Registration Dossier
Registration Dossier
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EC number: 201-947-4 | CAS number: 89-87-2
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
- Study period:
- 1987-11-24 to 1988-08-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study similar to recent OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-nitro-m-xylene
- EC Number:
- 201-947-4
- EC Name:
- 4-nitro-m-xylene
- Cas Number:
- 89-87-2
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 2,4-dimethyl-1-nitrobenzene
Constituent 1
Method
- Target gene:
- Salmonella: his-; rfa-; uvrB- (TA98 and TA100 additionally: R-factor)
E.coli: trp-; uvrA-
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1: 10, 33.3, 100, 333.3, 1000 and 5000 µg/plate
Experiment 2: 3.3, 10, 33.3, 100, 333.3, 1000 µg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- w/o metabolic activation
Migrated to IUCLID6: TA 1535, TA 100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylen-diamine, TA 1537, TA 1538, TA 98
- Remarks:
- w/o metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- w/o metabolic activation
Migrated to IUCLID6: WP2
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, all strains tested
- Remarks:
- with metabolic activation
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA 1537, TA 1538, TA 98, WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 1537, TA 1538, TA 98, WP2
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive TA 100 with and without metabolic activation, TA 1535 positive without metabolic activation.
In conclusion it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did induce point mutations by base pair changes in the genome of the strains TA 1535 and TA 100. Therefore, 4-Nitro-1,3-dimethylbenzol is considered to be mutagenic in this Salmonella typhimurium and Eschirichia Coli reverse mutation assay.
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