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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.2 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:
8.32 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC derivation was as follows justified:


PNEC freshwater sediment:


K_(susp-water) = 105.1


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


PNEC_freshwater sediment


= (K_(susp-water) / RHO_(susp)) * PNEC_water * 1000


= (105.1/1150) * 0.1 * 1000


= 9.14 mg/kg wwt


= 42.04 mg/kg dw


 


PNEC marine water sediment:


K_(susp-water) = 105.1


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


PNEC_marine water sediment


= (K_(susp-water) / RHO_(susp)) * PNEC_marine water * 1000


= (105.1/1150) * 0.01 * 1000


= 0.914 mg/kg wwt


= 4.204 mg/kg dw


 


PNEC soil:


K_(soil-water) = 125.2


RHO_(soil) = 1700


Conversion factor (wwt -> dwt): 1.13


PNEC_soil


= (K_(soil-water) / RHO_(soil)) * PNEC_freshwater * 1000


= (125.2/1700) * 0.1 * 1000


= 7.365 mg/kg wwt


= 8.32 mg/kg dw

Conclusion on classification

Acute aquatic toxicity:


96 h, LC50 (Danio rerio): >100 mg/L (nominal concentration)


48 h, EC50 (Daphnia magna): >100 mg/L (nominal concentration)


72 h, ErC50 (Desmodesmus subspicatus): >100 mg/L (nominal concentration)


 


Aquatic chronic toxicity:


72 h, NOEC (Desmodesmus subspicatus): ≥100 mg/L (nominal concentration)


Biodegradation: not readily biodegradable: 14.25 % after 28 days (% degradation O2 consumption, OECD 301 F)


Partition coefficient: log Kow > 5 at 20 °C


 


Classification according to CLP


The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be not biodegradable under the test conditions. In all aquatic tests the test item showed no toxic effect on the tested species up to the limit test concentration of 100 mg/L. The determined EC50 and NOEC for Daphnia magna and green algae were >100 mg/L. The LC50 to fish was determined to be >100 mg/L. Based on these results, the substance is not classified for short-term (acute) aquatic toxicity. As Urea  is poorly soluble in water, has a log Kow of >5 and is not readily biodegradable it needs to be classified for long-term (chronic) aquatic toxicity in Category 4 (H413) according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.