Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.284 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
2.84 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.03 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:
0.402 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The following relevant key results are currently available for deriving the classification of the substance for the environment:

- Cyprinus carpio: 96h-LC50: >100 mg/L

- Daphnia magna: 48h-EC50: 4.1 mg/L

- Pseudokirchneriella subcapitata: 72h-ErC50: 2.84 mg/L; 72h-ErC10: 0.32 mg/L

- Not readily biodegradable in an OECD 301B study

- Log Kow: -0.44

Acute (short-term) aquatic hazard

As the acute E(L)C50 values are >1 mg/L, the substance does not need to be classified for this hazard category according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

 

As the 48-EC50 and 72h-ErC50 are >1 but ≤10 mg/L, the substance needs to be classified for this hazard category in Category 2 according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations (GHS).

Chronic (long-term) aquatic hazard

One chronic value is available, for algae. As there are no chronic values available for fish and crustacea, the chronic classification has to be determined with the available chronic data for algae based on CLP Table 4.1.0 (b)(i), as the substance is not readily biodegradable, and with the available acute data for fish and daphnia magna based on CLP Table 4.1.0 (b) (iii). The most stringent classification is valid.

- CLP Table 4.1.0 (b)(i): As the 72h-ErC10 value is > 0.1 - ≤ 1 mg/L (0.32 mg/L), the substance needs to be classified based on this key result in Category 2.

- CLP Table 4.1.0 (b)(iii): As the 48h-EC50 value is >1 - ≤ 10 mg/L (4.1 mg/L) and the substance is not readily biodegradable, the substance needs to be classified based on this key result in Category 2.

It is therefore concluded that based on the currently available data, the substance needs to be classified in Category 2 for this hazard, according to CLP and according to GHS.

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