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EC number: 812-491-6
CAS number: 1312943-23-9
A study conducted with the substance
N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] (EC # 451-060-3, also
known as KY-UN), which is within the category definition of the MDI
category is read across to members of the polyurea MDI category.
No toxicity was observed up to and including the highest dose level, in
the absence and in the presence of S9 in the study performed. The test
item did not induce an increase in the mutation frequency. The test item
was considered to be non-mutagenic to L5178Y cells under the conditions
of the test.
A gene mutation test in mammalian cells was performed according to OECD
guideline 490 and GLP principles, to assess the potential of
N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to induce forward
mutations at the thymidine kinase locus in L5178Y mouse lymphoma cells.
The test item was tested up to and including a dose concentration of
12.5 µg/mL in the absence of S9-mix in a 3 and 24 hour treatment period
and in the presence of S9-mix in a 3 hour treatment period.
Positive control chemicals, methyl methanesulfonate and
cyclophosphamide, both produced significant increases in the mutation
frequency. The mutation frequency observed in the positive control
cultures was within the 95% control limits of the distribution of the
historical positive control database. It was therefore concluded that
the test conditions were adequate and that the metabolic activation
system (S9-mix) functioned properly. The test item precipitated at the
highest dose level of 12.5µg/ml, however, no toxicity
was observed up to and including the highest dose level, in the absence
and in the presence of S9-mix. The test item did not induce an increase
in the mutation frequency. Therefore, KY-UN is not mutagenic in the
mouse lymphoma L5178Y test system under the experimental conditions
described in the study.
Members of the MDI category are not classified based on the results from
in vitro and in vivo studies for genetic toxicity.
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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