1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester

Genetic toxicity: in vitro

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Test guideline 3

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

Test material information

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)

Controls

Controls 1

Positive controls:

yes

Remarks:

2 μg/plate for strains TA100 and TA1535

Positive control substance:

sodium azide

Remarks:

In the absence of S9 mix

Controls 2

Positive controls:

yes

Remarks:

50 μg/plate for strain TA1537

Positive control substance:

9-aminoacridine

Remarks:

In the absence of S9 mix

Controls 3

Positive controls:

yes

Remarks:

2 μg/plate for strain TA98

Positive control substance:

2-nitrofluorene

Remarks:

In the absence of S9 mix

Controls 4

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

Controls 5

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

Controls 6

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.