Safety evaluation of certain food additives - ipcs inchem

CALCIUM LIGNOSULFONATE (40–65) 23
Table 2. Incidence and mean severity of main microscopic findings in
mesenteric lymph node and kidneys
In light of the absence of mutagenicity/genotoxicity in vitro and the lack of
systemic bioavailability after oral administration (see section 2.1.1), in vivo
genotoxicity testing with oral application was considered to be scientifically
unjustified. Since Loomis & Beyer (1953) had shown that intravenous injection of
lignosulfonate results in deaths due to respiratory failure, applying the substance in
such a test by another route was not considered feasible.
2.2.3 Reproductive toxicity
Foamy histiocytosis Tubular vacuolation
Incidence Mean severity Incidence Mean severity
Group 1
Male 0/20 – 0/20 –
Female
Group 2
0/20 – 0/20 –
Male 4/20 1.0 0/20 –
Female
Group 3
3/20 1.0 0/20 –
Male 17/20 1.3 0/20 –
Female
Group 4
8/20 1.3 5/20 1.0
Male 20/20 2.3 3/20 1.0
Female
Recovery group 1
19/20 2.1 13/20 1.0
Male 0/10 – 0/10 –
Female
Recovery group 4
0/10 – 0/10 –
Male 10/10 2.1 4/10 1.0
Female 10/10 1.8 5/10 1.0
F, female; M, male.
The possible maternal and developmental toxicities of calcium lignosulfonate
(40–65) were investigated in female Wistar rats receiving target doses of 0, 100,
300 or 1000 mg/kg bw per day (22 animals per group) from day 6 post-coitum to
day 21 post-coitum (Thiel et al., 2006b). The dietary concentration was adjusted on
day 16 post-coitum to ensure intended dose levels. The diets with test item were