Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.4 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.994 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.04 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.994 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
8.05 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The octanol-water partition coefficient and soil adsorption coefficient for BMI are both low (log Kow = 1.5<3 and log Koc = 3<6); on this basis BMI is considered unlikely to adsorb to soil, and is unlikely to bioaccumulate.

Conclusion on classification

None of the available aquatic toxicity testing in Fish, Daphnia, Algae and Microorganisms (ASRIT) indicated any toxic effects. BMI has a very low solubility in water (<1 mg/L) but even when tested at the limit of water solubility in acute tests in each of these species no harmful effects were recorded (deaths or sublethal effects in fish, immobilisation in daphnia, or inhibition in algae or microorganisms). On this basis BMI does not meet the classification criteria for acute toxicity to aquatic organisms.

In long-term aquatic toxicity studies (Fish Early Life Stage and Daphnia Reproduction) BMI was found to have induced adverse effects on each of the assessed species (Fathead Minnow and Daphnia Magna, respectively). Of the available results, the most sensitive endpoint was found to be growth in Daphnia, measured in terms of body length; the No-Observed Effect Concentration was 4 µg/L and the Lowest-Observed Effect Concentration was 8.1 µg/L.

BMI was observed to hydrolyse rapidly (estimated half-life = 2 hours at 25°C at pH 7) however it was found not to be readily biodegradable; it is assumed that although BMI may readily undergo abiotic degredation, it does not proceed to full mineralisation and therefore it cannot be considered rapidly degradable with respect to the criteria indicated in Annex I of the CLP Regulation.

On the basis that the NOEC of the most-sensitive endpoint was <0.1 mg/L, BMI meets the criteria for classification in Chronic Category 1 for substances hazardous to the aquatic environment. As the NOEC is in the range 0.001 to 0.01 mg/L, the applicable M-factor is 10.