Traduction de «Subchronic toxicity » (Anglais → Français) :

The available data on short-term and subchronic toxicity, genotoxicity and chronic toxicity and carcinogenicity of montan acid esters were limited.

This shall include the submission of information on a core set of studies such as on metabolism/toxicokinetics, subchronic toxicity, genotoxicity, chronic toxicity, carcinogenicity and reproduction and developmental toxicity, accompanied by any other appropriate type of study.

The design of the toxicity study with genetically modified food and feed should be performed according to the ‘subchronic oral toxicity test repeated-dose 90-day oral toxicity study in rodents’ (see Table 1) following an adapted protocol.

For fermentation products, genotoxicity and subchronic toxicity studies must be provided unless:

6.4. Subchronic toxicity 90-day study, two species, one rodent and one non-rodent

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 * * *