Benzoic acid, 4-nitro-, 2-ethylhexyl ester

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-Nitrobenzoic acid-2-ethylhexylester

EC Number:

605-350-3

Cas Number:

16397-70-9

Molecular formula:

C15 H21 N O4

IUPAC Name:

p-Nitrobenzoic acid-2-ethylhexylester

Details on test material:

Name of the test substance used in the study report: p-Nitrobenzoesaeure-2-ethylhexylester
Purity: 99.9%
- Physical state: Yellow, clear liquid
- Lot/batch No.: 3299/95/146 A
- Stability under test conditions: confirmed by reanalysis
- Storage condition of test material: Room temperature

Method

Target gene:

his, trp

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S-9 mix

Test concentrations with justification for top dose:

20 - 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: (+)S-9 mix 2.5 µg / 60 µg 2-aminoanthracene; (-) S-9 mix: 5 µg N-methyl-N'-nitro-N-nitrosoguanidine (TA100,1535), 10 µg 4-nitro-o-phenylendiamine (TA98), 100 µg 9-aminoacridine (TA1537) and 10 µg N-ethyl-N'-nitro-N-nitrosoguanidine (E. coli)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DETERMINATION OF CYTOTOXICITY
- Method: background growth, titer determination

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

bacteria, other: S.typhimurium TA 1537, TA 98 and E. coli WP2

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium, other: TA 1535, TA 100

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A test substance precipitation was found from about 2000 µg/plate onward.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (mainly reduced titer) was observed from about 2000 - 2500 µg/plate onward with the Salmonella strains.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.