Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No data are available on acute toxicity of isolated (anhydrous) sodium diethyldithiocarbamate. However, as the substance is manufactured and marketed by the registrant solely as a saturated (ca. 26%) 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 sodium diethyldithiocarbamate (SDEC) was tested using 19.4% aqueous solution of the substance in a study with rats, resulting in the LD50 value of > 5000 mg/kg bw. Recalculated for 26% solution, this corresponds to LD50 > 3654 mg/kg bw. No data on dermal and inhalatory routes of exposure were available; however, this information is not required in accordance with the requirements of REACH Annex VII.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 654 mg/kg bw

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 diethyldithiocarbamate (SDEC).

No data on acute toxicity of isolated (anhydrous) sodium diethyldithiocarbamate are available. However, the substance is solely manufactured and marketed as a saturated aqueous solution (ca. 26% w/w) and it is not expected that exposure to pure substance may occur. Therefore for the risk assessment 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 sodium diethylcarbamate (SDEC) was tested using its 19.4% aqueous solution. LD50 values varying from 3350 and > 5000 mg/kg in rats and from 2000 to 2300 mg/kg in mouse have been reported in three different sources (Sumimoto Chemical Co., Ltd. 1977, Korablev 1965 and Rhone-Poulenc 1973). The most recent study of Sumimoto Chemical Co., Ltd., 1977 has been chosen as a key study. The test material was administered orally to a group of 10 males and 10 females at dose levels 1000, 2000, 3000, 4000 and 5000 mg/kg bw. After treatment the animals were observed for signs of intoxication during a 14-day period. Afterwards the animals were necropsied and LD50 value was calculated. There were no mortalities. At 1000 mg/kg bw, slight motor ataxia was observed. At 2000-3000 mg/kg bw, decrease of spontaneous motor activity, piloerection and irregular respiration were developed 30-60 minutes after administration and disappeared in 1-2 days. At 4000-5000 mg/kg, in addition to the above toxic symptoms, hind limb ataxia and dyspnea were noted. After 2-3 days all animals looked quite healthy again. The LD50 value for both male and female rats was determined to be > 5000 mg/kg bw. Considering that the tests have been performed with 19.4% aqueous solution, LD50 of > 970 mg/kg bw can be calculated for pure (anhydrous) SDEC based on these data. However, this value is meaningless in terms of classification and labeling and risk assessment, as the upper limit of LD50 is not known. Nevertheless, the obtained result indicate that LD50 of saturated (26%) aqueous solution will also be higher than the classification limit of 2000 mg/kg bw (recalculated LD50 for 26% solution is >3654 mg/kg bw). As the exposure to higher concentrations of pure substance are expected not to be possible, it is considered acceptable to use the available data for classification and labeling purposes.

No data on acute dermal and inhalation toxicity were available for assessment. However, in accordance with Column 2 of REACH Annex VII, these data are not required, as data on oral route are available.

Justification for classification or non-classification

Based on the acute oral LD50 of > 5000 mg/kg bw of 19.4% aqueous solution of sodium diethyldithiocarbamate, resulting in the calculated LD50 > 3654 mg/kg bw for 26% solution, the substance in its marketed form (as 26% solution) should not be classified as hazardous to health after acute oral exposure, according to the EU Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. It should be stated that this classification and labeling are not applicable for the isolated substance; however, as the substance is solely manufactured and marketed by the registrant as saturated (26%) aqueous solution, the classification as reported above is considered to be acceptable.