Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Reliable toxicity studies in fish, invertebrates and micro‑organisms are available for the test substance SPE1415 and the analogue substances ATMP and DTPMP and are included in the dossier. A waiver has been applied to the algal toxicity endpoint. The Key Studies are summarised below:

A reliable short-term toxicity study for the test substance SPE1415 with the freshwater crustacean Daphnia magna is available with a 48-hour EC50 of >100 mg/L. This is the lowest acute toxicity value from the aquatic studies for SPE1415, ATMP and DTPMP. This is supported by short-term toxicity studies with the analogue substances ATMP and DTPMP using Daphnia magna and Chironomus tentans, which report 48-hour EC50 values of 297 and 9,910 mg/L, respectively. Short-term studies with fish report LC50 ranging from 150 to 5,377 mg/L; the highest value relates to a seawater fish study.

Due to the complexing properties of SPE1415 with the essential nutrients present in algal test media it is not considered technically possible to conduct an assessment of the toxicity of SPE1415 to aquatic algae and cyanobacteria. Consequently, 100 mg/L is taken as the short-term toxicity endpoint for SPE1415 in aquatic organisms as this is the lowest acute toxicity value for SPE1415 and the analogue substances ATMP and DTPMP.

There are no freshwater long-term toxicity data available for the test substance SPE1415 but there are three reliable freshwater, long-term toxicity studies for fish and invertebrates with the analogue substances ATMP and DTMP. These long-term toxicity data with fish and invertebrates indicated similar sensitivities. Reliable NOEC values for fish with ATMP and DTPMP are 23 and 25.6 mg/L, respectively. A reliable long-term chronic toxicity study for read-across substance ATMP with the freshwater crustacean Daphnia magna was conducted and the 28-day NOEC (based on adult survival and reproduction) was determined to be >=25 mg/L.

Due to the complexing properties of SPE1415 with the subsequent limitiations on essential nutrients present in algal test media it is not considered technically possible to conduct an assessment of the toxicity of SPE1415 to aquatic algae and cyanobacteria. Consequently 23 mg/L is taken as the long-term toxicity endpoint to aquatic organisms as this is the lowest chronic (NOEC) toxicity value for SPE1415 and the analogue substances ATMP and DTPMP.

Additional supporting data on another confidential analogue substance is discussed in Additional Information.

Additional information