Safety evaluation of certain food additives - ipcs inchem

PHOSPHOLIPASE C EXPRESSED IN PICHIA PASTORIS 111
Table 1. Genotoxicity of phospholipase C in vitro and in vivo
End-point Test system Concentration Result Reference
Reverse mutation Salmonella typhimurium
TA98, TA100, TA1535 and
TA1537 and Escherichia
coli WP2uvrA
Chromosomal
aberration
Micronucleus
formation
that the no-observed-effect level (NOEL) is 2000 mg/kg bw per day (i.e. 1672 mg
TOS/kg bw per day), the highest dose tested in this study (Fogleman, 2005c).
2.2.3 Long-term studies of toxicity and carcinogenicity
No information was available.
2.2.4 Genotoxicity
Human lymphocytes
(in vitro)
The results of three genotoxicity studies with phospholipase C (batch
PLC-16449-PD267B) are summarized in Table 1. The first study was conducted in
accordance with Organisation for Economic Co-operation and Development
(OECD) Test Guideline 471 (Bacterial Reverse Mutation Test), the second was
conducted in accordance with OECD Test Guideline 473 (In Vitro Mammalian
Chromosome Aberration Test) and the third was conducted in accordance with
OECD Test Guideline 474 (Mammalian Erythrocyte Micronucleus Test). All three
studies were certified for compliance with GLP and quality assurance.
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
CD-1 mouse 500, 1000 or
2000 mg/kg bw
S9, 9000 × g supernatant from rat liver.
No information was available.
10–7690 μg/plate, ±S9 Negative Mecchi
(2005)
34–5000 μg/ml, ±S9 Negative Murli
(2005)
Negative Erexson
(2005)