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EC number: 950-156-7
CAS number: -
The substance consists of three structurally similar bisamides:
Experimental data on this substance are not available. The individual
constituents and mixtures of them and similar amides are considered
suitable read-across substances.
In guideline studies on three read-across substances,
12-hydroxyoctadecanoic acid, reaction products with
1,3-benzenedimethanamine and hexamethylenediamine,
1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene, no oral toxicity
on rats was observed at doses up to 2000 mg/kg bodyweight. Due to the
high structural similarity of the three-constituent substance to these
read-across substances the toxicity via oral route is expected to be
comparable and LD50 > 2000 mg/kg bodyweight is assumed.
Consequently, the acute toxic potential via oral route of the
substance is considered to be low based on read-across data. Testing of
the substance is not considered necessary. The substance does not need
to be classified for acute toxicity via oral route according to CLP
The purpose of the study was to evaluate the
potential toxic effect of the test item
“Bisamid” when administered as a single oral
dose to Wistar rats. The procedure according
to OECD Guideline 423 Acute Toxic Class
(ATC) method was used. A limit dose of 2000
mg/kg body weight was used as a starting
dose. The test item administered to 6
females at a limit dose did not cause death.
No signs of toxicity were observed during
the first 4 hours in females or the 14-day
observation period thereafter. At the end of
the study the body weights of all animals
were higher than the initial body weights. A
slight decrease of body weights in two
animals was observed between the first and
second week after administration of the test
item. During necropsy, no macroscopic
findings were observed. The LD50 of the test
item “Bisamid” is greater than 2000 mg/kg
body weight after single oral administration
to Wistar rats. Therefore, the test
substance is not classified as toxic by oral
route according to the criteria of EU CLP
The acute toxicity (oral) of
1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene is assessed in a
guideline study according to EU Method B.1 using Wistar rats. The LD50,
determined in a limit test, is > 2000 mg/kg bw. Consequently, the GHS
classification criteria for acute toxicity (oral) are not met.
The acute toxicity (oral) of 12-hydroxyoctadecanoic acid, reaction
products with 1,3-benzenedimethanamine and hexamethylenediamine is
assessed in a guideline study according to EU Method B.1 using
Sprague-Dawley rats. The LD50, determined in a limit test, is > 2000
mg/kg bw. Consequently, the GHS classification criteria for acute
toxicity (oral) are not met.
For the multi-constituent substance Reaction mass of
N,N'-[1,3-phenylenebis(methylene)]bis(12-hydroxyoctadecanamide) a LD50 >
2000 mg/kg bodyweight is assumed from the experimental data of suitable
read-across substances. For classification according to EU Regulation
No. 1272/2008 an LD50 of equal or less than 2000 mg/kg bw is required.
Therefore, the substance does not need to be classifiedfor acute
toxicity via oral route.
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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