Registration Dossier

Ecotoxicological information

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

Waiver related to environmental risk assessment:

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 are considered necessary to be provided for supporting the environmental risk assessment.

Waiver related to PBT assessment:

The substance has no CMR, R48, or STOT RE toxicity classification. Acute aquatic toxicity studies conducted up to the level of maximum water solubility revealed no detrimental effects. The screening assignment therefore is "not T". Even though the as of now available data make it appear as unlikely that the substance exhibits long-term toxic effects in the (aquatic) environment, it should be stated that it has not been confirmed yet if the long-term NOEC for aquatic organisms is less than 0.01 mg/L. However based on experimental results (BMF lipid normalised: 0.1218 and calculated BCF: 1806 L/kg) obtained from a dietary bioaccumulation study in rainbow trout BMDBM does not meet criteria for a B or vB substance.