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EC number: 696-026-0
CAS number: 1395383-69-3
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
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.
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.
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.
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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