Registration Dossier

Administrative data

Description of key information

For that endpoint, two reliable studies to assess the acute toxicity oral and dermal on the registered substance on rats was available. These studies were performed according to the OECD 423 guideline (acute toxicité oral) and OECD 402 guideline (acute toxicity dermal).

Under the experimental conditions, the registered substance " Zinc cyanide batch n°10185145" has an LD50 above 300mg/L for oral acute toxicity and an LD50 above 100mg/kg for dermal acute toxicity. Therfore, GHS classification of the test substance, Zinc cyanide was classified to be ‘Category 4 (> 300 mg/kg bw ~ 2,000 mg/kg bw) for oral acut toxicity and was classified to be ‘Category 2 (50 < LD50 200 mg/kg bw) for dermal acute toxicity.

The validity criteria were successful and the studies were therefore regarded as acceptable for that endpoint.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
other: gastric intubation
Vehicle:
other: Mineral oil
Details on oral exposure:
Animals were dosed via gastric intubation with disposable syringes fitted with intubation tubes. Animals were fasted overnight, approximately 12 hours prior to dosing. Drinking water was provided ad libitum. Feed was provided approximately 3 - 4 hours post dosing
Doses:
Four dose groups of three females per group were utilized as follows: Step 1, 2: 50 mg/kg bw, Step 3, 4: 300 mg/kg bw, Step 5: 2,000 mg/kg bw of the test substance
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
Step 1, 2: 50 mg/kg bw, Step 3, 4: 300 mg/kg bw, Step 5: 2,000 mg/kg bw of the test substance. After the administration, the number of mortality were observed for more than 3 days. All animals were monitored for clinical signs and body weight changes during the 14-day observation
period after administration. They were subjected to gross necropsy at the end of the observation period.
Statistics:
Statistical analysis was not performed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Based on:
test mat.
Mortality:
There were deaths in all animals at step 5. There were no deaths in any animals at step 1 ~ 4.
Clinical signs:
There were no clinical signs of in step 1(50 mg/kg bw), step 3(300 mg/kg bw) throughout the course of the study. Soiled perineal region in one animal at each step 2 (50 mg/kg bw) were evident on Day 1 after dosing. Decrease in locomotor activity, irregular respiration in two animals at each step 4 (300 mg/kg bw) were observed sporadically on Day 0 after dosing. Soiled perineal region, irregular respiration, decrease in locomotor activity, dirty nose, anorexia, crouching position in same animals at each step 4 (300 mg/kg bw) were observed sporadically on Day 1 ~ 3 after dosing. Decrease in locomotor activity, irregular respiration, cheyne-Stokes’s respiration, crawing position, lying on side, loss of locomotor activity in all animals at each step 5 (2,000 mg/kg bw) were observed sporadically on 0.5 ~ 3 hour after dosing. Death in all animals at each step 5 (2,000 mg/kg bw) were observed on 4 hour after dosing.
Body weight:
Decreased body weights were in two animals at step 4(300 mg/kg bw) at Day 1.
Gross pathology:
No grossly visible findings were evident in the all steps.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
As a result of the acute oral toxicity study in Sprague-Dawley rats, no mortalities were observed at 50 mg/kg bw(in step 1 and 2) and 300 mg/kg bw(in step 3 and 4), 3 mortalities were observed at 2,000 mg/kg bw(in step 5). In consequences, GHS classification of the test substance, Zinc cyanide was
classified to be ‘Category 4 (> 300 mg/kg bw ~ 2,000 mg/kg bw).
Executive summary:

For that endpoint, one reliable study to assess the acute toxicity oral on the registered substance on rats was available. The study was performed according to the OECD 423 guideline.

Under the experimental conditions, the registered substance " Zinc cyanide batch n°10185145" has an LD50 above 300mg/L. Therfore, GHS classification of the test substance, Zinc cyanide was classified to be ‘Category 4 (> 300 mg/kg bw ~ 2,000 mg/kg bw).

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
The dorsal skin was shaved, 24 hrs before application of test substance using electric clipper to make 5 cm X 5 cm normal naked skin. Shaved area was divided to section, and 4 cm X 4 cm squares were marked in each section. The gauze (DAE HAN MEDICAL) was attached to the film (Tegarderm, 3M), the test substance was applied to the gauze, wetted with the water for injection (DAIHAN PHARM. CO., LTD), and adhered to the skin, and then the tape (Coban, 3M) was wound and fixed. Non-permeable, non-irritable tape was used to
prevent evaporation or loss of the test substance. The test substance was applied once dermally for 24 hrs. At the end of the exposure period, residual test substance has removed, where practicable using saline (DAIHAN PHARM. CO., LTD).
Duration of exposure:
24 hours
Doses:
Individual dose was calculated based on the animal body weight recorded just prior to dosing at a dose body weight. It calculated a capacity in consideration of the weight of the test substance per 1mL.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Test group was consisted of one dose group at a dose of 0, 3.7, 11.1, 33.3, 100 mg/kg bw, 5 animals group both sexes. All animals were monitored for clinical signs and body weight changes during a 14-days observation period after dosing. They were subjected to gross necropsy at the end of the observation period.
Statistics:
The data of body weights were subjected to one-way ANOVA test for the significance which was judged at a probability value of p < 0.05
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 100 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths of in all animals throughout the course of the study.
Clinical signs:
There were no clinical signs of in all animals throughout the course of the study.
Body weight:
No abnormal body weight changes were observed relating to test substance administration.
Gross pathology:
No grossly visible findings were evident in the all animals.
Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
Based on the results of this study, the approximate lethal dose 50(LD50) of the test substance, Zinc cyanide, was greater than 100 mg/kg bw in male and female rats under the conditions of this study.
Executive summary:

For that endpoint, one reliable study to assess the acute toxicity dermal on the registered substance on rats was available. The study was performed according to the OECD 402 guideline.

Under the experimental conditions, the registered substance " Zinc cyanide batch n°10185145" has an LD50 above 100mg/kg. Therfore, GHS classification of the test substance, Zinc cyanide was classified to be ‘Category 2 (50 < LD50  200 mg/kg bw).

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
100 mg/kg bw

Additional information

Justification for classification or non-classification