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EC number: 948-518-4 | CAS number: -
The study was performed to assess the acute oral toxicity of 1,2 -Ethanediamine, N-(2 -aminoethyl)-, reaction products with glycidyl Ph ether, to the rat in accordance with OECD Guideline 420 and
EEC Commission Regulation No. 440/2008, Part B, Method B.1 bis.
Fasted female rats received a single oral gavage dose of the test item, formulated in PEG400 to form a clear solution, at the following dose levels:
Sighting investigations: 300 and 2000 mg/kg body weight one female rat at each dose level
Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight. Due to the number of deaths in the main study at 2000 mg/kg body weight, a further four fasted females were similarly dosed at 300 mg/kg body weight to complete the study.
During the study, clinical condition, body weight and macropathology investigations were undertaken.
Four females dosed at 2000 mg/kg were killed for welfare reasons on Day 1. Clinical signs prior to death comprised reduced body temperature, piloerection, underactive behavior, blue
extremities and partially closed eyelids in all animals, hunched posture in three animals, elevated gait and irregular breathing in two animals, flat posture, gasping and shallow
breathing in two animals and a convulsion in one animal. These signs were seen from approximately two hours after dosing. Macroscopic examination revealed yellow liquid fluid
contents in the stomach, duodenum and small and large intestines in all animals and in the caecum for two animals and congestion, characterized by darkened tissues/organs, in the
subcutaneous tissue, brain and spleen in all animals and the stomach, duodenum and small and large intestines for three animals. The duodenum and small and large intestines were
also enlarged, swollen or thickened in one animal.
No clinical signs were seen in any animal dosed at 300 mg/kg or the animal dosed at 2000 mg/kg in the sighting study.
All animals were considered to have achieved satisfactory body weight gains throughout the study.
No macroscopic abnormalities were revealed in any animal surviving until Day 15.
The acute median lethal oral dose (LD50) to rats of 1,2-Ethanediamine, N-(2 - aminoethyl)-,reaction products with glycidyl Ph ether was demonstrated to be between 300
and 2000 mg/kg body weight. 1,2-Ethanediamine, N-(2-aminoethyl)-,reaction products with glycidyl Ph ether is included in
Category 4, according to the Globally Harmonised System (GHS).
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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