Safety evaluation of certain food additives

the purified semi-refined cassia gum group died as a result of improper gavaging.
No compound-related adverse effects were reported for pregnancy incidence,
implantations, post-implantation loss or fetal defects upon necropsy. A statistically
significant reduction in mean daily food consumption and mean body weight gain
was observed in the pregnant animals of both 1000 mg/kg bw per day groups. These
effects are probably related to the viscous nature of cassia gum and were not
considered to be of toxicological relevance. The only finding in the offspring was a
statistically significantly increased fetal weight in the purified semi-refined cassia
gum group. No evidence of embryotoxicity or teratogenicity was observed in any of
the treated groups. The NOAEL was 1000 mg/kg bw per day, the highest dose
tested (Müller, 1989a).
In a related developmental toxicity study (certified for compliance with GLP
and QA), groups of 20 pregnant New Zealand White rabbits were administered
semi-refined cassia gum or purified semi-refined cassia gum following the same
study protocol and dosing regimen, the only difference being that the rabbits were
treated from days 6 to 27 post-coitum and were sacrificed and examined on day 28
post-coitum. Eleven animals (four controls, one animal of the 350 mg semi-refined
cassia gum/kg bw per day group, four animals of the 1000 mg semi-refined cassia
gum/kg bw per day group and two animals of the 1000 mg purified semi-refined
cassia gum/kg bw per day group) died during the treatment period or were killed
moribund. All deaths could be attributed to improper gavaging and/or were
incidental. A reduction (not statistically significant) in mean daily food consumption
(–19%) was reported in animals administered 1000 mg semi-refined cassia gum/kg
bw per day. Possibly secondary to this effect on food consumption, a slight, not
statistically significant reduction in mean fetal weights (–16%) was observed in this
group. These effects are probably related to the viscous nature of cassia gum and
were not considered to be of toxicological relevance. No compound-related adverse
effects were reported for pregnancy incidence, implantations, post-implantation loss
or fetal defects upon necropsy. The NOAEL was 1000 mg/kg bw per day, the highest
dose tested (Müller, 1989b).

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