Registration Dossier
Registration Dossier
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EC number: 203-778-1 | CAS number: 110-56-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-April to 16-May 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 79/831/EWG 5 B.14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-dichlorobutane
- EC Number:
- 203-778-1
- EC Name:
- 1,4-dichlorobutane
- Cas Number:
- 110-56-5
- Molecular formula:
- C4H8Cl2
- IUPAC Name:
- 1,4-dichlorobutane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 98, 100, 1535, 1537, 1538
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 8 - 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 and TA 1538
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Details on test system and experimental conditions:
- Two independent experiments: one plate incorporation (concentration 8 - 5000 µg/plate) and one pre-incubation assay (concentration 63 - 1000 µg/plate) with and without metabolic activation.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 500 or 1000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The tested substance 1,4-dichlorobutane was not mutagenic in the standard bacterial mutation test according to Ames with and without metabolic activation up to a tested concentration of 5000 µg/plate.
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