Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
2.55 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
25.5 µg/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:
99.9 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
9.99 µg/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:
5 µg/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 (24h) on daphnia = 299 mg/l and EC50 (7d) on lemna = 25.5 mg/l. The lowest value, i.e. EC50 = 25.5 mg/l, was used in the calculation of PNECwater.

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, i.e. 25.5 mg/l.

In a test on microorganisms, an IC50 (3h) > 100 mg/l was found. The value of PNECstpwas derived by applying 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. 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 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 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 Powabove 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 Powof -4.36 at 20 °C, 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 EC50 (7d) for lemna.

In short term studies on fish, daphnia and lemna, lemna resulted to be the most sensitive species, with an EC50 value of 25.5 mg/l after a 7 d exposure. Based on these results, no classification for acute toxicity is applied.

No chronic toxicity data was available from long-term studies.

In case of lack of chronic data, a decision on classification is based on acute toxicity data, potential of degradability and potential of bioaccumulation.

In particular,substances for which adequate chronic toxicity data are not available, are classified in:

- category chronic 1, when E(L)C50 < 1 mg/l

- category chronic 2, when E(L)C50 between 1 and 10 mg/l

- category chronic 3, when E(L)C50 between 10 and 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Pow ≥ 4).

As Basic Orange 064 is not ready biodegradable and the lowest EC50 value is between 10 and 100 mg/l, a classification in category chronic 3 for aquatic toxicity is applied according to the CLP Regulation (EC 1272/2008).