Registration Dossier

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:
100 000 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10 000 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:
19 941 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.7 mg/kg food

Additional information

Ecotoxicology studies were conducted with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of these avaialble studies for read-across extrapolation to FAT 41045 and for derivation of PNECs for FAT 41045 is considered to be appropriate.

Study reports have been available for consideration in respect of acute tests with fish, invertebrates, algae and micro-organism.

Based on these results, no hazard is expected for freshwater species. However, a PNEC freshwater was calculated in order to be used as input for the partitioning method to derive sediment and soil PNECs.

No measured data are currently available for marine organisms and therefore the marine PNEC is derived from data obtained for freshwater species (L/EC50=100 mg/l), applying an assessment factor of 10000 to give PNECseawater = 0.01 mg/l.

The intermittent releases PNEC is derived from lowest value obtained for freshwater species (L/EC50 = 100 mg/l), applying an assessment factor of 100 to give PNECwater,intermittent = 1 mg/l.

The PNEC for waste-water treatment is 10 mg/l based on the IC50 of 1000 mg/l and an assessment factor of 100.

No toxicity data are currently available for sediment-dwelling organisms, therefore it is not possible to determine a PNECsed based on measured data. According to the Technical Guidance Document, PNECsed can be calculated by the equilibrium partitioning method. Hence, PNECsed (freshwater) = 100000 mg/kg (based on Koc value of 10000000 and PNECfresh-water of 0.1 mg/l) will be used for risk characterisation.

No toxicity data are currently available for marine sediment-dwelling organisms, therefore it is not possible to determine a PNEC sediment (marine water) based on measured data. According to the Technical Guidance Document, PNEC sediment (marine water) can be calculated by the equilibrium partitioning method. Hence, PNEC sediment (marine water) = 10000 mg/kg (based on Koc value of 10000000 and PNECmarine-water of 0.01 mg/l) will be used for risk characterisation.

No soil toxicity data are currently available, therefore it is not possible to determine a PNECsoil based on measured data. According to the Technical Guidance Document, PNECsoil can be calculated by the equilibrium partitioning method. Hence, PNECsoil = 19941 mg/kg (based on Koc value of 10000000, PNECfresh-water of 0.1 mg/l, vapour pressure of 4.8E-14 Pa at 25 °C, and water solubility of 0.3 mg/l at 20 °C) will be used for risk characterisation.

Conclusion on classification

From the available information, the lowest short-term L/EC50 from each of three trophic levels (fish, Daphnia and algae) was above 100 mg/l. Therefore, FAT 41045 is not classified as per EU CLP (Regulation (EC) No 1272/2008) regulation for acute aquatic toxicity. However, considering the high logPow, the lack of biodegradability and the low water solubility, the substance is to be classified into Category 4 for chronic aquatic toxicity according to CLP (Regulation EC No 1272/2008) and with R53 according to DSD (Directive 67/548/EEC).