Registration Dossier
Registration Dossier
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EC number: 203-699-2 | CAS number: 109-73-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
- Principles of method if other than guideline:
- Method: acc. to Ames, B.N. et al. (1975): Mutation Research 31, 347:
Screening using the spot test with four tester strains, followed by a full test with a selection of strains
to re-test questionable results, here in TA 100. - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butylamine
- EC Number:
- 203-699-2
- EC Name:
- Butylamine
- Cas Number:
- 109-73-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- butan-1-amine
- Test material form:
- liquid
- Details on test material:
- n-Butylamine [CAS No. 109-73-9], commercial, no substance-specific data,
purity checked by TLC, GC or NMR, target purity >97 %
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:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Metabolic activation systems were derived from Arochlor-induced livers of male SD rats
- Test concentrations with justification for top dose:
- 1st test: 3.0 µmol/plate (spot test) in all strains
2nd test: 0.03, 0.3, 3.0 und 30 µmol/plate (full plate incorporation assay with TA 100) - Vehicle / solvent:
- Ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: various from the test spectrum
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Agar spot test (1st test); in agar (plate incorporation) (2nd test, TA100)
NUMBER OF REPLICATIONS: no data
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; other:
Results and discussion
Test resultsopen allclose all
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- spot test
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Positive controls validity:
- other: various other substances as expected
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not specified
- Positive controls validity:
- other: various other substances as expected
- Remarks on result:
- other: other: Salmonella typhimurium TA 98, TA 1535, TA 1537
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- No mutagenic activity was observed under the conditions of this test.
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