Registration Dossier
Registration Dossier
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EC number: 469-110-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Hydrolysis:
The hydrolysis study was not performed because the study was not technically feasible.
Biodegradability:
2 Screening tests were performed for ready biodegradation in water:
OECD 301 B: "Ready Biodegradability: CO2 Evolution Test
OECD 310: CO2 in Sealed Vessels (Headspace Test). The rationale for performing the OECD 310 instead of the enhanced ready biodegradability (ISO 10634 and modifications by Handley et al.) was discussed in a letter to the Dutch CA (attached to the dossier).
Both tests resulted in the test substance being not readily biodegradable.
The results of these tests, however, cannot be interpreted because the tested concentrations were far above the maximum water solubility. Thus, in view of lack of the optimal contact between the test substance and the medium in the test, no definitive conclusions can be drawn with respect of biodegradability of the test substance.
The QSAR BIOWIN was run to get supplementary information on biodegradability. QSAR's run on both components of the test substance revealed that the the Boethling criteria for ready biodegradation predicted not readily biodegradable whereas the MITI models predicted readily degradability of the substance. No conclusive evidence on the ready biodegradation was possible, but all estimations indicated that the substance biodegrades fast.
Thus, definitive conclusions with regard to ready biodegradation cannot be drawn from the non-interpretable and non-conclusive results. The substance, however, is deemed to biodegrade fast.
Bioaccumulation:
No experimental data is available for the registered substance. However, based on the high log Kow value (estimated logKow >10) and based on the Guidance document on PBT assessment R.11, this high logKow predicts the aquatic BCF value to be below the threshold value for vB (5000 L/kg) and B (2000 L/kg). Therefore, the substance would be considered to have an expected low bioavailability and thus a limited bioaccumulation potential.
In order to confirm this consideration, an analogue was found with a very low experimental BCF.
This analogue was considered appropriate for read-across and probably worst case for bioconcentration than the registered substance (lower MW and thus expected higher bioavailability). It is therefore deemed appropriate to use the bioconcentration data of this analogue to evaluate the bioaccumulation potential of the registered substance.
The low potential for bioaccumulation was additionally confirmed by the result of the QSAR from EPIWEB 4.0 run on the main component of the registered substance.
All information above can be combined in a weight-of-evidence that the registered substance is deemed to have limited bioaccumulation potential.
Adsorption/desorption:
In a study according to OECD 121 and EC C.19 test guidelines, the adsorption/desorption potential of AD-1000 in soil was determined with a HPLC estimation method. The substance eluted after the reference substance. Therefore, the Koc and log Koc value of AD-1000 are determined to be higher than the Koc and log Koc of the reference substance: (neutral pH) Koc > 4.3 x 10^5 log Koc > 5.6.
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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