2.2.5 Reproductive toxicity
(a)
Multigeneration studies
No multigeneration studies were available.
(b)
Developmental toxicity
No developmental toxicity studies were available.
2.3
Observations in humans
No information was available.
3.
DIETARY EXPOSURE
Branching glycosyltransferase can be used in a
wide range of foodstuffs, but
it is not expected to be present in the final product. The following estimation is based
on the worst-case assumption that the enzyme is used in all processed food and
beverages and remains in the products consumed. The
maximum amount of TOS
added to food is 48 mg/kg. Assuming a daily consumption of 750 g of food (50%)
and 1500 g of beverages (25%), according to the budget method,
the amount of
TOS ingested would be about 2 mg/kg bw per day for an adult weighing 60 kg.
4.
COMMENTS
4.1
Assessment of potential allergenicity
Branching glycosyltransferase was assessed for
potential allergenicity by
comparing its amino acid sequence with the sequences of known allergens
according to the bioinformatics criteria recommended
in the report of the Joint
Table 1. Genotoxicity of branching glycosyltransferase in vitro
End-point
Test
system
Concentration
Result
Reference
Reverse mutation
Salmonella
typhimurium TA98,
TA100, TA1535 and
TA1537 and
Escherichia coli
WP2uvrApKM101
156–5000 μg/ml
(liquid
culture
method), ±S9
Negative Pedersen
(2008)
Clastogenicity/
aneuploidy
Human lymphocytes
1st and 2nd
experiments: 2813,
3750 or 5000 μg/
ml, ±S9
Negative Whitwell (2008)
S9, 9000 ×
g supernatant from rat liver.
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