Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.27 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.27 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
11.5 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:
PNEC oral
PNEC value:
1.67 mg/kg food
Assessment factor:
300

Additional information

See individual justifications for PNECs. Assessment factors used were in accordance with the ECHA guidance document R.10 on the characterisation of dose-response for the environment (ECHA 2008).

The available Daphnia reproduction study and 14 day prolonged toxicity study in fish have not been assessed in the PNEC calculations, as they do not provide suitable data on test substance concentrations and do not provide definitive NOEC results. Therefore, the PNECs are based on the acute studies only.

Conclusion on classification

The substance is classified for the environment based on the available study data.

The results of acute toxicity testing in Daphnia, fish and algae gave the following results:

Acute toxicity to Daphnia magna: The 48 hour EC50 was determined to be 0.15 mg/l and the NOEC was determined to be 0.056 mg/l.

Acute toxicity to rainbow trout: The 96 hour LC50 was determined to be 0.27mg/l and the NOEC was determined to be 0.18 mg/l.

Algal inhibition: The effect of the test material on the growth of Scenedesmus subspicatus gave EC50 values of greater than 0.10 mg/l . Correspondingly the No Observed Effect Concentration was 0.10 mg/l.

Data for the algal study included geometric-mean measured results of the substance and degradant product, DIXT. The solubility of the substance was indicated to be around 0.10 mg/l in the test medium.

Results in the Daphnia and fish studies were determined as nominal concentrations. These tests used 'Tween 80' to produce dispersions and it is not certain what solubility was achieved in the test solutions. Despite this, as toxic effects were seen in the Daphnia and fish studies, but not in the algal study, the results of the Daphnia and fish studies are used for classification purposes.

The Daphnia and fish studies both gave EC/LC50 results of <1 mg/l and therefore, in accordance with the CLP criteria the substance is classified with Acute aquatic hazard Category 1.

In addition, the substance is cannot be considered to be readily biodegradable (between 10 and 15% degradation after 28 days) and has an octanol/water partition coefficient of log Pow >5.9. Therefore, in accordance with the CLP criteria the substance is also classified with Chronic aquatic hazard Category 1.

The available long-term studies (14 -day fish toxicity and Daphnia magna reproduction test) showed no effects with the tested 'saturated solution', but measured concentrations of the test substance were below the limit of detection. Therefore, these studies do not alter the classification.

The predicted BCF value for the test material is 165.7. However, as this is not an experimentally determined result, the result has not been considered in the classification of the substance.

Therefore, the following environmental classification is applicable to the substance:

Acute aqatic hazard - Category 1

Chronic aquatic hazard - Category 1

The following hazard statement will apply:

H410: Very toxic to aquatic life with long lasting effects.