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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
Sub-chronic 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. Recalculated for anhydrous substance, this corresponds to 332 mg/kg bw/day, respectively.
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 1019 mg/kg bw/day, respectively.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic 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:
- Subchronic feeding study was conducted to estimate the maximum tolerated dose (MTD) of sodium diethyldithiocarbamate. Groups of five rats of each sex were fed diets containing sodium diethyldithiocarbamate trihydrate at doses 1250, 2500, 5000, 10000, 20000 and 40000 ppm. The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation. At the end of the study, all animals were killed and necropsy and histopathological examinations were performed.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NCI Frederick Cancer Research Center animal farm (Frederick, Md.).
- Age at study initiation: 6 weeks
- Weight at study initiation: males 90 to 105 g, average at least 100 g; females 80 to 95 g, average at least 90 g
- Housing: polycarbonate cages (Lab Products Inc., Gar field, N.J.), 19 x 10-1/2 x 8 inches
- Diet: presterilized Wayne Sterilizable Lab Meal, provided ad libitum in suspended stainless steel hoppers and replenished at least three times per week
- Water: acidified to pH 2.5, supplied a£ libitum from glass bottles
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24
- Humidity (%): 45 to 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet: every 1 to 1-1/2 weeks in 6- to 12-kg batches
- Mixing appropriate amounts with: known weight of the chemical was first mixed with an equal weight of autoclaved Wayne Sterilizable Lab Meal with 4% fat (Allied Mills, Inc., Chicago, 111.), using a mortar and pestle. The mixing was continued with second and third additions of feed, and final mixing was performed with the remaining quantity of feed for a minimum of 15 minutes in a Patterson-Kelly twin-shell blender.
- Storage temperature of food: 5 °C - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 7 weeks, followed by 1 week post-treatment observation
- Frequency of treatment:
- Daily
- Dose / conc.:
- 1 250 ppm
- Dose / conc.:
- 2 500 ppm
- Dose / conc.:
- 5 000 ppm
- Dose / conc.:
- 10 000 ppm
- Dose / conc.:
- 20 000 ppm
- Dose / conc.:
- 40 000 ppm
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
-
BODY WEIGHT: Yes
- Time schedule for examinations: twice a week
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Ten percent depression in body weight was the major criterion for estimation of MTD's. The doses required to produce this response were determined by the following procedure: first, least squares regressions of mean body weights versus days on study were used to estimate mean body weights of each of the dosed groups at day 49. Next, probits of the percent weights of dosed groups at day 49 relative to weights of corresponding control groups were plotted against the logarithms of the doses, and least squares regressions fitted to the data were used to estimate the doses required to induce 10% depression in weight.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 425 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: The amount in mg/kg bw/day was calculated based on the test substance concentration in diet of 5000 ppm using the default values according to the report of Paulussen at al. (TNO report V98.390, 1998).
- Dose descriptor:
- NOAEL
- Effect level:
- 332 mg/kg bw/day (actual dose received)
- Based on:
- other: anhydrous substance
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: The amount in mg/kg bw/day was calculated based on the test substance concentration in diet of 5000 ppm using the default values according to the report of Paulussen at al. (TNO report V98.390, 1998).
- Critical effects observed:
- not specified
- Conclusions:
- The NOAEL of SDEC trihydrate after repeated dosing in the rat is 425 mg/kg bw/d, which corresponds to a NOAEL of 332 mg/kg bw of anhydrous SDEC.
- Executive summary:
In a subchronic feeding study with SDEC, groups of five Fischer 344 rats of each sex were fed diets containing SDEC trihydrate at doses 1250, 2500, 5000, 10000, 20000 and 40000 ppm. The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation. At the end of the study, all animals were killed and necropsy and histopathological examinations were performed. Effects were seen in the body weight of animasl due to treatment. A 10% depression in body weight was used for the estimation of the maximum tolerated dose (MTD) of SDEC. In the histopathology examination a very slight increase in splenic hematopoiesis and a very small amount of vacuolation of renal tubular epithelium were noted at 10000 ppm and above. Based on this the NOAEL of this study for SDEC trihydrate was 425 mg/kg bw (5000 ppm), while the respective NOAEL for the anhydrous SDEC is 332 mg/kg bw/d.
- Endpoint:
- sub-chronic 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:
- Subchronic feeding study was conducted to estimate the maximum tolerated dose (MTD) of sodium diethyldithiocarbamate. Groups of five mice of each sex were fed diets containing sodium diethyldithiocarbamate trihydrate at doses 2500, 5000, 6000, 8000 and 10000 ppm. The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation for male mice; for female mice the period of administration of the test chemical was 12 weeks. At the end of the study, all animals were killed and necropsy and histopathological examinations were performed.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NCI Frederick Cancer Research Center animal farm (Frederick, Md.).
- Age at study initiation: 6 weeks
- Weight at study initiation: males 18 to 22 g, averating at least 19.5 g; females 17 to 21 g, averaging at least 18.5 g
- Housing: polycarbonate cages (Lab Products Inc., Gar field, N.J.), 11-1/2 x 7-1/2 x 5 inches
- Diet: presterilized Wayne Sterilizable Lab Meal, provided ad libitum in suspended stainless steel hoppers and replenished at least three times per week
- Water: acidified to pH 2.5, supplied ab libitum from glass bottles
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24
- Humidity (%): 45 to 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet: every 1 to 1-1/2 weeks in 6- to 12-kg batches
- Mixing appropriate amounts with: known weight of the chemical was first mixed with an equal weight of autoclaved Wayne Sterilizable Lab Meal with 4% fat (Allied Mills, Inc., Chicago, 111.), using a mortar and pestle. The mixing was continued with second and third additions of feed, and final mixing was performed with the remaining quantity of feed for a minimum of 15 minutes in a Patterson-Kelly twin-shell blender.
- Storage temperature of food: 5 °C - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 7 weeks, followed by 1 week post-treatment observation for male mice; 12 weeks for female mice
- Frequency of treatment:
- Daily
- Dose / conc.:
- 2 500 ppm
- Dose / conc.:
- 5 000 ppm
- Dose / conc.:
- 6 000 ppm
- Dose / conc.:
- 8 000 ppm
- Dose / conc.:
- 10 000 ppm
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
-
BODY WEIGHT: Yes
- Time schedule for examinations: twice a week
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Ten percent depression in body weight was the major criterion for estimation of MTD's. The doses required to produce this response were determined by the following procedure: first, least squares regressions of mean body weights versus days on study were used to estimate mean body weights of each of the dosed groups at day 49. Next, probits of the percent weights of dosed groups at day 49 relative to weights of corresponding control groups were plotted against the logarithms of the doses, and least squares regressions fitted to the data were used to estimate the doses required to induce 10% depression in weight.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 305 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No effects observed at the highest dose tested. The amount in mg/kg bw/day was calculated based on the test substance concentration in diet of 10000 ppm using the default values according to the report of Paulussen at al. (TNO report V98.390, 1998).
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 019 mg/kg bw/day (actual dose received)
- Based on:
- other: anhydrous substance
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No effects observed at the highest dose tested. The amount in mg/kg bw/day was calculated based on the test substance concentration in diet of 10000 ppm using the default values according to the report of Paulussen at al. (TNO report V98.390, 1998).
- Critical effects observed:
- not specified
- Conclusions:
- The NOAEL of SDEC trihydrate after repeated dosing in the mouse is 1305 mg/kg bw/d (10000 ppm), which corresponds to a NOAEL of 1019 mg/kg bw of anhydrous SDEC.
- Executive summary:
In a subchronic feeding study with SDEC, groups of five B6C3F1 mice of each sex were fed diets containing SDEC trihydrate at doses 2500, 5000, 6000, 8000 and 10000 ppm. The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation. For female mice the period of administration of the test chemical was 12 weeks. At the end of the study, all animals were killed and necropsy and histopathological examinations were performed. No effects of any toxicological significance were seen up until and including the highest dose level. Therefore, the NOAEL of this study for SDEC was 1305 mg/kg bw (10000 ppm), while the respective NOAEL for the anhydrous SDEC is 1019 mg/kg bw/d.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 425 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- NTP studies
Additional information
Two sub-chronic 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
Classification of sodium diethyldithiocarbamate is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. This is considered to be applicable to both substance in its manufactured and marketed form (as 26% aqueous solution) and to the anhydrous substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.