4,5-dichloro-2-nitroaniline

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of Nitro Compounds in Salmonella typhimurium in the Presence of Flavin Mononucleotide in a Preincubation Assay

Author:

Vicki L. Dellarco and Michael J. Prival

Year:

1989

Bibliographic source:

Environmental and Molecular Mutagenesis 13: 116-127 (1989)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Gene mutation toxicity study was performed to evaluate the mutagenic nature of o-Nitroaniline

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2- Nitroaniline

Cas Number:

88-74-4

Molecular formula:

C6H6N2O2

IUPAC Name:

2- Nitroaniline

Details on test material:

- Name of test material: o-Nitroaniline
- IUPAC name: 2-Nitroaniline
- Molecular formula: C6H6N2O2
- Molecular weight: 138.125 g/mol
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material: o-Nitroaniline
- IUPAC name: 2-Nitroaniline
- Molecular formula: C6H6N2O2
- Molecular weight: 138.125 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 98%
- Impurities (identity and concentrations): 2%

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98 and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

The S-9 fraction was obtained from 10% aroclor 1254-induced rat liver

Test concentrations with justification for top dose:

0 - 10 µmol/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: p-dioxane
- Justification for choice of solvent/vehicle: The chemical was soluble in p-dioxane

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

p-dioxane

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

4-nitroquinoline-N-oxide

other: For S. typhimurium strain TA100, 2- aminoanthrene (1.25 or 10 µg per plate) was used with rat liver S9 mix and nitrofurantoin (0.5 µg/plate) in the absence of activation.

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: no data
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: duplicate plate counts

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: Colonies on all plates were hand counted

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for the presence of colonies

Statistics:

Mean

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

o-Nitroaniline did not induce mutation in Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of o-Nitroaniline. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system using the standard plate protocol. The chemical was dissolved in p-dioxane as solvent and used at dose levels 0- 10 µmol/plate. The plates were incubated for 2 days and observed for the presence of colonies. o-Nitroanilinedid not induce mutation in Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.