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- Practical Guide -
Page 136 of 153
Mutagenicity studies
Mutagenicity studies are useful primarily as a screening test to detect the substances
"suspected to have carcinogenic properties". The recommended tests can be found in
the "SCF-WG Explanatory Guidance".
Peroxisome proliferation study
See explanation given in the document "SCF-WG Explanatory Guidance".
Reproduction and teratogenicity studies
Studies on reproduction and teratogenicity have been requested for certain substances,
because of evidence that a number of substances in the group have adverse effects on
reproduction and/or are teratogenic. However, this data is only needed, if migration
exceeds 5 mg/kg of food (see "SCF Guidelines").
Neurotoxicity studies
Neurotoxicity studies have been requested for phosphoric and phosphorous acid esters,
because of evidence that a number of substances in this group have neurotoxic
properties. Tests with chickens or measurements of anticholinesterase activity would be
appropriate. However, such data is only needed, if migration exceeds 0.05 mg/kg of
food (see "SCF Guidelines").
2.3. List
In principle, classification in list 7 is based on some data being available, but
insufficient or inadequate to allow a classification into lists 0-4. Therefore the
additional data specified in the notation "needed" should be furnished.
Hydrolysis data
The SCF asks for information about the hydrolysis rate with the objective of reducing
the amount of toxicological testing required. Some chemical structures of monoesters
suggest ready hydrolysis into substances, which are already in list 0, 1, 2 or 3. Hence
the hydrolysis data is only requested for compounds specifically indicated.
As an example, the SCF required hydrolysis data only for acrylic and methacrylic
esters of monohydric alcohols or monoesters of the same acids with polyalcohols,
provided the alcohols were in lists 0, 1, 2 and 3. For all other esters of acrylic and
methacrylic acids, the general rules for the classification of the substances in the SCF
lists apply. The same for the esters of adipic, azelaic, citric, phosphoric, phosphorous,
phthalic, sebacic and trimellitic acid: hydrolysis data are requested only for those
monoesters, which may be hydrolysed to substances which are already in lists 0, 1, 2
and 3.
Hydrolysis may be demonstrated in foods or food simulants representing the range of
foods with which the substance may come into contact. Alternatively, or in cases where