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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 Oct 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
Deviations:
no
GLP compliance:
no
Remarks:
preliminary solubility test, not performed according to GLP
Type of study:
ARE-Nrf2 luciferase LuSens test method

Test material

Constituent 1
Chemical structure
Reference substance name:
Palladium dihydroxide
EC Number:
235-219-2
EC Name:
Palladium dihydroxide
Cas Number:
12135-22-7
Molecular formula:
H2O2Pd
IUPAC Name:
palladium(2+) dihydroxide
Details on test material:
Brown solid, purity 65.3% (as Palladium), stored at room temperature in the dark

In vitro test system

Details on the study design:
Due to the nature of the test item, a preliminary stock suspension/dispersion of the test item in Medium was prepared as follows:
On the day of the experiment, 33.45 mg of the test item were weight in a beaker. The appropriate volume of Medium (1.19 mL) was added into the beaker to formulate the test item.
The Sponsor has advised that DMSO should not be used as the vehicle.
Vehicle / solvent control:
cell culture medium

Results and discussion

In vitro / in chemico

Results
Key result
Group:
test chemical
Run / experiment:
other: solubility trials
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
other: Palladium dihydroxide did not produce a visually clear solution or a stable dispersion at sufficient concentrations to meet the OECD Test Guideline for ARE-Nrf2 Luciferase Test Method (LuSens).

Applicant's summary and conclusion

Interpretation of results:
other: Palladium dihydroxide did not produce a visually clear solution or a stable dispersion at sufficient concentrations to meet the OECD Test Guideline for ARE-Nrf2 Luciferase Test Method (LuSens).
Conclusions:
The test item Palladium dihydroxide formulated in treatment medium is considered unsuitable for the LuSens assay, under the conditions of this study.
Executive summary:

This study according to OECD442D (non-GLP) was performed to test the solubility of the Palladium dihydroxide and whether the test item is suitable for the ARE-Nrf2 Luciferase Test Method (LuSens).
A stock suspension was prepared in treatment medium. The stock suspension of 200 mM of the test item in treatment medium showed an unstable suspension/dispersion. A further dilution of this stock suspension in treatment medium could not be prepared.
The Sponsor has advised that DMSO should not be used as the vehicle.
Palladium dihydroxide did not produce a visually clear solution or a stable dispersion at sufficient concentrations to meet the OECD Test Guideline for ARE-Nrf2 Luciferase Test Method (LuSens).