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EC number: 701-388-0
CAS number: -
The results of three different reliable in vitro genotoxicity studies
(bacterial mutation, chromosome aberration, mammalian celll mutation),
conducted in both in the presence and absence of a metabolic activation
system, demonstrate that the substance is non-mutagenic and
non-genotoxic. The substance was also negative for mutagenicity in an
reliable (with restrictions given that it did not follow any guidelines
and not in accordance with GLP, but the study was conducted to
nationally acceptable standards) in vitro bacterial mutation assay both
in the presence and absence of a metabolic activation system.
The substance underwent a test to evaluate the mutagenic potential in
the Ames test according to the OECD Guideline 471 employing Salmonella
typhimurium strains TA1535, TA1537, TA100, TA98, and Eschericia coli
WP2, with and without S9 (metabolic activation). Under the conditions of
these tests the substance is considered to be non-mutagenic.
in vitro genotoxicity study (Ames test) the substance was tested for
mutagenicity in Salmonella typhimurium strains TA1535, TA1537, TA1538,
TA98 and TA100, and in Saccharomyces cerevisiae strain D4 in the
presence and in the absence of a metabolic activation system.
Concentrations of up to 10 μl/plate were tested. No evidence of
mutagenic activity was seen at any concentration of the substance in
either bacterial strain. It was concluded that the substance showed no
evidence of mutagenic activity in this bacterial system under the test
The substance underwent genotoxicity testing according to OECD Guideline
473 employing human lymphocytes, with and without metabolic activation
(S9 fraction). The substance was considered to non-genotoxic under the
conditions of the study.
In an in vitro cell
transformation assay to evaluate the mutagenic and clastogenic potential
L5178Y mouse lymphoma cells were exposed to the substance at
62.5, 125, 250, 500, 1000, 2000 μg/mL. the substance did not
induce any increases in the mutant frequency at the TK +/- locus in
L5178Y cells that exceeded the GEF, consequently it is considered to be
non-mutagenic in this assay.
An in vivo genotoxicity assay was conducted on the substance according
to OECD Guideline 474. The results of the test indicates that the
substance is non-genotoxic in vivo under the conditions of the study.
An in vivo gentoxicity assay was conducted on the substance according to
OECD Guideline 474. The results of the test indicates that the substance
is non-genotoxic in vivo under the conditions of the study.
Based on the findings
of several reliable genetic toxicity studies (in vitro and in vivo)
conducted on the substance, classification is not justified.
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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