Registration Dossier
Registration Dossier
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EC number: 941-187-7 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that only duplicate plates were used, and positive controls all required activation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- range of strains; duplicate not triplicate
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alcohols, C12-13
- EC Number:
- 278-306-0
- EC Name:
- Alcohols, C12-13
- Cas Number:
- 75782-86-4
- IUPAC Name:
- dodecan-1-ol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typrhimurium strains TA98, 100, 1535, 1537 and 1538; Escherichia coli strains WP2 and WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 0, 0.2, 2, 20, 200 (or 500 E. coli) and 2000 µg/plate
Results and discussion
Test results
- Species / strain:
- bacteria, other: Salmonella typrhimurium strains TA98, 100, 1535, 1537 and 1538; Escherichia coli strains WP2 and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- >2000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION CONCENTRATION: None reported
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
GENOTOXIC EFFECTS:
- With and without metabolic activation: There was no increase in reverse mutation rate in any of the test organisms.
Table 1a Experiment 1 and 3* Plate incorporation: revertants per plate (mean of 2 plates)
Concentration µg/plate |
E coli WP2 |
E coli WP2 uvrA |
TA 100 |
TA 1535 |
||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
0 |
9.8 |
10.3 |
9.55 |
17.5 |
38.8 |
47.0 |
7.0 |
4.0 |
0.2 |
13.3 |
9.3 |
7.8 |
19.0 |
46.3 |
55.8 |
10.3 |
4.8 |
2 |
12.3 |
11.0 |
7.5 |
18.5 |
46.0 |
52.0 |
5.5 |
5.0 |
20 |
9.5 |
9.8 |
7.3 |
15.8 |
48.0 |
55.0 |
6.5 |
3.8 |
200 |
11.8 |
7.5 |
13.5 |
13.5 |
44.3 |
56.8 |
12.5 |
.7.0 |
2000 |
11.5 |
18.0 |
6.8 |
3.5 |
49.8 |
60.0 |
8.5 |
10.0 |
Positive control |
143.8 |
24.8 |
109.2 |
454.0 |
50.3 |
158.3 |
1122.0 |
1077.3 |
* Salmonella strains were tested in experiment 3, E.coli in experiment 1
Table 1b Experiment 3 Plate incorporation: revertants per plate (mean of 2 plates)
Concentration µg/plate |
TA 1538 |
TA 98 |
TA 1537 |
|||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
0 |
7.8 |
11.0 |
7.3 |
13.5 |
7.8 |
5.8 |
0.2 |
3.8 |
11.0 |
4.0 |
12.3 |
6.8 |
6.5 |
2 |
4.8 |
9.8 |
5.8 |
14.5 |
5.5 |
4.8 |
20 |
3.8 |
11.0 |
6.5 |
12.8 |
6.8 |
6.3 |
200 |
5.0 |
12.8 |
7.5 |
10.8 |
10.0 |
12.3 |
2000 |
5.3 |
16.0 |
7.0 |
11.0 |
6.0 |
5.8 |
Positive control |
4.3 |
47.8 |
6.0 |
144.8 |
8.3 |
12.8 |
Table 2a Experiment 2 and 4* Plate incorporation: revertants per plate (mean of 2 plates)
Concentration µg/plate |
E coli WP2 |
E coli WP2 uvrA |
TA 100 |
TA 1535 |
||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
0 |
9.5 |
6.3 |
7.5 |
8.3 |
107.5 |
105.7 |
2.5 |
2.8 |
0.2 |
7.8 |
8.3 |
7.5 |
10.8 |
106.8 |
93.0 |
1.3 |
2.0 |
2 |
5.5 |
8.0 |
6.5 |
9.8 |
111.0 |
85.8 |
3.0 |
1.8 |
20 |
6.3 |
6.3 |
11.0 |
14.5 |
105.3 |
98.0 |
2.0 |
2.0 |
200 |
4.8 |
7.8 |
8.3 |
9.8 |
107.0 |
93.8 |
1.8 |
2.5 |
2000 |
5.8 |
7.3 |
7.5 |
10.8 |
101.8 |
95.0 |
0.8 |
1.5 |
Positive control |
179 |
15.8 |
353.3 |
606 |
117.3 |
203.5 |
476.3 |
569.0 |
* Salmonella strains were tested in experiment 4 (TA 100 in experiment 5), E.coli in experiment 2
Table 2b Experiment 4 Plate incorporation: revertants per plate (mean of 2 plates)
Concentration µg/plate |
TA 1538 |
TA 98 |
TA 1537 |
|||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
0 |
2.8 |
13.0 |
3.0 |
5.3 |
2.3 |
2.0 |
0.2 |
1.0 |
8.8 |
1.3 |
6.5 |
2.5 |
3.0 |
2 |
1.0 |
8.5 |
1.3 |
6.5 |
5.0 |
2.8 |
20 |
1.3 |
7.8 |
3.0 |
6.5 |
2.5 |
3.5 |
200 |
2.3 |
7.3 |
1.8 |
8.5 |
1.5 |
4.0 |
2000 |
1.5 |
3.8 |
0.3 |
7.8 |
2.5 |
2.3 |
Positive control |
2.0 |
34.8 |
2.5 |
28.5 |
2.8 |
8.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The C12-13 alcohol Dobanol 23 has been tested according to OECD 471 and under GLP. The test substance did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium or E. coli in the presence or absence of metabolic activation at dose levels up to 2000 µg/plate. Vehicle and positive controls produced expected results. There was no evidence of cytotoxicity at any dose level.
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