Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.1 mg/L

Assessment factor:

100

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:

1 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.1 mg/L

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:

0.363 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.036 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:

1 mg/kg soil dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Calculation of PNEC water was based on the result obtained in long-term study on Daphnia Magna reporting a NOEC > 10 mg/l. Assessment factors of 100 and 1000 were used for fresh water and marine water, respectively.

The derivation of PNEC water (intermittent releases) was 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. For marine water (intermittent release) the AF used is 1000.

The value of PNEC STP was 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, PNEC sediment for fresh water and marine water were calculated using equilibrium partitioning method. This method uses PNEC water for aquatic organisms and suspended matter/water partition coefficients as inputs. Note that this approach is used only as a rough screening since it may result in both an overestimation or underestimation of toxicity.

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 PNEC soil was done using the assessment factor method. The only data available is coming from a test on eisenia fetida for which a NOEC value is reported. The test follows OECD 207 thus the NOEC is better considered as an EC50 (acute toxicity value). The value obtained is EC50 > 1000 g/kg soil dw, thus the corresponding assessment factor is 1000.

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 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 = - 3.0, 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 EC_x(for fish and/or for crustacea and/or for algae or other aquatic plants) ≤ 0.1 mg/L,

Category Chronic2: Chronic NOEC or EC_x(for fish and/or for crustacea and/or for algae or other aquatic plants)> 0.1 to ≤ 1 mg/L;

The substance was tested in acute tests with fish, Daphnia and Lemna Gibba. No effects occurred and the LC50/EC50s were determined to be > 100 mg/L. Furthermore, chronic values are available for Daphnia Magna. The NOEC was determined to be > 10 mg/L and the substance is non-rapidly degradable.

In conclusion the substance is not classified for the water compartment.