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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
Young male and female albino rats were used as the experimental animals. The test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten males and ten females in one single dose of 25 ml/kg body weight They were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
EC Number:
238-677-1
EC Name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
Cas Number:
14634-93-6
Molecular formula:
C18H20N2S4Zn
IUPAC Name:
zinc(2+) bis([ethyl(phenyl)carbamothioyl]sulfanide)
Specific details on test material used for the study:
WTR 44 = Vulkacit P = CAS no. 14634-93-6
White powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young male and female albino rats (body weights 174 to 250 g and 97 to 165 g,respectively) from the Institute's colony (Wistar derived) were used as the experimental animals. The rats were housed in screen-bottomed cnges (five to a cage) in a well­ventilated room maintained at 25° C. Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: propylene glycol
Details on oral exposure:
The test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten males and ten females in one single dose of 25 ml/kg body weight. After treatment the rats received stock diet and tap water ad libitum.
Doses:
25 ml/kg body weight as a 40% (w/v) suspension = 10 g/kg bw.
No. of animals per sex per dose:
Ten males and ten females/dose
Control animals:
no
Details on study design:
The annimals were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Mortality:
Deaths occurred from day two to five after dosing (four males and one female).
Clinical signs:
Within a few hours after treatment the rats showed humpback behaviour, pale coloured legs and dark eyes. Very dark eyes and encrustations around the eyes and nostrils were seen during the first posttreatment week. Deaths occurred from day two to five after dosing (four males and one female). During the second week of the observation period the survivors recovered gradually, although they did not show an optimum condition at the end of the observation period.
Gross pathology:
Macroscopic examination of the survivors revealed dark coloured spleen and kidneys in all animals.

Any other information on results incl. tables

From the mortality rate obtained, it may be concluded that the oral LD50 of WTR 44 is higher than 10g/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is > 10000 mg/kg bw (rat, male and female).
Executive summary:

The test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten males and ten females in one single dose of 25 ml/kg (10000 mg/kg) body weight They were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors. Four male and 1 female rat died. The LD50 is > 10000 mg/kg bw.