Registration Dossier
Registration Dossier
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EC number: 259-587-9 | CAS number: 55310-46-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No data on genotoxocity of sodium dibenzyldithiocarbamate (SBEC) were available for assessment. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across.
GLP-compliant Ames tests, performed in accordance with OECD Guideline 471 and EPA OTS 798.5265 Guideline, are available for two structural analogues of sodium dibenzyldithiocarbamate, namely zinc bis(dibenzyldithiocarbamate) (ZBEC) and sodium dibutyldithiocarbamate (SDBC) (Life Science Research, 1990a and 1990b). The former substance is a zinc salt of the same dibenzylcarbamodithioic acid, while the latter compound is a sodium salt of a dibutylcarbamodithioic acid, which contains butyl instead of benzyl substituents at the amine function of dithiocarbamate moiety.
In both tests, the ability of the substance to induce gene mutation in bacteria with and without metabolic activation was studied in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at test concentrations 50, 158, 500, 1580 and 5000 µg per plate, using DMSO (ZBEC) and distilled water (SDBC) as a vehicle. In the study with ZBEC, inhibition of growth, observed as reduction in revertant colony numbers, occurred in all strains on at least one occasion of testing following exposure to the test substance at 5000 µg per plate, and in strain TA 100 at concentration 1580 µg per plate. In the test with SDBC, thinning of the background lawn was evidenced in the preliminary test at a dose level of 5000 μg per plate. In both cases, the test substance did not lead to the increase in the number of revertants in any strain both in the presence and absence of metabolic activation, indicating that both compounds are negative in Ames test. Based on these results, SBEC is considered to be not mutagenic in Ames test.
Short description of key information:
Based on the read-across with the structural analogues zinc bis(dibenzyldithiocarbamate) (ZBEC) and sodium dibutyldithiocarbamate (SDBC), sodium dibenzyldithiocarbamate (SBEC) is not genotoxic in Ames test.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the negative Ames test with the structural analogues of sodium dibenzyldithiocarbamate (SBEC), zinc bis(dibenzyldithiocarbamate) (ZBEC) and sodium dibutyldithiocarbamate (SDBC), classification for genetic toxicity is not warranted in accordance with EU Directive 67/548/EEC andEU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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