Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.063 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:
0.094 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Environmental fate and pathways:

Based on the biodegradation studies, the substance is not considered readily or inherently biodegradable. Therefore, the substance is considered persistent in the environment.

The adsorption coefficient (Koc) of the substance has been determined to be 80.5, corresponding to a log Koc at 1.91.This result indicates that the substance is highly mobile(according to P.J. McCall et al., 1980

Aquatic toxicity:

To assess aquatic toxicity properties of the test substance, data on the two mandatory species, regarding tonnage band requirements, were provided: invertebrates (OECD 202) and algae (OECD 201). Fish (OECD 203) data already existed and then added to the dataset.

Results are as follow:

-         Algae 72h-EC50 (growth rate) = 87 mg/L / Algae 72h-NOEC (growth rate) = 7.1 mg/L

-         Daphnia 48h-EC50 ≥ 100 mg/L

-         Fish 96h-LC50 = 53.7 mg/L

In addition, a study is available to assess the effect of the substance on the respiration of activated sewage sludge (OECD 209). The 3h-NOEC and 3h-EC50 were 190 mg/L and 390 mg/L, respectively.

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient). Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards.

Short-term aquatic toxicity data is available for all three trophic levels. The lowest short-term L(E)C50 was for fish with a 96-hour LC50 value of 53.7 mg/L. Chronic aquatic toxicity data is only available for algae; the 72-hour NOEC (growth rate) is 7.1 mg/L. The substance is not readily biodegradable and has a log Kow of 2.46.

Based on the above data, the substance is classified as Aquatic Chronic 3 (H412) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.