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EC number: 254-179-7
CAS number: 38888-98-1
Mutagenicity in vitro in bacteria:
A distillate containing 75 % diphenyl ethane, was tested for
mutagenicity in the Ames test according to OECD guideline 471 using 5
strains of Salmonella typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and
The test item produced no significant increase in revertants in
any strain and was considered non-mutagenic in this test.
SAS-40 was tested in the Salmonella typhimurium reverse mutation assay
according to OECD/EC guidelines with five histidine-requiring strains of
Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) with and
without metabolic activation (S9 -mix). Based on the results of this
study it can be concluded that SAS-40 is not mutagenic in the Salmonella
typhimurium reverse mutation assay.
Phenyl-tolyl-ethane was tested in the Salmonella typhimurium reverse
mutation assay according to OECD/EC guidelines with four
histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537,
TA98 and TA100) and in tester strain WP2uvrA with and without metabolic
activation (S9 -mix). Phenyl-tolyl-ethane did not induce a significant
dose-related increase in the number of revertant (His+) colonies in each
of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the
number of revertant (Trp+) colonies in tester strain WP2uvrA both in the
absence and presence of S9-metabolic activation.
In vitro chromosome aberration:
95510, a distillate containing 75% diphenylethane (DPE), was tested for
clastogenic potential using Chinese hamster ovary (CHO) cells -in vitro
according to OECD guideline 473 (In
vitro Mammalian Chromosome Aberration Test).
Cell cultures were exposed to XZ 95510 at concentrations of 5, 10, 20
and 40 ug/ml , both in the presence and absence of a metabolic
activation system (Aroclor- 1254 induced rat liver S9-mix) . There was
no reproducible evidence that XZ 95510 induced chromosome aberrations
and there was no indication of chromosomal ploidy changes in either the
presence or absence of the metabolic activation system.
A study according to OECD guideline 473 was performed to assess the
effect of Phenyl-tolyl-ethane on the number of chromosome aberrations in
cultured peripheral human lymphocytes in the presence and absence of a
metabolic activation system (phenobarbital and ß-naphthoflavone induced
rat liver S9-mix). Phenyl-tolyl-ethane was not clastogenic in
human lymphocytes under the experimental conditions described.
Mouse Lymphoma Assay:
This study according to OECD guideline 476 was performed to
investigate the potential of PTE to induce mutations at the mouse
lymphoma thymidine kinase locus using the cell line L5178Y.
The test item did not induce mutations in the mouse lymphoma
thymidine kinase locus assay using the cell line L5178Y in the absence
and presence of metabolic activation. Therefore, PTE is considered to be
non-mutagenic under the conditions of the mouse lymphoma assay.
Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro
sample of 99% diphenyl ethane was tested for genotoxicity by measuring
unscheduled DNA synthesis (U.D. S.) in primary rat hepatocytes in -vitro
according to OECD guideline 482
(Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in
Mammalian Cells In Vitro).
None of the concentrations of 99% diphenyl ethane showed any
evidence of increase DNA labelling. It was concluded that 99% diphenyl
ethane showed no evidence of genotoxicity in this U. D. S. assay.
Genetic toxicity in vivo:
In a mouse micronucleus test following OECD-guideline 474 under
GLP conditions, SAS-40 was administered intraperitoneally at the maximun
tolerated dose (400 mg/kg bw).
SAS-40 did not significantly increase the number of micronucleated
polychromatic erythrocytes or significantly decrease the ratio of
polychromatic to normochromatic erythrocytes at any of the time points.
It can be concluded that SAS-40 does not induce micronuclei.
All in vitro and in vivo tests in genetic toxicity showed negative
results. There is no reason to believe that the negative results would
not be relevant to humans. No further testing is required.
Based on the available data, no classification is needed.
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