amoxicillin after oral administration to humans, as well as in laboratory animals, was characterized by rapid absorption, distribution and elimination, with no accumulation.
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