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EC number: 205-710-6 | CAS number: 148-18-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
19.4% sodium diethyldithiocarbamate (SDEC)LD50 > 5000 mg/kg bw
Calculation based on the above:
26% aqueous solution SDEC LD50 > 3654 mg/kg bw
Anhydrous SDEC LD50 > 970 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- The test material was administered orally to a group of 10 males and 10 females in one single dose of 10 to 50 mL per kg body weight without dilution.
After treatment the animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors and LD50 value was calculated. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Experimental Animals, Shizuoka.
- Age at study initiation: 7-week old
- Weight at study initiation: 230-260 g (males); 180-210 g (females)
- Housing: 10 animals per cage
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1°C
- Humidity (%): 60 ± 10% R.H. - Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 1000, 2000, 3000, 4000 and 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes - Statistics:
- No data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: The value is determined for 19.4% solution of the substance; recalculated for pure SDEC and its 26% aqueous solution it corresponds to LD50 > 970 and >3654 mg/kg bw, respectively.
- Mortality:
- No death observed.
- Clinical signs:
- other:
- Gross pathology:
- No remarkable changes were found in any groups of the test animals.
- Other findings:
- No sex difference was observed in type, intensity and duration of the toxic symptoms.
- Conclusions:
- The acute oral LD50 of 19.4% aqueous solution SDEC was calculated to be >5000 mg/kg. This corresponds to >970 and >3654 mg/kg bw for the anhydrous SDEC and it 26% aqueous solution.
- Executive summary:
In this acute oral toxicity study, 19.4% aqueous solution of SDEC was administered orally to a group of 10 males and 10 female Sprague Dawley rats (per dose) at levels of 1000, 2000, 3000, 4000 and 5000 mg/kg bw. After treatment the animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors and LD50 value was calculated. No mortality was seen. At 30 to 60 minutes after administration (at 2000 mg/kg and above), a decrease of spontaneous motor activity, piloerection, and irregular respiration were developed, and disappeared in 1-2 days. In addition to the above toxic symptoms, hind limb ataxia and dyspnea were noted at the two highest dose levels. After 2-3 days all animals looked quite healthy again. No remarkable changes were observed in any groups of the test animals at the autopsy. The acute oral LD50 was calculated to be >5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 970 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- > 3 654
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.
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.
Potential risks associated with exposure to either the anhydrous form or the 26% aqueous solution of SDEC were assessed based on the data with the 19.4% solution. Acute oral toxicity of sodium diethyldithiocarbamate 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 a 26% solution, this corresponds to LD50 > 3654 mg/kg bw. Recalculated for the anhydrous form this results to an LD50 > 970 mg/kg bw.
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 the 26% solution, classification for the substance in its marketed form (as 26% solution) as hazardous to health after acute oral exposure is not warranted following the (CLP) Regulation (EC) No. 1272/2008. However, as safety precaution the 26% solution will be given the same classification for acute oral toxicity as its anhydrous form. The anhydrous is classified as Acute Tox. 4, H302, based on the recalculation of the LD50 results (> 970 mg/kg bw).
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