Nitrobenzene

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (only 4 strains tested, only summarized data shown)

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity test results for 250 chemicals.

Author:

Haworth, S. et al.

Year:

1983

Bibliographic source:

Environ. Mutagen. Supplement 1, 3-142

Materials and methods

Principles of method if other than guideline:

Method: other: pre-incubation modification of the Ames test acc. to Yahagi, T. et al. (1975), Cancer Lett. 1, 91-96

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Nitrobenzene

EC Number:

202-716-0

EC Name:

Nitrobenzene

Cas Number:

98-95-3

Molecular formula:

C6H5NO2

IUPAC Name:

nitrobenzene

Details on test material:

- Name of test material (as cited in study report): nitrobenzene, American Cyanamid
- Analytical purity: > 99.9%
- Lot/batch No.: 9071

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA1535, TA1537, TA100, and TA98

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

liver S-9 was prepared from male Sprague-Dawley rats and Syrian hamsters that were induced with Aroclor 1254

Test concentrations with justification for top dose:

10, 33, 100, 333 and 1000 ug/plate

Vehicle / solvent:

DMSO was used as a solvent.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

choline chloride, glycerol, glycine, mannitol and sodium phosphate

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (all strains ± S9), 4-nitro-o-phenylenediamine (TA98 -S9), sodium azide (TA100/Ta1535-S9), 9-aminoacridine (TA1537-S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 20 min at 37 °C
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h at 37 °C


NUMBER OF REPLICATIONS: three plates


DETERMINATION OF CYTOTOXICITY
- Method: other: In dose setting expriments, the test chemical was checked for toxicity to TA100 up to a concentration of 10 mg/plate or the limit of solubility, both in the presence and absence of S9 mix. Indications of toxicity were viability in complete medium and reduced numbers of revertant colonies per plate and/or thinning or absence of the bacterial lawn

Evaluation criteria:

A positive response was indicated by a reproducible, dose-related increase, whether it be twofold over background or not. Questionable or inconclusive were low-level responses that were not reproducible or results that did not show a definite trend. It also included tests in which an elevated revertant colony yield occured at only a single dose level.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Concentrations were chosen so that the high dose exhibited some degree of toxicity (see dose setting experiments).

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative