Registration Dossier
Registration Dossier
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EC number: 230-565-0 | CAS number: 7195-44-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Bis(2,3-epoxypropyl)terephthalate was mutagenic in vitro (Ames test and mouse lymphoma test), but did not show any chromosme aberration when applied in vivo to rats or mice in somatic or germs cells respectively.
Short description of key information:
Bis(2,3-epoxypropyl)terephthalate was evaluated for genotoxic potential in the standard Ames/Salmonella gene mutation test, in the mouse lymphoma mutagenicty assay in vitro as well as in two in vivo chromosome aberration tets. Bis(2,3-epoxypropyl)terephthalate was positive in the Ames test and in the in vitro mouse lymphoma test. However, the substance was negative for induction of chromosome damage in an oral rat micronucleus study and in oral mouse spermatogonial chromsome aberration study.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the above stated assessment of the genotoxic potential bis (2,3-epoxypropyl) terephthalate (Ames test positive, in vitro mammalian cell gene mutation test positive, 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 classified according 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.
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