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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.10.2010 to 26.11.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
EC Number:
700-453-0
Cas Number:
59802-05-0
Molecular formula:
C26H42O4
IUPAC Name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix
Vehicle / solvent:
DMSO (A.C.S. spectrophotometric grade)
Controlsopen allclose all
Positive controls:
yes
Remarks:
2 μg/plate for strains TA100 and TA1535
Positive control substance:
sodium azide
Remarks:
In the absence of S9 mix
Positive controls:
yes
Remarks:
50 μg/plate for strain TA1537
Positive control substance:
9-aminoacridine
Remarks:
In the absence of S9 mix
Positive controls:
yes
Remarks:
2 μg/plate for strain TA98
Positive control substance:
2-nitrofluorene
Remarks:
In the absence of S9 mix
Positive controls:
yes
Remarks:
2 μg/plate for strain WP2 uvrA (pKM101)
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
In the absence of S9 mix
Positive controls:
yes
Remarks:
5 μg/plate for strains TA100 and TA1535 10 μg/plate for strain WP2 uvrA (pKM101)
Positive control substance:
other: 2-Aminoanthracene
Remarks:
In the presence of S9 mix
Positive controls:
yes
Remarks:
5 μg/plate for strains TA98 and TA1537
Positive control substance:
benzo(a)pyrene
Remarks:
In the presence of S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar
- Cell density at seeding (if applicable):at least 109 per mL

DURATION

- Exposure duration: 72 h
- Expression time (cells in growth medium):


NUMBER OF REPLICATIONS: Three
Evaluation criteria:
For a test to be considered valid, the mean of the vehicle control revertant colony numbers for
each strain should lie within or close to the 99% confidence limits of the current historical
control range of the laboratory unless otherwise justified by the Study Director.
Also, the
positive control compounds must induce an increase in mean revertant colony numbers of at
least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle
controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 109/mL.

Results and discussion

Test results
Key result
Species / strain:
bacteria, other: S.typhimurium TA1535, TA1537, TA98, TA100; E.coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
It is concluded that Bis(C9 (branched)alkyl) benzene-1,4-dicarboxylate showed no evidence
of mutagenic activity in this bacterial system under the test conditions employed.