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
PNEC marine water (intermittent releases):
0.1 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.036 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:
0.014 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Aquatic toxicity potential of substance FAT 40034/F was evaluated in studies conducted on three trophic levels that include fish, invertebrates and lemna. Studies conducted for evaluation of toxicity to microorganisms are also available. The key values are presented below:

In a 48 h acute fish toxicity test, the test substance FAT 40034was observed to have 48 h TL50 to Rainbow trout >1000 mg/L.

The 48 h EC50 value of the test substance FAT 40034 to Daphnia magna was determined to be >100 mg/L. The NOEC value for 48 hours was determined to be 100 mg/L.

In a GLP-compliant OECD Guideline 221 study, Lemna gibba (Duckweed) exposed to the test item FAT 40034 recorded: 7 day ErC50 based upon the frond number is >100 mg/L. 7 day EyC50 based upon the frond numbers is >100 mg/L. 7 day ErC50 based upon the frond dry weight is >100 mg/L. 7 day EyC50 based upon the frond dry weight is >100 mg/L.The NOEC was 0.64 mg/L and the LOEC was >100 mg /L.Therefore, it can be concluded that there were no toxic effects at saturation.

 

The IC50 value of the test substance FAT 40034 is greater than 300 mg/L.

The PNEC for waste-water treatment is 3 mg/L based on the IC50 of >300 mg/L obtained in the activated sludge respiration inhibition test and an assessment factor of 100.

No long-term studies on aquatic organisms are available and thus PNECs for aqueous environment were derived by the assessment method based on acute aquatic toxicity data. PNECs for sediment and soil were derived by applying the partitioning method.

The substance has a low potential for bioaccumulation and its hazards for predators via the food chain are not anticipated.

Conclusion on classification

The substance was tested for all three trophic levels in the aquatic environment using acute test design and the lowest effect concentration is found to be EC/LC 50 >100 mg/L.

The substance is considered non-biodegradable and hence will be not-classified for aquatic toxicity hazards according to CLP.