Reaction mass of bis(oxiran-2-ylmethyl) terephthalate and tris(oxiran-2-ylmethyl) benzene-1,2,4-tricarboxylate

Endpoint summary

Additional information

Reaction mass of Bis(2,3-epoxypropyl)terephthalate and tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate was tested under GLP conditions for genetic toxicity in vitro in a Bacterial reverse mutation assay, mammalian cell gene mutation and mammalian chromosomes aberration test. Due to the presence of the epoxy groups which are well know to be reactive with DNA, it is without surprise that the three in vitro tests led to positive results. The two main compounds were tested separately for mutagenicity in vivo. For each compound negative results were obtained in an in vivo micronucleus study performed with rats and in an in vivo germ-cell cytogenetic study performed with mice.

Reaction mass of Bis(2,3-epoxypropyl)terephthalate and tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate is therefore considered as negative for mutagenicity.

Justification for selection of genetic toxicity endpoint
All four existing in vivo studies are considered as key value for the chemical safety assessment.

Short description of key information:
Reaction mass of Bis(2,3-epoxypropyl)terephthalate and tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate was evaluated for genotoxic potential in the standard bacterial reverse mutation test, in the mammalian cell gene mutation in vitro as well as in the in vitro mammalian chromosomes aberration test. The results was positive in all three tests in vitro which is not surprising considering the epoxy groups and knowing that most of the epoxy compounds are known to be mutagenic under in vitro conditions.
However, the two main compounds were tested separately in an oral rat micronucleus study and in oral mouse spermatogonial chromsome aberration study. All in vivo studies are negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above stated assessment of the genotoxic potential of reaction mass of Bis(2,3-epoxypropyl)terephthalate and tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate (Ames test positive,in vitro mammalian cell gene mutation test positive, in vitro mammalian chromosomes aberration test positive, and for the two main compounds separately in vivo mammalian micronucleus test in bone marrow cells negative and in vivo spermatogonia chromosome aberration test negative) the substance is deemed non-genotoxic and accordingly does not need to be classifiedaccording to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.