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All studies on acute toxicity were conducted in GLP studies following international guidelines.

Short-term toxicity to fish: The acute toxicity to fish was determined in a GLP study following the EU Method C.1. After 96 hours of exposure a LC50 of higher than 5.03 mg/L was determined under semi-static conditions. All results are expressed in terms of geometric mean measured concentrations.

Short-term toxicity to invertebrates: The acute toxicity to daphnia magna was investigated in a static GLP study following OECD 202. A saturated test solution with the concentration of 4.6 mg/L (calculated on the basis of TOC-analysis) had no adverse effects on the mobility of Daphnia within 48 hours.

Toxicity to aquatic algae: The toxicity to algae was tested in a GLP study following the EU Method C.3 under static exposure conditions. An E[r]C50 of 0.51 mg/L was determined and a NOEC[r] of 0.013 mg/L was calculated after 72 hrs. All results are expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 1.2 % to 5.7 % of nominal values at 72 hours.

Toxicity to micro-organisms: Norethisterone was exposed to Pseudomonas putida in a GLP study following the German standard "DIN 38412-8". The saturated test solution (approx. 7.8 mg/L) had no inhibitory effect on the growth of Pseudomonas putida under static conditions. The growth inhibition of the reference substance was in good agreement with the historical data base of this laboratory.

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