Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 mg/L
PNEC freshwater (intermittent releases):
0 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.246 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

No effects on organisms were found in the base-set tests of acute aquatic ecotoxicity. Due to technical difficulties in detection of the actual concentration of the substance in the water (under the limit of detection) the water solubility value for FR-245 was determine to be less than 1ug/l. Based on the extreme low solubility and results from aquatic ecotoxicity studies it is assumed that the substance is unlikely to be available to the aquatic organisms in the water column. Thus, aquatic compartment is not relevant for FR-245.

FR-245 was more likely expected to be found in the sediment and soil compartments rather than in the water compartment.

Therefore, studies of the toxicity to sediment and soil organisms were performed.

No effects were found in the sediment organism the midge Chironomus riparius during the prolonged sediment toxicity. NOEC >1000mg/kg dry sediment. 28 -day EC50 >1000mg/kg dry sediment (highest concentration tested).

No effects were found on mortality, reproduction and bodyweight in the earthworm Eisenia fetida in the prolonged test of earthworm reproduction in an artificial soil. NOEC >1000mg/kg dry soil. 28 -day EC50 >1000mg/kg dry soil (highest concentration tested).

In order to determine the effect of the test substance on the seedling emergence and growth, six species of terrestrial non-target higher plants were tested. Results: A soil-incorporated application of FR-245 at nominal concentrations ranging up to 1000

mg/kg dry soil resulted in slight treatment related effects, but no reductions greater than 50% relative to the

control were observed on any test endpoint for any species. The EC50 for all six species tested was greater than 1000mg/kg dry soil.

NOEC for Allium cepa and Cucumis sativuswas greater than 1000mg/kgdry soil. The NOEC for Lolium perenne

and Brassica alba was greater than 333mg/kg dry soil. The NOEC for Lactuca sativawas greater than 37

mg/kg dry soil. The most sensitive species was Lycopersicon esculentum with an NOEC 12.3mg/kg dry soil.

Conclusion on classification

The results of testing the effects of FR-245 on the toxicity of organisms in the aquatic, sediment and terrestrial compartments

indicate that FR-245 does not have to be classified for the environment.