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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, predates GLP, minor restrictions, but adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium diethyldithiocarbamate
EC Number:
205-710-6
EC Name:
Sodium diethyldithiocarbamate
Cas Number:
148-18-5
Molecular formula:
C5H11NS2.Na
IUPAC Name:
sodium (diethylcarbamothioyl)sulfanide

Test animals

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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1°C
- Humidity (%): 60 ± 10% R.H.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
Doses:
1000, 2000, 3000, 4000 and 5000 mg/kg
No. of animals per sex per dose:
a group of 10 males and 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
No data

Results and discussion

Effect levels
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 substance it corresponds to LD50 > 970 mg/kg bw.
Mortality:
No death observed.
Clinical signs:
At 1000 mg/kg: Slight motor ataxia were observed.
At 2000-3000 mg/kg: At 30-60 minutes after administration, decrease of spontaneous motor activity, piloerection, irregular respiration were developed, 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.
Body weight:
No data
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.

Applicant's summary and conclusion