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EC number: 231-072-3
CAS number: 7429-90-5
No Al treatment related effects on viability were observed.
During the in-life litter check, no milk in the stomach,
cold, weak and/or pale pups’ appearance and scabs on the tail were
observed. The authors state that these findings were of small
appearance, within the normal biological variation for rats of this age
and strain and were not associated with Al treatment.
The pups of female No.56 (40 mg/kg) showed signs of cannibalism.
No changes in body weight were observed for male and female pups
born from the Al-treated dams and control dams (Appendix 1, p.27).
Only absolute/relative brain weights were studied.
No changes in the absolute brain weight for male pups born from
the Al-treated dams and control dams were observed (Appendix 1, p.28).
1000 mg /kg
Statistically higher absolute brain weight (by 7%) was noted in
female pups born from dams treated to 1000 mg/kg Al chloride basic.- 0.568±0.0328
vs. 0.530± 0.0445 in control group, respectively.
No changes in the relative brain weight (organ to body weight, %)
for the 1000 mg/kg dose group were observed.
40 and 200 mg/kg
No differences in the absolute and relative brain weight were
observed between female pups born from dams exposed to 200 and 40 mg/kg
of the Al chloride basic and female pups born from control females.
Please see section “clinical signs”.
Details on results
No toxicologically significant changes in pup development were
noted during PND 0-4 (no further details were provided).
This GLP study was performed in accordance with OECD Test Guideline (TG)
422 and adds to the weight of evidence for the absence of
reproductive/breeding, mating impairment and early postnatal
developmental effects due to short-term exposure to high doses of
aluminium chloride (basic).
No mortality or clinical signs of intoxication were observed in male and
female Wistar rats due to treatment with Al chloride basic at dose
levels of 40, 200, and 1000 mg/kg body weight.
Treatment with Al chloride basic by oral gavage revealed paternal
toxicity (irritation effect on glandular stomach mucosa, local effect)
at 1000 mg/kg in both the male and female Wistar rats. Based on findings
observed macroscopically (red foci or thickening of the grandular mucosa
of the stomach) and supported by microscopic examination, the
maternal/parental No Observed Adverse Effect Level (NOAEL) for local
toxic effects on stomach was established at 200 mg/kg and LOAEL – at
level 1000 mg/kg, for both males and females.
Several statistically significant changes in clinical biochemistry
parameters were observed at 1000 mg/kg suggesting a possible impact on
the blood system (decreased Hb level in males, MCHC in both Al treated
males and females), on the liver (decreased total protein and albumin in
blood serum) and possibly the kidney functions (increase potassium
level) at this dose. Decreased Hb levels were observed in two other
doses in males but no dose response relationship was observed. Lack of
relevant baseline values for the observed clinical data limit the
interpretation of the results. The authors consider the and clinical
biochemistry and haematology changes observed at 1000 mg/kg to be of
slight nature and generally within the range expected for rats of this
age and strain. Because any morphological correlates were absent, these
changes were considered not indicative of organ dysfunction and not of
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