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EC number: 202-773-1
CAS number: 99-62-7
See "attached background material"
The test item Eastman ™ meta-Diisopropylbenzene was assessed for its
potential to induce mutations at the mouse lymphoma thymidine kinase
locus using the cell line L5178Y. The selection of the concentrations
used in the main experiments was based on data from a pre-experiments.
The test item was investigated at the following concentrations:
Experiment I with metabolic activation: 0.10, 0.20, 0.40, 0.80, 1.20,
1.60, 2.00, 2.40, 2.80 and 3.00 mM and without metabolic activation:
0.05, 0.08, 0.10, 0.15, 0.20, 0.30, 0.40 and 0.50 mM Experiment II with
metabolic activation: 0.01, 0.02, 0.05, 0.1 0, 0.20, 0.30, 0.35 and 0.40
mM and without metabolic activation: 0.002, 0.005, 0.01, 0.02, 0.05,
0.10, 0.15 and 0.20 mM Precipitation of the test item was noted in the
pre-experiment I with and without metabolic activation at a
concentration of 2.4 mM and higher. In the experiments I and II with and
without metabolic activation and in the pre-experiment II without
metabolic activation no precipitation was noted. Growth inhibition was
observed in experiment I and II with and without metabolic activation.
In experiment I with metabolic activation the relative total growth
(RTG) was 12.3% for the highest concentration (3.00 mM) evaluated. The
highest concentration evaluated without metabolic activation was 0.50 mM
with a RTG of21.5%. In experiment II with metabolic activation the
relative total growth (RTG) was 15.7% for the highest concentration
(0.40 mM) evaluated. The highest concentration evaluated without
metabolic activation was 0.20 mM with a RTG of 7.9%. In experiment I and
II no biologically relevant increase of mutants was found after
treatment with the test item (with and without metabolic activation).
The Global Evaluation Factor (GEF; defined as the mean of the
negative/vehicle mutant frequency plus one standard deviation; data
gathered from ten laboratories) was not exceeded by the induced mutant
frequency at any concentration. No dose-response relationship was
observed. Additionally, in experiment I and II colony sizing showed no
clastogenic effects induced by the test item under the experimental
conditions (with and without metabolic activation). EMS, MMS and B[a]P
were used as positive controls and showed distinct and biologically
relevant effects in mutation frequency. Additionally, MMS and B[a]P
significantly increased the number of small colonies, thus proving the
efficiency of the test system to indicate potential clastogenic effects.
The mixed isomers of
m-DIPB and p-DIPB were evaluated in a bacterial reverse mutation (Ames)
assay using Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and
Escherichia coli WP2 uvrA, with or without an exogenous metabolic
activation system. Data indicate that the mixed isomers of DIPB were not
mutagenic, either in the presence or absence of metabolic activation.
The mixed isomers of
m-DIPB and p-DIPB also were evaluated in
a chromosomal aberration assay in Chinese hamster lung cells (CHL/IU),
with or without an exogenous metabolic activation system. Data
indicate that the mixed isomers of DIPB did not produce either
chromosome aberrations or polyploidy.
m-DIPB also was evaluated in a mammalian cell (mouse
lymphoma) mutagenesis assay, with or without an exogenous metabolic
activation system. Data indicate that m-DIPB was not mutagenic, either
in the presence or absence of metabolic activation.
Based upon negative findings from exposure of m-DIPB (in combination
with p-DIPB) in a bacterial reverse mutation (Ames) assay and a
mammalian cell chromosome aberration assay and negative findings from
exposure of m-DIPB in a mammalian cell mutagenesis assay, it was
determined that m-DIPB does not satisfy the criteria for classification
as an ocular irritant according to EU Classification,
Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC)
No. 1272/2008 or UN Globally Harmonized System of Classification and
Labelling of Chemicals (GHS).
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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