Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.027 mg/L
PNEC freshwater (intermittent releases):
0.027 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.027 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
11.96 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
11.96 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.384 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
100 mg/kg food
Assessment factor:
90

Additional information

No detrimental effects at all were being reported in the available short term ecotoxicity studies conducted at the level of maximum water solubility (5 µm filtered test solution prepared at a nominal loading of 100 mg/L). PNECs therefore were not derived from adverse effects observed at a certain test item concentration, and the subsequent application of assessment factors.

For this reason as reported above“preliminary PNECs aqua” were derived on the basis of the water solubility (0.027 mg/L). The EPM method for calculation of preliminary PNEC sediment and preliminary PNEC soil was used and an additional factor 10 was applied as the substance shows a high octanol-water coefficient of log Kow >5.

Reported preliminary PNEC aqua freshwater, PNEC aqua marine water, and PNEC aqua intermittent release all were being calculated on this basis.

The PNEC STP of 100 mg/L is based on an activated sludge respiration inhibition study. The substance was tested above the water solubility level. The calculated PNEC STP is in line with observations made at wastewater treatment facilities where BMDBM was found to have a tendency to adsorb to sludge while not inhibiting the wastewater treatment process.

The calculation of the NOEC(mammal, food, chronic) of 100 mg/kg food is based on the NOAEL of 450 mg/kg body weight resulting from the 90 days oral study on rats.

However for further risk assessment based on ECHA's "Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment", a long-term test has to be carried out for substances showing no toxicity in short-term tests if the log Kow > 3 (or BCF > 100) and if the PEClocal/regional is > 1/100th of the water solubility. Based on this it is to be concluded that no hazard is expected from substance BMDBM if the PEClocal/regional always remains < 1/100th of the water solubility. 

For further risk assessment a worst case "PNEC aqua" was applied which is 1/100th of the water solubility of 0.027 mg/L, i.e. PNEC aqua = 0.0003 mg/L.

Worst case PNEC aqua freshwater, PNEC aqua marine water, and PNEC aqua intermittent release all were being calculated on this basis.

Consequently computation of PNEC soil and PNEC sediment also refers to a maximum PEC of 1/100 maximum water solubility. On this basis the EP method was applied and the respective PNECs were being calculated. These values include an additional assessment factor of 10 since the substance has a high octanol-water partition coefficient with log Kow >5.

Conclusion on classification

Based on above discussions, in a preliminary assessment the substance BMDBM shall be assessed as "aquatic toxicity unlikely".

So far only the two short term toxicity studies on fish and daphnids as well as the study on algal growth inhibition are available. In all these studies from 2001 the test item was being applied at concentrations up to the reported water solubility level of 0.003 mg/L. No toxic effects on each of the three species were being observed. This absence of acute toxic effects basically can be pinpointed to the extremely poor water solubility of the test item. In the absence of long-term aquatic toxicity studies it cannot be fully ruled out that low concentrations of the test item might exhibit chronic effects to aquatic organisms. For such cases in the DSD classification and labelling system a classification R53 is applicable, which relates to Aquatic Chronic Toxicity Category 4 in the CLP regulation.