Registration Dossier
Registration Dossier
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EC number: 233-593-1 | CAS number: 10254-57-6
Endpoint summary
Administrative data
Description of key information
The solubility of the test item in the buffer solutions at pH 4.0, pH 7.0 and pH 9.0 was very low, therefore, no further testing could be performed on the substance (RCC Ltd, 2007), therefore, no hydrolysis result can be provided and further testing is waived.
Additional information
Hydrolysis:
In an OECD 111 study conducted to GLP, the solubility of methylene bis(dibutyldithiocarbamate) in the buffer solutions pH 4.0, pH 7.0 and pH 9.0 was very low. It was not possible to increase the solubility of the test substance with the use of different solubilizers (acetone, acetonitrile and ethanol). Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.
According to the EEC Directive 92/69 Section C.7, the method is applicable only to water soluble substances. The test item shows no significant solubility in the different solvent systems. Therefore, no further testing could be performed on the substance at pH 4, pH 7 and pH 9. (RCC Ltd, 2007).
According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006 a Hydrolysis study can be waivered if the substance is highly water insoluble. In an OECD 111 study it was not possible to increase the solubility (0.247 mg/l) of methylene bis(dibutyldithiocarbamate) with the use of different solvents, therefore, no hydrolysis result can be provided and further testing is waived.
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