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EC number: 201-035-6 | CAS number: 77-53-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- EC Number:
- 201-035-6
- EC Name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- Cas Number:
- 77-53-2
- Molecular formula:
- C15H26O
- IUPAC Name:
- [3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 5000 µg/plate
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- benzo(a)pyrene
- other: 2-Amino-Anthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
Any other information on results incl. tables
An increase of the number of revertant colonies in the treatment with metabolic activation could be observed towards the bacteria strain TA1535 in three concentrations (5000, 1500 and 500 µg/plate). A concentration-related increase over the tested range was found.
In the treatment without metabolic activation, four concentrations (5000, 1500, 500 and 150 µg/plate) showed an increase of the number of revertant colonies towards the bacteria strain TA1535. In this case, no concentration-related increase over the tested range was found.
Therefore, the test item is stated as mutagenic under the test conditions.
To verify the toxicity results, a further experiment was performed with the bacteria strains TA97a, TA98 and TA100 with lower concentrations.
The mean revertant values of the three replicates are presented in the following table.
Table8.1‑a Mean Revertants Experiment 1a
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
79 |
90 |
43 |
49 |
78 |
77 |
324 |
339 |
13 |
16 |
sd |
13.3 |
16.4 |
5.5 |
9.0 |
3.5 |
3.2 |
45.4 |
19.7 |
1.0 |
4.2 |
|
DMSO |
Mean |
80 |
99 |
44 |
41 |
86 |
86 |
299 |
347 |
16 |
14 |
sd |
24.6 |
5.7 |
4.9 |
9.5 |
12.7 |
7.0 |
37.8 |
19.7 |
3.5 |
3.1 |
|
Positive |
Mean |
512 |
1125 |
392 |
227 |
1256 |
1312 |
1200 |
1163 |
251 |
224 |
sd |
72.8 |
50.8 |
28.0 |
40.9 |
133.1 |
181.7 |
104.0 |
46.9 |
26.0 |
90.9 |
|
f(I) |
6.40 |
11.36 |
8.91 |
5.54 |
16.10 |
15.26 |
4.01 |
3.35 |
19.31 |
16.00 |
|
5000 µg/plate |
Mean |
45 |
19 |
0 |
0 |
37 |
26 |
301 |
275 |
165 |
117 |
sd |
4.0 |
3.1 |
0.0 |
0.0 |
3.6 |
4.2 |
39.3 |
47.7 |
53.3 |
29.5 |
|
f(I) |
0.56 |
0.19 |
0.00 |
0.00 |
0.43 |
0.30 |
1.01 |
0.79 |
10.31 |
8.36 |
|
1500 µg/plate |
Mean |
16 |
15 |
0 |
0 |
33 |
19 |
261 |
291 |
188 |
101 |
sd |
2.1 |
1.7 |
0.0 |
0.0 |
1.5 |
1.2 |
51.0 |
56.8 |
41.8 |
12.2 |
|
f(I) |
0.20 |
0.15 |
0.00 |
0.00 |
0.38 |
0.22 |
0.87 |
0.84 |
11.75 |
7.21 |
|
500 µg/plate |
Mean |
51 |
34 |
0 |
0 |
40 |
28 |
317 |
291 |
145 |
58 |
sd |
4.2 |
4.7 |
0.0 |
0.0 |
6.1 |
10.0 |
23.4 |
34.9 |
32.3 |
19.1 |
|
f(I) |
0.64 |
0.34 |
0.00 |
0.00 |
0.47 |
0.33 |
1.06 |
0.84 |
9.06 |
4.14 |
|
150 µg/plate |
Mean |
75 |
77 |
0 |
0 |
95 |
83 |
241 |
308 |
127 |
20 |
sd |
10.6 |
15.9 |
0.0 |
0.0 |
20.2 |
10.5 |
63.3 |
52.0 |
11.5 |
3.2 |
|
f(I) |
0.94 |
0.78 |
0.00 |
0.00 |
1.10 |
0.97 |
0.81 |
0.89 |
7.94 |
1.43 |
|
50 µg/plate |
Mean |
81 |
132 |
9 |
9 |
77 |
83 |
225 |
324 |
20 |
16 |
sd |
9.9 |
6.0 |
2.1 |
2.0 |
11.5 |
7.6 |
30.3 |
45.4 |
6.1 |
3.1 |
|
f(I) |
1.01 |
1.33 |
0.20 |
0.22 |
0.90 |
0.97 |
0.75 |
0.93 |
1.25 |
1.14 |
|
f(I) = increase factor, calculation see chapter7.4, page21
Applicant's summary and conclusion
- Conclusions:
- The test item [3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol) showed an increase in the number of revertants in the bacteria strain TA1535 in experiment 1a.
All negative and nearly all strain-specific positive control values (one marginal exception in experiment 1a) were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that [3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol) is mutagenic in the Salmonella typhimurium test strain TA1535 in the absence and presence of met-abolic activation under the experimental conditions in the present study. - Executive summary:
Two valid experiments were performed.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
The test item[3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol)was tested in theSalmonella typhimuriumreverse mutation assay with five strains ofSalmonella typhimurium(TA97a, TA98, TA100, TA102 and TA1535).
The test was performed in two experiments in the absence and presence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
Experiment 1a:
In this experiment,the test item (dissolved in DMSO) was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method.
The test item showed no precipitates on the plates at any of the concentrations.
Signs of toxicity were observed towards the following bacteria strains in the respective concentrations:
· Bacteria strain TA97a: 5000, 1500 and 500 µg/plate (decrease in the number of revertants)
· Bacteria strain TA98: 5000, 1500, 500, 150 and 50 µg/plate (decrease in the number of revertants)
· Bacteria strain TA100: 5000, 1500 and 500 µg/plate (decrease in the number of revertants)
The bacterial background lawn was not reduced at any of the concentrations.
The results of this experiment showed that three of the tested concentrations showed an increase in the number of revertants in the tested strain TA1535, in the presence and the absence of metabolic activation.
Experiment 1b:
Based on the toxicity results of the experiment 1a,the test item was tested up to concentrations of 500 µg/plate in the absence and presence of S9-mix in the bacteria strains TA97a and TA100 and up to concentrations of 50 µg/plate in the absence and presence of S9-mix in the bacteria strain TA98 using the plate incorporation method.
The test item showed no precipitates on the plates at any of the concentrations.
Signs of toxicity were observed in the following concentrations:
· Bacteria strain TA97a: 500 µg/plate (decrease in the number of revertants)
· Bacteria strain TA98: 50 µg/plate (decrease in the number of revertants)
Bacteria strain TA100: 500 µg/plate (decrease in the number of revertants)
The results of this experiments showed that the test item caused no increase in the number of revertants in these three bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of this study it is concluded that[3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol)is mutagenic in theSalmonella typhimuriumstrainTA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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