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:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.039 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No long-term studies were available. Available short term studies showed LC50 (96h) on fish > 100 mg/l, EC50 (48h) on daphnia > 100 mg/l and EC50 (72h) on algae > 100 mg/l, as nominal concentrations. Therefore, the concentration of 100 mg/l was used in the calculation of PNEC water .

Assessment factors of 1000 and 10000 were used for fresh water and marine water, respectively.

The derivation of PNECwater, intermittent was done by applying an assessment factor of 100.

The value of PNECstp was derived using 100 mg/l derived from a toxicity study to microorganisms where the EC50 > 100 mg/l was observed.

Due to the lack of ecotoxicological data, PNECsediment for fresh water and marine water were calculated using equilibrium partitioning method. This method uses PNECwater for aquatic organisms and suspended matter/water partition coefficients as inputs. Bulk density of wet suspended matter is 1150 kg/m3. Note that this approach is used only as a rough screening since it may result in both an overestimation or underestimation of toxicity. The suspended matter-water partition coefficient was computed and resulted as 0.979 m3/m3. A correction factor of 4.6 from wet weight to dry weigth was applied to obtain the final PNECsediment.

The amount of test substance in the air compartment was expected to be very low, since the substance is a solid with a negligible vapour pressure. Therefore, no hazard was identified.

The calculation of PNECsoil was done using the equilibrium partitioning method, based on the assumption that soil toxicity, expressed in terms of freely-dissolved substance concentration in the pore water, is the same as aquatic toxicity. The pore water concentration is correlated with the bioavailable fraction. Note that this approach was originally developed for sediments but it may be applied to soil. In the calculation of PNECsoil, PNECwaterfor aquatic organisms and soil-water partition coefficient were used as inputs. Bulk density of wet soil is 1700 kg/m3. Soil-water partition coefficient was computed and resulted as 0.295 m3/m3. A correction factor of 1.13 from wet weight to dry weight was applied to obtain the final PNECsoil.

Secondary poisoning concerns toxic effects in the higher members of the food chain which results from ingestion of organisms from lower trophic levels that contain accumulated substances. It is relevant for highly lipophilic organic chemicals, with a log Pow above the cutoff value of 4 reported in the CLP Regulation (EC 1272/2008). Due to the absence of potential for bioaccumulation indicated by a log Pow of -2.9, test substance was considered as not hazardous with respect to secondary poisoning.

Conclusion on classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment when the following criteria are met:

A )Acute (short-term) aquatic hazard Category Acute 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/L.

B) Long-term aquatic hazard

(i) Non-rapidly degradable substances for which there are adequate chronic toxicity data available:

Category Chronic 1: Chronic NOEC or ECx (for fish) and/or Chronic NOEC or ECx (for crustacea) and/or Chronic NOEC or ECx (for algae or other aquatic plants)0,1 mg/L

Category Chronic 2: Chronic NOEC or ECx (for fish) and/or Chronic NOEC or ECx (for crustacea) and/or Chronic NOEC or ECx (for algae or other aquatic plants)1 mg/L.

(iii) Substances for which adequate chronic toxicity data are not available and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/L

Category Chronic 2: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants)> 1 to ≤10 mg/L

Category Chronic 3:96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/L.

 

The substance is not rapidly degradable and the available short-term toxicity tests to fish, invertebrate and algae fixed the effect levels that do not meet the criteria fo Aquatic toxicity. However, the substance is listed in Annex VI of CLP regulation (EC 1272/2008) and is classfied as Aquatic Chronic 3.