Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 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
Guideline:
other: EpiOcularTM Eye Irritation Test (OCL-200-EIT).
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Trizinc bis[hexacyanidocobaltate] dodecahydrate
EC Number:
942-358-9
Cas Number:
69207-66-5
Molecular formula:
Zn3[Co(CN)6]2 ·12H2O
IUPAC Name:
Trizinc bis[hexacyanidocobaltate] dodecahydrate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Any other information on results incl. tables

Determined viability of culture treated by Zinc Hexacyanocobaltate (67.6%) fulfilled the criteria for non-irritancy.

Therefore the test item Zinc Hexacyanocobaltate is considered to be non-irritant to the eye.

The tissue viability met the acceptance criterion (mean OD of negative control was 1.384).

The viability of culture treated by positive control methyl acetate was 29.1%. The positive control met the acceptance criterion: mean tissue viability less than 60%. The viability of culture treated by Zinc Hexacyanocobaltate was 67.6%.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test item Zinc Hexacyanocobaltate according to Evaluation criteria and Acceptance criteria is considered to be Non-irritant (NI) (the test item-treated tissue viability is > 60% relative to negative control-treated tissue viability).