Registration Dossier

Diss Factsheets

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:
1983
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

Constituent 1
Chemical structure
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

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:
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 clinical signs noted were lethargy, lacrimation, dyspnea, salivation, ruffled coat, rhinorrhea, hunched gait and to a lesser part also diarrhea, ataxia and scrotal irritation.
Body weight:
Effect of the test article on 7-day weight gain appeared to be dose-related.
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