Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.98 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.4 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.77 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.67 mg/kg food
Assessment factor:
300

Additional information

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

A PNECaquatic of 0.033 mg/l has been derived from 33 mg/l (LC50 value-96 h) for effects on fish acute toxicity test (the lowest short-term EC50 from each of three trophic levels (fish, Daphnia and algae)) by an assessment factor of 1000.

No measured data are currently available for marine organisms therefore the marine PNEC is derived from data obtained for freshwater species (LC50 >33 mg/l), applying an assessment factor of 10000 to give PNECseawater = 0.0033 mg/l.

The intermittent releases PNEC is derived from lowest value obtained for freshwater species (LC50 >33 mg/l), applying an assessment factor of 100 to give PNECwater,intermittent = 0.33 mg/l.

The PNEC for waste-water treatment is 3.2 mg/l based on the IC50 of 320 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) = 3.98 mg/kg 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) =0.40 mg/kg will be used for risk characterisation.

No 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 =0.77 mg/kg will be used for risk characterisation.

A PNECoral of 66.6 mg/kg food is derived from the toxicity data (28 d repeated dose toxicity NOAEL = 1000 mg/kg body weight/day) applying an assessment factor of 300.

Below table is the summary of the value of PNEC in each compartment.

 

Compartment

Value of PNEC

Freshwater

0.033 mg/l

STP micro-organisms

3.2 mg/l

Seawater

0.0033 mg/l (extrapolation from freshwater)

intermittent release

0.33 mg/l (extrapolation from freshwater)

PNECsediment (freshwater)

3.98 mg/kg

PNECsediment (marine water)

0.40 mg/kg

PNECsoil

0.77 mg/kg

PNECoral

66.67 mg/kg food

Conclusion on classification

From the available information, the lowest short-term EC/L50 from each of three trophic levels (fish, Daphnia and algae) was above 33 mg/l in fish acute toxicity test. And from the hydrolysis test result, FAT 45176/A can be hydrolyzed soon at pH 7 and 9 at 25 °C. Therefore, there would be no need to classify this substance for aquatic toxicity according to CLP (Regulation EC No 127272008). However, as the substance is listed in Annex VI of CLP with a harmonised classification for chronic aquatic toxicity category 3 this classification is adopted in the GHS and DSD section (equivalent to R52/53).