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EC number: 308-783-3
CAS number: 98510-75-9
Day 0 [g]
Day 7 [g]
Day 14 [g]
Average weight gain [%]
The test substance Formamidopropyldimethylbetain (50% based on solid
matter, active matter: 41.5%) is a clear yellowish liquid. For labelling
and classification purposes the test substance was tested regarding its
acute toxic potential following oral application. Slight acute oral
toxicity of the test substance was expected. Therefore the starting dose
of 300 mg/kg body weight was chosen in the Acute-Toxic-Class-Method
procedure, according to the OECD Guideline for the Testing of Chemicals
No. 423 "Acute Oral Toxicity - Acute Toxic Class Method". A total of
twelve female rats of the strain White Wistar were used in the study.
The test substance was applied by gavage undiluted and as 10% (w/w)
solution in tap water. No toxic symptoms after administration of 300
mg/kg body weight were observed in six animals. In the next step the
test substance was applied to six rats at a dose level of 2000 mg/kg
body weight. No toxic symptoms were observed in this group, as well. No
death occurred in all groups of the dose levels 300 mg/kg and 2000 mg/kg
body weight. Body weight development of all animals was positive 7 days
and 14 days post application. The necropsy 14 days after oral
application showed no substance related morphological visible pathologic
organ findings. Thus, the LD50-value for the test substance is higher
than 2000 mg/kg bw, corresponding to > 830 mg/kg bw in terms of active
substance. Therefore, the test substance Formamidopropyldimethylbetain
50% does not need to be classified according to the Globally Harmonised
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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