Registration Dossier
Registration Dossier
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EC number: 402-070-1 | CAS number: 88122-99-0 UVINUL T 150
Endpoint summary
Administrative data
Description of key information
Hydrolysis
In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is technically not feasible and does not need to be conducted since the test chemical is insoluble in water.
Biodegradation in water
The ready biodegradation oftest chemicalwas conducted in accordance to OECD guideline 301C (Ready Biodegradability: Modified MITI Test (I)) and 79/831/EWG Annex V, Part C.5.2, respectively for 28 days. Aniline was used as a reference substance for the study. Reference substance undergoes 80% degradation in 28 days. No degradation oftest chemicalwas observed using BOD parameter after a period of 28 days. Therefore, it is concluded that the test chemical was not readily biodegradable in water.
Biodegradation in water and sediment
Estimation Programs Interface (2018) prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 13.4% of the chemical will partition into water according to the Mackay fugacity model level III and the half-life period of test chemical in water is estimated to be 60 days (1440 hrs). The half-life (60 days estimated by EPI suite) indicates that the chemical is persistent in water and the exposure risk to aquatic animals is moderate to high whereas the half-life period of test chemical in sediment is estimated to be 541.66 days (13000 hrs). However, as the percentage release of test chemical into the sediment is less than 1% (i.e, reported as 0.00192%), indicates that test chemical is not persistent in sediment.
Biodegradation in soil
The half-life period of test chemical in soil was estimated using Level III Fugacity Model by EPI Suite version 4.1 estimation database (2018). If released into the environment, 86.5% of the chemical will partition into soil according to the Mackay fugacity model level III. The half-life period of test chemical in soil is estimated to be 120 days (2880 hrs). Based on this half-life value of test chemical, it is concluded that the chemical is not persistent in the soil environment and the exposure risk to soil dwelling animals is moderate to low.
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.
Adsorption / desorption
The adsorption coefficient Koc in soil and in sewage sludge of test chemical was determined by the Reverse Phase High Performance Liquid Chromatographic method according to OECD Guideline No. 121 for testing of Chemicals. The study was performed at a temperature of 23°C and pH 4-10, respectively. . Each of the reference substance and test substance were were analysed by Modular HPLC system with UV/Vis detector. Acetonitrile was used as a mobile phase. 5µl of test chemical was introduced in the column. The dead time of the HPLC system was measure with formamide. The reference substance used for the study were formamide, methyl benzoate, naphthalene, methiocarb, pyrazophos, alpha-endosulfan, diclofo-methyl and DDT, respectively. The Log Koc value of test chemical was determined to be > 5.63 dimensionless at 23°C. This log Koc value indicates that the substance has a very strong sorption to soil and sediment and therefore have negligible migration potential to ground water.
Additional information
Hydrolysis
In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is technically not feasible and does not need to be conducted since the test chemical is insoluble in water.
Biodegradation in water
Various experimental studies of the test chemical were reviewed for determining the biodegradability of test chemical and their results are summarized below:
In an experimental key study,the ready biodegradation oftest chemicalwas conducted in accordance to OECD guideline 301C (Ready Biodegradability: Modified MITI Test (I)) and 79/831/EWG Annex V, Part C.5.2, respectively for 28 days. Aniline was used as a reference substance for the study. Reference substance undergoes 80% degradation in 28 days. No degradation oftest chemicalwas observed using BOD parameter after a period of 28 days. Therefore, it is concluded that the test chemical was not readily biodegradable in water.
Another biodegradation study was conducted according to the manometric respirometry test for determining the biodegradability of the test chemical for 28 days. Aniline was used as a reference substance for the study. The percentage degradation of test chemical was determined to be 0% after a period of 28 days. Thus, based on percentage degradation, test chemical is considered to be not readily biodegradable in nature.
On the basis of above results, it is concluded that test chemical is expected to be not readily degradable in nature.
Biodegradation in water and sediment
Estimation Programs Interface (2018) prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 13.4% of the chemical will partition into water according to the Mackay fugacity model level III and the half-life period of test chemical in water is estimated to be 60 days (1440 hrs). The half-life (60 days estimated by EPI suite) indicates that the chemical is persistent in water and the exposure risk to aquatic animals is moderate to high whereas the half-life period of test chemical in sediment is estimated to be 541.66 days (13000 hrs). However, as the percentage release of test chemical into the sediment is less than 1% (i.e, reported as 0.00192%), indicates that test chemical is not persistent in sediment.
Biodegradation in soil
The half-life period of test chemical in soil was estimated using Level III Fugacity Model by EPI Suite version 4.1 estimation database (2018). If released into the environment, 86.5% of the chemical will partition into soil according to the Mackay fugacity model level III. The half-life period of test chemical in soil is estimated to be 120 days (2880 hrs). Based on this half-life value of test chemical, it is concluded that the chemical is not persistent in the soil environment and the exposure risk to soil dwelling animals is moderate to low.
On the basis of available information, the test chemical can be considered to be not readily biodegradable in nature.
Bioaccumulation: aquatic / sediment
Various predicted data of the test chemical and supporting weight of evidence studies for its read across chemical were reviewed for the bioaccumulation end point which are summarized as below:
In a prediction done using the BCFBAF Program of Estimation Programs Interface 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).
From CompTox Chemistry Dashboard using OPERA (OPEn (quantitative) structure-activity Relationship Application) V1.02 model in which calculation based on PaDEL descriptors (calculate molecular descriptors and fingerprints of chemical), the bioaccumulation i.e BCF for test chemical was estimated to be 48.8 dimensionless . The predicted BCF result based on the 5 OECD principles.
In a supporting weight of evidence study from authoritative database (2018) and secondary source (2014), bioaccumulation experiment was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to ‘’OECD TG 305C “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 was prepared in HCO-50.Test chemical nominal conc. used for the study was 2 mg/land 0.2 mg/l, respectively. 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 in the range of 0.1-0.23 L/Kg at a conc. of 2 mg/l and 1-2.7 L/Kg at a conc. of 0.2 mg/l, respectively.
For the test chemical, bioaccumulation study was conducted on test organism Cyprinus carpio for 28 days for evaluating the bioconcentration factor (BCF value) of test chemical (J-CHECK, 2018). The study was performed according to ‘’OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)’’ andother 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 was prepared in HCO-20.Test chemical nominal conc. used for the study was 1mg/l and 0.1 mg/l, respectively. Analytical method involve therecovery ratio: Test water : 100 % (Only dilution was conducted as the pretreatment in the test water analysis.), Fish : 84.5 %, - Limit of quantitation : Test water : 1st concentration area : 0.040 mg/L, 2nd concentration area : 0.0040 mg/L, Fish : 790 ng/g. Range finding study involve the TLm (48h) > 100mg/l on Rice fish (Oryzias latipes). Lipid content of the test organisms was determined to be 2.45% and 2.44% at the start and end of exposure, respectively. The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.82-4.1 L/Kg at a conc. of 1 mg/l and 7.9-17 L/Kg at a conc. of 0.1 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 upto 48.8,which does not exceeds the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.
Adsorption / desorption
The adsorption coefficient Koc in soil and in sewage sludge of test chemical was determined by the Reverse Phase High Performance Liquid Chromatographic method according to OECD Guideline No. 121 for testing of Chemicals. The study was performed at a temperature of 23°C and pH 4-10, respectively. . Each of the reference substance and test substance were were analysed by Modular HPLC system with UV/Vis detector. Acetonitrile was used as a mobile phase. 5µl of test chemical was introduced in the column. The dead time of the HPLC system was measure with formamide. The reference substance used for the study were formamide, methyl benzoate, naphthalene, methiocarb, pyrazophos, alpha-endosulfan, diclofo-methyl and DDT, respectively. The Log Koc value of test chemical was determined to be > 5.63 dimensionless at 23°C. This log Koc value indicates that the substance has a very strong sorption to soil and sediment and therefore have negligible migration potential to ground water.
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