Registration Dossier
Registration Dossier
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EC number: 202-675-9 | CAS number: 98-51-1
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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic toxicology testing of 41 industrial chemicals.
- Author:
- Dean BJ et al.
- Year:
- 1 985
- Bibliographic source:
- Mutat Res 153: 57-77.
Materials and methods
- Principles of method if other than guideline:
- The test was carried out according to Ames BN et al (1975). Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test. Mutat Res 31: 347-364.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-tert-butyltoluene
- EC Number:
- 202-675-9
- EC Name:
- 4-tert-butyltoluene
- Cas Number:
- 98-51-1
- Molecular formula:
- C11H16
- IUPAC Name:
- 1-tert-butyl-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): p-tert-butyltoluene
- Analytical purity: 96%
- Impurities (identity and concentrations): no data
- Lot/batch No.: S19815
No further data.
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
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9
- Test concentrations with justification for top dose:
- 0.2, 2, 20, 500, 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; hexane
- Justification for choice of solvent/vehicle: no data
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 4
Plate incorporation test with and without metabolic activation with S-9 mix prepared from liver homogenate of Aroclor 1254-pretreated rats. The test was carried out in quadruplicate. Negative controls treated with the vehicle (dimethylsulfoxide and hexane) and positive controls (treatment not clearly specified) were included in each replicate. A preliminary cytotoxicity test was not carried out.
No further data. - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- 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
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