Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitizing potential of sodium dibuthyldithiocarbamate (SDBC) in its manufactured and marketed form (as ca. 47% aqueous solution) was studied in a GLP-compliant mouse Local Lymph Node assay (LLNA). Groups of 5 female CDA/J mice were epidermally treated (25 μL/ear) with 10, 25 and 50% of the test substance (as manufactured) in DMF. The control group was treated with the same amount of vehicle only. Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine. After approximately five hours, all animals were sacrificed and the draining lymph node of each ear was excised to determine the number of desintegrations per minute (DPM) by scintillation counter. The stimulation indices (SI; ratio DPM for test group to DPM for control group) were determined for each dose level. The SI were 1.1, 2.4 and 7.7 for 10, 25 and 50% test concentrations, respectively, respectively, suggesting that sodium dibuthyldithiocarbamate is sensitizing to skin.


Migrated from Short description of key information:
Skin sensitizing potential of sodium dibuthyldithiocarbamate (SDBC) in its manufactured and marketed form (as ca. 47% aqueous solution) was studied in a GLP-compliant mouse Local Lymph Node assay (LLNA). The Stimulation Indices (SI) were 1.1, 2.4 and 7.7 for 10, 25 and 50% test concentrations of the substance (as manufactured) in dimethylformamide (DMF), respectively, suggesting that sodium dibutyldithiocarbamate is sensitizing to skin.

Justification for classification or non-classification

Based on the Stimulation Index of 7.7 for 50% test substance (as 46.2% aqueous solution) in Local Lymph Node Assay, classification of sodium dibutyldithiocarbamate as sensitizing to skin (Xi, R43) in accordance with Directive 67/548/EEC is suggested. In accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, it should be classified as Category 1, H317 (may cause an allergic skin reaction). It is obvious that pure substance should also be considered as a skin sensitizer and classified and labeled accordingly.