Registration Dossier
Registration Dossier
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EC number: 247-955-1 | CAS number: 26748-41-4
Endpoint summary
Administrative data
Description of key information
In a 96-hour semi-static acute toxicity test according to OECD guideline 203 with zebrafish, the LC50 value was 0.33 mg/L (measured concentration). The no-observed-effect concentration (NOEC) was 0.24 mg/L (measured concentration).
The performance of a test for long-term toxicity to fish was considered not scientifically justified.
In a 48-hour acute toxicity test with Daphnia according to OECD guideline 202, the EC50 value was 0.79 mg/L (nominal concentration). The no-observed-effect concentration (NOEC) was 0.381 mg/L (nominal concentration).
In a study according to OECD guideline 211, the 21-day NOEC based on reproduction was calculated to be 0.049 mg/L (measured concentration). The LOEC was calculated to be 0.32 mg/L (measured concentration).
In a 72-hour toxicity test according to OECD guideline 201 with green algae, the EC50 value was 0.48 mg/L (measured concentration). The no-observed-effect concentration (NOEC) was 0.03 mg/L (measured concentration). The 72-h EC10 value based on growth rate was determined as 0.06 mg/L.
The toxicity to microorganisms was assessed according to OECD guideline 209, EU-method C.11 and EPS OPPTS 850.6800. After 3 hours of exposure, an EC10 of 966.9 mg/L was detected. The EC50 was calculated to be 2053.9 mg/L.
Additional information
The acute toxicity to fish was assessed according to OECD guideline 203, EU-method C.1 and EPA OPPTS 850.1075. In this 96-hour semi-static acute toxicity test with zebrafish, the LC50 value was 0.33 mg/L (measured concentration). The no-observed-effect concentration (NOEC) was 0.24 mg/L (measured concentration).
The performance of a test for long-term toxicity to fish was considered not scientifically justified. REACH Regulation No. 1907/2006, Annex VIII, Sect. 9.1.3, Col. 2, states as follows: “9.1.3: The study (long-term toxicity to fish) does not need to be conducted if: - there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes” TBPND is not stable in aquatic environment. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with water and organic matter, the test item undergoes rapid degradation resulting in the formation of respective alcohols and acids. In addition, the substance is not poorly water soluble and is not expected to have potential for bioaccumulation (calculated BCF = 925 L/kg wwt). Thus, the CSA does not show a need for an additional long-term aquatic test. Risk assessment is based on the long-term daphnia study.
The acute toxicity to invertebrates was assessed according to OECD guideline 202 and EU-method C.2. In this 48-hour acute toxicity test with daphnia, the EC50 value was 0.79 mg/L (nominal concentration). The no-observed-effect concentration (NOEC) was 0.381 mg/L (nominal concentration).
The long-term toxicity to invertebrates was assessed according to OECD guideline 211. In this study the 21-day NOEC based on reproduction was calculated to be 0.049 mg/L (measured concentration). The LOEC was calculated to be 0.32 mg/L (measured concentration).
The toxicity to algae was assessed according to OECD guideline 201, EU-method C.3 and EPA OPPTS 850.4500. In this 72-hour toxicity test with green algae, the LC50 value was 0.48 mg/L (measured concentration). The no-observed-effect concentration (NOEC) was 0.03 mg/L (measured concentration).
The toxicity to microorganisms was assessed according to OECD guideline 209, EU-method C.11 and EPS OPPTS 850.6800. After 3 hours of exposure an EC10 of 966.9 mg/L was detected. The EC50 was calculated to be 2053.9 mg/L.
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