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EC number: 411-370-1
CAS number: 82857-68-9
GM 102 E
The acute oral toxicity of the test item GM102E was investigated
in a study performed on Sprague Dawley rats at concentrations of 67, 100
and 150 mg/kg.
The test was performed according to OECD guideline 401 and in
compliance with GLP.
The test item was administered by gavage to 5 male rats per dose
and a further group of 5 females was tested at 67 mg/kg of GM102E. The
test item was dissolved in deionized water before administration and the
administration volume was kept constant at 10 ml/kg b.w. in all the
All rats were treated after a 16 hours fasting period. The animals
were weighed twice before treatment (at randomization and on day 1 just
before the study) and on days 3, 8 and 14 after exposure period. They
were clinically observed for 14 days following treatment. On day 15 all
treated rats were killed by excision of the femoral arteries, after i.p.
overdosage anesthesia with 5% sodium pentobarbital. Animals which died
and animals killed at the end of the study were submitted to a thourough
Piloerection, hunched posture and diarrhea were clinically
observed in animals treated at the lowest dose (67 mg/kg) starting from
2 hours and lasting up to 24 hours after the test item administration.
Animals treated at the highest doses (100 and 150 mg/kg) showed the same
clinical signs and, in addition, sedation and/or hypoactivity and
sporadic cases of shallow breathing, chromodacryorrhea and pallor of the
skin and apparent mucosae. These signs started from 30 minutes – 4 hours
and lasted up to 6 hours – day 3 of the study. Recovery of all surviving
rats was achieved within days 2 – 4 of the study.
Body weight gain resulted unaffected by treatment in animals
treated at the lowest dose. Surviving male rats treated at 100 and 150
mg/kg showed decrease in body weight or low body weight gain at the day
3 weighing. Body weight gain returned to normal at the subsequent
At the autopsy, animals which died showed congestion of the lungs,
kidnays, stomach, intestine and thymus and also paleness of the liver
and thinning walls with catharral or catharral-hemorrhagic content in
At the autopsy carried out at the end of the observation period no
appreciable macroscopic findings were evident in any treated rat.
One male treated at 100 mg/kg and 4 males treated at 150 mg/kg
died within 2 hours of treatment. No animals treated at 67 mg/kg died.
The LD50 was calculated to be 122.8 mg/kg with 95% confidence limits of
100.4 – 150.2 mg/kg.
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 be classified as toxic by ingestion (Acute
tox. Category 3, H301).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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