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90-day oral toxicity studies, normally in two species
Studies on absorption, distribution, metabolism and excretion
Studies on reproduction in one species, and developmental toxicity,
normally in two species
Studies on long-term toxicity/carcinogenicity, normally in two species
These studies should be carried out according to prevailing EU or OECD
guidelines, including "Good Laboratory Practice". The substances tested
should be of the same specification as described in section 1.
Health information on people exposed occupationally would be regarded as
useful ancillary information.
Reduced core set
Under certain circumstances the core set of tests may not be required and only
the tests indicated below may have to be provided.
8.3.1 In cases where migration is in the range from 0.05 - 5 mg/kg of food / food
simulant, the following data are needed:
The 3 mutagenicity tests mentioned in point 7.2
A 90-day oral toxicity study
Data to demonstrate the absence of potential for accumulation in man
8.3.2 In cases where migration is below 0.05 mg/kg of food / food simulant the
following data are needed:
The 3 mutagenicity tests mentioned in point 7.2.
Special investigations/additional studies
If the above-mentioned studies or prior knowledge or structural considerations
indicate that other biological effects such as peroxisomal proliferation,
neurotoxicity, immunotoxicity or endocrinological events may occur,
additional studies may be required.
At present no validated methods are available for studies in laboratory animals
which would allow assessment of a substance's potential to cause intolerance
and/or allergic reactions in susceptible individuals following oral exposure.
However, studies on dermal or inhalation sensitisation may give information
relevant for possible hazards from occupational exposure and could be helpful
in assessing consumer safety.
Under certain circumstances, particularly those relating to the chemical nature
of the substance to be used in food contact materials, the tests normally to be