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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: flakes
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
Controls
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- Positive controls:
- yes
- Remarks:
- TA98, TA100, TA1535 and TA1537 strains of Salmonella typhimurium and WP2uvrA (pKM101) strain of Escherichia coli
- Details on test system and experimental conditions:
- TA98, TA100, TA1535 and TA1537 strains of Salmonella typhimurium and WP2uvrA (pKM101) strain of Escherichia coli
- Rationale for test conditions:
- The results of the study from both the initial and confirmatory mutation assay showed that, Licocare RBW 300 FL TP did not show any positive mutagenic increase at any of the tested doses either in the presence or in the absence of metabolic activation. Under identical test conditions, there was more than 3-fold increase in the mean numbers of revertant colonies in the positive controls, demonstrating the sensitivity of the assay procedure used.
- Evaluation criteria:
- Tester strain integrity
All Salmonella typhimurium tester strains and the Escherichia coli tester strain used in this assay must demonstrate their growth potential in the presence of histidine and tryptophan, respectively.
All Salmonella typhimurium tester strains must exhibit sensitivity to crystal violet and ultraviolet light to demonstrate the presence of rfa mutation and uvrB mutation, respectively.
Escherichia coli tester strain must exhibit sensitivity to ultraviolet light to demonstrate the presence of uvrA mutation.
Salmonella typhimurium strains TA98 and TA100 and Escherichia coli strain WP2uvrA (pKM101) must exhibit resistance to ampicillin to demonstrate the presence of the plasmid R-factor.
• The spontaneous reversion rates in the vehicle control must be in the range of in-house historical data.
• There must be at least three non-toxic dose levels.
• The top dose selected should demonstrate toxicity. In case of non-toxic test items, the top dose tested should be 5000 µg/plate.
• All tester strain culture titers must be in the range of 1-2 x 109 cells/mL to ensure that appropriate numbers of bacteria are used for plating.
• The positive control substances should produce a more than 3-fold increase in mutant colony frequencies when compared to the respective vehicle control plates.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Results of Preliminary Toxicity Test
Treatment (mg/plate) |
TA 100 revertant colonies/plate* |
||||||||||||
Presence of Metabolic Activation |
Absence of Metabolic Activation |
||||||||||||
Mean |
Background lawn Intensity** |
Precipitation** |
Mean |
Background lawn Intensity** |
Precipitation** |
||||||||
DMSO |
112 |
4+ |
NPO |
113 |
4+ |
NPO |
|||||||
50 |
111 |
4+ |
NPO |
107 |
4+ |
NPO |
|||||||
100 |
112 |
4+ |
NPO |
107 |
4+ |
NPO |
|||||||
200 |
109 |
4+ |
NPO |
108 |
4+ |
NPO |
|||||||
400 |
106 |
4+ |
NPO |
107 |
4+ |
NPO |
|||||||
800 |
107 |
4+ |
NPO |
105 |
4+ |
NPO |
|||||||
1600 |
108 |
4+ |
NPO |
107 |
4+ |
NPO |
|||||||
3200 |
108 |
4+ |
NPO |
107 |
4+ |
NPO |
|||||||
5000 |
106 |
4+ |
NPO |
107 |
4+ |
NPO |
*: Mean of two replicates **: Refer Appendix 7
Table 2. Viable Counts of the Overnight Culture of the Tester Strains
Tester Strains |
Viable Counts (x 109CFU/mL*) |
||||
Initial Mutation Assay |
Confirmatory Mutation Assay |
||||
TA98 |
1.54 |
1.56 |
|||
TA100 |
1.58 |
1.57 |
|||
TA1535 |
1.55 |
1.56 |
|||
TA1537 |
1.56 |
1.58 |
|||
WP2uvrA (pKM101) |
1.63 |
1.62 |
* Required Cell count: 1-2x109Colony Forming Units (CFU)/mL
TALBE 3. Summary Results of Initial Mutation Assay in the Presence of Metabolic Activation
Treatment (µg/plate) |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA(pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
DMSO |
26 |
2 |
NA |
108 |
3 |
NA |
16 |
3 |
NA |
13 |
3 |
NA |
148 |
3 |
NA |
50 |
25 |
2 |
0.96 |
108 |
2 |
1.00 |
16 |
2 |
1.02 |
13 |
2 |
1.00 |
146 |
3 |
0.99 |
158 |
26 |
2 |
1.00 |
105 |
2 |
0.97 |
15 |
2 |
0.94 |
13 |
2 |
0.95 |
147 |
4 |
0.99 |
500 |
26 |
2 |
1.01 |
105 |
3 |
0.98 |
14 |
2 |
0.88 |
12 |
1 |
0.90 |
146 |
4 |
0.99 |
1581 |
25 |
2 |
0.95 |
105 |
3 |
0.97 |
13 |
3 |
0.83 |
12 |
2 |
0.88 |
147 |
4 |
0.99 |
5000 |
25 |
3 |
0.95 |
106 |
3 |
0.98 |
13 |
2 |
0.83 |
11 |
1 |
0.83 |
146 |
2 |
0.99 |
Positive controls |
364c |
8c |
14.01c |
765c |
15c |
7.08c |
163c |
6c |
10.21c |
164c |
9c |
12.33c |
576d |
8d |
3.89d |
aValues are means of three replicates calculated from Appendix 3 and are rounded off to the nearest whole number bRatio of treated/vehicle control (mean revertants per plate). The presentation was made using the mean values with decimals before rounding off to the nearest whole number. Hence, some of the values may not match if calculated using the rounded-off mean values of this summary table. cTA98, TA100, TA1535, TA1537: 2-Aminoanthracene (4 µg/plate) dWP2uvrA(pKM101): 2-Aminoanthracene (30 µg/plate) NA: Not applicable SD: Standard deviation |
Table 4. Summary Results of Initial Mutation Assay in the Absence of Metabolic Activation
Treatment (µg/plate) |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA(pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
DMSO |
26 |
2 |
NA |
107 |
2 |
NA |
14 |
2 |
NA |
14 |
2 |
NA |
146 |
3 |
NA |
50 |
24 |
3 |
0.95 |
107 |
3 |
1.00 |
15 |
2 |
1.07 |
12 |
3 |
0.90 |
148 |
2 |
1.01 |
158 |
25 |
2 |
0.97 |
107 |
5 |
1.00 |
15 |
2 |
1.02 |
12 |
2 |
0.90 |
148 |
4 |
1.02 |
500 |
25 |
2 |
0.97 |
104 |
3 |
0.98 |
14 |
3 |
0.98 |
13 |
2 |
0.93 |
145 |
3 |
0.99 |
1581 |
25 |
3 |
0.97 |
106 |
4 |
0.99 |
14 |
3 |
0.95 |
13 |
3 |
0.93 |
146 |
3 |
1.00 |
5000 |
24 |
2 |
0.93 |
105 |
4 |
0.98 |
14 |
2 |
1.00 |
13 |
2 |
0.93 |
144 |
3 |
0.99 |
Positive controls |
273c |
9c |
10.65c |
562d |
7d |
5.26d |
152d |
10d |
10.63d |
163e |
12e |
11.92e |
566f |
14f |
3.89f |
aValues are means of three replicates calculated from Appendix 4 and are rounded off to the nearest whole number bRatio of treated/vehicle control (mean revertants per plate). The presentation was made using the mean values with decimals before rounding off to the nearest whole number. Hence, some of the values may not match if calculated using the rounded-off mean values of this summary table. cTA98: 2-Nitrofluorene (2 µg/plate), dTA100, TA1535: Sodium azide (1 µg/plate), eTA1537: 9-Aminoacridine (50 µg/plate), fWP2uvrA(pKM101): 4-Nitroquinoline-1-oxide (4 µg/plate) NA: Not applicable SD: Standard deviation |
Table 5. Summary Results of Confirmatory Mutation Assayin the Presence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
DMSO |
26 |
3 |
NA |
112 |
3 |
NA |
17 |
2 |
NA |
15 |
3 |
NA |
147 |
5 |
NA |
50 |
26 |
2 |
0.99 |
107 |
4 |
0.96 |
16 |
3 |
0.98 |
13 |
2 |
0.86 |
148 |
4 |
1.00 |
158 |
25 |
2 |
0.95 |
109 |
3 |
0.97 |
16 |
3 |
0.94 |
14 |
2 |
0.95 |
148 |
3 |
1.01 |
500 |
25 |
3 |
0.95 |
104 |
4 |
0.93 |
16 |
2 |
0.94 |
13 |
2 |
0.89 |
146 |
3 |
1.00 |
1581 |
26 |
2 |
1.00 |
107 |
3 |
0.96 |
15 |
3 |
0.88 |
13 |
2 |
0.86 |
146 |
4 |
1.00 |
5000 |
25 |
3 |
0.94 |
108 |
3 |
0.96 |
14 |
3 |
0.82 |
13 |
3 |
0.89 |
144 |
4 |
0.98 |
Positive controls |
372c |
15c |
14.11c |
766c |
22c |
6.86c |
155c |
9c |
9.32c |
161c |
13c |
11.00c |
568d |
18d |
3.87d |
aValues are means of three replicates calculated from Appendix 5 and are rounded off to the nearest whole number bRatio of treated/vehicle control (mean revertants per plate).The presentation was made using the mean values with decimals before rounding off to the nearest whole number. Hence, some of the values may not match if calculated using the rounded-off mean values of this summary table. cTA98, TA100, TA1535, TA1537: 2-Aminoanthracene (4 µg/plate) dWP2uvrA(pKM101): 2-Aminoanthracene (30 µg/plate) NA: Not applicable SD: Standard deviation |
Table 6. Summary Results of Confirmatory Mutation Assay in the Absence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
DMSO |
27 |
2 |
NA |
108 |
2 |
NA |
16 |
2 |
NA |
14 |
3 |
NA |
148 |
3 |
NA |
50 |
25 |
2 |
0.95 |
107 |
4 |
0.99 |
15 |
2 |
0.92 |
12 |
2 |
0.85 |
147 |
3 |
0.99 |
158 |
27 |
2 |
1.00 |
106 |
3 |
0.98 |
15 |
1 |
0.90 |
12 |
1 |
0.85 |
146 |
4 |
0.99 |
500 |
25 |
3 |
0.94 |
108 |
3 |
1.00 |
16 |
3 |
1.00 |
11 |
2 |
0.78 |
146 |
4 |
0.99 |
1581 |
26 |
2 |
0.97 |
107 |
4 |
0.99 |
15 |
3 |
0.90 |
12 |
2 |
0.88 |
145 |
3 |
0.98 |
5000 |
25 |
2 |
0.94 |
103 |
3 |
0.96 |
14 |
2 |
0.88 |
12 |
2 |
0.90 |
145 |
4 |
0.98 |
Positive controls |
276c |
15c |
10.36c |
567d |
19d |
5.25d |
158d |
11d |
9.65d |
166e |
11e |
12.12e |
564f |
8f |
3.80f |
aValues are means of three replicates calculated from Appendix 6 and are rounded off to the nearest whole number bRatio of treated/vehicle control (mean revertants per plate). The presentation was made using the mean values with decimals before rounding off to the nearest whole number. Hence, some of the values may not match if calculated using the rounded-off mean values of this summary table. cTA98: 2-Nitrofluorene (2 µg/plate), dTA100, TA1535: Sodium azide (1 µg/plate) eTA1537: 9-Aminoacridine (50 µg/plate), fWP2uvrA(pKM101): 4-Nitroquinoline-1-oxide (4 µg/plate) NA: Not applicable SD: Standard deviation |
Applicant's summary and conclusion
- Conclusions:
- All criteria for a valid study were met as described in the study plan. It is concluded that the test item, Licocare RBW 300 FL TP, was not mutagenic in this bacterial reverse mutation test up to the OECD 471-recommended top dose of 5000 µg/plate under the conditions of testing employed.
- Executive summary:
The test item, Licocare RBW 300 FL TP was tested for its mutagenic potential in the bacterial reverse mutation assay. The study was conducted using TA98, TA100, TA1535 and TA1537 strains ofSalmonella typhimuriumand WP2uvrA (pKM101) strain ofEscherichia coliin three phases, a preliminary toxicity test, an initial mutation assay and a confirmatory mutation assay. The bacterial tester strains were exposed to the test item in the presence and absence of metabolic activation system (S9 fraction prepared from Aroclor 1254 induced rat liver).
Licocare RBW 300 FL TP formed a free flowing suspension in Dimethyl sulfoxide (DMSO) at 50 mg/mL.
In a preliminary toxicity test for the selection of test doses for the mutation assay, the test itemdid not precipitate on the basal agar plates at any of the tested doses.The test item did not show toxicity to the tester strain TA100 at any of the tested doses as the intensity of the bacterial background lawn as well as the mean number of revertant colonies were comparable to the vehicle control plates. Based on these observations, the test item was tested up to the OECD 471-recommended top dose of 5000 µg/plate in the mutation assay.
In the mutation assay, the bacterial tester strains were exposed to Licocare RBW 300 FL TPin triplicate at 50, 158, 500, 1581 and 5000mg/plate. The initial mutation assay was conducted using the direct plate incorporation mode of exposure and the confirmatory mutation assay was conducted using the pre-incubation mode of exposure. The vehicle control (DMSO) and the appropriate positive controls were tested simultaneously. The mean and standard deviation of numbers of revertant colonies were calculated for each test dose and the controls for all the tester strains.
The results of the study from both the initial and confirmatory mutation assay showed that, Licocare RBW 300 FL TP did not show any positive mutagenic increase at any of the tested doses either in the presence or in the absence of metabolic activation. Under identical test conditions, there was more than 3-fold increase in the mean numbers of revertant colonies in the positive controls, demonstrating the sensitivity of the assay procedure used.
The study indicated that Licocare RBW 300 FL TP was not mutagenic in this Bacterial Reverse Mutation Assay up to the OECD 471-recommended top dose of 5000mg/plate, under the conditions of testing employed.
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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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