Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitization potential of potassium dicyanoaurate was tested in two mouse local lymph node assays. In the first assay, groups of 4 mice were treated with nominal concentrations of 1, 2.5 and 5% w/w potassium dicyanoaurate in dimethylformamide, applied on three consecutive days to the dorsal surface of each ear in a volume of 25µL, following OECD guideline 429 and EU method B.42. The Stimulation Indices were 7.98, 8.61 and 9.88 for 1, 2.5 and 5% w/w, respectively (Pooles 2014). In the second assay, 8 replicates of 5 mice each were treated with nominal concentrations of 0.5, 1.75 and 5% w/v potassium dicyanoaurate in dimethylformamide, applied on three consecutive days to the dorsal surface of each ear in a volume of 25µL, following OECD guideline 442B and NIH No. 99-4494. The Stimulation Indices were 3.7, 2.8 and 3.1 for 0.5, 1.75 and 5% w/v, respectively (Carathers 2015). Potassium dicyanoaurate is considered to be a sensitiser based on EU and OECD GHS criteria.


Migrated from Short description of key information:
Mouse Local Lymph Node Assay (OECD429).
Mouse Local Lymph Node Assay (OECD442b)

Justification for selection of skin sensitisation endpoint:
The results of two local lymph node assays provide evidence of skin sensitisation, based on EU and OECD GHS criteria. The standard OECD429 design study has been taken as the key study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to GHS and EU CLP 1272/2008, potassium dicyanoaurate is classified as Category 1 for skin sensitisation, based on the results from two mouse local lymph node assays.