1-Octadecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

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.

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.

Justification for classification or non-classification

Members of the MDI category are not classified based on the results from in vitro and in vivo studies for genetic toxicity.