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Short-term toxicity to fish

The acute toxicity to the zebra fish Danio rerio of the REACH substance "Stearic acid, reaction product with 2-aminoethanol, maleic anhydride and sodium sulfite" (UVCB) was investigated in a GLP-compliant study performed according to OECD Guideline 203. Up to and including the limit test concentration (100% filtrate of a saturated solution at a loading rate of 398.4 mg test item/L equivalent to 100 mg active ingredients/L), no mortalities were observed during the 96-hour exposure period. Therefore, it can be concluded that the LC50 (96 h) to fish based on nominal concentrations is higher than 398.4 mg test item/L, equivalent to 100 mg active ingredients/L.

Short-term toxicity to aquatic invertebrates

The acute toxicity to the water flea Daphnia magna of the REACH substance "Stearic acid, reaction product with 2-aminoethanol, maleic anhydride and sodium sulfite" (UVCB) was investigated in a GLP-compliant study performed according to OECD Guideline 202. No clear concentration-response relationship was observed between the control and the saturated solutions at loading rates of 398.4, 199.2, 99.6, 49.8 and 24.9 mg test item/L, equivalent to 100, 50, 25, 12.5 and 6.3 mg active ingredients/L. No considerable effect was found up to and including the highest concentration tested. It is therefore concluded that the EC50 is higher than 398.4 mg test item/L ,equivalent to 100 mg active ingredients/L.

Toxicity to aquatic algae

The toxicity to the green algaRaphidocelis subcapitata(former name:Pseudokirchneriella subcapitata) of the REACH substance "Stearic acid, reaction product with 2-aminoethanol, maleic anhydride and sodium sulfite" (UVCB) was investigated in a GLP-compliant study performed according to OECD Guideline 201. A clear concentration-response relationship was observed for the biological parameters yield and growth rate during the exposure period.

The ErC50 ofRaphidocelis subcapitatawas stated to be >504 mg test item/L (statistically evaluated value: 708 mg test item/L, equivalent to 177.7 mg active ingredients/L) based on nominal concentrations. The ErC10 was evaluated to be 4.52 mg test item/L (equivalent to 1.13 mg active ingredients/L). The NOEC based on nominal concentration appeared to be lower than 0.960 mg test item/L (equivalent to 0.242 mg active ingredients/L).

The EyC50 ofRaphidocelis subcapitatawas stated to be 6.99 mg test item/L (equivalent to 1.75 mg active ingredients/L) based on nominal concentrations. The EyC10 was evaluated to be 0.20 mg test item/L (equivalent to 0.05 mg active ingredients/L). The NOEC based on nominal concentration appeared to be lower than 0.960 mg test item/L (equivalent to 0.242 mg active ingredients/L).

Toxicity to activated sludge bacteria

The effect of the REACH substance "Stearic acid, reaction product with 2-aminoethanol, maleic anhydride and sodium sulfite" (UVCB) on the respiration rate of activated sludge bacteria was investigated in a GLP-compliant study performed according to OECD Guideline 209. The respiration rate of the test system was measured after a 3-hour contact period with the test item. The effect of the test item on the respiration of nitrifying bacteria was investigated in a preliminary non-GLP range-finding test.

The preliminary non-GLP range-finding test including a nitrification inhibition control showed no inhibition of total respiration at up to 1000 mg test item/L (equivalent to 251 mg active ingredients/L); an inhibition of nitrification-related respiration was not observed in the range-finding test. The definitive test showed no concentration-response relationship with no inhibition of total respiration rate compared to the control respiration at up to 1000 mg test item/L. A supplemental test was performed at 1000, 2000 and 4000 mg test item/L to investigate potential effects on the respiration rate at 2000 and 4000 mg test item/L, and to confirm the absence of effects on the respiration rate at 1000 mg test item/L as seen in the definitive test. This supplemental test showed no inhibition of total respiration. The results of this study show that the EC20, EC50, EC80 are > 4000 mg test item/L (equivalent to 1004 mg active ingredients/L).

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