Registration Dossier
Registration Dossier
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EC number: 203-120-3 | CAS number: 103-53-7
Endpoint summary
Administrative data
Description of key information
Aquatic toxicity towards Daphnia and algae has been evaluated for this substance.
There is one study available in which the toxicity to Daphnia was assessed according to OECD 202. Under the conditions of the present study no biologically significant effects were observed in the tested concentration range up to 1 mg/L (this concentration is based on water solubility of the substance, nominal concentration 100 mg/L), hence, it can be concluded that no biological significant effect has been determined within water solubility.
The toxicity to algae was assessed according to OECD 201. The test item (including its metabolite) was found to inhibit the growth of the freshwater green algae after 72 hours with the following effect values (based on time weighted average test item concentration): The EC50-value for inhibition of growth rate ErC50 (72h) > 96.3 µg/L (highest test concentration tested = saturated solution), ErC10 was 62.3 µg/L and the NOEC-value after 72 hours was 21.2 µg/L.
The TWA measured concentration of the saturated solution was found to be 96.3 µg/L. Hence, it can be concluded that the EC50 value is above water solubility of the test item.
Additional information
The registrant evaluated the need for repetition of the acute Daphnia test as within the current test (2001), concentrations were not determined analytically. It was the intention to monitor concentrations of the test substance with DOC measurements, but all concentrations appeared to be below the limit of detection for DOC (1 mg/L). Based on the results of the more recent algae study (2017), this is however not unlikely as also within the algae study nominal concentration of 100 mg/l resulted in saturated solutions of approximately 0.1 mg/L.
The registrant concludes at this stage that re-testing is not deemed necessary for the following reasons:
- Based on the information available for algae ErC10 < 0.1 mg/L the substance is already classified for chronic aquatic toxicity, category 1. No additional study result (acute data) will modify this conclusion.
- Within the 1 -10 tpa tonnage band no CSA is generated, hence no PNECs are to be derived. An additional Daphnia study would (within this tonnage band) not have any impact.
- Similar concentration ranges were selected for both the algae and daphnia study making it reasonable to assume that also within the Daphnia medium a nominal concentration of 100 mg/L would result in saturated concentrations.
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