Registration Dossier
Registration Dossier
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EC number: 209-836-2 | CAS number: 594-36-5
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:
- 06.02.2006 to 09.03.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-chloro-2-methylbutane
- EC Number:
- 209-836-2
- EC Name:
- 2-chloro-2-methylbutane
- Cas Number:
- 594-36-5
- Molecular formula:
- C5H11Cl
- IUPAC Name:
- 2-chloro-2-methylbutane
- Test material form:
- liquid
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 1.2 to 5000 µg/plate
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- TA100; 0.01 µg/plate
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
- Remarks:
- Without S9 Mix
- Positive controls:
- yes
- Remarks:
- TA1535; 0.5 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- Without S9 Mix
- Positive controls:
- yes
- Remarks:
- WP2 uvrA; 0.01 µg/plate
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9 Mix
- Positive controls:
- yes
- Remarks:
- TA 98; 0.1 µg/plate
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9 Mix
- Positive controls:
- yes
- Remarks:
- TA 1537: 1.0 µg/plate
- Positive control substance:
- other: 6-Chloro-9-[3-(2-chloroethylamino )-propylamino ]-2-methoxyacridine dihydrochloride (ICR-191)
- Remarks:
- Without S9 Mix
- Positive controls:
- yes
- Remarks:
- TA 100; 1.0 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 Mix
- Positive controls:
- yes
- Remarks:
- TA 1535; 2.0 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 Mix
- Positive controls:
- yes
- Remarks:
- WP2 uvrA; 10.0 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 Mix
- Positive controls:
- yes
- Remarks:
- TA 98; 0.5 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 mix
- Positive controls:
- yes
- Remarks:
- TA 1537; 2.0 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 Mix
- Details on test system and experimental conditions:
- Method: Preincubation method
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537 and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 1250 (S. typhimurium) - 5000 (E. coli) µg/plate
Any other information on results incl. tables
Growth inhibition of bacteria induced by the test substance was observed at and above the doses below:
Bacterial strains |
Without S9 Mix |
With S9 Mix |
| TA100 | 1250 µg/plate | 1250 µg/plate |
| TA1535 | 1250 µg/plate | 1250 µg/plate |
| WP2 uvrA | 2500 µg/plate | 2500 µg/plate |
| TA98 | 1250 µg/plate | 1250 µg/plate |
| TA1537 | 1250 µg/plate | 2500 µg/plate |
Precipitate of the test chemical was not observed either with or without S9 Mix.
No bacterial growth was detected in the sterility test on the test chemical solution and S9 Mix.
Applicant's summary and conclusion
- Conclusions:
- Based on these results, it was concluded that 2-chloro-2-methylbutane is not mutagenic under the conditions tested.
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