Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 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:
0.004 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Using available ecotoxicological data, the PNECs were calculated to be 0.000065 mg/L for Freshwater and 0.0000065 mg/L for Marine Water.  For the calculation of the Freshwater and Marine water PNECs; a 48-hour acute toxicity EC50 value of > 0.065 mg/L was obtained from a study with Daphnia magna where there were no effects seen at the limit of water solubility.  Conservative assessment factors of 1000 for Freshwater and 10000 for Marine Water were applied to the results of this study.  For the STP PNEC, a 3-hour EC50 of > 1000 mg/L was available for activated sludge respiration inhibition. A NOEC was not available.  An assessment factor of 100 was applied to the EC50 to derive a PNEC for STP of 10 mg/L.  No toxicity test results were available for Freshwater Sediment or Marine Sediment organisms; therefore the Equilibrium Partitioning Method (EPM) was applied to the Freshwater and Marine PNECs to derive sediment PNECs.  The Koc was calculated from the Kow to be 51200 L/kg.  The PNECs for sediments were divided by an additional factor of 10 because the Log Kow was > 5. The final value was then divided by a factor of 4.6 to convert from wet weight to dry weight. The PNECs for Freshwater and Marine Sediments were calculated to be 0.033 mg/kg dry wt. and 0.0033 mg/kg dry wt, respectively.  For Grassland and Agricultural soil, no toxicity testing results were available.  The EPM method was applied to the Freshwater PNEC to derive soil PNECs. The value was divided by an additional factor of 10 because the log KOW was > 5.  The final value was then divided by a factor of 1.13 to convert from wet weight to dry weight. Using the calculated Koc , the PNEC for Grassland and Agricultural soil was determined to be 0.0044 mg/kg dry weight.  FC-770 was found to be not readily biodegradable and the log Kow was > 3.0. However, due to lack of exposure in the water column and efficient elimination via air exhalation (log Koa = 1.47) as well as the lack of evidence of toxicity, uptake and metabolism in mammalian studies, bioaccumulation of FC-770 in aquatic or terrestrial organisms is not expected. FC-770 is not classified STOT (repeated exposure) category 1 or 2 nor is it classified as toxic for reproduction category 1A, 1B or 2. Therefore, a secondary poisoning evaluation is not required. Therefore, the PNEC oral is not applicable. There is no intermittent release of FC-770.

Conclusion on classification

FC-770

GHS (CLP):

Hazards to the aquatic environment (acute/short-term): Reason for no classification: conclusive but not sufficient for classification

Hazards to the aquatic environment (long-term): Reason for no classification: conclusive but not sufficient for classification

Hazardous to the ozone layer: Reason for no classification: conclusive but not sufficient for classification

DSD:

Environment: Conclusive but not sufficient for classification

Cell Crude FC-770

GHS (CLP)

Hazards to the aquatic environment (acute/short-term): Reason for no classification: conclusive but not sufficient for classification

Hazards to the aquatic environment (long-term): Reason for no classification: data lacking

Hazardous to the ozone layer: Reason for no classification: conclusive but not sufficient for classification

DSD:

Environment: Conclusive but not sufficient for classification