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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(diethyldithiocarbamato-S,S')tellurium
EC Number:
244-121-9
EC Name:
Tetrakis(diethyldithiocarbamato-S,S')tellurium
Cas Number:
20941-65-5
Molecular formula:
C20H40N4S8Te
IUPAC Name:
tetrakis(diethyldithiocarbamato-S,S')tellurium
Test material form:
solid
Specific details on test material used for the study:
- Name of the test item (as cited in study report): Tellurium diethyldithiocarbamate
- Batch No.: MT-5D 494
- Appearance: Yellow, powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England.
- Weight at study initiation: 2.1-3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet: SQC Standard Rabbit Diet (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 10 days

ENVIRONMENT
- Temperature: 20-21 °C
- Humidity: 45%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
24 hours prior to treatment hair was clipped from the dorso-lumbar region of each rabbit exposing an area approximately 10% of the total body surface area. The test substance was applied by spreading evenly over the clipped treatment site in as uniform a manner as possible moistened with 2.0 ml/kg bodyweight saline. The site was then covered with gauze backed with an occlusive dressing encircled firmly around the trunk of the animal. After the exposure period of 24 hours, the dressing was removed and the treatment site gently washed with water to remove any residual test substance. "Elizabethan" collars were fitted on each rabbit and were worn approximately 23 hours to prevent ingestion of any residual substance.
Duration of exposure:
24 hours
Doses:
2g/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed once in the morning and once at the end of the experimental day. The following were recorded at each observation: approximate time of death of individual rabbits; nature, severity, approximate time of onset and duration of each sign of toxicity. The bodyweight of each rabbit eas recorded on Days 1, 2, 3, 5, 8, 11 and 15 or at death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female rabbit was found dead on Day 12.
Clinical signs:
On one occasion during Day 1 (approximately 1.5 hours after dosing) one male and one female rabbit showed an abnormal (unsteady) gait. All other animals appeared normal.

Signs of reaction to treatment over the following days included pilo-erection in two male rabbits on Day 3 and poor food consumption in one male rabbit between Days 5 and 7 and in two female rabbits between Days 4 and 7 and 10 and 11 respectively. In one female rabbit a mucoid discharge was observed from the anus.

There were no dermal reactions at the site of application in any of the rabbits, although some staining of the skin and adjacent fur, by the test substance, was observed.
Body weight:
A bodyweight loss was seen prior to death in the female rabbit.

A bodyweight loss was recorded for one male rabbit on Day 2, for three males and five females on Day 3, one male and one female on Day 5, one female on Day 8 and one male and one female on Day 11. Poor weight gains were recorded on Day 2 for one male and four females, for one male on Day 3, for one male on Day 5, for one female on Day 8, for one male on Day 11 and for one male on Day 15.
Gross pathology:
Autopsy of the dead female rabbit revealed gaseous filled stomach and intestines. Terminal autopsy revealed a diffuse minimal congestion in the lungs of one male rabbit.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met