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EC number: -
CAS number: -
An update of the tonnage band to 10-100
tonnes is planned for x.y-dialkyldihydro-oxazolo-oxazole (Sa 190). In
that respect a step-wise approach shall be applied in order to generate
and provide the data required according to the relevant Annex VIII of
the REACh regulation. We have identified genotoxicity as a knock-out
criterion for further using Sa 190 in our products. Therefore, as a
first step we have conducted in vitro genotoxicity tests as required
according to Annex VIII, Section 8.4 - namely an in vitro chromosome
aberration (OECD TG 473) and an in vitro gene mutation test with
mammalian cells (HPRT, OECD TG 476).
While the gene mutation test yielded a
negative result, the chromosome aberration test was positive (see study
results in section 7.6.1). Taking into account the available negative
results of gene mutation tests (1. with bacteria (AMES) and 2. with
mammalian cells (HPRT)), from a scientific point of view there is no
concern with regard to gene mutation. However, since the in vitro
chromosome aberration test was positive, the substances might have a
According to the REACH regulation,
"appropriate in vivo mutagenicity studies shall be considered in case of
a positive result in any of the genotoxicity studies in Annex VII or
VIII". A micronucleus assay according to OECD TG 474 is such an
appropriate study from our perspective. In section 7.6.2 of this dossier
we therefore propose to conduct an in vivo micronucleus assay.
In addition to the clarification required by
the the REACh regulation, we will discontinue using
x.y-dialkyldihydro-oxazolo-oxazole (Sa 190) in our products if a
clastogenic potential would be confirmed, and thus we would also not
need to update the tonnage band in this case. Therefore, we decided not
to continue the preparations for the planned tonnage band update until
it is clarified whether x.y-dialkyldihydro-oxazolo-oxazole (Sa 190) has
a clastogenic potential. Toxicological data other than the mentioned in
vitro genotoxicity results required for the tonnage band of 10 - 100
tonnes are therefore not yet available but will be generated and
provided as soon as possible after a negative outcome of the proposed in
vivo micronucleus test.
Please see also testing proposal in Chapter
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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