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Short-term toxicity to aquatic invertebrates

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Since the substance is poor soluble in water the long-term toxicity testing on aquatic invertebrates should be considered instead of short-term toxicity testing. A GLP key study conducted according to OECD Guideline 211 is available for the substance. No ecotoxicity effect was observed (21-d NOEC >= 10 mg/L, nominal, BASF SE, 2014).

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In a GLP guideline study following OECD 202 Daphnia magna were exposed for 48 hours to a saturated solution of tris-2 -ethylhexylamine (limit test with a nominal concentration of 100 mg/L). Analytical monitoring could not be performed since the limit of quantification was above the water solubility of approx. 0.002 mg/L. All reasonable efforts were taken to produce a saturated solution of the test substance in test media, following the guidance in OECD 23. According to OECD 23, for tests with chemicals that can not be quantified by analytical methods at the concentrations causing effects, the effect concentration can be expressed based on the nominal concentrations. Undissolved test material was not removed. The daphnids were exposed to the total load of the test substance using an organism chamber in the test vessel. No adverse effects on the test organisms were observed. Based on nominal concentrations, the 48-h EC50 for effects on Daphnia is > 100 mg/L (BASF SE, 2010). Additional studies are available (BASF, 1984 a, b; BASF, 2007) which were not considered due to physical effects (daphnids were entrapped at the surface of the test vessels).

Since the substance is poor soluble in water the long-term toxicity testing on aquatic invertebrates should be considered instead of short-term toxicity testing. A GLP key study conducted according to OECD Guideline 211 is available for the substance. No ecotoxicity effect was observed (21-d NOEC >= 10 mg/L, nominal, BASF SE, 2014).

Moreover, according to Regulation (EC) 1907/2006, Annex VII, Section 9.1.1 Column 2, the study on the short-term toxicity to aquatic invertebrates does not need to be conducted if long-term aquatic toxicity study on aquatic invertebrates is available.

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