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EC number: 610-848-9
CAS number: 52479-58-0
The potential mutagenicity of Poly[oxy(methyl-1,2-ethanediyl)],
bacterial cells has been assessed in vitro in a bacterial reverse
mutation assay conducted according to OECD Test Guideline 471 (May,
2008). Negative results were obtained in Histidine-dependent auxotrophic
mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and
TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2
uvrA (pKM101), both in the presence and in the absence of metabolic
activation in the form of S9 mix.
There are no studies available on the in vitro genotoxicity of Poly[oxy(methyl-1,2-ethanediyl)],
Based on existing datasets, structural and chemical considerations,
read-across from the substance to in vitro genotoxicity studies in
mammalian cells on Propylidynetrimethanol, ethoxylated (TMP EO) is
appropriate to meet the REACH Annex VII-IX data requirements.
Read-across is scientifically justified and also enables the REACH
requirements to be adequately addressed, while avoiding unnecessary
animal testing in accordance with EU Directive 86/609/EEC.
The clastogenic potential of TMP EO in vitro has been investigated in a
chromosome aberration test using Chinese hamster V79 cells carried out
according to OECD Test Guideline 473 (Nern, 2010). Negative results were
observed in the study: TMP EO was not clastogenic.
The potential for TMP EO to cause gene mutations in mammalian cells in
vitro has been investigated in the hypoxanthine-guanine phosphoribosyl
transferase locus (HPRT) in V79 cells in a study conducted according to
OECD Test Guideline 476 (Entian, 2010). Negative
results were obtained in the forward mutation assay with and without
metabolic activation (rat liver S9 mix).
Studies on TMP EO do not show evidence of genotoxicity in mammalian
cells in vitro. Based on read-across to these studies, Poly[oxy(methyl-1,2-ethanediyl)],
not predicted to have genotoxic potential in mammalian cells in vitro.
In accordance with column 2 of REACH Annex VIII, as the available in
vitro studies did not reveal any genotoxic potential for the substance,
in vivo genetic toxicity studies are not necessary.
not mutagenic in bacterial cells in vitro. Based on read-across to
available in vitro cytogenicity and gene mutation studies conducted
using Propylidynetrimethanol, ethoxylated (TMP EO), the substance is not
predicted to have genotoxic potential in mammalian cells in vitro. The
substance does not meet the criteria for classification for genotoxicity
according to Directive 67/548/EEC or Regulation 1272/2008/EC.
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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