Registration Dossier
Registration Dossier
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EC number: 215-664-9 | CAS number: 1338-41-6
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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Details on test material:
- - Name of test material (as cited in study report): docosanoic acid
- Physical state: white solid
- Analytical purity: 85.9%
- Lot/batch No.: 60805X
- Storage condition of test material: The test substance was kept under room temperature before use.
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium), trp operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from livers of Sprague-Dawley males, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (0.01 µg/plate); sodium azide (0.5 µg/plate); aminoacridine hydrochloride (80 µg/plate); +S9: 2-aminoanthracene (1.0 µg/plate;TA100), (2 µg/plate;TA1535; TA1537), (10 µg/plate;WP2 uvrA), (0.5 µg/plate;TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A positive result was considered when the number of revertant colonies was at least two fold higher on the test plates than the number of revertants on the respective control plates in addition to a clear dose-dependency.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: observed in all treatment groups
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Cytotoxicity was not observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Test results of experiment 1 (preincubation)
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
0# |
95 ± 2 |
15 ± 1 |
25 ± 2 |
23 ± 3 |
9 ± 2 |
- |
156+ |
94 ± 3 |
11 ± 1 |
27 ± 3 |
21 ± 2 |
8 ± 3 |
- |
313+ |
94 ± 4 |
12 ± 2 |
24 ± 1 |
21 ± 4 |
10 ± 2 |
- |
625+ |
89 ± 2 |
14 ± 3 |
26 ± 1 |
18 ± 2 |
8 ± 1 |
- |
1250+ |
82 ± 4 |
13 ± 1 |
25 ± 3 |
21 ± 3 |
8 ± 3 |
- |
2500+ |
80 ± 2 |
11 ± 1 |
26 ± 1 |
17 ± 3 |
10 ± 4 |
- |
5000+ |
78 ± 2 |
9 ± 2 |
28 ± 1 |
14 ± 4 |
10 ± 3 |
Positive control, -S9 |
Name Concentration (µg/plate) Mean No. of colonies/plate (average of 3±SD) |
AF-2
0.01 µg/plate
687 ± 12 |
NaN3
0.5 µg/plate
687 ± 12 |
AF-2
0.01 µg/plate
687 ± 12 |
AF-2
0.1 µg/plate
687 ± 12 |
ACR
80 µg/plate
687 ± 12 |
+ |
0# |
112 ± 4 |
13 ± 1 |
31 ± 2 |
33 ± 2 |
7 ± 1 |
+ |
156+ |
103 ± 4 |
12 ± 3 |
27 ± 3 |
30 ± 3 |
10 ± 3 |
+ |
313+ |
106 ± 10 |
10 ± 4 |
26 ± 1 |
34 ± 4 |
11 ± 3 |
+ |
625+ |
97 ± 3 |
12 ± 2 |
27 ± 1 |
29 ± 4 |
10 ± 3 |
+ |
1250+ |
97 ± 5 |
12 ± 4 |
28 ± 5 |
30 ± 2 |
10 ± 1 |
+ |
2500+ |
98 ± 3 |
12 ± 3 |
27 ± 3 |
30 ± 2 |
10 ± 3 |
+ |
5000+ |
99 ± 9 |
9 ± 2 |
28 ± 2 |
29 ± 1 |
9 ± 1 |
Positive control, +S9 |
Name Concentration (µg/plate) Mean No. of colonies/plate (average of 3±SD) |
2-AA
1 µg/plate
723 ± 12 |
2-AA
2 µg/plate
383 ± 5 |
2-AA
10 µg/plate
516 ± 5 |
2-AA
0.5 µg/plate
366 ± 19 |
2-AA
2 µg/plate
687 ± 12 |
#: Solvent control (DMSO), +: visible precipitation occured at the end of the exposure period
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: sodium azide
ACR: 9-aminoacridine hydrochloride
2-AA: 2-aminoanthracene
Table 2: Test results of experiment 2 (preincubation)
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
0 |
95 ± 2 |
16 ± 2 |
26 ± 3 |
23 ± 2 |
5 ± 1 |
- |
156+ |
94 ± 3 |
14 ± 1 |
25 ± 1 |
23 ± 3 |
6 ± 2 |
- |
313+ |
95 ± 3 |
14 ± 3 |
26 ± 2 |
23 ± 4 |
6 ± 2 |
- |
625+ |
90 ± 0 |
17 ± 1 |
24 ± 3 |
22 ± 2 |
7 ± 0 |
- |
1250+ |
89 ± 5 |
15 ± 1 |
25 ± 3 |
21 ± 2 |
5 ± 2 |
- |
2500+ |
85 ± 5 |
15 ± 2 |
23 ± 1 |
20 ± 1 |
7 ± 1 |
- |
5000+ |
88 ± 3 |
15 ± 3 |
22 ± 2 |
20 ± 1 |
4 ± 1 |
Positive control, -S9 |
Name Concentration (µg/plate) Mean No. of colonies/plate (average of 3±SD) |
AF-2
0.01µg/plate
734 ± 14 |
NaN3
0.5 µg/plate
433 ± 3 |
AF-2
0.01µg/plate
128 ± 6 |
AF-2
0.1 µg/plate
439 ± 7 |
ACR
80 µg/plate
503 ± 5 |
+ |
0+ |
107 ± 3 |
15 ± 2 |
29 ± 2 |
26 ± 2 |
14 ± 1 |
+ |
156+ |
100 ± 2 |
15 ± 1 |
28 ± 1 |
29 ± 2 |
14 ± 2 |
+ |
313+ |
99 ± 4 |
13 ± 4 |
29 ± 3 |
30 ± 8 |
14 ± 1 |
+ |
625+ |
103 ± 3 |
14 ± 2 |
27 ± 2 |
30 ± 4 |
15 ± 2 |
+ |
1250+ |
101 ± 4 |
12 ± 2 |
28 ± 5 |
28 ± 2 |
13 ± 1 |
+ |
2500+ |
98 ± 2 |
13 ± 2 |
26 ± 2 |
26 ± 1 |
11 ± 1 |
+ |
5000+ |
96 ± 5 |
10 ± 1 |
26 ± 2 |
24 ± 1 |
12 ± 2 |
Positive control, +S9 |
Name Concentration (µg/plate) Mean No. of colonies/plate (average of 3±SD) |
2-AA
1 µg/plate
678 ± 17 |
2-AA
2 µg/plate
393 ± 5 |
2-AA
10 µg/plate
521 ± 22 |
2-AA
0.5 µg/plate
423 ± 31 |
2-AA
2 µg/plate
173 ± 13 |
#: Solvent control (DMSO), +: visible precipitation occured at the end of the exposure period
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: sodium azide
ACR: 9-aminoacridine hydrochloride
2-AA: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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