Conventional Test Method:

In vivo Mammalian Phototoxicity Test

Alternative Test Method:

Name & Description:

In Vitro 3T3 Neural Red Uptake (NRU) Phototoxicity Test

This test predicts acute phototoxicity effects in animals and humans in vivo. The viability of mouse Balb/c 3T3 cells is determined following their exposure to a test compound in the presence and absence of simulated solar light. Cytotoxicity (cell death) is measured as a reduction in the uptake and binding of Neutral Red dye by the cells.

Validation Status:

EU: Validated by EU/COLIPA and endorsed as valid by ESAC (1997)

Regulatory Status:

OECD: TG 432 (2004)

EU: Accepted by European Commission as method B.41 in Annex V of EU Council Directive 67/548/EEC. This test must be used to determine phototoxic effects of chemicals, and animal tests are prohibited for this purpose in all EU member states (2000)

Effect or Potential Effect on Animal Use:

Replacement

References:

• ECVAM (1997) ESAC statement on the scientific validity of the 3T3 NRU PT test (as an in vitro test for phototoxic potential).
• ECVAM (1997) 3T3 NRU Phototoxicity Assay INVITTOX No. 78.
• ECVAM (1998) ESAC Statement on the application of the 3T3 NRU PT test to UV filter chemicals.
• OECD (2004) OECD Guideline for Testing of Chemicals. Test Guideline 432: In Vitro 3T3 NRU Phototoxicity Test.

Information Last Reviewed:

May 2012