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Environmental fate & pathways

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The biodegradation test was conducted to evaluate the biodegradation of the test substance in water in accordance with the Test Method Relating to New Chemical Substances <Biodegradability Test of Chemical Substances by Microorganisms> with GLP. After 28 days, from the degradability results based on the BOD (av. 0%) and the residual test substance amount (av. 2%) as well as the peak shape of the test substance on the HPLC chromatogram which showed no change, it is concluded that the test substance is not readily degradable and was not transformed structurally under the conditions of this test. The substance is highly insoluble (water solubility: < 0.025 mg/l), thus the biodegradation simulation test in water can be waived according to REACH Annex IX column 2. And based on the screening test result of biodegradation in water, we can conclude the test substance is persistent and very persistent substance for the worst case consideration. Thus, no more simulation test for sediment and soil are needed.

The bioconcentration test was conducted in accordance with Bioconcentration test of chemical substances in fish and shellfish with GLP to evaluate the bioaccumulation potential of the test substance for 28 days. 0.2 mg/L, 0.02 mg/L and 0 mg/L of test substance in test water were applied to Carp fish. The bioconcentration factor at the steady-state (BCFss) was <3 at the high concentration level, and <21 at the low concentration level. Based on the results above, it is concluded that the bioaccumulation potential of the test substance in fish is low under the test condition.

The adsorption study was conducted according to OECD TG 121 with GLP. The determination of the Koc for test substances that are ionized for at least 10% within pH 5.5 to 7.5 should be performed with both the ionized and non-ionized form. Therefore, the pKa values of the test substance were calculated using the Perrin calculation method (pKalc 5.0, module in Pallas 3.0). Based on the calculations, the HPLC analysis was performed at neutral pH. In a first test, solutions of references substances and the test substance were analysed but no peaks were observed in the chromatograms of E-200. The concentration of the test substance solution was 10.7 mg/l. And the concentration of the test substance solution was 103 mg/l. Thus the Adsorption coefficient Koc of Epikote P is >4.3 x 105 (log Koc >5.63) based the first and the additional test result.

The hydrolysis test is waived according to REACH Annex IX column 2 for the highly insoluble (water solubility: < 0.025 mg/l) property.