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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation in vitro:

 

 2, 5 dinitrochlorobenzene was used as a test compound to evaluate its toxic nature in the Salmonella typhimurium tester strain TA-100. The mutagenicity assay was performed as per the Ames et al without any modifications. In accordance with the marked mutagenic response noted, 2, 5 dinitrochlorobenzene is mutagenic in vitro.

 

Link to relevant study records
Reference
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: Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
A sample of 2, 5 dinitrochlorobenzene, determined to be have purity greater than 98%, was tested in the Salmonella typhimurium plate assay.
GLP compliance:
no
Type of assay:
bacterial gene mutation assay
Target gene:
Reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
no data
Test concentrations with justification for top dose:
1 µg/plate
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
no
Positive control substance:
sodium azide
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 available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

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

NUMBER OF REPLICATIONS: Four

NUMBER OF CELLS EVALUATED: No data available

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

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

OTHER: Colony counts were determined with an automatic colony counter (3M Model 620).
Evaluation criteria:
His+ Revertants/Plate was observed
Statistics:
The Student t test was employed to
statistically evaluate the mutation frequencies; Mean ± SEM
Species / strain:
S. typhimurium TA 100
Metabolic activation:
not specified
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No data available
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
positive

The gene toxicity in vitro response for the test compound 2,5 dinitrochlorobenzene in the Salmonella typhimurium tester strain TA-100 is positive.
Executive summary:

2, 5 dinitrochlorobenzene was used as a test compound to evaluate its toxic nature in theSalmonella typhimuriumtester strain TA-100. The mutagenicity assay was performed as per the Ames et al without any modifications.

In accordance with the marked mutagenic response noted, 2, 5 dinitrochlorobenzene is mutagenic in vitro.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical. The studies are as mentioned below:

 

 

2, 5 dinitrochlorobenzene was used as a test compound to evaluate its toxic nature in the Salmonella typhimurium tester strain TA-100. The mutagenicity assay was performed as per the Ames et al without any modifications. In accordance with the marked mutagenic response noted, 2, 5 dinitrochlorobenzene is mutagenic in vitro.

 

In another study, the mutagenicity of 2, 5- Dichloronitrobenzene in Salmonella typhimurium strains TA98, TA1538, TA1537, TA100 and TA1535 was examined. The pour plate/ preincubation test was carried out under the conditions of absence and presence of liver microsomal activation. On the basis of results obtained, 2, 5- Dichloronitrobenzene is considered to be a mutagen.

 

Mutagenicity of 2, 5 dinitrochlorobenzene was also tested by pre-incubation method using Salmonella typhimurium TA100 and TA98 strains with and without S9 mix. The chemical was tested at a concentration of 0, 100, 250, 500, 1000, 2500 and 5000 µg/plate concentration in duplicate. Number of revertant colonies obtained was noted. On the basis of results obtained the test material 2, 5 dinitrochlorobenzene acts as a mutagen for the strain TA100 whereas it did not induce gene mutation in the strain TA98 both in the presence and absence of S9 metabolic activation system.

Based on the data available, 2,5 dinitrochlorobenzene exhibits gene mutation in vitro. Hence the test chemical is likely to classify as a gene mutant in vitro in the category "Muta 2".

Justification for classification or non-classification

Based on the data available, 2,5 dinitrochlorobenzene exhibits gene mutation in vitro. Hence the test chemical is likely to classify as a gene mutant in vitro.