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EC number: 411-370-1
CAS number: 82857-68-9
GM 102 E
The effects of a repeated oral administration of the test item
GM102E were studied during 28 days on Sprague Dawley Crl:CD(SD)BR rats.
The test item was administered by gavage to rats once a day for 4
consecutive weeks. The test item was dissolved in deionized water before
administration in order to obtain the following doses: 6.25, 12.5, 25
and 50 mg/kg/day and a control group was exposed only to deionized
water. Each tested group consisted of 5 males and 5 females. The
administration volume was kept constant at 10 ml/kg b.w. in all the
At the end of the 4-week exposure period, blood collection was
performed for all animals and they were killed immediately for
No animals were found dead during the study. Based on clinical
observations (clinical signs observed daily, body weight observed
weekly, food consumption, ophthalmoscopic observations) the only effect
attributable to treatment was salivation just after dosing which was
observed in almost all animals treated at 25 and 50 mg/kg/day starting
from week 3 onwards.
Overall body weight gain in surviving males and females was within
the range expected for rats of this strain and age used in this type of
Laboratory investigations (hematology, blood chemistry and
urinalysis) and post-mortem examinations (gross pathology, organ weights
and histology) did not reveal any treatment-related changes.
Thus, based on the results of the study, the NOAEL for 28-day
repeat dose administration of GM102E by oral route in the rat is
considered to be 50 mg/kg/day while the NOEL is considered to be 12.5
Based on these results and according to the Regulation (EC) No
1272/2008 on classification, labelling and packaging of substances and
mixtures (CLP), GM102E should not be classified as toxic after repeated
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