Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.027 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0 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

Air

Hazard assessment conclusion:
no hazard identified

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:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

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.In addition one longterm study for reproduction on Daphnia magna (OECD 211) was performed which did not indicate any adverse effects up to the solubility of BMDBM in the test medium. Since there will be an additional longterm study in fish (OECD 210) performed, the PNEC freshwater /marine water has not been recalculated for the time being.

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.

Conclusion on classification

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

So far 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 in the test medium 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 addition a long-term aquatic toxicity study according to OECD 211 was performed and did not show any adverse effects up to the solubility limit of the substance in the test medium. For this reason, no classification is required according to the CLP regulation.