Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.99 µg/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:
3 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

BIT did not fulfill the strict conditions of ready biodegradability tests to be considered readily biodegradable. On inherent biodegradability tests, BIT was also not considered inherently biodegradable. In aquatic systems with estuarine and sea water, BIT can be degraded rapidly with half-lives at 12ºC of 2-3 days in estuarine water and 5-12 days in sea water. In sandy loam soils the resulting half-lives were 9-14 hours.This means the substance is demonstrated to be ultimately degraded in a surface water simulation test with a half-life of < 16 days (corresponding to a degradation of >70 % within 28 days); thus it can be considered that BIT is rapidly degradable.

There are adequate chronic toxicity data available. The algae demonstrated to be the most sensitive trophic level regarding long-term effects with

a 72-hour NOEC of 0.0403 mg BIT/L. This value is < 0.1 mg/L, thus Chronic Category 2 is applied.

Further, based on the EU CLP (EC/1272/2008) Guidance document, an M-factor of 1 for Aquatic Acute 1 and an M-factor of 1 for Aquatic Chronic classification can be proposed for the substance based on the EC/LC50 and NOEC/EC10 values from the available toxicity studies.