Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Biodegradation in water:

The percentage degradation of test substance was determined to be 84.5 % degradation of test chemical by using unacclimated activated sludge and 82.1% degradation of test chemical by using acclimated activated sludge. Thus, based on percentage degradation, test chemical was considered to be readily biodegradable in water.

Biodegradation in water and sediment:

Estimation Programs Interface prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 5.96% 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). Based on this half-life value, it indicates that test chemical is 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. If released into the environment, 73.8% 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.

Additional information

Biodegradation in water:

Biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test substance. The study was performed according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test) under aerobic conditions.Two activated sludge test systems were included. The first system was collected from a municipal sewage treatment plant in Downingtown (PA, USA) that received primarily domestic sewage and was considered to be unacclimated to nicotine. The second system was collected from a wastewater treatment plant located in Winston-Salem (NC, USA) that received wastewater from a cigarette manufacturing facility and was considered to be acclimated to nicotine. In this test, mineral media containing test chemical (10 mg C/L) as the nominal sole source of organic carbon were aerated in CO2-free air for 28 d. Biodegradation of test chemical over the test period was indicated by production of CO2. The evolved CO2 was captured using a serial barium hydroxide trapping system in which the CO2 reacted with Ba(OH)2 to form an insoluble BaCO3 precipitate. The amount of CO2 produced was calculated indirectly by titration of the remaining hydroxide with 0.05 N standardized HCl. A procedural control in which sodium benzoate (10 mg C/L) was used as the sole source of organic carbon was included to confirm the activity of the inocula, and a toxicity control containing both test chemical (10 mg C/L) and sodium benzoate (10 mg C/L) was included to ensure the test substance was not adversely affecting the inocula. Nonspecific production of CO2 was indicated by an abiotic sterile control that contained test chemical (10 mg C/L) and 0.01% HgCl2 but no inocula. The percentage degradation of test substance was determined to be 84.5 % degradation of test chemical by using unacclimated activated sludge and 82.1% degradation of test chemical by using acclimated activated sludge. Thus, based on percentage degradation, test chemical was considered to be readily biodegradable in water.

Biodegradation in water and sediment:

Estimation Programs Interface prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 5.96% 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). Based on this half-life value, it indicates that test chemical is persistent in sediment.

In addition to this, biodegradation in water and sediment endpoint can also be considered for waiver as per in accordance with column 2 of Annex IX of the REACH regulation, testing for this end point is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable in water.

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. If released into the environment, 73.8% 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.

In addition to this, biodegradation in soil endpoint can also be considered for waiver as per in accordance with column 2 of Annex IX of the REACH regulation, testing for this end point is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable in water.