Registration Dossier
Registration Dossier
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EC number: 274-581-6 | CAS number: 70356-09-1
Endpoint summary
Administrative data
Description of key information
Additional information
Aquatic short-term toxicity
Two short term toxicity studies on fish and daphnids as well as the study on algal growth inhibition are available. No acute adverse effects to any of the test organisms was observed up to the range of the water solubility level of 0.03 mg/L (5 µm filtered test solution prepared at a nominal loading of 100 mg/L). No toxic effects on each of the three species were being observed. This absence of acute toxic effects basically can be traced back to the extremely poor water solubility of the test item. For such cases, i.e. the water solubility of a test item is poor but the test item is suspect to potentially exhibit certain aquatic toxic properties, in the DSD Regulation a classification as R53 and in the CLP Regulation as Aquatic Chronic Toxicity Category 4 is applicable (so-called safety net classification). In the recent water solubility study the maximum water solubility of BMBDM was determined to be 0.027 mg/L.
Aquatic long-term toxicity
Long-term toxicity to aquatic invertebrates
The test item Butyl methoxydibenzoyl methane had no toxic effects on survival, growth and reproduction of Daphnia magna after the exposure period of 21 days at the mean measured concentration of 3.0 μg/L, corresponding to the highest concentration of test item that could be reached in test water. Thus, the 21-day NOEC of the test item was determined to be 3.0 μg/L (mean measured), representing the water solubility limit of the test item. The 21-day LOEC and the 21-day EC10 values for the different endpoints were > 3.0 μg/L.
Long-term toxicity to fish
Based on ECHA guidance documents it is to be concluded that no hazard is seen from substance BMDBM if the PEClocal/regional always remains 1/100th of the water solubility. In this way a "PNEC aqua" was applied which is 1/100th of the water solubility of 0.027 mg/L, i.e. PNEC aqua = 0.27 µg/L. On this basis the chemical safety assessment revealed a PEC/PNEC ratio for the aquatic compartment smaller than 1, so that no risk for aquatic organisms at any substance life cycle stage from the stage of formulation up to the stage of its intended use is likely. Therefore, no tests on long-term toxicity tests with fish were considered necessary to be provided for supporting the environmental risk assessment.
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