Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Subchronic toxicity studies with rats and mice were avalable for assessment with sodium diethyldithiocarbamate trihydrate, which were performed as a part of carcinogenicity study. In the study with rats, NOAEL was 425 mg/kg bw/day, based on a very slight increase in splenic hematopoiesis and a very small amount of vacuolation of renal tubular epithelium. In the study with mice, no effects were observed at the highest tested dose, resulting in NOAEL of 1305 mg/kg bw/day. Recalculated for anhydrous substance, this corresponds to 332 and 1019 mg/kg bw/day, respectively.

Key value for chemical safety assessment

Additional information

Two subchronic toxicity with mice and rats, performed as dose range-finding studies for the NTP carcinogenicity assay (NTP, 1979), were available for assessment. Groups of five rats and mice of each sex were fed diets containing sodium diethyldithiocarbamate (SDEC) in its trihydrate form at dose levels of 1250, 2500, 5000, 10000, 20000 and 40000 ppm for rats and 2500, 5000, 6000, 8000 and 10000 ppm for mice. Groups of five control animals of each species and sex were administered basal diet only. The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation for rats and male mice; for female mice the period of administration of the test chemical was 12 weeks. Each animal was weighed twice per week. The studies were conducted to estimate the maximum tolerated doses of sodium diethyldithiocarbamate, with 10% depression in body weight being the major criterion for estimation of MTD's. At the end of the subchronic studies, all animals were killed and necropsied. In the rat study, a NOAEL of 5000 ppm, corresponding 425 mg/kg bw/day (value calculated using the default values according to the report of Paulussen at al. (TNO report V98.390, 1998)) was established, based on a very slight increase in splenic hematopoiesis and a very small amount of vacuolation of renal tubular epithelium. Recalculated for anhydrous substance, this results in NOAEL of 332 mg/kg bw/day. No lesions related to the test chemical were observed in male and female mice at the highest dose level, resulting in NOAEL of 1305 mg/kg bw/day. Recalculated for anhydrous substance, this results in NOAEL of 1019 mg/kg bw/day.

Justification for classification or non-classification

Based on the calculated NOAEL of 332 mg/kg bw/day for the anhydrous substance, which is higher than the cut-off value of 50 mg/kg bw/day established for subchronic studies by EU Directive 67/548/EEC, classification of sodium diethyldithiocarbamate is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. This classification is considered to be applicable to both substance in its manufactured and marketed form (as 26% aqueous solution) and to the anhydrous substance.