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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1987
Report date:
1987
Reference Type:
publication
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Method: other: acc. to Haworth et al. 1983
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl(ethyl)amine
EC Number:
236-415-0
EC Name:
Butyl(ethyl)amine
Cas Number:
13360-63-9
Molecular formula:
C6H15N
IUPAC Name:
butyl(ethyl)amine
Details on test material:
- Name of test material (as cited in study report): Ethyl-N-Butylamine
- Source: Aldrich
- Purity: 99%

Method

Species / strain
Species / strain / cell type:
other: TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Metabolic activation system:
microsomes from rat liver and hamster liver
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000, 3333 µg/plate
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Standard Salmonella typhimurium reverse mutation assay

Results and discussion

Test results
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:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: preincubation

Any other information on results incl. tables

Strain TA100
Dose No Activation
(Negative)
No Activation
(Negative)
10% HLI
(Negative)
10% HLI
(Negative)
10% RLI
(Negative)
10% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
139 8.7 108 7.9 197 19.2 157 5.7 174 7.2 169 16.1
33     
131 11.7 115 5.6 175 8.4 172 11.6 211 8.1 167 16.9
100     
136 5 108 9.6 177 3.5 146 2.8 205 11.9 176 2.2
333     
132 8.4 110 1.2 171 13.3 159 8.6 197 6.1 164 14.9
1000     
128 6 94 3 168 3.4 143 4.8 190 5.6 158 15
3333     
141 4.1 102 7.8 142 8.4 121 9.5 165 11.6 133 4.9
Positive Control 1165 54.9 1226 71.9 1416 138.1 1972 90.9 2061 147.8 1595 129

Strain TA1535

Dose No Activation
(Negative)
No Activation
(Negative)
10% HLI
(Negative)
10% HLI
(Negative)
10% RLI
(Negative)
10% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
20 0.9 10 1.9 28 2.1 16 0.3 26 1.5 13 2.2
10     
    14 1.8     22 2.3     9 1.5
33     
19 1.9 18 4.7 32 2.5 19 0.9 20 0.6 13 2.7
100     
25 3.8 13 1.7 28 3.2 24 1.5 20 2.1 14 0.7
333     
24 2.3 11 0.7 28 2.9 20 2.1 23 2.6 12 1.3
1000     
17 1.2 9 1.5 27 1.2 15 1.3 19 0.3 10 1.5
3333     
0 0     0 0     0 0    
Positive Control 1322 31.2 1002 81.7 371 29.4 244 5.9 670 139.1 161 7.7

Strain TA1537

Dose No Activation
(Negative)
No Activation
(Negative)
10% HLI
(Negative)
10% HLI
(Negative)
10% RLI
(Negative)
10% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
13 1.5 13 0.6 23 2.8 22 0.9 19 0.9 16 1.8
10     
            22 5.2        
33     
11 0.6 10 1 26 2.1 18 2.1 19 2 24 1.2
100     
15 1.8 14 1.9 24 3.5 22 1.3 17 0.9 21 0.9
333     
11 1.9 6 4.1 23 2.3 22 1.5 19 1.5 18 2.2
1000     
20 1.3 10 3.5 26 0.9 23 4.5 13 1.5 19 2.9
3333     
0 0.3 t 0 0     2 0.9 2 0.9
Positive Control 363 39.1 631 81 220 20.1 289 14.8 364 31.3 634 10.1

Strain TA98

Dose No Activation
(Negative)
No Activation
(Equivocal)
10% HLI
(Negative)
10% HLI
(Negative)
10% RLI
(Negative)
10% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
20 2 14 1.2 34 3.2 27 3.6 33 3.2 25 2.1
33     
31 3.2 19 2 27 2.6 29 2.9 33 2.5 25 1.5
100     
24 4 25 2.3 21 4 23 0.6 32 3.5 28 2.3
333     
29 3.3 25 3.5 17 2.8 21 1.7 28 3.7 22 1.2
1000     
23 3.8 20 4.3 22 0.6 28 2.6 29 4.4 25 2
3333     
19 4.1 26 0.3 19 5.8 16 0.7 17 2.6 19 0.9
Positive Control 221 14 242 17.8 1348 172.6 2062 65 854 139.4 1671 36.3
Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

Butylethylamine (10 -3333 µg/plate) was negative in a bacterial reverse mutation assay (Ames test; preincubation), with and without metabolic acitivation using liver microsomes from Syrian hamster and rat liver. The Salmonella typhimurium test strains were TA100, TA1535, TA1537, and TA98. Cytotoxicity was seen at 1000 or 3333 µg/plate, depending on the test strain (Zeiger, 1987).

The study is fully reliable and suitable for assessment.