Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Stability
Hydrolysis
According to 9.2.2.1. Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the hydrolysis of a substance does not need to be conducted if the substance water solubility is below 0.1mg/L at 20°C. The registered substance has a water solubility of less than 0.0506 mg/L, therefore, this endpoint is waived.
Biodegradation
Biodegradation in water: screening test
In a study conducted according to OECD 301B, under GLP conditions, the test material attained 26% degradation after 28 days and, therefore, is not readily biodegradable.
Biodegradation in water and sediment
In an OECD 308 study, conducted according to GLP, the test material dissipated rapidly from the water of both aquatic sediment systems, with DT50 values of 2.6 days (Calwich Abbey Lake) and 10.4 days (Emperor Lake). The DT50 value in the sediment phase of Calwich Abbey Lake was 811 days, based on two sampling intervals. The DT50 value for the decline in the sediment phase of Emperor Lake could not be calculated, as the test material (as % applied parent) continued to increase until the last sampling interval. Decline in the overall aquatic sediment system was slow and corresponded to DT50 values of 657 days (Calwich Abbey Lake) and 636 days (Emperor Lake).
Due to the low solubility of the test material and rapid partitioning from the aqueous phase to the sediment, aerobic mineralisation in surface water – simulation biodegradation testing according to OECD Testing Guideline No. 309 is considered technically not feasible.
Biodegradation in soil
In an OECD 307 study, conducted according to GLP, the mean distribution and recovery of radioactivity ranged from 99.7 to 106.2% AR in Cuckney soil, 93.9 to 103.4% AR in Drayton soil, 97.6 to 107.2% AR in Elmton soil, and 95.2 to 106.2% AR in Calke soil. Low levels of radioactivity were detected in the bound residues (mean values =10.6% applied radioactivity) and mean mineralization of the test item to CO2 was less than or equal to 0.9% applied radioactivity. There was little or no evidence for degradation of test material in soil at 12 +/- 2 deg C and pF2, under aerobic conditions, and kinetic analysis of the data was therefore considered inappropriate.
Bioaccumulation
Bioaccumulation
No experimental study on bioaccumulation is available on the registered substance.
To address the bioaccumulation endpoint a QSAR assessment, using the Estimation Programs Interface (EPI) SuiteTM BCFBAF v3.01, was completed as part of a weight of evidence approach on the primary constituent of the test material and an appropriate read across substance stearyl erucamide (CAS 10094-45-8) with is structurally similar to the registered substance. These substances are expected to be metabolised by fatty acid amide hydrolase and esterases. Any differences among the substance structures are not expected to result in any significant differences in their environmental behaviour.
Primary constituent: The BCF was predicted to be 381.4 L/kg ww by BCFBAF v3.01 (EPISUITE, 2013).
Stearyl erucamide: The BCF of stearyl erucamide was predicted to be 113.1 L/kg ww by BCFBAF v3.01 (EPISUITE, 2013).
Based on the above information, as a worst case example, the primary constituent presented the highest BCF value of 381.4 L/kg ww. This value has therefore been used to represent the bioaccumulation potential of the registered substance.
Considering that the applicability domain of the QSAR is not fulfilled for both substances, a bioacumulation test on fish is proposed according the TG OECD 305 - III. Based upon the estimated BCF of 381.4 L/kg ww, the registered substance remain not expected to bioaccumulate in the environment.
Transport and Distribution
Adsorption/desorption
In a study conducted according to TG OECD 121, under GLP conditions, the adsorption coefficient (Koc) of the test material is greater than 4.27 x 105, resulting in a log Koc > 5.63, based on the reference standard with the highest log Koc tested. This value indicates that the test material is immobile in soil.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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