Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 530 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
253 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:
505 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). Finally, one of the calculated BCF values were above 500 (706 for isocyanurate) while the other was clearly below (10.1 for the corresponding diamine).The criteria, however, have all to be fulfilled and this is not the case here.

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