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EC number: 236-828-6
CAS number: 13501-76-3
were chosen as key when the available study was of relevance and of
sufficient quality for classification, labelling and for risk
key bacterial mutagenicity study on
(3-chloropropyl)diethoxymethylsilane was conducted according to OECD TG
471 and under GLP, the test substance induced a mutagenic effect in S.
typhimurium TA 1535 with and without metabolic activation. Appropriate
positive and solvent controls were included and gave expected results.
substance is considered to be a direct-acting mutagen, inducing base
pair mutations (Hüls AG,1995).
data are available for mutagenicity to a bacterial strain capable of
detecting cross-linking or oxidising mutagens. In view of the lack of
genetic toxicity demonstrated in studies on mammalian cells [and in
vivo], and the absence of structural features that indicate that
such mutagenicity is likely,testing in an appropriate 5th strain
is not considered necessary. In addition, the only silicon-containing
substance which has given a positive result in a bacterial strain
capable of detecting cross-linking or oxidising mutagens contains an
epoxy- side-chain (which is associated with cross-linking mutagenicity),
and this substance was positive in Salmonella typhimurium strains
TA 100, TA 1535 as well as in E.coli WP2 uvrA.
key mammalian cell gene mutation study on
(3-chloropropyl)diethoxymethylsilane was conducted according to OCED TG
476 and under GLP, the test substance was non-mutagenic in CHO cells
under the conditions of the test. Appropriate positive and
solvent controls were included and gave expected results (Hüls
key in vivo erythrocyte micronucleus study on
(3-chloropropyl)diethoxymethylsilane was conducted according to EU
Method B.12 and under GLP, the test substance was not genotoxic under
the conditions of the test. Appropriate positive and
solvent controls were included and gave expected results. It
should be noted that the PCE / NCE ratio was reduced in the test
substance indicating toxicity to bone marrow and demonstrating that the
test substance reached the target tissue (Hüls AG,1996).
test substance was considered to be a direct-acting mutagen after a
bacterial reverse mutation assay. Further mutagenicity testing in
mammalian cells in contrast was negative, indicating that the effect
observed in bacteria was not relevant to mammalian cells. In vitro
cytogenicity testing is not required as there is a reliable in vivo
micronucleus study available. The results of this study were also
negative, confirming the conclusion from the in vitro studies
that the test substance has no genotoxic potential.
Based on the available in vitro and
in vivo data on mutagenicity of the registered substance,
(3-chloropropyl)diethoxymethylsilane is not classified for mutagenicity
according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.
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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