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Registration Dossier
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EC number: 229-942-2 | CAS number: 6850-63-1
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD Guideline 471 with acceptable restrictions (no details about the test substance solution [55.2% test substance] used; no data on pH; no analytical control of test solutions; no data about historical controls [but vehicle control within values published elsewhere]).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- 2,6-dimethylcyclohexylamine
- EC Number:
- 229-942-2
- EC Name:
- 2,6-dimethylcyclohexylamine
- Cas Number:
- 6850-63-1
- Molecular formula:
- C8H17N
- IUPAC Name:
- 2,6-dimethylcyclohexan-1-amine
- Details on test material:
- 2,6-Dimethylcyclohexylamine "roh"; purity 55.2%; colourless to yellowish liquid
no further data
Constituent 1
Method
- Target gene:
- His- (S. typhimurium)
Try- (E.coli)
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 100, 98, 1535, 1537, E. coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9-fraction prepared from livers of rats i.p. injected with 500 mg/kg bw Aroclor1254 5 days prior to sacrifice.
- Test concentrations with justification for top dose:
- 3 independent experiments with and without metabolic activation
1) standard plate test: 0; 40; 200; 1,000; 5,000 and 10, 000 µg/plate
2) preincubation assay: 0; 20; 100; 500; 2,500 and 5,000 µg/plate
3) preincubation assay: 0; 62.5; 125; 250; 500 and 1,000 pg/plate - Vehicle / solvent:
- DMSO (dimethylsulfoxide)
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- S9-mix prepared freshly prior to experiment.
3 plates per dose level.
Positive control with S-9 mix:
2.5 µg/plate 2-aminoanthracene (2-AA) dissolved in DMSO for the strains TA 100, TA 98, TA 1537 and TA 1535
and 60 µg/plate 2-aminoanthracene dissolved in DMSO for the strain E. coli WP2 uvrA
Positive control without S-9 mix:
5 µg/plate N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) dissolved in DMSO for the strains TA 100 and TA 1535
10 µg/plate 4-nitro-o-phenylendiamine (NOPD) dissolved in DMSO for the strain TA 98
100 µg/plate 9-aminoacridine chioride monohydrate (AAC) dissolved in DMS0 for the strain TA 1537
10 µg/plate N-ethyl-N'-nitro-N-nitrosoguanidin (ENNG) dissolved in DMS0 for the strain E. coli WP2 uvrA - Evaluation criteria:
- - doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Statistics:
- Mean +- SD (standard deviation) was calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- bacteria, other: Salmonella typhimurium TA 100, 98, 1535, 1537, E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > or = 5000 µg/plate; see Table below
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: Salmonella typhimurium TA 100, 98, 1535, 1537, E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > or = 1000 µg/plate; see Table below
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No test substance precipitation was found.
No data about historical controls but vehicle controls within values published elsewhere.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data - Remarks on result:
- other: other: standard plate test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mutagenicity in the Ames test with and without metabolic activation
Mean number of revertants +- standard deviation
Dose in µg per plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli WP2uvrA |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
- |
Standard plate test |
|||||||||
DMSO |
32+-3 |
49+-10 |
101+-20 |
106+-10 |
16+-2 |
23+-4 |
10+-2 |
8+-3 |
21+-4 |
42+-7 |
40 |
28+-4 |
40+-11 |
111+-6 |
118+-11 |
24+-6 |
16+-5 |
8+-4 |
8+-2 |
29+-2 |
46+-14 |
200 |
21+-8 |
44+-16 |
85+-11 |
120+-17 |
19+-3 |
19+-2 |
6+-2 |
5+-2 |
27+-4 |
53+-10 |
1000 |
28+-1 |
43+-6 |
78+-22 |
125+-3 |
26+-6 |
15+-6 |
9+-1 |
6+-2 |
33+-3 |
50+-4 |
5000 |
28+-3 |
34+-10 |
Toxic |
145+-11 |
16+-7 |
20+-2 |
10+-3 |
4+-1 |
29+-6 |
36+-8 |
10000 |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
20+-4 toxic |
Positive control |
927+-164 |
658+-64 |
513+-7 |
800+-65 |
541+-20 |
119+-20 |
159+-48 |
75+-4 |
730+-46 |
235+-40 |
- |
Preincubation assay (I) |
|||||||||
DMSO |
26+-3 |
35+-5 |
102+-3 |
109+-8 |
19+-2 |
18+-2 |
11+-2 |
9+-2 |
27+-6 |
40+-5 |
20 |
25+-2 |
33+-3 |
110+-6 |
100+-5 |
17+-1 |
16+-1 |
12+-4 |
9+-2 |
31+-4 |
32+-6 |
100 |
26+-5 |
37+-1 |
94+-8 |
100+-4 |
15+-1 |
14+-4 |
9+-2 |
7+-3 |
29+-3 |
22+-2 |
500 |
22+-6 |
26+-3 |
85+-13 |
101+-8 |
10+-0 |
13+-3 |
7+-3 |
7+-2 |
24+-3 |
18+-2 |
2500 |
Toxic |
Toxic |
Toxic |
66+-2 toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
13+-2 toxic |
5000 |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Toxic |
Positive control |
1188+- 128 |
758+-101 |
1261+-54 |
713+-51 |
1129+- 146 |
132+-10 |
765+-23 |
119+-7 |
536+-51 |
194+-18 |
- |
Preincubation assay (II) |
|||||||||
DMSO |
27+-7 |
44+-11 |
109+-11 |
99+-2 |
16+-1 |
14+-4 |
7+-1 |
12+-4 |
43+-9 |
33+-1 |
62.5 |
36+-7 |
37+-10 |
104+-4 |
103+-5 |
21+-8 |
14+-3 |
7+-1 |
13+-2 |
42+-4 |
29+-5 |
125 |
34+-6 |
45+-4 |
98+-4 |
100+-10 |
13+-3 |
13+-3 |
10+-2 |
11+-2 |
42+-11 |
31+-7 |
250 |
36+-3 |
40+-8 |
109+-28 |
122+-4 |
21+-2 |
17+-5 |
8+-2 |
9+-2 |
49+-2 |
29+-6 |
500 |
38+-2 |
35+-8 |
76+-12 |
109+-23 |
17+-2 |
18+-6 |
8+-1 |
7+-3 |
35+-12 |
29+-2 |
1000 |
29+-5 |
38+-4 |
72+-11 |
103+-8 |
8+-4 toxic |
16+-3 toxic |
9+-3 |
7+-3 toxic |
41+-4 |
26+-4 |
Positive control |
969+-89 |
814+-125 |
909+-82 |
853+-44 |
1284+-66 |
125+-16 |
861+-46 |
166+-23 |
606+-52 |
253+-33 |
MA: metabolic activation
Applicant's summary and conclusion
- Conclusions:
- No mutagenic activity was detected with and without metabolic activation even at cytotoxic concentrations in the Ames test using S.typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA.
- Executive summary:
The study is comparable to OECD Guideline 471 with acceptable restrictions (no details about the test substance solution used [55.2% test substance]; no data on pH; no analytical control of test solutions; no data about historical controls [but vehicle control within values published elsewhere]).
In the Ames test with S.typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA the test substance was studied using two different protocols with and without addition of a metabolic activation system: the standard plate test (dose levels: 0; 40; 200; 1000; 5000 and 10000 µg/plate) and the preincubation method (0; 20; 100; 500; 2500 and 5000 µg/plate or in a 2nd trial 0; 62.5; 125; 250; 500 and 1000 µg/plate). Negative and positive controls were valid. In each test system cytotoxic concentrations were reached. There was no increase in revertants in any strain.
Conclusion: No mutagenic activity was detected with and without metabolic activation even at cytotoxic concentrations in the Ames test using S.typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA.
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