Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 000 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

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.

PBT AND vPvB ASSESSMENT

Summary and overall conclusions on PBT or vPvB properties

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

 

PBT/vPvB criteria and justification

Persistence Assessment: As a conservative approach the substance is assumed to be "not readily biodegradable" since EC 500 -029-3 is readily biodegradable but EC 500-044-5 is not. The substance is therefore regarded as potentially persistent.

 

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/vB.

 

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.

 

Emission Characterisation

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