Potassium dicyanoargentate

Endpoint summary

Description of key information

The conduct of both in vivo and in vitro skin sensitisation tests was waived principally on the basis of the positive result in the in vitro human epidermis (he-EpiDerm) conducted in accordance with OECD431 test guideline.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to GHS and EU CLP 1272/2008, potassium dicyanoargentate is classified as category 1A for skin corrosion, as an adverse effect was observed within an hour with 3 minutes of exposure to the substance.

Reason / purpose for cross-reference:

data waiving: supporting information

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to GHS and EU CLP 1272/2008, potassium dicyanoargentate is classified as category 1A for skin corrosion, as an adverse effect was observed within an hour with 3 minutes of exposure to the substance. In addition, the two guideline in vitro studies that could be conducted for this endpoint were considered to be unsuitable. It is advised that no one in vitro study should be considered on its own to cover this endpoint. The two guideline studies available were identified as OECD442C (In chemico Skin Sensiisation: Direct Peptide Reactivity Assay (DPRA)) and OECD442D (In vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (KeratinoSens)). The DPRA method is considered to evaluate the Molecular Initiating event (MIE) stage of the skin sensitisation Adverse Outcome Pathway (AOP) whereas the KeratinoSens method evaluates the second phase of the AOP looking at specific cell signalling pathways in the process. The DPRA method is not applicable for the testing of metal compounds since they are known to react with proteins with mechanisms other than covalent binding, and the KeratinoSens method should not be considered on its own.

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

The conduct of an in vivo skin sensitisation test in the mouse (LLNA, OECD229) was waived on the basis of positive skin corrosion result in the in vitro human epidermis study (OECD431). The potential for conducting in vitro alternatives for this endpoint was considered, however, the two available guideline tests were found to be unsuitable. It is advised that no one in vitro study should be considered on its own to cover this endpoint. The two guideline studies available were identified as OECD442C (in chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)) and OECD442D (in vitro Skin sensitisation: ARE-Nrf2Luciferase Test Method (KeratinoSens™)). The DPRA method is considered to evaluate the Molecular Initiating Event (MIE) stage of the Adverse Outcome Pathway (AOP) whereas the KeratinoSens™ method evaluates the second phase of the AOP looking at specific cell signalling pathways in the process. The DPRA method is not applicable for the testing of metal compounds since they are known to react with proteins with mechanisms other than covalent binding, and the KeratinoSens™ method should not be considered on its own.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No specific test to evaluate sensitisation could be conducted as a consequence of the corrosive nature of the test substance or because of the unsuitability of in vitro alternative tests. Therefore, the test substance could not be classified for this endpoint.