Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
8.8 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
14 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.88 µg/L
Assessment factor:
500
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:
1.02 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.102 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:
0.199 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

The PNECaqua (freshwater) for the aquatic environment is derived from the lowest effect level observed for the available chronic end-points (for D. magna, NOEC = 0.44 mg/L) and applying an assessment factor of 50, to obtain the PNEC aqua (freshwater) of 8.8 ppb. 


The PNEC aqua (intermittent) is derived from the lowest short-term exposure EC/LC50 (1.4 mg/L, 48hr EC50 for D. magna) and an assessmentactor of 100 is applied to obtain the PNEC aqua (intermittent) of 14 ppb.


No marine species were tested. No tests on toxicity to sediment-dwelling organisms or soil organisms are available


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 = 0.222 mg/kg wet weight; PNEC sediment marine water = 0.0222 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 = 0.175 mg/kg wet weight).


 


PNEC secondary poisoning was derived from the available information on repeated dose toxicity (OECD 408) NOAEL 30 mg/kg bw/day with R. norvegicus converting to a concentration (NOEC) by multiplying by a factor of 20 and dividing by an assessment factor of 90 (90 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 Daphnia with a 48h EC50 of 1.4 mg/L. Chronic aquatic toxicity data is only available for algae and Daphnia; the 72-hour NOEC and EC10 are, respectively, 0.72 mg/L and 2.6 mg/L (based on growth rate), and, the NOEC for Daphnia reproduction has been derived as 0.44 mg/L using a robust read-across approach to a close structural analogue. 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.