Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.018 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.111 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.111 mg/L

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:
0.069 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.007 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:
0.003 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

A long-term study on fish and a toxicity study on algae are available, for which the following results were obtained: NOEC (Oncorhynchus mykiss, 21 d) = 0.876 mg/L and NOEC (Scenedesmus subspicatus, 72 h) < 1.9 mg/L.

Based on the available information on aquatic organisms, fish seems to be the most sensitive species. Also algae presents a low effect concentration. However, toxicity effects on algae could be overestimated as coloured substance (dye).

Therefore, the most sensitive aquatic organism is considered to be fish and for this reason the concentration of 0.876 mg/L [NOEC (Oncorhynchus mykiss, 21 d)] is used for the PNEC calculation.

Short-term results from three trophic levels are available. Short-term toxicity studies are available for fish, aquatic invertebrate and algae for which the following results are obtained: LC50 (Oncorhynchus mykiss, 96 h) = 11.13 mg/L, EC50 (Daphnia magna, 24 h) = 617 mg/L and ErC50 (Scenedesmus subspicatus, 72h) = 8.2 mg/L. Due to the nature of the substance (dye) and the slight difference between the effect values, fish can be considered as more representative organism than algae for the assessment of the aquatic toxicity potential. Therefore, the LC50 (Oncorhynchus mykiss, 96 h) = 11.13 mg/L is considered for the PNEC intermittent release.

Assessment factors of 50 and 500 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. An assessment factor of 100 was applied.

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 is expected to be very low, since the substance is a solid with a negligible vapour pressure. Therefore, no hazard is 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, PNECwater for 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) No. 1272/2008. Due to the absence of potential for bioaccumulation indicated by a log Pow of <-3.4, test substance was considered as not hazardous with respect to secondary poisoning.

Conclusion on classification

According to the CLP Regulation (EC) no. 1272/2008, Part 4: Environmental Hazards, not rapidly degradable substances for which adeguate data (acute and chronic) are available can be classified for aquatic environment hazard when the following criteria are met:

(a) Short-term (acute) aquatic hazard

Category Acute 1: 96 h LC50(fish) and/or 48 h EC50(crustacea) and/or 72 or 96 h ErC50(algae or other aquatic plants) ≤ 1 mg/l.

(b) Long-term (chronic) 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)0,1 mg/l and/or Chronic NOEC or ECx (for crustacea)0,1 mg/l 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)1 mg/l and/or Chronic NOEC or ECx (for crustacea)1 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants)1 mg/l.

The substance is not rapidly degradable and the available long-term toxicity tests to fish fixed effect level that meets Category Chronic 2 classification criteria. Therefore, the substance is classified for aquatic toxicity as Category Chronic 2 (H411) according to the CLP Regulation (EC) no. 1272/2008.