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EC number: 629-817-6
CAS number: 1236215-65-8
An acute oral
toxicity study (limit test) was performed with
aluminium hydroxide (SH-20 Muster) infemale CRL (WI)BR
This study has been
performed in accordance with the OECD 423 (17thDecember
2001), Commission Regulation (EC) No 440/2008, B.1
tris (L 142, 30 May 2008), OPPTS 870.1100 (EPA
712-C-98-190, August 1998) and the Principles of Good
Laboratory Practice (Hungarian GLP Regulations:
9/2001. (III. 30)
was administered by a single oral gavage to animals
after an overnight food withdrawal at a concentration
of 2000 mg/mL in vehicle (PEG 400) with a treatment
volume of 10 mL/kg bw.
during this study included mortality, clinical signs,
body weight and body weight gain.Clinical observations
were performed on all animals at 30 minutes, 1, 2, 3,
4 and 6 hours after dosing and daily for 14 days
thereafter. Body weight was measured on days 1, 0 and
7 and before necropsy.Necroscopy was performed onall
animals on day 14.
During the 14 days
of the observation period, there was no mortality or
clinical signs of intoxication related to aluminium
hydroxide administration at 2000 mg/kg bw. Soft faeces
were recorded in all treated animals at first day of
administration. It was no differences in body weight
gains between aluminium treated and control animals.
examination at the end of the observation period did
not reveal any aluminium-related changes of the
internal organs of the aluminium treated animals
compared to the control group.
Under the conditions
of this study, the acute oral median lethal dose (LD50)
of the aluminium hydroxide/SH-20 Muster was above 2000
mg/kg bw in female CRL:(WI)BR rats.
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