Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

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

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: tissue viability
Value:
> 50
Remarks on result:
other:
Remarks:
Time point: 60 min. (migrated information)

In vivo

Other effects:
Validity of the test method was ascertained by positive control 5% SDS. Three tissue replicates were used for each treatment (exposure time 60 minutes), including negative and positive control.
The tissue viability met the acceptance criterion (mean OD of negative control was 1.694.
The viability of culture treated by positive control 5% SDS was 8.1%. The positive control met the acceptance criterion: mean tissue viability less than 20%.
Determined viability of culture treated by Zinc Hexacyanocobaltate dodecahydrate (96.0%) fulfilled the criteria for irritancy.
Therefore the product Zinc Hexacyanocobaltate dodecahydrate is considered to be nonirritant to skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU and GHS
Conclusions:
Based on results of the study, the product Zinc Hexacyanocobaltate dodecahydrate according to the Evaluation criteria and Acceptance criteria is considered to be Non-Irritant (NI) (mean tissue viability > 50%).