Appendix C: Environmental Fate and Ecotoxicological Investigations Environmental Fate Ready biodegradability Notified chemical (99.2% purity) OECD TG 301 C Ready Biodegradability: Modified MITI Test (I). Inoculum Activated sludge Exposure Period 28 days Auxiliary Solvent None Analytical Monitoring Oxygen consumption measuring apparatus and gas chromatography Remarks - Method The test was conducted according to the test guideline without significant deviation from the protocol. Test substance Aniline Day % Degradation Day % Degradation 7 0 7 76 14 0 14 92 21 0 21 93 28 6 28 94 Remarks - Results The difference of the BOD biodegradation between replicates is 30%, which does not meet the validity criterion of < 20%. However, the same conclusion can be derived based on the test results, irrelevant of the difference between replicates. The notified chemical is not considered to be readily biodegradable. CERI (2014) Bioaccumulation Notified chemical OECD TG 305 Bioaccumulation in Fish: Aqueous and Dietary Exposure. Japanese Chemical Substance Control Law: Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body. Species (Common carp) Cyprinus carpio Exposure Period Exposure: 28 days Depuration: None Auxiliary Solvent None Concentration Range Nominal: 0.5 µg/L Actual: 0.428 µg/L Analytical Monitoring Gas chromatography mass spectrometry Remarks - Method The test was conducted under semi static conditions (test water was renewed every 8-16 hours). The BCF of the test item was observed to be independent of the test concentration in the preliminary test. Thus, the BCF study was performed on one test concentration. The test was conducted in accordance with the test guideline above, with no significant deviation in protocol reported. Bioconcentration Factor BCF = 72 - 150 CT50 Not determined Remarks - Results All validity criteria for the test were satisfied. During the exposure period of 28 days, the mortalities in both control and treated fish were 0% at the
Appendix C: Environmental Fate and Ecotoxicological Investigations Environmental Fate Ready biodegradability Notified chemical (99.2% purity) OECD TG 301 C Ready Biodegradability: Modified MITI Test (I). Inoculum Activated sludge Exposure Period 28 days Auxiliary Solvent None Analytical Monitoring Oxygen consumption measuring apparatus and gas chromatography Remarks - Method The test was conducted according to the test guideline without significant deviation from the protocol. Test substance Aniline Day % Degradation Day % Degradation 7 0 7 76 14 21 28 0 0 6 14 21 28 92 93 94 Remarks - Results The difference of the BOD biodegradation between replicates is 30%, which does not meet the validity criterion of < 20%. However, the same conclusion can be derived based on the test results, irrelevant of the difference between replicates. The notified chemical is not considered to be readily biodegradable. CERI (2014) Bioaccumulation Notified chemical OECD TG 305 Bioaccumulation in Fish: Aqueous and Dietary Exposure. Japanese Chemical Substance Control Law: Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body. Species Cyprinus carpio (Common carp) Exposure Period Exposure: 28 days Depuration: None Auxiliary Solvent None Concentration Range Nominal: 0.5 µg/L Actual: 0.428 µg/L Analytical Monitoring Gas chromatography mass spectrometry Remarks - Method The test was conducted under semi static conditions (test water was renewed every 8-16 hours). The BCF of the test item was observed to be independent of the test concentration in the preliminary test. Thus, the BCF study was performed on one test concentration. The test was conducted in accordance with the test guideline above, with no significant deviation in protocol reported. Bioconcentration Factor BCF = 72 - 150 CT50 Not determined Remarks - Results All validity criteria for the test were satisfied. During the exposure period of 28 days, the mortalities in both control and treated fish were 0% at the