Who Food Additives Series 59 Safety Evaluation Of ... - ipcs inchem

ACIDIFIED SODIUM CHLORITE 11
Table 3. Acute toxicity of sodium chlorate
Species Sex Route LD 50 (mg/kg bw) Reference
Dog NS Oral 600 a Sheahan et al. (1971)
NS, not stated.
a
Unclear if doses expressed as sodium chlorate or chlorate.
2.2.2 Short-term studies of toxicity
(a)
Acidified sodium chlorite
Guinea-pigs
The toxicity of the germicidal gel and liquid ASC products has been
investigated following vaginal administration to female albino Hartley guinea-pigs.
Groups of eight animals received the germicidal gel at a dose of 1 g/kg bw, a high
concentration of the liquid at a dose of 2.5 g/kg bw or a low concentration of the
liquid (60% of the high concentration), equivalent to 294, 735 and 441 mg chlorite/
kg bw. The gel was administered intravaginally daily for 30 days, whereas the liquid
was applied over the external vaginal area 3 times per day for 10 days. Observations
included overt signs of toxicity, food consumption, body weights, blood and
urinalysis, ophthalmological examinations, macroscopic abnormalities at necropsy
and histopathology. The only observations significantly different in the germicidal
product–treated animals compared with placebo were as follows. Haemoglobin,
mean cell haemoglobin and direct bilirubin were increased and carbon dioxide was
decreased in the blood of the high- and low-concentration liquid groups: all were
considered to be within the normal range. A significant decrease in the relative liver
weight was reported for the germicidal gel group. Some changes in relative organ
weights were reported for the animals receiving the germicidal liquid, although these
were mostly not concentration related and were not accompanied by histological
changes. Fatty livers were detected in two animals from each group in the gel study,
including placebo and saline control, and therefore were not considered related to
the germicidal product. Macroscopic and histological changes were observed in the
vaginas of animals treated with the germicidal gel but not the liquid (Abdel-Rahman
et al., 1987b).
Rabbits
The germicidal gel product described in section 1.2 was applied to the
shaven skin of albino New Zealand White rabbits (13 of each sex) at 0.5, 1.0 or 2.0
g/kg bw (equivalent to 147, 294 and 588 mg chlorite/kg bw per day) daily for 4 weeks.
A control group received the gel base with no active ingredients. Blood samples
were taken after 15 days and at the end of the treatment and analysed for a range
of parameters. There were no overt signs of toxicity or differences in weight gain or
relative organ weights. The haematocrit percentage was significantly increased and
mean corpuscular haemoglobin concentration significantly decreased in the group