Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.085 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.51 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.019 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:
0.018 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC freshwater, marine waters, and intermittent release was derived based on the data on acute aquatic toxicity and on chronic aquatic toxicity where available following the guidance (GIRCSR Section 10, ECHA 2008). If combination of studies with confirmed EC50 values or NOECs and limit tests was available for one taxonomic groups, preference was given to the data with confirmed (no) effect concentrations. In the absence of a confirmed (no) effect concentration from testing of one of species of the three trophic levels, the lowest confirmed (no) effect concentration of the other species was used to derive the PNEC.

Conclusion on classification

There were no effects observed up to 100 mg/l (nominal) in any acute aquatic toxicity testing. These results do not warrant classsification according to GHS EU implementation.

Preliminary PBT Assessment

 

An assessment of the PBT status of the substance has been made using all available data. The information available suggests that the substance does not meet the PBT screening criteria as outlined in Directive 2006/121/EC (Appendix A).

 

Persistence Assessment

In a OECD301F (manometric) study with 9% mineralisation at 28 days was observed. In three inherent tests, mineralisation was ranging from 20-36% after 28 days. It can be concluded from the available screening tests that the substance exhibits inherent (primary) biodegradability, and is therefore not expected to persist indefinitely in the environment. However, since the substance is not readily biodegradable and the biodegradation was less than 70% in the inherent tests, it has to be classified as P, according to the PBT screening criteria.

Bioaccumulation Assessment

In the absence of a measured BCF value, the log KOW can be used as a screening criterion for bioaccumulative potential (i.e. >4.5). As the log KOW of the substance is below 4.5, the B/vB criterion is not met. Therefore the substance is identified as not B.

 

Toxicity Assessment

The acute effect information for all three trophic levels is much higher than the screening criterion of 0.1 mg/l. It can therefore be expected that the substance is not toxic towards aquatic organisms.

 

Summary and Overall Conclusions on PBT or vPvB Properties

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.

 

Emission Characterisation

The substance is not a PBT/vPvB substance, therefore the emission characterisation does not need to be conducted