Registration Dossier
Registration Dossier
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EC number: 918-481-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Biodegradation in water: screening tests
Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics, biodegraded 80% after 28 days under the conditions of the study and is readily biodegradable.
Hydrocarbons, C9-C11, cyclics, <2% aromatics biodegraded to an extent of 53% after 28 days. The data support characterizing Hydrocarbons, C9-C11, cyclics, <2% aromatics as exhibiting moderate rate of biodegradation (inherently biodegradable).
A persistence (P) screening assessment has been realized for decane using EPI suite BIOWIN 2, 3 and 6 (v4.10) models, in accordance with Reach Guidance R.11. The Biowin 2 probability being 0.9908 > 0.5, and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months (value 3.4814 > 2.2), the criteria indicating that the substance does not biodegrade fast are not fulfilled. The Biowin 6 probability being 0.8691 > 0.5 and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months, the criteria indicating that the substance does not biodegrade fast are not fulfilled. So, the biodegradation prediction by BIOWIN does not lead to the conclusion that Decane would be persistent.
A persistence (P) screening assessment has been realized for undecane using EPI suite BIOWIN 2, 3 and 6 (v4.10) models, in accordance with Reach Guidance R.11. The Biowin 2 probability being 0.9888 > 0.5, and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months (value 3.4504 > 2.2), the criteria indicating that the substance does not biodegrade fast are not fulfilled. The Biowin 6 probability being 0.8718 > 0.5 and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months, the criteria indicating that the substance does not biodegrade fast are not fulfilled. So, the biodegradation prediction by BIOWIN does not lead to the conclusion that Undecane would be persistent.
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics biodegraded to an extent of 31% after 28 days and 41% after 41 days during a non-acclimated phase of the test. Hydrocarbons, C10-C12, isoalkanes, <2% aromatics biodegraded to an extent of 42% after 28 days and 48% after 41 days during an acclimated phase of the test.
Hydrocarbons, C10-C12, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. Hydrocarbons, C10-C12, isoalkanes, cyclics, <2% aromatics is not inherently biodegradable.
Hydrocarbons, C10-C13, isoalkanes, cyclics, <2% aromatics, biodegraded 89.8% after 28 days under the conditions of the study and is readily biodegradable.
Hydrocarbons, C10-C14, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. Hydrocarbons, C10-C14, isoalkanes, cyclics, <2% aromatics is not inherently biodegradable.
Hydrocarbons, C11-C12, n-alkanes, <2% aromatics biodegraded to an extent of approximately 77% after 28 days. The data support characterizing Hydrocarbons, C11-C12, n-alkanes, <2% aromatics as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics, a multi-component substance, biodegraded to an extent of 69% after 28 days. The data support characterizing Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
A persistence (P) screening assessment has been realized for dodecane using EPI suite BIOWIN 2, 3 and 6 (v4.10) models, in accordance with Reach Guidance R.11. The Biowin 2 probability being 0.9863 > 0.5, and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months (value 3.4194 > 2.2), the criteria indicating that the substance does not biodegrade fast are not fulfilled. The Biowin 6 probability being 0.8746 > 0.5 and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months, the criteria indicating that the substance does not biodegrade fast are not fulfilled. So, the biodegradation prediction by BIOWIN does not lead to the conclusion that Dodecane would be persistent.
Hydrocarbons, C12-C13, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. Hydrocarbons, C12-C13, isoalkanes, cyclics, <2% aromatics is not inherently biodegradable.
Hydrocarbons, C12-C16, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 22% after 28 days and 50% after 70 days. Hydrocarbons, C12-C16, isoalkanes, cyclics, <2% aromatics is not readily biodegradable, but can be considered inherently biodegradable.
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics, a multi-component substance, biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
Tridecane biodegraded to an extent of 83% after 28 days and 86% after 32 days. The data support characterizing tridecane as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C13-C14, n-alkanes, <2% aromatics biodegraded to an extent of approximately 79% after 28 days. The data support characterizing Hydrocarbons, C13-C14, n-alkanes, <2% aromatics as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C13-C15, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 16.95% after 24 days and 20.62% after 31 days. Hydrocarbons, C13-C15, isoalkanes, cyclics, <2% aromatics is not inherently biodegradable.
Tetradecane biodegraded to an extent of approximately 80% after 28 days and 38 days. The data support characterizing tetradecane as rapidly biodegradable (readily biodegradable).
A persistence (P) screening assessment has been realized for tetradecane using EPI suite BIOWIN 2, 3 and 6 (v4.10) models, in accordance with Reach Guidance R.11. The Biowin 2 probability being 0.9797 > 0.5, and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months (value 3.3574 > 2.2), the criteria indicating that the substance does not biodegrade fast are not fulfilled. The Biowin 6 probability being 0.8799 > 0.5 and the Biowin 3 ultimate biodegradation time frame being "days-weeks" < months, the criteria indicating that the substance does not biodegrade fast are not fulfilled. So, the biodegradation prediction by BIOWIN does not lead to the conclusion that Tetradecane would be persistent.
Biodegradation in water and sediment: simulation tests
Biodegradation in water
Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics, biodegraded to an extent of 69% after 28 days in seawater that used the indigenous microorganisms in the seawater sample as a sole source of the inoculum.
Hydrocarbons, C12-C14, isoalkanes, <2% aromatics biodegraded to an extent of 11% in sea water after 28 days.
Biodegradation in soil
In accordance with column 2 of REACH Annex IX, the simulation testing on ultimate degradation in soil does not need to be conducted as C9 -C14 Aliphatics (< 2% aromatics) are readily biodegradable. However, data is available from a Guideline (OECD 304 A) study conducted on Hydrocarbons, C11 -C14, n-alkanes, isoalkanes, cyclics, <2% aromatics and is presented below.
Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics, biodegraded to a great extent (>60%) in a silt loam soil at a rate comparable to the control, rapeseed oil (62 to 67%), within a two month test period as measured in respirometric oxygen consumption tests. The half-life, based on three tests was 45 days. This extent was replicated in two separate studies.
Additional information
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