in vivo cytogenetic study

in vivo mammalian bone-marrow-cytogenic test

in vitro mammalian cytogenetic test

Although additional tests including in vitro cell based assays or in vivo tests on animal models have not been validated to date for regulatory purposes, they may provide useful additional information, for example, on the potential of the newly expressed protein for de novo sensitisation.

(ii) OECD Test Guideline No. 475, “Genetic Toxicology: In Vivo Mammalian Bone Marrow Cytogenetic Test — Chromosomal Analysis”, published April 4, 1984 in the OECD Standard referred to in section 1.

The current understanding for PAFT I, II and III testing programs is summarized below : Acute Toxicity - all 5 compounds Subchronic Toxicity - all 5 compounds Developmental Toxicity (both rat and rabbit) - all 5 compounds Combined chronic toxicity/carcinogenicity study - HCFC-123 ) HCFC-141b ) Rats HFC-134a ) HCFC-124 A rodent species other than the rat (hamster or mouse are likely candidates) Mutagenicity - all 5 compounds tested by : Ames, in vitro chromosome aberrations (human lymphocyte and/or cultured mammalian cells) and in vivo mouse micronucleus Reproductive effects (2 generations) - HCFC-123, HCFC-141b Neurotoxicity - neurotoxic ...[+++]ity testing by functional observational battery with limited neuropathology for HCFC-123 and HCFC-141b * * *

Although additional tests including in vitro cell based assays or in vivo tests on animal models have not been validated to date for regulatory purposes, they may provide useful additional information, for example, on the potential of the newly expressed protein for de novo sensitisation.