Registration Dossier
Registration Dossier
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EC number: 259-587-9 | CAS number: 55310-46-8
Endpoint summary
Administrative data
Description of key information
No data are available on acute toxicity of isolated (anhydrous) sodium dibenzyldithiocarbamate. However, as the substance is manufactured and marketed by the registrant solely as a saturated (ca. 17%) aqueous solution, an exposure to pure substance is not expected to be possible. Therefore for the risk assessment purposes it is considered to be acceptable and in fact more relevant to use acute toxicity data on the substance as manufactured.
Acute oral toxicity of 16.9% aqueous solution of sodium dibenzyldithiocarbamate is low (LD50 > 2000 mg/kg bw ), based on the study with rats performed in accordance with OECD 401 and GLP.
Key value for chemical safety assessment
Additional information
As the substance is manufactured and marketed in amounts 1-10 tonne per year, the requirements of REACH Annex VII apply. Therefore only data on acute toxicity by oral route are required for sodium dibenzyldithiocarbamate (SBEC).
No data on acute toxicity of isolated (anhydrous) sodium dibenzyldithiocarbamate are available. However, the substance is solely manufactured and marketed by the registrant as a saturated aqueous solution (ca. 17% w/w) and it is not expected that exposure to pure substance is possible. Therefore for the risk assessment purposes it is considered to be acceptable and in fact more relevant to use acute toxicity data on the substance as manufactured.
Acute toxicity of SBEC in 16.9% aqueous solution was studied in a GLP-compliant acute oral toxicity study with rats (Life Science Research Ltd, 1992a), performed in accordance with OECD guideline 401. Rats were administered a limit dose of 2000 mg/kg bw of 16.9% solution of sodium dibenzyldithiocarbamate by gavage, using water as a vehicle. Signs of reaction to treatment included lethargy, underactivity, staggering gait, clonic convulsions, bradypnoea, hyperpnoea, piloerection and hunched posture on the day of dosing. All animals were overtly normal two days later. No significant macroscopic lesions were noted at gross pathology. The acute oral LD50 value of 16.9% aqueous solution was determined to exceed 2000 mg/kg bw, based on the results of this study. If this value is recalculated for the anhydrous sodium dibenzyldithiocarbamate, using 16.9% concentration, this corresponds to LD50 of > 338 mg/kg bw/day. However, this value has no practical meaning, as it does not indicate the upper limit of LD50 for the isolated substance. As only exposure to the solution may occur, the acute toxicity data on the solution shall be used for classification and labelling purposes.
Justification for classification or non-classification
Based on the acute oral LD50 of > 2000 mg/kg bw for 16.9% aqueous solution of sodium dibenzyldithiocarbamate, the substance in its marketed form (as ca. 17% solution) should not be classified as hazardous to health after acute oral exposure, according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. It should be stated that this classification and labelling are not applicable for the isolated substance; however, as the substance is solely manufactured and marketed as saturated (ca. 17%) aqueous solution, the classification as reported above is considered to be acceptable.
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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