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EC number: 258-753-8
CAS number: 53770-52-8
The mean absolute cloning efficiency
(ACE) at selection and mean mutation frequency per 1 x 106cells
(MF) in the absence and presence of metabolic activation for trial I and
trial II are provided below:
+ S9 (2% v/v S9)
mutagenic potential of zinc
was assessed both in the absence and presence of metabolic activation
using the CHO-K1 cell line. Zinc
was tested in two independent experiments, with and without metabolic
activation. Ethyl methanesulfonate (0.4 µL/mL) and benzo(a)pyrene (6
µg/mL) were used as the positive control in the absence and presence of
metabolic activation, respectively.
CHO-K1 cells were exposed to zinc
at the test concentrations of ranging from 156.25, to 5000 µg/mL both in
the absence and presence of metabolic activation for a period of 4 hours.
significant dose-related effect was observed at any of the treated
concentrations during either trial of the experiments.
relevant influence of the test item on pH value or osmolality was
observed. The spontaneous mutation level was (negative control) within
the acceptable limit in both the trials, validating the acceptability of
the test system. The increased mutant frequency observed in positive
controls demonstrated the efficiency of the test system and suitability
of the test procedures and conditions employed in the study.
these results, it is concluded that zinc
does not have potential to induce gene mutations at thehgprtlocus
of CHO-K1 cells both in the absence and presence of metabolic activation
under the present experimental conditions.
In vitro mammalian cell gene forward mutation
test at the hgprt locus of the Chinese hamster ovary (CHO)-K1 cell line
using zinc 3,5-bis(α-methylbenzyl)salicylate: From these results, it is
concluded that zinc 3,5-bis(α-methylbenzyl)salicylate does not have
potential to induce gene mutations at the hgprt locus of CHO-K1 cells,
both in the absence and presence of metabolic activation under the
present experimental conditions.
Mixture containing 30.2% zinc
3,5-bis(alpha-methylbenzyl)salicylate: Reverse Mutation Assay ''Ames
Test'' Using Salmonella Typhimurium Project Number 318/38: The mixture
was found to be non-mutagenic under the conditions of this test.
Mixture containing 30.2% zinc
3,5-bis(alpha-methylbenzyl)salicylate: Metaphase Analysis In Human
Lymphocytes In Vitro Project Number 318/39: The mixture produced no
significant increases in the frequency of chromosome aberrations either
in the presence or absence of a liver enzyme metabolising system; this
mixture is therefore considered to be non-clastogenic to human
lymphocytes in vitro.
Justification for read-across
Two of the three studies described above were
conducted using a liquid mixture containing 30.2% zinc
The remaining substances present in the
PSMS-11 and PVA are not considered to be
hazardous substances. DIBLAME is classified as H315: Causes skin
irritation, H317: May cause an allergic skin reaction and H411: Toxic to
aquatic life with long lasting effects. However, the concentration of
DIBLAME in the mixture is below that which triggers classification of
the mixture for these hazards. Therefore, it is considered justified to
read-across from this mixture to zinc 3,5-bis(α-methylbenzyl)salicylate.
studies have been ranked reliability 1 or 2 according to the Klimisch et
al system. This ranking was deemed appropriate because these studies are
conducted according to recognised test methods. Sufficient dose ranges
and numbers are detailed; hence they are appropriate for use based on
reliability and animal welfare grounds.
results triggered no classification in accordance with the CLP
Regulation (EC No 1272/2008).
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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