Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Irritation / corrosion parameter:
other: other: tissue viability
Value:
> 50
Remarks on result:
other:
Remarks:
Time point: 60 min. (migrated information)
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.
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%).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
other: EpiOcularTM Eye Irritation Test (OCL-200-EIT).
Deviations:
no
GLP compliance:
yes (incl. certificate)

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%.

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).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
One study available.

Justification for selection of eye irritation endpoint:
One study available.

Justification for classification or non-classification

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%).

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).