Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-104-5 | CAS number: 66069-34-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Several studies were conducted on a range of species including the rat, dog, mouse and monkey. The studies looked into adsorption, excretion, metabolism and distribution of potassium clavulanate within these animals.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Several studies were conducted on a range of species including the rat, dog, mouse and monkey. The studies looked into adsorption, excretion, metabolism and distribution of potassium clavulanate within the dog, mouse, monkey and rat. The results can be seen below:
Adsorption:
Mouse:
Absorption In the mouse appears to be variable. Blood concentrations of between 14 and 29 µg/ml were obtained after oral administration of 100 mg/kg. Subcutaneous administration at the same dose gave blood concentrations roughly five-fold higher than this (80 - 120 µg/ml).
Rat:
After orally dosing the rat with 100 mg/kg, blood concentrations were low, 0.9 to 2.9 µg/ml. Intramuscular administration of 500 mg/kg gave peak blood levels of 200 to 340 µg/ml after 15 to 30 minutes.
Dog:
Blood concentrations in the dog after oral administration of 90 mg/kg gave peak concentrations at 1 hour of between 17 and 33 µg/ml, but vomiting frequently occurs at this dose level. Intramuscular administration at 90 mg/kg resulted in higher blood concentrations, approximately three times greater
than from the corresponding oral dose occurring after 30 minutes. In repeat dose studies at 100 mg/kg similar results have been obtained indicating no accumulation of BRL. 14151.
Monkey:
Oral administration of BRL 14151 at 100 mg/kg to the squirrel monkey gave blood concentrations of 24 - 37 µg/ml. Intramuscular administration of 10 mg/kg produced blood concentrations of 10 to 15 µg/ml.
Urinary recovery values were low and very variable in all the specieis tested and through all the routes of administration tested (intramuscular and via te oral route).
The following results were obtained from radioactive studies to assess the distribution of potassium clavulanate:
The information obtained so far indicates that in the rat the absorption of 14C-BRL 14151 or its metabolites after oral administration is greater than that indicated by the non-radioactive studies carried out where only BRL.14151 was measured in urine. The radioactive studies have also indicated that in the rat the bile is currently a minor route of elimination of the 14C-compound or its metabolites and that extensive metabolism of the 14C-BRL.14151 occurs when the compound is administered orally.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
