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GLP tests conducted in accordance with international (OECD) test guidelines for three trophic groups have been conducted. The results of which are summarised below:

OECD 201: Algal inhibition assay Pseudokirchneriella subcapitata strain CCAP 278/4

72-h ErC50= 4.1 mg/L

72-h ErC10= 0.11 mg/L

 

OECD 202: Acute Toxicity to Daphnia magna

48-h EC50= 48 mg/L

48-h NOEC = 32 mg/L

 

OECD 203: Acute toxicity to Fish (Oncorhynchus mykiss) (threshold approach)

96-h EC50= >4.1 mg/L

48-h NOEC = 4.1 mg/L

 

In accordance with the recommendations of REACh, the test was conducted according to the threshold approach recommended by the European Chemicals Agency. Using this approach the lowest EC50value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50is greater than the threshold concentration. The EC50value obtained from the Algal Growth Inhibition study (Harlan Study Number 41402541) was the lowest of these two EC50values and hence the test was conducted at a single concentration of 4.1 mg/L.

Based on the above results the algal study provides the lowest toxicity endpoint and therefore this will be used for PNEC derivation.

An EC50 of 430 mg/L was obtained in the activated sludge respiration inhibition study (OECD 209). The assessment factor (SF) = 100 was taken according to the guidance Table R.10-6, as value comes from a Growth inhibition test with Pseudomonas putida.