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EC number: 243-072-0
CAS number: 19438-60-9
A bacterial reverse mutation assay (Ames test) has been undertaken
following OECD/EU test methods. Experiments were performed both in the
absence and presence of metabolic activation at concentrations up to
5000 µg/plate. The substance did not induce reverse mutation inSalmonella
The ability to cause chromosomal damage has been investigated in
cultured human lymphocytes,in vitroin the absence and presence of
S9 metabolic activation according to OECD/EU test methods. Two
independent experiments were performed, in the first the cells were
treated for 3 hours in the presence and absence of S9 metabolism and
harvested after 24 hours, this corresponding to approximately 1.5 cell
cycles. The second experiment was performed using the same 24 hour
harvest time with continuous exposure until harvest. 4 -MHHPA) did not
induce chromosomal aberrations.
Gene mutation has been investigated by assaying for the induction
of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells
afterin vitrotreatment, in the absence and presence of
S9 metabolic activation, using a fluctuation method. Methods used were
in accordance with OECD/EU test guidelines. Two independent assays were
performed. 4-MHHPA did not induce mutations at the TK locus of L5178Y
mouse lymphoma cells.
REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that
appropriatein vivomutagenicity studies should be considered in
those cases of a positive result in any of the in vitro genotoxicity
studies. In vitro investigations were negative and in vivo studies are
therefore regarded as inappropriate and not in line with current
concerns regarding animal welfare and the use of animals in scientific
Potential genotoxic effects have been examined using three separate
in-vitro assays, one using bacterial cells and two using mammalian cell
lines. All tests were negative and classification is not indicated.
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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