Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.16 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:
0.17 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
3.3 mg/kg food
Assessment factor:
300

Additional information

ECHA guidance states that a substance which has a log Kow ≥3 or a BCF ≥ 100 and

no mitigating property (such as rapid hydrolysis or ready biodegradability) exhibits the potential for food chain exposures. The substance has a log Kow of 3.63, and failed the 10-day window in a ready biodegradability assay (although the substance was shown to be rapidly biodegradable under enhanced conditions). Therefore, as a conservative assumption, the potential for food chain exposures was evaluated by derivation of the PNECoral, although food chain exposures are unlikely.

Conclusion on classification

GHS: The substance has an acute aquatic toxicity based on the 96-h acute fish toxicity test of 624 mg/L, 48-h EC50from an acute invertebrate toxicity assay of > 100 mg/L in Daphnia magna and a 72-h algal growth inhibition ErC50(based on growth rate) of > 100 mg/L in Desmodesmus subspicatus; each of these values is >100 mg/L. Since the substance does not exhibit low solubility (water solubility is 42,000 mg/L at 22oC) and there is no demonstrated acute toxicity to aquatic organisms at concentrations of 100 mg/L or less, the substance is not classified with respect to the aquatic environment under GHS.

DSD-DPD:  The substance has an acute aquatic toxicity based on the 96-h acute fish toxicity test of 624 mg/L, 48-h EC50from an acute invertebrate toxicity assay of > 100 mg/L inDaphnia magnaand a 72-h algal growth inhibition ErC50(based on growth rate) of > 100 mg/L in Desmodesmus subspicatus; each of these values is >100 mg/L.

Since the substance does not exhibit low solubility (water solubility is 42,000 mg/L at 22oC) and there is no demonstrated acute toxicity to aquatic organisms at concentrations of 100 mg/L or less, the substance is not classified with respect to the aquatic environment under DSD-DPD.

In the absence of aquatic chronic toxicity information, the classification was based on the acute aquatic toxicity values from the three trophic levels. The substance has an acute aquatic toxicity based on the 96-h acute fish toxicity test of 624 mg/L, 48-h EC50from an acute invertebrate toxicity assay of > 100 mg/L in Daphnia magna and a 72-h algal growth inhibition ErC50(based on growth rate) of > 100 mg/L in Desmodesmus subspicatus; each of these values is >100 mg/L. Since the substance does not exhibit low solubility (water solubility is 42,000 mg/L at 22oC) and there is no demonstrated acute toxicity to aquatic organisms at concentrations of 100 mg/L or less, the substance is not classified with respect to the aquatic environment under DSD-DPD or under GHS.