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Please compare the three Assay Possibilities.



Components
BALB 3T3 / Neutral Red Uptake Assay (OECD GD 129)
Human BJ /Neutral Red Uptake Assay
Human THP-1 Macrophage / WST-1 Assay
Validation

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intra-laboratory validation in FICAM
intra-laboratory validation in FICAM
Assay System
Mouse BALB/3T3 Fibroblasts
Human BJ Fibroblasts
THP-1 Monocytes activated towards Macrophages with Phorbol 12-myristate 13-acetate
Cytotoxicity Testing

Cytotoxicity testing is performed in a dose-response format using 8 different test item concentrations with 6 parallels of each to determine the concentration that reduces NRU by 50% compared to negative (untreated) control.

• Cytotoxicity testing is performed in a dose-response format using 8 different test item concentrations with 6 parallels of each to determine the concentration that reduces NRU by 50% compared to negative (untreated) control.

• Cytotoxicity testing is performed in a dose-response format using 8 different test item concentrations with 6 parallels of each to determine the concentration that reduces formazan production (indicating the number of living, metabolically active cells) 50% compared to negative (untreated) control.

Exposure

Exposure time 48 hrs at 37°C, 5.0% CO2

Exposure time 48 hrs at 37°C, 5.0% CO2

Exposure time 24 hrs at 37°C, 5.0% CO2

Assay starting Conditions

Full OECD GD 129 compliance protocol requires dose range finder test and two main tests: Dose range finder test covers a large concentration range, it is performed to determine the starting doses for the main test. The main tests are performed to determine the IC50 value.

The assay starts with dose range finder test that covers a large concentration range to determine the starting doses for the main test. 1-2 main tests are performed to determine the IC50 value.

The assay starts with dose range finder test that covers a large concentration range to determine the starting doses for the main test. 1-2 main tests are performed to determine the IC50 value.

Alternate procedure to above

Other options: One test with 8 different test item concentrations. If not otherwise agreed, the concentration range starts from the highest soluble concentration diluted downwards using half-log dilution. IC50 will be determined. Dose-range finder test as described above, and based on its results, one main test with 8 different test item concentrations to determine IC50 value

Alternatively, one test with 8 different test item concentrations is performed. If not otherwise agreed, the concentration range starts from the highest soluble concentration diluted downwards using half-log dilution. IC50 will be determined

Alternatively, one test with 8 different test item concentrations is performed. If not otherwise agreed, the concentration range starts from the highest soluble concentration diluted downwards using half-log dilution. IC50 will be determined

Assay Suitability
The assay is suitable for soluble test items.
The assay is suitable for soluble test items.
The assay is suitable for soluble test items.
Controls

Sodium Dodecyl Sulphate (SDS) is used as positive control in each testing series. Medium with or without solvent is used as negative (untreated) control in each testing series and for each test item

Sodium Dodecyl Sulphate (SDS) is used as positive control in each testing series. Medium with or without solvent is used as negative (untreated) control in each testing series and for each test item

Triclosan is used as positive control in each testing series. Medium with or without solvent is used as negative (untreated) control in each testing series and for each test item

Options GLP Compliance

The assay can be performed in compliance with GLP, or as a non-GLP assay.

The assay can be performed in compliance with GLP, or as a non-GLP assay.

The assay can be performed in compliance with GLP, or as a non-GLP assay.