Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% solution
Doses:
A limit dose of 2000 mg/kg was used as starting dose. The required amount of the test item (according body weight) was mixed with vehicle (carboxymethyl cellulose - 1% solution) shortly before administration.
No. of animals per sex per dose:
Groups of 6 females were dosed (Group of 3 females were dosed. Test item-related mortality was not produced during 24 hours group of 3 females were tested at the same dose).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw

Any other information on results incl. tables

All 6/6 females survived the limit dose 2000 mg/kg.

No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.

The body weights of all animals were increasing during the study. No body weight losses were observed between one and two week after administration.

All animals were necropsied. During necropsy, no macroscopically changes were noticed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on OECD 423 Annex 2d: Test Procedure with a Starting Dose of 2000 mg/kg Body Weight it can be concluded that the test item Zinc Hexacyanocobaltae Dodecahydrate is classified in Category 5/Unclassified with the cut off LD50 ≥ 5000 mg/kg, after single oral administration to Wistar rats.