Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.2 µg/L
Assessment factor:
1 000

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.72 µg/L
Assessment factor:
10 000

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
6 mg/L
Assessment factor:
10

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.023 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:
0.043 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Short-term toxicity tests for algae and Daphnia are available (read across). The 48h EC50 value for Daphnia is 15.6 mg/l, and the 72h ErC50 for algae is 8.4 mg/L, both derived from read across from Hyacinth body #3. For fish a predicted 96h LC50 value using ECOSAR was derived being 7.2 mg/L. Based on the lowest available acute data for fish with an LC50 value of 7.2 mg/L, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of EU CLP.

 

As only one chronic value is available (algae), the aquatic chronic classification needs to be derived on both chronic and acute toxicity data and the most stringent outcome needs to be taken into consideration. The only chronic available value is the ErC10 of algae being 5.8 mg/L. In combination with the substance not being readily biodegradable this would not lead to chronic classification according to Table 4.1.0 (b) (i) of CLP. In view of the available acute data for two other trophic levels, Daphnia and fish, the more stringent value is chosen- the one obtained for fish (7.2 mg/l). Since the LC50 is 7.2 mg/L, the substance is not readily biodegradable and has a log Kow of 3.5, the substance needs to be classified as Category Chronic 2 (H411) according to Figure 4.1.1 and Table 4.1.0(b) (iii) of EU CLP.

 

Overall, it can be concluded that Hyacinth body needs to be classified for the environment as Category Chronic 2 (H411) in accordance with the criteria outlined in EU CLP (1272/2008/EC and its updates).

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