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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Since no effects were observed in the study on long-term toxicity on invertebrates, according to ECHA decision number SEV-D-2114476777-28-01/F a study on long-term toxicity to fish has to be conducted to assess the T-criterion. The study is ongoing, but won't be finalized until the deadline set by ECHA (January 3th, 2023). There are several reasons for the delay. Initially, due to the poor solubility of the substance and the low test temperatures, it was not possible to achieve a homogenous test solution at saturation concentration, even under consideration of the methodologies listed in OECD 23. Further, two range-finder tests had to be aborted because of poor egg survival and hatching success in the control treatments. The delay caused by these factors, significant changes in the trout farming industry as well as an outbreak of a listed disease led to a shortage of 'green' eggs and milt in the UK. For these reasons the study was transferred from the UK to the US in order to finalize the study and provide the information requested by ECHA as fast as possible. Detailed justifications from the CRO including a revised timeline are attached.
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Description of key information

Key value for chemical safety assessment

Additional information

 


No reliable long-term toxicity test to fish are available with O,O,O-triphenylthiophosphate.


In a BCF study according to (GAKUSHUIN UNIVERSITY 1999) performed with O,O,O-triphenylphosphorotioate in a lower purity (purity > 25%) no adverse effects on fish were observed during 56 days of exposure in concentrations within the solubility range of CAS 597 -82 -0. The test concentrations of CAS 597 -82 -0 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 a test substance containing CAS 597 -82 -0 as major constitiuent (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 a substance containing triphenylthiophosphate as main constituent (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.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 with this test substance 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 EC for the major constituent CAS 597-82-0 is higher than the saturation concentration using a loading rate of 1mg/L (WAF).


A long-term toxicity study to aquatic invertebrates according to OECD 211 is currently ongoing and a long-term toxicity study to fish according to OECD 210 is planned since the information were required in a decision on substance evaluation.