Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
0.004 mg/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

In the absence of aquatic chronic toxicity information, the classification was based on the lowest acute aquatic toxicity value from the three trophic levels (i.e., the LC50 in fish of 0.16 mg/L, the ErC50 of 0.0269 mg/L in algae and the EC50 in daphnids of 0.0041 mg/L. The substance was shown to be rapidly biodegradable, and therefore is unlikely to result in direct and indirect exposures of the aquatic compartment. The substance has a predicted octanol-water partition coefficient (log Kow) of 1.71,which is substantially below the criterion (log Kow ≥ 4.0) above which a substance exhibits the potential for chronic toxicity. However, the substance is a surface-active agent, and ionizes in the aquatic milieu. Therefore, the log Kow may not be a reliable predictor of the potential for bioaccumulation, and an experimentally-determined value for bioconcentration factor (BCF) is not available. Nevertheless, the available information indicates that the substance has a low potential for aquatic bioaccumulation, based on its strong adsorption to soils, sediment and activated sludge, and its demonstrated rapid aerobic biodegradation; substances that degrade rapidly in the environment “are likely to be rapidly metabolized in organisms” in accordance with ECHA guidance (ECHA, Guidance on information requirements and chemical safety assessment, Chapter R.7C, Endpoint-specific guidance, Section R.7.10.3.4, p. 26, November 2012). Therefore, the substance was classified as Acute Category 1 with an M-factor of 100. The substance has been assigned hazard statement H400 (Very toxic to aquatic life), with the GHS pictogram for hazardous to the aquatic environment, the signal word “Warning” (if not otherwise assigned the signal word “Danger” based on one or more other hazard classes), and precautionary statements P273 (Avoid release to the environment), P391 (Collect spillage) and P501 (Dispose of contents/container to...) under GHS.