Registration Dossier
Registration Dossier
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EC number: 246-305-4 | CAS number: 24544-04-5
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:
- April 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study performed in accordance with the corresponding OECD-/EU-testing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,6-diisopropylaniline
- EC Number:
- 246-305-4
- EC Name:
- 2,6-diisopropylaniline
- Cas Number:
- 24544-04-5
- Molecular formula:
- C12H19N
- IUPAC Name:
- 2,6-bis(propan-2-yl)aniline
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): T1567
- Molecular weight: 177.3
- Freezing point: -45 °F
- Boiling point: 495 °F
- Physical state: brown clear liquid
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: in glass containers in the dark at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Dr. Bruce Ames, Univ.of California, Berkeley, Ca.
- Properly maintained: yes - Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-liver fractions of rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 1 ul; 0.3 ul; 0.1 ul; 0.03 ul; 0.01 ul/p!ate in the absence and presence of exogenous metabolic activation
- Vehicle / solvent:
- Sectrophotometric grade dimethylsulfoxide (DMSO, CAS 67-68-5); Lot KHML, obtained from Mallinckrodt Chemical Company, St. Louis, Mo. Dilutions were made on the day required.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Evaluation criteria:
- The numbers of revertant colonies from each set of triplicate plates were averaged and the standard deviation calculated. The average number of revertant colonies found in the test compound plates was compared to that found with the solvent control. A compound is considered a mutagen if a dose related increase in the number of revertant colonies is found in the treatment groups. The first dose level considered for the increase must have an average number of revertant colonies which is three times that of the solvent control.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The negative controls, positive controls, and sterility controls all fulfilled requirements for determination of a valid test.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
No detectable mutagenic activity was found for test article T1567 when the Salmonella/microsomal assay was performed - Executive summary:
This reverse mutation assay was performed in 1980 in accordance with OECD-guidelines without GLP. Five Salm. typh. strains (TA1535, TA1537, TA1538, TA98 and TA100) were tested with and without metabolic activation. Test concentrations ranged from 0.01 ug/plate up to 1 ug/plate.
No detectable mutagenic activity was found for test article T1567 when the Salmonella/microsomal assay was performed
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