Comparative studies has shown a similarity between results of in vivo and in vitro studies, making this implementation safe and viable.

Below, a relation of In vitro studies following OECD normative.

• Bovine corneal opacity and permeability test (BCOP) (OECD 437);
• In vitro skin corrosion test. Assay with reconstructed human epidermis (RHE) (OECD 431);
• In vitro skin irritation test. Assay with reconstructed human epidermis (RHE) (OECD 439);
• Local lymph node assay: BRDU-ELISA (OECD 442B);
• In vitro micronucleus test with mammalian cells (OECD 487);

Genotoxicity and mutagenicity studies

Genotoxicity and mutagenicity studies are performed to predict chromosomal mutations, as an early marker for carcinogenesis. They can also detect compounds able to induce gene mutation by base pairs substitution. Theses assays are made to understand mechanisms of mutation induction in germinal line, caused by carcinogenic or toxic substances which can impair the development and reproduction.

• Micronucleous test in vitro – MNVit (OECD 487)
• Reversal gene mutation test (Ames Test) (OECD 471)

The GLP 0021 scope can be consulted at INMETRO webpage