Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 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:
0.1 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10.4 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:
20.04 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the relevant assessment factors to the lowest L(E)C50 in accordance with ECHA Guidance R.10. The lowest short-term L(E)C50 was for fish with a 96 hr LC50 value of 1.05 mg/l.

PNEC STP is derived from the available study on microbial respiration inhibition study NOEC of 31.6 mg/L by applying an assessment factor of 10.

Wet weight PNECs for sediment and soil were calculated wusing equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6 for sediment and 1.13 for soil.

PNEC secondary poisoning was derived from the available information on repeated dose toxicity on mammals by applying an appropriate assessment factor based on the study duration (90) to the product of the NOAEL (25mg/kg bw/d) and the factor animals used for the study (20 - Rats>6weeks) in accordance with ECHA guidance R.10.8.

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 hr LC50 value of 1.05 mg/l. Chronic aquatic toxicity data is only available for algae; the NOEC is 0.70 mg/L (based on growth rate, analogue substance Cyclamen Aldehyde). Bourgeonal is readily biodegradable and has a log Kow of 3.2.

Based on the above data, Bourgeonal 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.