Sodium dibenzyldithiocarbamate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No data on skin sensitizing properties 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 it is considered to be acceptable and in fact more relevant to use skin sensitization data on the substance as manufactured.

The ability of sodium dibenzyldithiocarbamate (SBEC) in 16.9% aqueous solution to induce skin sensitization was studied in a local lymph node assay (LLNA) according to OECD guideline 429 and GLP (Notox B.V., 2001). The 25 μl of the test substance as 25%, 50% and 100% in DMF (dimethylformamide) was applied to the dorsal surface of each mouse ear on three consecutive days. The stimulation index (SI) values calculated for each concentration were 0.77, 0.47 and 0.53, respectively, indicating that the substance as manufactured (as ca. 17% aqueous solution) does not possess skin sensitizing properties. It should be noted that no conclusion on the skin sensitizing properties of the pure (anhydrous) substance can be made based on these data.

Migrated from Short description of key information:
No data are available on skin sensitizing properties 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 skin sensitization data on the substance as manufactured.
Based on the results of GLP-compliant OECD 429 Guideline study, the substance in its marketed form (as ca. 17% aqueous solution) is considered to be not sensitizing (stimulation index of 0.53 in LLNA test).

Justification for classification or non-classification

Based on the SI value of 0.53 obtained in the GLP-compliant LLNA assay for sodium dibenzyldithiocarbamate in its marketed form (as 16.9% aqueous solution), the substance should not be classified as skin sensitizer 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 these classification and labeling are not applicable for the isolated substance; however, as the substance is solely manufactured and marketed by the registrant as a saturated (ca. 17%) aqueous solution, the classification as reported above is considered to be acceptable.