Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc cyanide
EC Number:
209-162-9
EC Name:
Zinc cyanide
Cas Number:
557-21-1
Molecular formula:
Zn(CN)2
IUPAC Name:
ZINC DICYANIDE
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

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.

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.