Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.126 mg/kg sediment dw
Assessment factor:
4.6
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.013 mg/kg sediment dw
Assessment factor:
4.6
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:
0.025 mg/kg soil dw
Assessment factor:
1.13
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Three studies on the acute aquatic toxicity of the substance are available with the following findings: Freshwater fish: LC50 = 1.092 mg/L; Freshwater invertebrates: EC50 = 1.4mg/L; Freshwater algae: EC50 = 3.8 mg/L.

Chronic aquatic toxicity data is only available for algae; the 96-hour NOEC is 0.70 mg/L (based on growth rate). No marine species were tested. No tests on toxicity to sediment-dwelling organisms or soil organisms are available. 

The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the following assessment factors to the lowest L(E)C50 of 1.092 mg/L: PNEC aqua (freshwater): 1000; PNEC aqua (marine water): 10000; PNEC aqua (intermittent): 100.

PNEC STP is derived from the available study on microbial respiration inhibition study giving a EC50 (over 3 hours) of 100mg/L by applying an assessment factor of 100.

PNECs for sediment and soil are calculated from the aquatic PNECs with the equilibrium partitioning method according to ECHA guidance R.10. 

PNEC sediment (freshwater/marine water): Wet weight PNECs are calculated with Ksusp-water = 28.95 m3/m3, density of suspended particles = 1150 kg/m3 (wet weight); conversion to dry weight is done with factor of 4.6. (PNEC sediment freshwater = 2.75E-2 mg/kg wet weight; PNEC sediment marine water = 2.75E-3 mg/kg wet weight).

PNEC soil: Wet weight PNECs are calculated with Ksoil-water = 34.06 m3/m3, density of soil = 1700 kg/m3 (wet weight); conversion to dry weight is done with factor of 1.13 (PNEC soil = 0.0219 mg/kg wet weight)

PNEC secondary poisoning was derived from the available information on repeated dose toxicity 300 mg/kg bw converting to PNECoral by i) by multiplying by a factor of 33.3 (Oryctolagus cuniculus, rabbit) to convert to a concentration (NOEC) and ii) dividing by an assessment factor of 300 (<28 day study) in accordance with ECHA 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 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 1.09 mg/l. Chronic aquatic toxicity data is only available for algae; the 96-hour NOEC is 0.70 mg/L (based on growth rate). Cyclamen aldehyde is readily biodegradable and has a log Kow of 3.4.

Based on the above data, Cyclamen aldehyde 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.