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Bioaccumulation: aquatic / sediment

BCFBAF model of Estimation Programs Interface (2018) was used to predict the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 3.162 L/kg whole body w.w (at 25 deg C) which does not exceed the bio concentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Additional information

Bioaccumulation: aquatic / sediment

Predicted data of the test chemical and various experimental studies of its read across substance were reviewed for the bioaccumulation end point which are summarized as below:

 

In a prediction done using the BCFBAF program of Estimation Programs Interface, the bioconcentration factor (BCF) of test chemical (2018). The bioconcentration factor (BCF) of test chemical was estimated to be 3.162 L/kg whole body w.w (at 25 deg C).

 

In a supporting weight of evidence study from authoritative database (2019) and secondary sources,bioaccumulation study was conducted on test organism Cyprinus carpio for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed in accordance with the OECD TG 305 C "Bioaccumulation: Test for the Degree of Bioconcentration in Fish" and other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively at 25±2°C and dissolved oxygen content of 6 -8 mg/l for 6 weeks. Cyprinus carpio (weight ca. 30 gm, length ca. 10 cm) supplied by Sugishama fish farm was used as a test organism for the study. Lipid content of the test organism at the start of exposure was 5.2%. Test organisms were fed with pelleted food about 1 % of body weight twice/day. Fishes were reared in an acclimatization tank (flow through system) for 28 days. Details on analytical methods involve the recovery ratio: Test water: 1st concentration area: 94.6%, 2nd concentration area : 91.3%, Fish: 85.9%, - Limit of quantitation: Fish : 0.093 ppm. Test chemical nominal conc. used for the study was 0.2 mg/land 0.02 mg/l. Dimethyl sulfoxide was used as a vehicle. Range finding study involves the TLm (48 hr) ≥ 50 ppm (w/v) on Rice fish (Oryzias latipes). Glass tank was used as a test vessel. Test vessel contains 15 -20 fish per level in glass tank. Total hardness, COD, chloride, and other parameters were measured every 6 months. In addition to this, water temperature, pH and dissolved oxygen were also measured continuously. The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 1.4– 4.7 L/Kg at a conc. of 0.2 mg/l and 6.4 – 28 L/Kg at a conc. of 0.02 mg/l, respectively.

 

For the test chemical, bioaccumulation study was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical (from handbook (2008), authoritative database and secondary source). The study was performed according to ‘’OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)’’ and other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively. Cyprinus carpio was used as a test organism for the study. Test chemical nominal conc. used for the study was 2 mg/l and 0.2 mg/l, respectively. Analytical method involve the recovery ratio: Test water : 1st concentration area : 98.4 %, 2nd concentration area : 95.4 %, Fish : 62.2 %, - Limit of detection : Test water : 1st concentration area : 0.15 ppm, 2nd concentration area : 0.016 ppm, Fish : 2.1 ppm. Range finding study involve the TLm (48h) ≥ 1000 ppm (w/v) on Rice fish (Oryzias latipes).The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be ≤ 1.1 L/Kg at a conc. of 2 mg/l and ≤ 11 L/Kg at a conc. of 0.2 mg/l, respectively.

 

On the basis of above results for test chemical, it can be concluded that the BCF value of test chemical was evaluated to be ranges from 1.1 to 28, respectively,which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Bioaccumulation endpoint can also be considered for waiver as per in accordance with column 2 of Annex IX of the REACH regulation, testing for this endpoint is scientifically not necessary and does not need to be conducted since the test chemical has a low potential for bioaccumulation based on logKow ≤ 3.