Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.127 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.27 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.013 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
266 700 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
26 670 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:
53 183 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs fresh water, marine water and intermittent release were derived based on three studies on acute toxictiy representing three trophic levels. PNECs for sediment and soil were based on the EPM approach. PNEC air and PNEC secondary poisoning did not have to be derived as no hazard (fulfilling criteria) could be identified.

Conclusion on classification

There is no need for a classification in accordance with Regulation (EC) No 1272/2008 as there was no NOEC <= 1 mg / L and no E/LC50 <= 100 mg / L. HDI trimer showed rapid hydrolysis in < 1 hour with formation of mainly polyurea as well as minor amounts of the corresponding triamine. Polyurea can be expected to have a poor water solubility and to be chemically inert. The calculated low Kow values of the main and minor hydrolysis product were both above 4 (9.81 and 5.54). However, the calculated BCF values were clearly below 500 (3.2 and 367.7).

Thus, HDI trimer does not need to be classified for acute or chronic toxicity or even with respect to "safety net" criteria.