Registration Dossier
Registration Dossier
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EC number: 204-820-1 | CAS number: 127-06-0
Endpoint summary
Administrative data
Description of key information
Additional information
Stability in the environment:
In accordance with Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), information regarding phototransformation in air, as well as in water and soil, is not mandatory.
Reliable measured hydrolysis study for acetone oxime and the analogue, butanone oxime is available and included in the dossier. Environment Canada (2010) published data regarding the hydrolysis of the analogue substance, butanone oxime. The information shows that the analogue, butanone oxime is degraded by 14% over a 4 -day window at a pH of 7 and a temperature of 20oC due to hydrolysis. The half-life was determined to be 18.5 days. Consequently, this study result will be taken for hydrolysis endpoint.
Biodegradation:
A reliable measured biodegradation study in water for acetone oxime is available and included in the dossier. Reliable studies on the biodegradation in sediment and soil are not available, however a waiver is applied for these endpoints.
A reliable (Klimisch 1) biodegradation study has been conducted for acetone oxime and is included in this dossier. The key study, Bayless (2012), determined that acetone oxime is not readily biodegradable. Consequently this study will be taken for the biodegradation in water endpoint.
Waiver. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2, 9.2.1.3 and 9.2.1.4 respectively) do not need to be conducted as direct or indirect exposure of surface water, soil and sediment is unlikely.The chemical safety assessment does not indicate any need to investigate further the degradation of the substance and its degradation products. Also, the substance’s low hydrophilicity is demonstrated by the very low log octanol-water partition coefficient (Log Kow) of 0.077 at a neutral pH and low Koc (0.517) indicating low adsorptive potential. Therefore, no additional degradation testing is necessary based on unlikely exposure. Identification of degradation products (required in Section 9.2.3) is also not necessary.
Bioaccumulation:
Reliable measured bioconcentration in fish information is not available for acetone oxime. However, reliable measured bioconcentration data is available for the analogue, butanone oxime, and is included in the dossier. Ministry of Economic Trade and Industry of Japan (METI) (1982) conducted a reliable (Klimisch 2) GLP compliant study following OECD 305C method. The common carp (Cyprinus carpio) were exposed to 0.2 and 2 mg/L of butanone oxime for 42 days. The measured BCF range for the 0.2 mg/L exposure was 2.8-5.8. The measured BCF range for the 2.0 mg/L exposure was 0.5-0.6. Therefore, these values will be taken for the bioaccumulation in fish endpoint. Based on results of this study and the measured low log Kow of 0.077, bioaccumulation of the test substance is not expected.
In accordance with Column 2 of REACH annex IX, the bioaccumulation test on terrestrial organisms need not be conducted if the substance has a low potential for bioaccumulation (for instance a log Kow <3) and/or a low potential to cross biological membranes or if direct and indirect exposure of the aquatic compartment is unlikely. The partition coefficient of acetone oxime was determined in a reliable study (Walker 2012) where the measured Kow is 0.077. Therefore, acetone oxime is considered to have low potential for bioaccumulation. No further testing is required.
Transport and distribution:
Waiver. In accordance with column 2 of REACH Annexes XIII, the adsorption / desorption study (required in section 9.3.1 and 9.3.3) do not need to be conducted if, based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient). Reliable measured data for absorption are not available for acetone oxime. However, reliable modelled data are available and included in the dossier. The European Union System for the Evaluation of Substances (EUSES) model was used to estimate adsorption for acetone oxime. Using the measured log Kow of 0.077, a Koc of 0.517 was estimated
Waiver. In accordance with the REACH Regulations, determination of Henry’s Law constant is not a standard information requirement.
Waiver. In accordance with the REACH Regulations distribution is not a standard information requirement
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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