Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July - Aug 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 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

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

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
Experiment started at concentration of 50%. The next dose level of 100 % was selected according to OECD Guideline 429.
No. of animals per dose:
The animals were divided to the experimental groups:
1. Negative control (vehicle) - 5 animals
2. Positive control - 10 animals
(Notice: positive control was repeated because one animal died during experiment)
3. Test item- 50% concentration - 5 animals
4. Test item – 100% concentration - 5 animals
Additional animals (n=10) reserved for the other dose levels of test item were not used in this study.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: At both doses of test item very similar stimulation indices were achieved, with stimulation index for 50% concentration of 1.95 and 100% concentration of 2.14, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 533 dpm (conc. 50%) and 671 dpm (conc.100%)

Any other information on results incl. tables

After application of Zinc hexacyanocobaltate dodecahydrate at the concentrations of 50% and 100%, the animals did not show visible clinical symptoms either of local irritation or systemic toxicity.

No significant (in comparison with control group) changes in the body weights only slight increase of lymph node weights after treatment with test item were observed.

It can be concluded that Zinc hexacyanocobaltate dodecahydrate exert moderate proliferation of lymphocytes under the conditions of the performed test.

Zinc hexacyanocobaltate dodecahydrate was tested without skin sensitization effect up to a maximum dose 100% (SI ˂ 3).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Zinc hexacyanocobaltate dodecahydrate did not exert positive effect under the experimental conditions of the performed test and in accordance with the results obtained in this study is considered to be non-skin sensitizing agent.