Registration Dossier
Registration Dossier
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EC number: 941-981-3 | 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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study in Japanese only, however, basic data are given in English; tested with the source substance Methyl laurate (CAS No. 111-82-0).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimal agar
- Additional strain / cell type characteristics:
- other:
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- First and second experiment:
Without metabolic activation: 1.56, 3.13, 6.25, 12.5, 25 and 50 µg/plate (TA100 and TA1537); 6.25, 12.5, 25, 50, 100 and 200 µg/plate (TA1535 and TA98); 313, 625, 1250, 2500 and 5000 µg/plate (WP2)
With metabolic activation: 12.5, 25, 50, 100, 200 and 400 µg/plate (TA1537); 25, 50,100, 200, 400 and 800 (TA100 and TA1535); 50, 100, 200, 400, 800 and 1600 (TA98); 313, 625, 1250, 2500 and 5000 µg/plate (WP2) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9 mix: 2-Aminoanthracene (0.5 (TA98), 1 (TA100), 2 (TA1535/1537), 10 µg/plate (WP2uvrA)); -S9 mix: 0.01 µg/plate 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, WP2, TA98), 0.5 µg/plate sodium azide (TA1535) and 80 µg/plate 9-Aminoacridine (TA1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates in each of two independent experiments
- Evaluation criteria:
- Colonies were counted for 3 plates. If the mean value is at least twice as high as the vehicle control and repeatedability or dose responsibility is observed, the substance is considered as positive . Otherwise it is considered as negative.
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:
- cytotoxicity
- Remarks:
- at 500 µg/plate (TA 1535, +S9), at at 50 µg/plate (TA 1535, -S9),at 150 µg/plate (TA 1537, +S9), at 25 µg/plate (TA 1537, -S9), at 800 µg/plate (TA 98, -S9), at 50 µg/plate (-S9), at 400 µg/plate (TA 100, +S9), at 25 µg/plate (TA 100, -S9)
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 result of experiment 1
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 |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
0 |
99 ± 10.4 |
11 ± 2.5 |
19 ± 4.4 |
7 ± 2.6 |
– |
1.56 |
107 ± 7.6 |
ND |
ND |
9 ± 4.0 |
– |
3.13 |
107 ± 18.7 |
ND |
ND |
8 ± 1.5 |
– |
6.25 |
95 ± 0.6 |
8 ± 0.6 |
17 ± 2.5 |
5 ± 1.2 |
– |
12.5 |
100 ± 3.5 |
12 ± 7.5 |
13 ± 2.1 |
7 ± 2.6 |
– |
25 |
86 ± 4.0 |
10 ± 1.0 |
19 ± 2.5 |
7 ± 2.5 |
– |
50 |
72 ± 9.2 |
13 ± 3.5 |
19 ± 2.9 |
6 ± 2.5 |
– |
100 |
- |
11 ± 4.0 |
22 ± 2.3 |
- |
– |
200 |
- |
11 ± 1.2 |
21 ± 1.5 |
- |
Positive controls, –S9 |
Name |
AF2 |
SA |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
503 ± 22.3 |
197 ± 7.5 |
781 ± 42.9 |
772 ± 50.3 |
|
+ |
0 |
119 ± 10.4 |
15 ± 5.1 |
28 ± 3.5 |
11 ± 2.1 |
+ |
12.5 |
ND |
ND |
ND |
15 ± 2.3 |
+ |
25 |
128 ± 17.8 |
12 ± 0.6 |
ND |
11 ± 3.5 |
+ |
50 |
136 ± 8.6 |
16 ± 3.8 |
32 ± 4.4 |
8 ± 2.0 |
+ |
100 |
122 ± 21.7 |
16 ± 2.6 |
29 ± 0.6 |
11 ± 4.0 |
+ |
200 |
95 ± 16.5 |
10 ± 4.5 |
26 ± 2.1 |
17 ± 2.1 |
+ |
400 |
120 ± 19.7 |
12 ± 1.0 |
25 ± 6.7 |
7 ± 2.9 |
+ |
800 |
74 ± 7.1 |
9 ± 0.0 |
27 ± 1.7 |
|
+ |
1600 |
|
|
18 ± 4.7 |
|
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
2 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1269 ± 167.2 |
317 ± 11.7 |
427 ± 35.4 |
252 ± 9.0 |
|
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate |
Base-pair substitution type |
||
WP2uvrA |
||
– |
0 |
21 ± 1.0 |
– |
313 |
26 ± 2.5 |
– |
625 |
29 ± 1.5 |
– |
1250 |
25 ± 2.6 |
– |
2500 |
28 ± 5.0 |
– |
5000 |
25 ± 3.5 |
Positive controls, –S9 |
Name |
AF2 |
Concentrations (μg/plate) |
0.01 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
106 ± 5.6 |
|
+ |
0 |
25 ± 2.6 |
+ |
313 |
26 ± 5.3 |
+ |
625 |
32 ± 6.8 |
+ |
1250 |
37 ± 7.6 |
+ |
2500 |
26 ± 3.5 |
+ |
5000 |
19 ± 7.0 |
Positive controls, +S9 |
Name |
2AA |
Concentrations (μg/plate) |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1343 ± 79.7 |
Table 2: Test result of experiment 2
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 |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
0 |
122 ± 14.6 |
12 ± 2.6 |
24 ± 4.0 |
8 ± 4.6 |
– |
1.56 |
142 ± 8.0 |
ND |
ND |
10 ± 4.0 |
– |
3.13 |
136 ± 23.7 |
ND |
ND |
11 ± 3.1 |
– |
6.25 |
112 ± 5.0 |
17 ± 1.5 |
19 ± 2.5 |
10 ± 4.0 |
– |
12.5 |
115 ± 12.5 |
16 ± 4.0 |
20 ± 3.8 |
7 ± 2.5 |
– |
25 |
129 ± 11.2 |
11 ± 3.5 |
21 ± 4.2 |
8 ± 3.1 |
– |
50 |
108 ± 14.6 |
11 ± 2.0 |
17 ± 2.6 |
7 ± 3.5 |
– |
100 |
|
12 ± 1.5 |
18 ± 2.1 |
|
– |
200 |
|
14 ± 3.5 |
20 ± 3.5 |
|
Positive controls, –S9 |
Name |
AF2 |
SA |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
667 ± 16.2 |
240 ± 6.8 |
940 ± 12.7 |
1058 ± 53.3 |
|
+ |
0 |
131 ± 6.1 |
11 ± 2.1 |
31 ± 9.0 |
18 ± 4.4 |
+ |
12.5 |
ND |
ND |
ND |
20 ± 2.6 |
+ |
25 |
151 ± 11.3 |
15 ± 1.0 |
ND |
15 ± 6.0 |
+ |
50 |
147 ± 14.5 |
16 ± 2.6 |
33 ± 5.5 |
23 ± 6.8 |
+ |
100 |
143 ± 4.2 |
14 ± 4.0 |
30 ± 3.0 |
17 ± 0.6 |
+ |
200 |
129 ± 20.1 |
12 ± 4.0 |
31 ± 6.7 |
15 ± 1.7 |
+ |
400 |
102 ± 6.0 |
12 ± 3.2 |
28 ± 1.5 |
9 ± 0.6 |
+ |
800 |
89 ± 4.2 |
13 ± 3.1 |
22 ± 3.6 |
|
+ |
1600 |
|
|
12 ± 1.0 |
|
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
2 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1227 ± 103.5 |
286 ± 14.8 |
493 ± 63.5 |
296 ± 3.2 |
|
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate |
Base-pair substitution type |
||
WP2uvrA |
||
– |
0 |
27 ± 2.1 |
– |
313 |
22 ± 4.9 |
– |
625 |
30 ± 2.1 |
– |
1250 |
22 ± 3.6 |
– |
2500 |
26 ± 5.2 |
– |
5000 |
24 ± 4.0 |
Positive controls, –S9 |
Name |
AF2 |
Concentrations (μg/plate) |
0.01 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
150 ± 41.0 |
|
+ |
0 |
22 ± 5.1 |
+ |
313 |
25 ± 1.5 |
+ |
625 |
22 ± 4.4 |
+ |
1250 |
28 ± 5.5 |
+ |
2500 |
17 ± 4.9 |
+ |
5000 |
23 ± 3.0 |
Positive controls, +S9 |
Name |
2AA |
Concentrations (μg/plate) |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1531 ± 18.7 |
AF2: 2 -(2-Furyl)-3 -(5-nitro-2-furyl)acrylamide
SA: Sodium azide
9AA: 9-Aminoacridine
2AA: 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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