Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Endpoint summary
Administrative data
Description of key information
Additional information
Stability of HMBDA 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.
No data are available on hydrolysis of HMBDA its constituents or constituent classes. In Annex VIII column 2 of the REACH Regulation, it is suggested, that a study on the "Hydrolysis as function of pH" does not need to be conducted if the “substance is highly insoluble". Therefore, a study on the "Hydrolysis as function of pH" does not have to be conducted for HMBDA.
Biodegradation of HMBDA:
A reliable measured biodegradation study for HMBDA is available and included in the dossier. A reliable study by Penwell and Roberts (1994) showed that HMBDA did not degraded in 28 days and is therefore, the substance is considered not readily biodegradable. Consequently, this study will be taken as the biodegradation endpoint for HMBDA.
Waiver. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water and the sediment simulation test (required in Sections 9.2.1.2 and 9.2.1.4 respectively) and soil simulation test (required in Sections 9.2.1.3) do not need to be conducted as direct or indirect exposure of sediment is unlikely. Exposure potential is expected to be minimal as the substance is an intermediate product and manufactured and utilized only at one location in the EU and handled under strictly controlled conditions. Also, the substance’s low hydrophilicity is demonstrated by the very low log octanol-water partition coefficient (Log Kow) of 0.465 at a neutral pH. The solubility of HMBDA has also been determined to be very low, making testing difficult. Therefore, no testing is necessary based on minimal exposure and low solubility. Identification of degradation products (required in Section 9.2.3) is also not necessary.
Bioaccumulation of HMBDA:
Measured bioconcentration information is not available for HMBDA, therefore a waiver is applied.
In accordance with Column 2 of REACH annex IX, the bioaccumulation test on fish 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. The partition coefficient of HMBDA was determined in a reliable study (Kennedy 1994) where the measured Kow is 0.465. Therefore, HMBDA is considered to have low potential for bioaccumulation and no further testing is required.
Transport and distribution of HMBDA:
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). The partition coefficient of HMBDA was determined in a reliable study (Kennedy 1994) where the measured log Kow is 0.465. Therefore, HMBDA is considered to have low potential for absorption and no further testing is required.
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
