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Toxicological information

Genetic toxicity: in vitro

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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: Guidelinestudy, GLP

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2-dichloro-4-nitrobenzene, purity: 96 %

Method

Species / strain
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1537, TA1538, E. coliWP2uvrA/pKM101
Additional strain characteristics:
other:
Metabolic activation:
with and without
Metabolic activation system:
liver S9-fraction from male Sprague-Dawley rats induced by sodium phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
trial 1: +/- S9-mix: 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
trial 2: +/-S9-mix: 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313 µg/plate
Vehicle:
- Vehicle(s)/solvent(s) used: ; DMSO
Controls
Negative controls:
yes
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2- Aminoanthracene, Sodium azide, 9-Aminoacridine, Furylfuramide
Details on test system and conditions:
METHOD OF APPLICATION: preincubation;
DETERMINAION OF TOXICITY: growth inhibition



OTHER:
Evaluation criteria:
Two-hold rule criteria was used for data evaluation (Ames et al 1975). The chemicals were considered to be mutagenic when a dose related increase in revertant colony count was observed and the number of revertant colonies per plate with the test substance was more than twice that of the negative control and when a reproducibility of the test result was observed.
Statistics:
see above

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: S. Typhimurium TA 98, TA1535, TA1537, E.coli WP2uvrA/pKM101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
no further data

Any other information on results incl. tables

1,2 -dichloro-4 -nitrobenzene was tested in the Ames test according to OECD TG 471 up to cytotoxicity using the preincubation metholology and yielded a positive result only in Salmonella typhimurium TA 100 in the presence and in the absence of an additional metabolic activation system. S. Typhimurium TA 98, TA1535, TA1537 and E.Coli WPurvA/pKM101 yielded negative results in the

presence and in the absence of an additional metabolic activation system

Applicant's summary and conclusion

Executive summary:

1,2 -dichloro-4 -nitrobenzene, tested in the Ames test according to OECD TG 471 with and without a metabolic activation system and up to cytotoxicity, yielded a positive result (JETOC 2005)