Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.009 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.09 mg/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:
0.455 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.045 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:
0.382 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 results for fish, daphnia and algae are available for the substance. The L/EC50 and ErC50 are > 100, > 100 and > 90 mg/L, respectively. Based on the lowest available acute data, in this case algae, the substance does not need to be classified for acute aquatic hazard according to Table 4.1.0 (a) of CLP.

As only one reliable long-term toxicity endpoint is available from the algae study, chronic classification needs to be derived on both acute and chronic data and the worst case should be taken. Based on chronic data (ErL10 = 11.2 mg/L), 3-methyl sulfolane does not have to be classified according to CLP Table 4.1.0 b(i). In addition, in view of the substance not being readily biodegradable, having a log Kow – 0.4 and the lowest acute data being > 90 mg/L for algae, the substance does not need to be classified for long term aquatic toxicity according to Figure 4.1.1 and Table 4.1.0, (b) iii of CLP.

Based on above, 3 methyl sulfolane does not need to be classified for the environment according to EU CLP (EC 1272/2008 and its updates). M factor for acute and chronic toxicity is not applicable.

The substance does not have to be classified for aquatic hazard.

The substance is not PBT or vPvB.