Sodium dibenzyldithiocarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliance OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(a) Test substance characterisation and stability not developed in accordance with the standard. (b) Stability, homogeneity and achieved concentrations not confirmed by chemical analysis.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dibenzyldithiocarbamate

EC Number:

259-587-9

EC Name:

Sodium dibenzyldithiocarbamate

Cas Number:

55310-46-8

Molecular formula:

C15H15NS2.Na

IUPAC Name:

sodium (dibenzylcarbamothioyl)sulfanide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England.
- Age at study initiation: approximately 5 weeks old
- Weight at study initiation: 96-107 grams (males), 107-109 grams (females)
- Fasting period before study: 18 hours before administration of test material
- Housing: 5 animals of the same sex per cage
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 34-56% R.H.
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod: 12 hrs dark / 12 hrs artificial light per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test material was prepared at the appropriate concentration in purified water (obtained by the reverse osmosis of tap water). The dosage was calculated and expressed gravimetrically in terms of the material as received. A fresh formulation of the test material was prepared on the morning of administration and any surplus remaining after dosing was destroyed on the same day.
On the basis of the results of a preliminary study, the main study was carried out using a single group of five male and five female rats given a single oral administration of Perkacit SBEC at the maximum practicable dosage of 2000 mg/kg (Regulatory limit test), at a volume-dosage of 20 ml/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

a single group of 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3 separate inspections during the first hour after dosing and two further inspections during the remainder of Day 1. From Day 2, animals inspected twice daily. The body weight of each animals recorded on the day before dosing and on Days 1, 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: The value is determined for 16.9% solution of the substance; recalculated for pure substance it corresponds to LD50 > 338 mg/kg bw.

Mortality:

No death.

Clinical signs:

Signs of reaction to treatment comprised lethargy, underactivity, staggering gait, clonic convulsions, bradypnoea, hyperpnoea, piloerection and hunched posture on the day of dosing. All animals were overtly normal two days later.

Body weight:

The animals achieved expected body weight gains.

Gross pathology:

No significant macroscopic lesion.