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EC number: 229-942-2 | CAS number: 6850-63-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on key study results, the Ames test is negative.
Link to relevant study records
- 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]).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His- (S. typhimurium)
Try- (E.coli) - 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)
- 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.
- 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'.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In an Ames test comparable to OECD Guideline 471 (TA98, 100, 1535, 1537 and E. coli WP2uvrA) 2,6-dimethylcyclohexylamine was tested for mutagenicity 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.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered not to be classified for mutagenic effects according to Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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