Registration Dossier
Registration Dossier
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EC number: 201-755-0 | CAS number: 87-59-2
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 011
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)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,3-xylidine
- EC Number:
- 201-755-0
- EC Name:
- 2,3-xylidine
- Cas Number:
- 87-59-2
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2,3-dimethylaniline
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5,6-benzoflavon
- Test concentrations with justification for top dose:
- -S9 mix;
0, 78.1, 156, 313, 625, 1250, 2500 μg/plate (TA1537)
0, 156 - 5000 μg/plate (TA100, TA1535, TA98, WP2)
+S9 mix;
0, 78.1 - 2500 μg/plate (TA100)
0, 156 - 5000 μg/plate (TA1535, TA98, TA1537, WP2) - Vehicle / solvent:
- DMSO
Controls
- Positive controls:
- yes
- Remarks:
- -S9 mix, 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (TA100, TA98, WP2), Sodium azide (TA1535) and 9-Aminoacridine (TA1537) +S9 mix, 2-Aminoanthracene (five strains)
Results and discussion
Any other information on results incl. tables
This chemical induced mutations in S. typhimurium TA100 with an S9 mix. Toxicity was observed at 1250 μg/plate (TA1537), 2500 μg/plate (TA100, TA1535, TA98), 5000 μg/plate (WP2) without an S9 mix, and at 1250 μg/plate (TA100), 2500 μg/plate (TA1537), 5000 μg/plate (TA1535, TA98, WP2) with an S9 mix.
Genetic effects:
Salmonella typhimurium TA100:
Without metabolic activation: negative
With metabolic activation: positive
Salmonella typhimurium TA1535, TA98, TA1537:
Without metabolic activation: negative
With metabolic activation: negative
Escherichia coli WP2 uvrA:
Without metabolic activation: negative
With metabolic activation: negative
Applicant's summary and conclusion
- Conclusions:
- 2,3-Dimethylaniline was mutagenic only in Salmonella typhimurium TA100, and only with an exogeneous metabolic activation system.
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