Sodium diethyldithiocarbamate

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

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

Test material information

Constituent 1

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: ad libitum
- Water: 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)

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.

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