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Long-term toxicity to fish

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No reliable long-term toxicity test to fish are available. The available study was invalidated due to major flaws related to improper preparations of the test solutions. 
However, as no toxicity was observed in the acute test long-term toxicity is not expected. Furthermore, in a bioaccumulation study fish were exposed to the uvcb substance (see IUCLID chapter 5.3.1). During 56 days of exposure in concentrations in the solubility range of triphenylthiophosphate no adverse effects were observed. In addition based on the substance properties (low water solubility, high adsorption potential and potential to be degraded in aquatic media), it can be concluded that the aquatic compartment is not the compartment of concern. The chemical safety assessment according to Annex 1 REACH does not indicate the need of further long-term ecotoxicological testing with aquatic organisms. Thus, a long-term test with fish does not need to be conducted in accordance with animal welfare reasons.

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Additional information

In a BCF study according to (GAKUSHUIN UNIVERSITY 1999) performed with the uvcb substance no adverse effects on fish were observed during 56 days of exposure in concentrations within the solubility range. The test concentrations of major constituents were verified in this test (See IUCLID chapter 5.3.1).

A test on early-life stage toxicity in fish according to OECD 210 was performed with the uvcb substance (Wildlife International 2003).

However, this study was invalidated due to major flaws related to improper preparations of the test solutions:

The available test was re-evaluated for validity and considering the latest recommendations of OECD No. 23: Guidance Document on the Aquatic Toxicity Testing of Difficult Substances and Mixtures it is concluded that the study suffers from major flaws which are related to improper preparation of the test solutions resulting in the presence of undissolved test substance in the test vessels. Since the test item (EC 421-820-9) is a multi-constituent substance, test solutions for aquatic ecotoxicity tests should be prepared as water accommodated fractions (WAF) as recommended by OECD No. 23: Guidance Document on the Aquatic Toxicity Testing of Difficult Substances and Mixtures (the available acute tests on fish, Daphnia and algae were prepared as WAF solutions resulting in NOECs > 100 mg/L). In the present test, the test solutions were prepared as dilutions of a solvent stock solution. Measured concentrations of the stock solutions were 91-97% of nominal but the measured test solutions were 39-128% of nominal. This level of variability in the analytical results is typically indicative of undissolved substance. The report also confirms the visual presence of undissolved substance in the diluters. The OECD No. 23 guidance document explicitly discourages both the use of solvents and serial dilution when testing multi-component substances. Therefore, the study is not reliable and was not further considered in the ecotoxicological risk assessment.

In accordance with column 2 of REACH Annex IX, long term toxicity test for fish is required (section 9.1.6). However, as no toxicity was observed in the acute test long-term toxicity is not expected. Furthermore, in a bioaccumulation study fish were exposed to the uvcb substance (see IUCLID chapter 5.3.1). During 56 days of exposure in concentrations in the solubility range no adverse effects were observed. In addition based on the constituents properties (low water solubility, high adsorption potential and potential to be degraded in aquatic media), it can be concluded that the aquatic compartment is not the compartment of concern.

However, to adequately address the substance toxic potential due to the low water solubility it was decided to repeat the chronic toxicity test on daphnids according to OECD guideline 211 under consideration of the OECD guidance document no 23 on difficult substances(BASF, 2015). No effects up to a loading rate of 5.5mg/L (WAF) were observed.Based on these data it can be expected that NOEC and EC10 for the major constituents (> 20%) is higher than the saturation concentration using a loading rate of 1mg/L (WAF).

The chemical safety assessment according to Annex 1 REACH does not indicate the need of further long-term ecotoxicological testing with aquatic organisms. Thus, a long-term test with fish does not need to be conducted in accordance with animal welfare reasons.