Registration Dossier
Registration Dossier
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EC number: 204-875-1 | CAS number: 128-03-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Potassium dimethyldithiocarbamate
- EC Number:
- 204-875-1
- EC Name:
- Potassium dimethyldithiocarbamate
- Cas Number:
- 128-03-0
- Molecular formula:
- C3H7NS2.K
- IUPAC Name:
- potassium (dimethylcarbamothioyl)sulfanide
- Details on test material:
- - Name of test material (as cited in study report): Busan 85
- Physical state: Yellow-green coloured liquid
- Analytical purity: 50% KDDC
- Lot/batch No.: 2-7728
- Stability under test conditions: Stable for at least one year
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York
- Age at study initiation: 10-14 weeks
- Weight at study initiation: ♂: 170-220 g; ♀: 136-190 g
- Fasting period before study: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 159, 182, 195, 209, 240, 275 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 1585, 1820, 1950, 2089, 2399, 2754 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observations for death or overt signs of toxicity: 2 hours-intervals on the day of dosing, thereafter once daily for fourteen days
Body weights: prior to dosing, weekly thereafter and at sacrifice Necropsy: at scheduled sacrifice - Statistics:
- LD50 was determined using Statistical Analysis System (SAS) PROBIT procedure
Results and discussion
- Preliminary study:
- 5/5 males and 5/5 females died after administration of 5000 mg/kg.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 030 mg/kg bw
- 95% CL:
- 1 884 - 2 184
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 196 mg/kg bw
- 95% CL:
- 1 888 - 2 485
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 867 mg/kg bw
- 95% CL:
- 1 713 - 2 054
- Mortality:
- see Table below
- Clinical signs:
- other: At doses above and including 2754 mg/kg bw, Busan 85 caused death in all animals, while all females died at doses above and including 1995 mg/kg bw. Some of the animals dying acutely were noted as having muscular spasm, tremor or convulsion. Other clinic
- Gross pathology:
- The major finding at necropsy in the acutely died animals included a reddish fluid in the stomach, reddening of the gastric mucosa and pulmonary congestion.
Applicant's summary and conclusion
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