Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.8 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.28 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.73 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.75 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.7 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10 mg/kg food
Assessment factor:
300

Additional information

For pelagic as well as for sediment organisms the PNECs are based on long-term toxicity data for three species with different living and feeding condititons. The PNEC derived from studies on sediment organisms (3.7 mg/kg dw) did not deviate from the one based on equilibrium partitioning (3.5 mg/kg dw). The PNECsoil derived from testing on three terrestrial trophic levels is 2.7 mg/kg dw which is in the same order of magnitude as the PNECsoil derived from aquatic/sediment organisms via EPM (0.7 mg/kg dw).

Conclusion on classification

The short-term LC50 or EC50 values were 1.4, 1.3 and > 2.6, for fish, daphnia and algae, respectively, so between 1 and 10 mg/l. Therefore OTNE needs to be classified as toxic to aquatic life. OTNE does not meet the criteria for readily/rapidly biodegradable, therefore it also needs to be classified as a chronic hazard to the environment.

For CLP, chronic toxicity data should be used for the classification of long-term hazards if available. Chronic toxicity tests are available for fish, invertebrates and algae. The lowest NOEC / EC10 in these chronic tests is a 21d-NOEC reproduction of 0.028 mg/l for Daphnia magna. Therefore, based on the available chronic data, OTNE needs to be classified for its long-term hazard to the environment according to CLP. As the substance does not meet the criteria for rapidly biodegradable, Aquatic Chronic 1 is applicable. The classification according to Annex I Regulation 1272/2008/EC (CLP) is H410 (Aquatic Chronic 1).