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EC number: - | CAS number: -
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- Additional toxicological data
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15 June 2012 to 30 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 471 guideline sudy in compliance with the GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- No 2011/40
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- other: Liquid at ambient temperature
- Details on test material:
- - Name of test material (as cited in study report): Dermalcare MAP L-213/S (or Dermalcare MAP L213S)
- Physical state: yellowish liquid
- Stability under test conditions: the test item is assumed to be stable by the sponsor
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- Each strain contains one mutation in the histidine operon, resulting in a requirement for histidine.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: additional mutations in rfa and uvrB genes. For the strains TA98, TA100 and TA102 presence of an additional plasmid pKM101 in order to enhance their sensitivity of detection of some mutagens. See Table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction obtained by Moltox (USA) and obtained from the liver of the rats treated with Aroclor 1254 (500 mg/kg bw) by the intraperitoneal route. Each batch is tested and validated by Moltox for its ability to activate B[a]P and 2- amino anthracene.
- Test concentrations with justification for top dose:
- Preliminary assay: 10; 100; 500; 1000; 2500 and 5000 µg/plate
First experiment -S9 mix (TA1535; TA 1537; TA98): 0.82; 2.47; 7.41; 22.2; 66.7 and 200 µg/plate
First experiment - S9 mix (TA 100 and TA102) and +S9 mix (TA1535; TA1537; TA98 and TA102): 2.47; 7.41; 22.2; 66.7; 200 and 600 µg/plate
First experiment + S9 mix (TA100): 7.41; 22.2; 66.7; 200; 600 and 1800 µg/plate
Second experiment -S9 mix (TA1535; TA1537; TA98) and +S9 mix (TA98): 0.82; 2.47; 7.41; 22.2; 66.7 and 200 µg/plate
Second experiment - S9 mix (TA 100 and TA102) and +S9 mix (TA1535; TA1537 and TA102): 2.47; 7.41; 22.2; 66.7; 200 and 600 µg/plate
Second experiment + S9 mix (TA100): 7.41; 22.2; 66.7; 200; 600 and 1800 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injections
- Justification for choice of solvent/vehicle: the test item is soluble in water for injections at 50 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injections (batch No. 2F0703 (CDM Lavoisier, France)).
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-anthramine
- Remarks:
- see details in table 7.6.1/2
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for the first experiment and the second experiment without metabolic activation; preincubation for the second experiment with metabolic activation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 or 72 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: in preliminary assay: one plate/concentration, in the main studies: 3 plates/concentration; 2 independent experiments
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants and/or a thinning of the bacterial lawn
OTHER EXAMINATIONS:
not applicable - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship would have been considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Statistics:
- no statistics were performed.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- see tables 7.6.1/3 to 7.6.1/6
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in all strains, in both experiments, with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no precipitate was observed up to 5000 µg/plate
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: In the absence of S9 mix, a moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose-levels ≥ 500 µg/plate towards the TA 98 and TA 102 strains and at dose-levels ≥ 1000 µg/plate towards the TA 100 strain.
In the presence of S9 mix, a moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose-levels ≥ 1000 µg/plate towards the TA 98 and TA 102 strains and at dose-levels ≥ 2500 µg/plate towards the TA 100 strain.
COMPARISON WITH HISTORICAL CONTROL DATA: The number of revertants for the vehicle and positive controls met the acceptance criteria. The study was therefore considered to be valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Without S9 mix,a strong toxicity was noted at dose-levels ≥ 200 µg/plate towards the TA 1535, TA 98 and TA 102 strains and at 600 µg/plate towards the TA 100 strain in both experiments. For the TA 1537 strain, a moderate to strong toxicity was noted at dose-levels ≥ 66.7 µg/plate and at dose-levels ≥ 22.2 µg/plate in the first and second experiments, respectively.
With S9 mix, using the direct plate incorporation method, a strong toxicity was noted at 600 µg/plate towards the TA 1535, TA 1537, TA 98 and TA 102 strains, and a moderate toxicity was observed at 1800 µg/plate towards the TA 100 strain. Using the pre-incubation method, a moderate to strong toxicity was noted at dose-levels ≥ 200 µg/plate towards the TA 1535, TA 1537, TA 98 and TA 102 strains, and at 1800 µg/plate towards the TA 100 strain. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/3:Number of revertants per plate in the absence of metabolic activation in the first test (direct plate incorporation method)
Dermalcare MAP L-213/S Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
|
0* |
12 |
5 |
4 |
2 |
34 |
8 |
156 |
38 |
397 |
36 |
0.82 |
13 |
3 |
7 |
3 |
23 |
4 |
- |
- |
- |
- |
2.47 |
14 |
3 |
6 |
3 |
36 |
18 |
240 |
84 |
377 |
16 |
7.41 |
13 |
0 |
4 |
2 |
43 |
18 |
206 |
33 |
414 |
46 |
22.2 |
11 |
3 |
6 |
2 |
30 |
9 |
184 |
9 |
299 |
9 |
66.7 |
11 |
5 |
3 |
2 |
15 |
3 |
264 |
69 |
277 |
48 |
200 |
3 |
2 |
9 |
4 |
0 |
1 |
302 |
11 |
38 |
45 |
600 |
- |
- |
- |
- |
- |
- |
93 |
25 |
8 |
2 |
1800 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Positive control** |
512 |
35 |
471 |
108 |
107 |
14 |
471 |
76 |
1771 |
47 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA1535 and TA100 strains
- 9AA (50 µg/plate) in TA1537 strain
- 2NF (0.5 µg/plate) in TA 98 strain
- MMC ( 0.5 µg/plate) in TA 102 strain
Table 7.6.1/4: Number of revertants per plate in the presence of metabolic activation (S9 mix) in the first test (direct plate incorporation method)
Dermalcare MAP L-213/S Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
|
0* |
17 |
3 |
11 |
2 |
36 |
7 |
149 |
3 |
552 |
101 |
0.82 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2.47 |
29 |
8 |
10 |
4 |
33 |
2 |
- |
- |
786 |
125 |
7.41 |
21 |
5 |
10 |
2 |
29 |
6 |
203 |
56 |
735 |
35 |
22.2 |
15 |
9 |
14 |
4 |
35 |
8 |
144 |
10 |
609 |
75 |
66.7 |
19 |
2 |
7 |
4 |
28 |
6 |
171 |
17 |
422 |
61 |
200 |
11 |
3 |
8 |
3 |
17 |
3 |
223 |
27 |
294 |
73 |
600 |
3 |
3 |
3 |
3 |
9 |
7 |
165 |
24 |
91 |
16 |
1800 |
- |
- |
- |
- |
- |
- |
139 |
11 |
- |
- |
Positive control** |
159 |
25 |
105 |
15 |
788 |
39 |
535 |
66 |
3673 |
1457 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
-2AM(2µg/plate) in TA1535, TA1537, TA98 strains
- BAP (5µg/plate) in TA100 strain
-2AM(10µg/plate) in TA102 strain
Table 7.6.1/5: Number of revertants per plate in the absence of metabolic activation in the second test (direct plate incorporation method)
Dermalcare MAP L-213/S Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
|
0* |
13 |
4 |
11 |
5 |
30 |
6 |
145 |
29 |
367 |
12 |
0.82 |
18 |
2 |
7 |
3 |
23 |
2 |
- |
- |
- |
- |
2.47 |
17 |
4 |
10 |
8 |
40 |
9 |
122 |
7 |
421 |
33 |
7.41 |
20 |
3 |
11 |
6 |
38 |
8 |
180 |
49 |
540 |
112 |
22.2 |
8 |
7 |
4 |
3 |
30 |
7 |
172 |
38 |
367 |
31 |
66.7 |
14 |
11 |
1 |
1 |
16 |
4 |
133 |
19 |
282 |
18 |
200 |
8 |
1 |
6 |
6 |
2 |
2 |
116 |
6 |
23 |
7 |
600 |
- |
- |
- |
- |
- |
- |
143 |
37 |
27 |
23 |
1800 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Positive control** |
450 |
10 |
981 |
507 |
132 |
39 |
472 |
81 |
1825 |
219 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA1535 and TA100 strains
- 9AA (50 µg/plate) in TA1537 strain
- 2NF (0.5 µg/plate) in TA 98 strain
- MMC ( 0.5 µg/plate) in TA 102 strain
Table 7.6.1/6: Number of revertants per plate in the presence of metabolic activation (S9 mix) in the second test (pre-incubation method)
Dermalcare MAP L-213/S Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
|
0* |
15 |
6 |
10 |
3 |
20 |
4 |
108 |
3 |
468 |
40 |
0.82 |
- |
- |
- |
- |
20 |
3 |
- |
- |
- |
- |
2.47 |
15 |
2 |
8 |
0 |
29 |
9 |
- |
- |
523 |
33 |
7.41 |
12 |
1 |
9 |
1 |
17 |
8 |
130 |
10 |
505 |
72 |
22.2 |
18 |
2 |
10 |
2 |
19 |
3 |
96 |
17 |
478 |
59 |
66.7 |
14 |
3 |
8 |
5 |
21 |
12 |
119 |
7 |
561 |
37 |
200 |
11 |
7 |
5 |
2 |
21 |
7 |
121 |
7 |
349 |
73 |
600 |
5 |
2 |
0 |
0 |
- |
- |
68 |
14 |
91 |
16 |
1800 |
- |
- |
- |
- |
- |
- |
44 |
8 |
- |
- |
Positive control** |
123 |
9 |
152 |
15 |
959 |
43 |
486 |
387 |
1639 |
124 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
-2AM(2µg/plate) in TA1535, TA1537, TA98 strains
- BAP (5µg/plate) in TA100 strain
-2AM(10µg/plate) in TA102 strain
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the test conditions, Dermalcare MAP L-213/S did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium. - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD No.471 guideline, Dermalcare MAP L-213/S diluted in water was tested inS. typhimuriumTA1535, TA1537, TA100, TA98 and TA102 in the presence and the absence of mammalian metabolic activation (S9) using the direct incorporation or the preincubation method. Dermalcare MAP L-213/S as an aqueous solution contains 25.6% of solid content. Therefore a correction factor of 3.91 was applied to calculate the tested concentrations in order to test the solid content of Dermalcare MAP L-213/S at 100%. Six known mutagens (Sodium azide; 9-Aminoacridine; 2-Nitrofluorene; Mitomycin C; 2-Anthramine and Benzoapyrene), dissolved in dimethylsulfoxide (except for Mitomycin C which was dissolved in distilled water), were used to check the sensitivity of the test system.
A preliminary study (one plate/concentration) was performed in order to determine the appropriate concentrations for the two independent main studies (3 plates/concentration). In the preliminary study, the bacterial strains TA98; TA100 and TA102 were exposed to the test substance at the following concentrations: 0; 10; 100; 500; 1000; 2500 and 5000 µg/plate. The test item was freely soluble up to the highest tested concentration. Cytotoxicity, assessed by the decrease in the number of revertants and/or the thinning of the bacterial lawn, was observed in all strains. In the absence of S9 mix, a moderate to strong toxicity was noted at dose-levels ≥ 500 µg/plate towards the TA 98 and TA 102 strains and at dose-levels ≥ 1000 µg/plate towards the TA 100 strain. In the presence of S9 mix, a moderate to strong toxicity was noted at dose-levels ≥ 1000 µg/plate towards the TA 98 and TA 102 strains and at dose-levels ≥ 2500 µg/plate towards the TA 100 strain.
In the main studies Dermalcare MAP L-213/S was tested without S9 mix at2.47,7.41, 22.2, 66.7, 200 and 600 µg/plate for the TA 100 and TA 102 strains in both experiments and at 0.82,2.47,7.41, 22.2, 66.7 and 200 µg/plate for the TA 1535, TA 1537 and TA 98 strains in both experiments. In the presence of metabolic activation, Dermalcare MAP L-213/S was tested at7.41,22.2, 66.7, 200, 600 and 1800 µg/plate in TA 100 strain in both experiments,2.47,7.41,22.2, 66.7, 200 and 600 µg/plate in TA 1535, TA 1537 and TA 102 strains in both experiments and in the TA98 inthe first experiment, 0.82,2.47,7.41, 22.2, 66.7 and 200 µg/plate in TA 98 strain in the second experiment.
Cytotoxicity was observed in all strains in both experiments and whatever the metabolic condition used (i.e. with or without S9 mix). The number of revertants for the vehicle and positive controls met the acceptance criteria. The study was therefore considered to be valid. The test item did not induce any noteworthy or biologically relevant increase in the number of revertants, in any of the other tested strains.
Under the test conditions, Dermalcare MAP L-213/S did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium. This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 471.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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