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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint summary

Administrative data

Description of key information

Additional information

Four aquatic toxicity studies have been conducted on the surrogate material Potassium clavulanate according to GLP and OECD guidelines, these studies have been conducted on Lepomis macrochirus (blue gill sunfish), Oncorhynchus mykiss (rainbow trout), Daphnia magna (water flea) and Pseudokirchneriella subcapitata (green algae).

The results of the four acute aquatic toxicity studies are as follows:

Fish (Blue gill sunfish) ( LC50 = > 790 mg/L Blue gill sunfish NOEC = 790 mg/L

Daphnia EC50 = > 1610 mg/L Daphnia NOEC = 1610 mg/L

Algae EC50 = > 170 mg/L Algae NOEC = 17 mg/L

Rainbow trout LC50 = > 960 mg/L-1 NOEC = 960 mg/L-1.

Both fish studies were conducted at around the same time, both studies were tested for 96 hours under static conditions on fresh water species. The study conducted on the bluegill sunfish was chosen as the key study, as this produced the worst case result and there was very little difference between the two studies.

An ASRI study was conducted on the test material tBA clavulanate. The effect of the test item on the respiration of activated sewage sludge gave a 3-Hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L.

From the results of these studies on the surrogate material (Potassium clavulanate) it can be seen that the algae is the most sensitive species to the surrogate test material. The algae study produced the lowest EC50 value out of all three aquatic toxicity studies, and was tested at much lower concentrations than compared to the Acute Fish and Acute Daphnia study. The results of the acute Algae study were not sufficient to warrant classification, as the test material TBA clavulanate is readily biodegradable in water (73%). Therefore the test material has not been classified as hazardous to the environment.