Registration Dossier

Administrative data

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

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 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes

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(2+) bis(iminomethanide)
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.