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

ACIDIFIED SODIUM CHLORITE 21
Table 5. BMD10 and BMDL10 calculations for thyroid gland follicular cell
hypertrophy in male F344/N rats administered sodium chlorate in drinkingwater
for 2 years
Model
Log
(likelihood)
p-value AIC
Chisquare
P-value Accept BMD10
(mg/kg
bw per
day)
BMDL10
(mg/kg
bw per
day)
Full model –83.49
Gamma
multistage
–85.46 0.14 174.9 4.13 0.13 ?? 3.5 2.8
Log-logistic –83.61 0.65 173.2 0.24 0.65 Yes 1.9 1.1
Multistage –85.46 0.14 174.9 4.13 0.13 ?? 3.5 2.8
Log-probit –86.20 0.07 176.4 5.74 0.06 ?? 5.9 4.4
Quantallinear
–85.46 0.14 174.9 4.13 0.13 ?? 3.5 2.8
Weibull –85.46 0.13 174.9 4.13 0.13 ?? 3.5 2.8
Reduced
model
–127.46
AIC, Akaike Information Criterion.
and 588 mg chlorite/kg bw). Control groups either received placebo gel containing
gelling agents but no active ingredients or were untreated. The mice were observed
daily, weighed weekly and sacrificed on GD 18. Individual fetal weights, length and
sex were recorded, and gross examination for external abnormalities was carried
out for all live fetuses. Half of the fetuses from each litter were examined for soft
tissue malformations, and the remainder for skeletal abnormalities. No statistically
significant effects were reported in either the dams or the fetuses (Gerges et al.,
1985).
In a similar study, the germicidal liquid was administered by gavage to groups
of 20 Swiss Webster mice at doses equivalent to 132 and 198 mg sodium chlorite/
kg bw per day (98 and 147 mg chlorite/kg bw). A negative control group received
deionized water only, and a positive control group received 100 mg cortisone/kg bw.
The mice were observed daily, weighed weekly and sacrificed on GD 18. Fetuses
were removed, and the number of live and dead fetuses and the number of
resorptions were recorded. The sex, weight and length of each fetus were recorded,
and each was examined for gross external malformations. Half of the fetuses were
examined for skeletal abnormalities, and the remainder for soft tissue abnormalities.
No statistically significant effects were reported in either the dams or the fetuses
(Skowronski et al., 1985).
The germicidal gel product was applied topically to the shaven backs of
groups of 20 pregnant Sprague-Dawley rats from GD 6 to GD 15 at 1 and 2 g/kg