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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
21.7 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:
43.4 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Calculation of PNECwaterwas based on results obtained in short-term studies on fish, daphnia and algae, namely L(E)C50 > 100 mg/l. These results indicate the lack of acute toxicity for the three trophic levels up to concentration of 100 mg/l. Assessment factors of 1000 and 10000 were used for fresh water and marine water, respectively.

The derivation of PNECwater, intermittentwas done by applying an assessment factor of 100 to the lowest value obtained in at least three short-term aquatic toxicity studies from three trophic levels. Accordingly, a concentration of 100 mg/l was used.

The value of PNECstpwas derived from the result of the activated sludge respiration inhibition test EC50 > 1000 mg/l by using an assessment factor of 100.

Due to the lack of ecotoxicological data, PNECsedimentfor fresh water and marine water were calculated using equilibrium partitioning method. This method uses PNECwaterfor 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. An experimental value for partition coefficient organic carbon-water was available for similar substance 01, namely log Koc = 4.34 equivalent to Koc = 21700 l/kg at 20 °C. Based on this experimental data, the suspended matter-water partition coefficient was computed and resulted as 543 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 PNECsoilwas 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 are used as inputs. Bulk density of wet soil is 1700 kg/m3. Based on an experimental log Koc of 4.34, the soil-water partition coefficient was computed and resulted as 651 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 Kow 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 Kow of 1.776, test substance was considered as not hazardous with respect to secondary poisoning.

Conclusion on classification

According to the CLP Regulation (EC 1272/2008), the threshold of classification of a substance for acute aquatic toxicity is 1 mg/l. This limit is compared with LC50 (96h) for fish, EC50 (48 h) for daphnia and EC50 (72 - 96 h) for algae or aquatic plants.

Due to the low water solubility of test substance, below 20 mg/l at 20 °C and pH 7.11, at concentrations reported in available tests, a large fraction of substance is expected to be undissolved in water. This may possibly cause physical effects not related to substance toxicity.

 

In all available 96-hour or 48-hour tests on fish, mortality was recorded, leading to LC50 > 100 mg/l as nominal concentration of active ingredient.

Toxicity on daphnia was assessed in 48 -hour studies. In one study, acute immobilisation was seen in 5 % of daphnia exposed at nominal concentration of 100 mg/l, while in another study, no toxicity was seen at 200 mg/l of active ingredient.

Toxicity on algae was assessed in 72 -hour tests. In one case, EC50 for algal growth rate was identified as 330 mg/l of active ingredient; in the other case, no effects were observed at 100 % v/v satured solution.

Since no acute toxicity was recorded at levels in excess of the water solubility and water solubility is below the detection limit of the analytical method for the substance (see section 4.8), L(E)C50 for classification purposes may be considered to be greater than the water solubility.

No chronic toxicity data is available from long-term studies. In case of lack of chronic data, the potential for chronic toxicity is identified by appropriate combinations of acute toxicity data and lack of biodegradability. The threshold of classification is 100 mg/l.

Since no acute toxicity of test substance was seen at the limit of solubility in water, in presence of an excess of undissolved test substance, no classification for both acute and chronic aquatic toxicity was applied according to the CLP Regulation (EC 1272/2008).