Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1 588.5 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
158.8 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:
316.2 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

Classification based on biodegradation, bioaccumulation and acute aquatic data

Water solubility:     0.034 mg/L (OECD 105)  

Biodegradation:      0% within 28 d (OECD 301F)

LogKow:                  6.3 (OECD 117)

Aquatic acute toxicity

For fish: LC50(96 h) > 1000 mg/L, (UBA-Vorschrift, Letale Wirkung beim Zebrabärbling, Brachydanio Rerio)

For aquatic invertebrates: EC50(48h) > 1000 mg/L (UBA Vorschrift, determination of immobilization of daphnids, Daphnia Magna)

For algae: ErC50(72 h) > 1000 mg/L, (DIN 38 412 part, Desmodesmus subspicatus)

No toxicity in the range of the low water solubility of the test substance has been observed in any of the studies. Although these results do not allow classification, there are nevertheless some grounds for concern. Substances with low water solubility for which no acute toxicity is recorded at levels up to the water solubility [L(E)C50(s) is/are above the water solubility] and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, should be classified in the Chronic Category 4 ("safety net" classification) unless other scientific evidence exists showing classification to be unnecessary.

Based on the results from the aquatic toxicity studies and since the substance has a low water solubility, is not readily biodegradable and has a log Kow > 4, the substance is classified as Aquatic Chronic 4 (Hazard statement: H413) in accordance with European Regulation (EC) No. 1272/2008.