Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.45 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
14.5 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10.56 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:
20.22 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
313 mg/kg food
Assessment factor:
90

Additional information

The PNECs for the aquatic environment are derived from the lowest L(E)C50 observed in the available acute aquatic toxicity tests by applying the appropriate assessment factors. The lowest short-term L(E)C50 was for fish with a 96-hour LC50 value of 1.45 mg/l

PNEC STP was derived from the available study on microbial respiration inhibition study giving a NOEC of  36.1 mg/L by applying an assessment factor of 10. The PNEC secondary poisoning was derived from the available information on repeated dose toxicity of 14.3mg/kg bw/day by applying an assessment factor of 90. For Soil and sediment PNECs, wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6 (1.13 soil).

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient). Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).

Short-term aquatic toxicity data is available for all three trophic levels. The lowest short-term L(E)C50 was for fish with a 96-hour LC50 value of 1.45 mg/l. Chronic aquatic toxicity data is only available for algae; the 72-hour NOEC is 0.759 mg/L (using the number of cells/mL, the average specific growth rate, or the area under the growth curve). Nonanal is readily biodegradable and has a log Kow of 3.8.

Based on the above data, nonanal is classified as R51/53 according to Directive 67/548/EEC (DSD) and Aquatic Chronic 3 (H412) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.