Registration Dossier

Ecotoxicological information

Ecotoxicological Summary

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Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.085 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

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

Additional information

The acute toxicity studies in Fish and Daphnia produced no adverse results, with repective EC50 / LC50 values presented as limits at > 100 mg/L (the limit of the test concentrations measured). The substance is not considered to be environmentally dangerous on this basis.

The original R52/53 labelling attributed to the substance is due to the Algae result observed in the study; this is also a limit value at >87 mg/L. However it should be noted that under the current REACH regulation for which this registration is being made, there have been some alterations to the manner in which Algal data is interpreted. It is known that the following is applicable:

1. In algal studies, the result based on growth rate shall be used for evaluation instead of those for biomass. Thus, the result of the algae study is ErC50 >87 mg/L (measured). However there is no reason to recalculate nominal concentrations with measured concentrations as long as the result of the analytical monitoring is >80% of the nominal concentration. For this reason, the actual result which should be reported within this registration under REACH should be ErC50 >100 mg/L (nominal).


2. The decrease of  growth rate at the highest concentration (87/100 mg/L) was given as 23%. A further examination of the probit analysis has been undertaken by an independent consultant whom has extrapolated the original values with ToxRat (version 2.10.05), Weibull distribution.

 

The results of this assessment are as follows:

Based on nominal concentrations: ErC50 = 175 mg/L (95%CV: lower 145 mg/L, higher 253 mg/L).
Based on measured concentrations: ErC50 = 152 mg/L (95%CV: lower 125 mg/L, higher 221 mg/L).

 

As such, these revised values indicate that classification as R52/53 is no longer applicable. The substance is therefore proposed to be “not classified” and appropriate comments are detailed within Section 2 of the registration dossier.

Conclusion on classification

The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. ufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Given the revised results for the Algae study, the results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute environmental effects is therefore required.