Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate showed mutagenic properties in vitro with positive results observed in the bacterial reverse mutation assay as well as in a mammalian cell gene mutation assay (mouse lymphoma) whereas in a cell transformation test the substance was considered without an effect suggesting of a cell transformation potential.

Equivocal results were noted in a pre-guideline in vivo nucleus anomaly test, which is a non-validated test system similar to the micronucleus test. In a pre-guideline sister chromatid exchange study in somatic cells of chinese hamsters a dose related increase of exanges was observed suggesting a clastogenic effect in vivo. However, a new in vivo mammalian erythrocyte micronucleus test performed according to OECD guideline 474 and under GLP conditions showed that bis(2,3-epoxypropyl)- cyclohexane-1,2-dicarboxylate is not clastogenic or aneugenic.

After re-examination of the substance description and based on the ECHA Guidance for identification and naming of substances under REACH, the lead registrant agreed with the other SIEF members that the identifiers (CAS number and EC name) used for the toxicological, ecotoxicological and physico-chemical testing are not representative of the UVCB substance used for the testing. Consequently, the EC name Bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate and CAS number 5493-45-8, mentioned in the testing reports and refering to a monoconstituent substance are incorrect and should be read as 1,3-Isobenzofurandione, hexahydro-, reaction products with epichlorohydrin with CAS number 1395383-69-3, which is representative of the registered UVCB substance used effectively.


Short description of key information:
Bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate was studied in a new in vivo mammalian erythrocyte micronucleus test performed according to OECD guideline 474 and under GLP conditions which showed that bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate is not clastogenic or aneugenic.

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)cyclohexane-1,2-dicarboxylate (Ames test positive, in vitro mammalian cell gene mutation test positive, in vivo mammalian micronucleus test in bone marrow cells 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.