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Toxicological information

Genetic toxicity: in vitro

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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:
1980

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

Constituent 1
Chemical structure
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 %

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.