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EC number: 256-974-4 | CAS number: 51115-67-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In two key studies of 1986, the potential of WS-23 to induce bacterial mutagenicity was investigated using the AMES assays equivalent or similar to the OECD TG 471.
In the first study (report number: CC/81/86), a standard Plate Incorporation Assay (Ames test) was performed twice on WS-23 using five concentrations of WS-23 spaced at log10 intervals. The concentrations of the test material used per Petri dish were, as follows: 1.58, 2.5, 5, 7.5 and 10 mg/plate. The assay was performed with three levels of S9 (5, 10 and 20 %) with and without pre-incubation.
Three plates were prepared for each concentration of material tested. Similar numbers of plates were also prepared for appropriate positive and negative (solvent, DMSO) controls. Untreated controls were also included. The plates were incubated at 37 degrees C for either 2 or 3 days. Colonies were counted on an Artek 880 counter.
A reduction in the number of revertants and thinning or complete absence of background lawn were observed on several plates treated with the higher concentration (10 mg/plate) of WS 23. The toxicity was dependent on the concentration of S9 used and was more evident with pre-incubation (observed toxicity at 7.5 and 10 mg/plate).
No increase in the number of the revertant colonies occurred with any of the five strains of bacteria at test concentrations of WS-23 up to 10 mg/plate at any of the three levels of S9 mix, either with of without pre-incubation.
In one test only, with TA 1537 in the presence of 5% S9, there was an increase in the number of revertants three concentrations of twice the spontaneous control value. These increases were neither dose related nor reproducible. The spontaneous revertant values on the control plates were unusually low in this test and the observed increase was therefore considered spurious.
In the absence of any evidence of mutagenic potential it was concluded that WS-23 is not mutagenic towards five strains of S. typhimurium up to 5 mg/plate. Interpretation of the data described in this study suggests that WS-23 is unlikely to present a genotoxic hazard.
In the second key study (report number: 10120/5), the toxicity assay was performed with five concentrations of WS 23: 0.5 µg, 5 µg, 50 µg, 500 µg and 5 mg. These concentrations were tested against all 5 strains of S. typhimurium both with and without addition of S9. Different levels of toxicity of WS-23 towards each bacterial strain were observed, and toxicity was also dependent on the presence or absence of S9.
The mutagenicity assay (AMES test) was performed twice with five concentrations of WS-23: 50 µg, 158 µg, 500 µg, 1.58 mg and 5 mg/plate. The assay was performed with and without addition of S9. Briefly, the bacterial plates were inverted and incubated at 37 Celsius degrees for 2-3 days. The mean number of colonies and standard deviation for each set of plates were calculated.
The results of the main assay showed, that WS-23 did not induce mutations in the genomes of the organisms used under the conditions of the assay. Therefore, it was concluded, that there was no evidence to support that WS-23 is a mutagen.
Overall, negative results for mutagenicity were concluded for the test substance, WS-23.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 August 1986 till 8 September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- OECD TG 471
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- with and without pre-incubation
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: PPF/U.K.
- Sample Number: S15100-T01
- Test item: N 2,3-Trimethyl-2-isopropyl butanamide (WS23),
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Stock solutions of DMSO - 50 mg/ml. - Target gene:
- TA 1535 hisG46, rfa-, uvrB-
TA 1537 hisC3076, rfa-, uvrB-
TA 1538 hisD3052, rfa-, uvrB-, pKM101
TA 100 hisG46, rfa-, uvrB-, pKM101 - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine-dependent bacteria strains
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: histidine-dependent bacteria strains
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 derived from Aroclor-induced rat liver
- Test concentrations with justification for top dose:
- Number of dose levels and concentration (mg/plate): 1.58, 2.5, 5, 7,5 and 10 (concentrations spaced at log10 intervals).
The concentrations of WS-23, which were used in the mutation assay were determined from a dose range finding toxicity assay using 5 strains of S. typhimurium. The toxicity assay was performed with 5 concentrations of WS-23 spaced at log10 intervals. - Vehicle / solvent:
- Vehicle: DMSO.
WS23 was found to be readily soluble in DMSO. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- Positive controls: 2-aminoanthracene - stock solution in DMSO Sodium azide - stock solutions in distilled water and filter sterilised 2-nitrofluorene - stock solution in DMSO 9-aminoacridine - stock solution in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Bacteria, test material and metabolising system were incorporated into the top agar of the Petri dishes. The strains were tested routinely for sensitivity to crystal violet, ultraviolet light and, where applicable, resistance to ampicillin.
Negative controls were treated only with the solvent - DMSO.
The petri dishes were incubated for 2 to 3 days, as appropriate, and the number of revertants was determined for each treatment.
Cultures of bacteria of known concentrations were diluted using PBS to about 5x10E3 cells/ml. 0.1 ml of diluted bacteria was added to 2 ml molten top agar followed by 0.1 ml test solution or solvent and 0.5 ml S9 mix or cofactor mix. The top agar was allowed to solidify at room temperature before inversion of the plates for incubation at 37 degrees C. Three plates were prepared for each concentration tested.
After 2-3 days, the plates were removed from the incubator and the number of colonies on each plate were determined. - Rationale for test conditions:
- Certain auxotrophic histidine requiring strains of Salmonella exist which readily undergo reversion to histidine independence under the action of chemical mutagens. The test consists of treating histidine-dependent bacteria with the test material plating out on selective medium (i.e. medium not containing histidine), incubating for 2-3 days and finally counting the mutant colonies.
- Evaluation criteria:
- The average number of mutant colonies per plate is compared with the average number of spontaneous revertants in the control. A dose-related increase in the number of colonies which reaches at least a doubling of the control values is usually considered to be a positive response.
- Statistics:
- Thee number of bacterial colonies on each plate were determined using Artek 880 automatic colony counter. The number of colonies of bacteria which grew following each treatment is expressed as a percentage of the number of colonies which grew on control plates. The mean number of colonies and standard deviation for each set of plates were calculated, as were the percentage survival including 95% confidence limits.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 7,5 and 10 mg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- other: untreated cells
- Positive controls validity:
- valid
- Remarks:
- 2-aminoanthracene, sodium azide
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 10 mg/plate without and 7,5 and 10 mg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- other: untreated cells
- Positive controls validity:
- valid
- Remarks:
- 2-aminoanthracene, 9-aminoacridine
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 7,5 and 10 mg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- other: untreated cells
- Positive controls validity:
- valid
- Remarks:
- 2-aminoanthracene, sodium azide
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 7,5 and 10 mg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- other: untreated cells
- Positive controls validity:
- valid
- Remarks:
- 2-aminoanthracene, 2-nitrofluorene
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 7,5 and 10 mg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- other: untreated cells
- Positive controls validity:
- valid
- Remarks:
- 2-aminoanthracene, 2-nitrofluorene
- Remarks on result:
- other: negative
- Conclusions:
- Based on this testing, it is concluded, that under conditions used in the assay, WS-23 was not mutagenic towards five strains of S. typhimurium.
- Executive summary:
The objective of this study was to investigate the potential of WS-23 to be a bacterial mutagen.
For this reason, a standard Plate Incorporation Assay (Ames test) was performed twice on WS-23 using five concentrations of WS-23 spaced at log10 intervals. The concentrations of the test material used per Petri dish were, as follows: 1.58, 2.5, 5, 7.5 and 10 mg/plate. The assay was performed with three levels of S9 (5, 10 and 20 %) with and without pre-incubation.
Three plates were prepared for each concentration of material tested. Similar numbers of plates were also prepared for appropriate positive and negative (solvent, DMSO) controls. Untreated controls were also included. The plates were incubated at 37 degrees C for either 2 or 3 days. Colonies were counted on an Artek 880 counter.
A reduction in the number of revertants and thinning or complete absence of background lawn were observed on several plates treated with the higher concentration (10 mg/plate) of WS 23. The toxicity was dependent on the concentration of S9 used and was more evident with pre-incubation (observed toxicity at 7.5 and 10 mg/plate).
No increase in the number of the revertant colonies occurred with any of the five strains of bacteria at test concentrations of WS-23 up to 10 mg/plate at any of the three levels of S9 mix, either with of without pre-incubation.
In one test only, with TA 1537 in the presence of 5% S9, there was an increase in the number of revertants three concentrations of twice the spontaneous control value. These increases were neither dose related nor reproducible. The spontaneous revertant values on the control plates were unusually low in this test and the observed increase was therefore considered spurious.
In the absence of any evidence of mutagenic potential it is concluded that WS-23 is not mutagenic towards five strains of S. typhimurium up to 5 mg/plate.
Interpretation of the data described in this study suggests that WS-23 is unlikely to present a genotoxic hazard.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 27 February 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Test material: N,2,3 trimethyl-2-isopropyl butanamide (WS23)
ESL Sample Number 515100 -TOl
No analyses to confirm the identity of the test material were performed as part of this study. - Target gene:
- The strains of Salmonella typhimurium used were as follows:
TA 1535 hisG46, rfa-, uvrB-
TA 1537 hisC3076, rfa-, uvrB-
TA 1538 hisD3052, rfa-, uvrB-
TA 98 hisD3052, rfa-, uvrB-, pKMlOl
TA 100 hisG46, rfa-, uvrB-, pKMlOl. - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine-dependent bacteria strains
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (derived from Aroclor-induced rat liver)
- Test concentrations with justification for top dose:
- The concentrations of WS-23 used in this mutation assay were determined from a dose range finding toxicity assay using 5 strains of S. typhimurium. The toxicity assay was performed with 5 concentrations of WS-23 spaced at log10 intervals. The amounts of test material used per Petri dish were 0.5 µg, 5 µg, 50 µg, 500 µg and 5 mg and these were tested against all 5 strains of S. typhimurium both with and without addition of S9. The concentrations of WS-23 used in the mutation assays were chosen to comply with OECD/EEC guidelines which recommend a top dose level of 5 mg/plate or a top dose which is within the dose range producing a toxic response.
- Vehicle / solvent:
- WS-23 was found to be readily soluble in dimethylsulphoxide (DMSO) and so stock solutions were prepared in this solvent at 50 mg/ml. No analyses were performed to confirm these concentrations.
Positive controls:
With 59 mix;
2-aminoanthracene, 0.63, 2 and 4 µg/plate as
appropriate.
Without 59 mix;
2-nitrofluorene 10 µg/plate, sodium azide 5
and 10 µg/plate, 9-aminoacridine 20 and 40
µg/plate.
Stock solutions of all the above mutagens were prepared at 1 mg/ml in the appropriate solvents and dilutions prepared as required. Solvent-only negative controls were used as appropriate.
Water was used as a solvent for sodium azide only and DMSO was a solvent for test material and remaining positive control materials. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO/water
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, Sodium azide, 2-nitrofluorene, 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION and DURATION
0.1 ml of an overnight culture of bacteria of about 2 x l0 E9 cells / ml was added to 2.0 ml of soft agar containing a trace of histidine and biotin, followed by 0.1 ml of test material and 0.5 ml of S9 μM mix (for metabolism) or cofactor solution (non-metabolism). This was poured over and poured onto a 9 cm Petri dish containing Vogel-Bonner E medium. Three plates were prepared for each concentration of the tested substance. Similar numbers of plates were also prepared for appropriate positive and negative (solvent) controls. The plates were incubated at 37 degrees C for either 2 or 3 days. Colonies were counted on an Artek 880 counter. - Rationale for test conditions:
- The test consists of treating histidine-dependent bacteria with the test material, plating out on selective medium (i.e. medium not containing histidine), incubating for 2-3 days and finally counting the mutant colonies.
Some materials are themselves non-mutagenic but may become mutagenic after metabolism. To allow for this, a postmitochondrial supernatant fraction from rat liver, together with the required cofactors (collectively known as the S9 mix) may be incorporated into the test system. Materials are routinely tested with and without exogenous metabolism. - Evaluation criteria:
- The average number of mutant colonies per plate is compared with the average number of spontaneous revertants in the control. A dose-related increase in the number of colonies which reaches at least a doubling of the control values is considered to be a mutagenic response.
- Statistics:
- The number of colonies of bacteria which grew following each treatment is expressed as a percentage of the number of colonies which grew on control plates. The mean number of colonies and standard deviation for each set of plates were calculated, as were the percentage survival and 95% confidence limits as described by Duncan and Brookes (1973).
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Remarks:
- DMSO, water
- Positive controls validity:
- valid
- Remarks:
- 2AA, NAAZ
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Positive controls validity:
- valid
- Remarks:
- 2AA, 9AA
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Positive controls validity:
- valid
- Remarks:
- 2AA, 2NF
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Positive controls validity:
- valid
- Remarks:
- 2AA, 2NF
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Remarks:
- DMSO, water
- Positive controls validity:
- valid
- Remarks:
- 2AA, NAAZ
- Conclusions:
- WS-23 did not cause a dose-related reproducible increase in reversion to occur in any of the five S.typhimurium strains of bacteria up to 5 mg/plate.
- Executive summary:
The objective of this study equivalent or similar to OECD TG 471, was to provide information on the mutagenic potential of WS-23 in a bacterial mutation assay (Ames Test).
In the Toxicity (Survival) Assay, the toxicity assay was performed with five concentrations of WS 23: 0.5 µg, 5 µg, 50 µg, 500 µg and 5 mg. These concentrations were tested against all 5 strains of S. typhimurium both with and without addition of S9. Different levels of toxicity of WS-23 towards each bacterial strain were observed, and toxicity was also dependent on the presence or absence of S9.
The mutagenicity assay (AMES test) was performed twice with five concentrations of WS-23: 50 µg, 158 µg, 500 µg, 1.58 mg and 5 mg/plate. The assay was performed with and without addition of S9. Briefly, the bacterial plates were inverted and incubated at 37 Celsius degrees for 2-3 days. The mean number of colonies and standard deviation for each set of plates were calculated.
The results of the main assay showed, that WS-23 did not induce mutations in the genomes of the organisms used under the conditions of the assay. Therefore, it was concluded, that there was no evidence to support that WS-23 is a mutagen.
Referenceopen allclose all
Table 1: Mutagenicity Assay Results Test 1 – TA1537 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1537 |
- |
0 |
5 |
2.7 |
1.5 |
3, 4, 1 |
1580 |
7.7 |
1.5 |
8, 9, 6 * |
|||
2500 |
8.5 |
0.7 |
C, 9, 8 * |
|||
5000 |
6 |
2.6 |
7, 3, 8 * |
|||
7500 |
4 |
1.7 |
2, 5, 5 |
|||
10000 |
3.7 |
2.1 |
3, 2, 6 |
|||
- |
0 |
10 |
8.3 |
4 |
4, 9, 12 |
|
1580 |
7.3 |
0.6 |
8, 7, 7 |
|||
2500 |
5.7 |
1.2 |
7, 5, 5 |
|||
5000 |
5.7 |
0.6 |
6, 6, 5 |
|||
7500 |
5.7 |
2.5 |
3, 6, 8 |
|||
10000 |
4.3 |
2.9 |
6, 6, 1 |
|||
- |
0 |
20 |
4 |
0 |
4, 4, 4 |
|
1580 |
6 |
3.5 |
2, 8, 8 |
|||
2500 |
3.3 |
1.2 |
2, 4, 4 |
|||
5000 |
3.3 |
1.5 |
2, 3, 5 |
|||
7500 |
4 |
2.6 |
3, 2, 7 |
|||
10000 |
1.7 |
1.2 |
1, 3, 1 |
|||
Untreated |
0 |
9.7 |
4.9 |
12, 4, 13 |
||
+ |
0 |
5 |
4.3 |
2.9 |
1, 6, 6 |
|
1580 |
5.3 |
3.5 |
5, 9, 2 |
|||
2500 |
6.3 |
2.1 |
8, 4, 7 |
|||
5000 |
5.3 |
2.9 |
2, 7, 7 |
|||
7500 |
1.7 |
1.2 |
1, 1, 3 |
|||
10000 |
2.7 |
1.5 |
3, 1, 4 |
|||
+ |
0 |
10 |
6.3 |
0.6 |
6, 6, 7 |
|
1580 |
6 |
3 |
6, 9, 3 |
|||
2500 |
3.3 |
2.5 |
6, 3, 1 |
|||
5000 |
4 |
1 |
5, 4, 3 |
|||
7500 |
0.3 T |
0.6 |
0, 0, 1 |
|||
10000 |
0.3 T |
0.6 |
1, 0, 0 |
|||
+ |
0 |
20 |
6 |
2.6 |
4, 9, 5 |
|
1580 |
4.7 |
1.5 |
5, 6, 3 |
|||
2500 |
5.7 |
1.5 |
4, 6, 7 |
|||
5000 |
1 T |
1 |
2, 1, 0 |
|||
7500 |
0 T |
|
|
|||
10000 |
0 |
|
|
|||
Untreated |
0 |
6.7 |
1.5 |
5, 7, 8 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
-
|
|
10 |
8.3 |
4 |
4, 9, 12 |
2AA |
2 |
|
554 |
56 |
497, 556, 609 |
|
DMSO |
+ |
|
10 |
6.3 |
0.6 |
6, 6, 7 |
2AA |
2 |
|
446.3 |
21.6 |
431, 437, 471 |
|
* = doubling of negative control values S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation 2AA = 2-aminoanthracene administered with DMSO as a vehicle |
|||||
Table 2: Mutagenicity Assay Results Test 1 – TA1538 Strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1538 |
- |
0 |
5 |
19.3 |
6.5 |
24, 28, 16 |
1580 |
19.7 |
5 |
24, 17, 19 |
|||
2500 |
16.3 |
2.1 |
28, 19, 16 |
|||
5000 |
19.7 |
5.7 |
23, 16, 25 |
|||
7500 |
16 |
2.6 |
25, 24, ND |
|||
10000 |
12.7 |
6.4 |
23, 26, 16 |
|||
- |
0 |
10 |
22.7 |
6.1 |
24, 28, 16 |
|
1580 |
20 |
3.6 |
24, 17, 19 |
|||
2500 |
21 |
6.2 |
28, 19, 16 |
|||
5000 |
21.3 |
4.7 |
23, 16, 25 |
|||
7500 |
24.5 |
0.7 |
25, 24, ND |
|||
10000 |
21.7 |
5.1 |
23, 26, 16 |
|||
- |
0 |
20 |
23.7 |
5.7 |
19, 22, 30 |
|
1580 |
|
24 |
5.8 |
C, 22, 26 |
||
2500 |
|
19 |
3 |
22, 16, 19 |
||
5000 |
|
21 |
2.6 |
20, 19, 24 |
||
7500 |
|
22.7 |
5.1 |
27, 17, 24 |
||
10000 |
|
21.3 |
2.1 |
23, 19, 22 |
||
Untreated |
0 |
11.3 |
2.1 |
12, 13, 9 |
||
+ |
0 |
5 |
16 |
1 |
15, 17, 16 |
|
1580 |
24.7 |
2.1 |
23, 27, 24 |
|||
2500 |
20 |
4.6 |
25, 16, 19 |
|||
5000 |
13 |
2.6 |
16, 11, 12 |
|||
7500 |
6 T |
6.9 |
14, 2, 2 |
|||
10000 |
0 T |
|
|
|||
+ |
0 |
10 |
17.3 |
4.5 |
13, 17, 22 |
|
1580 |
|
21.7 |
5.5 |
16, 27, 22 |
||
2500 |
|
24 |
9 |
33, 24, 15 |
||
5000 |
|
10 |
1.7 |
9, 9, 12 |
||
7500 |
|
0 T |
|
|
||
10000 |
|
0.3 T |
0.6 |
0, 0, 1 |
||
+ |
0 |
20 |
21.3 |
302 |
25, 19, 20 |
|
1580 |
|
21.3 |
5 |
16, 26, 22 |
||
2500 |
|
24.7 |
308 |
22, 23, 29 |
||
5000 |
|
18 |
5.3 |
24, 14, 16 |
||
7500 |
|
12.3 T |
5.1 |
11, 8, 18 |
||
10000 |
|
0 T |
|
|
||
Untreated |
0 |
19.3 |
5.1 |
15, 18, 25 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
22.7 |
6.1 |
24, 28, 16 |
2AA |
|
2 |
|
1785.3 |
33.8 |
1750, 1817, 1789 |
DMSO |
+ |
|
10 |
17.3 |
4.5 |
13, 17, 22 |
2AA |
|
2 |
|
642 |
30.8 |
607, 665, 654 |
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 3: Mutagenicity Assay Results Test 1 – TA98 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA98 |
- |
0 |
5 |
33 |
4.4 |
38, 30, 31 |
1580 |
27.7 |
7.1 |
20, 34, 29 |
|||
2500 |
26 |
10.1 |
15, 38, 35 |
|||
5000 |
26.7 |
11 |
26, 38, 16 |
|||
7500 |
27.7 |
6.4 |
35, 25, 23 |
|||
10000 |
24.3 |
2.5 |
27, 22, 24 |
|||
|
- |
0 |
10 |
38.7 |
3.1 |
38, 42, 36 |
1580 |
27.7 |
3.2 |
24, 30, 29 |
|||
2500 |
34.3 |
6.7 |
31, 42, 30 |
|||
5000 |
28 |
3.5 |
30, 24, 30 |
|||
7500 |
29.3 |
9 |
38, 30, 20 |
|||
10000 |
29 |
5.6 |
28, 35, 24 |
|||
|
- |
0 |
20 |
31 |
3 |
34, 28, 31 |
1580 |
33 |
4 |
33, 37, 29 |
|||
2500 |
32 |
4.6 |
33, 27, 36 |
|||
5000 |
28.7 |
7.6 |
27, 37, 22 |
|||
7500 |
28.3 |
5.5 |
34, 28, 23 |
|||
10000 |
36 |
0 |
36, 36, 36 |
|||
Untreated |
0 |
34.3 |
6.4 |
39, 27, 37 |
||
|
+ |
0 |
5 |
32 |
4.4 |
34, 35, 27 |
1580 |
29.3 |
7.8 |
27, 38, 23 |
|||
2500 |
29.7 |
3.5 |
26, 33, 30 |
|||
5000 |
26 |
7 |
18, 29, 31 |
|||
7500 |
18.3 |
2.1 |
16, 20, 19 |
|||
10000 |
15.3 |
5.7 |
9, 20, 17 |
|||
|
+ |
0 |
10 |
33 |
5.6 |
34, 27, 38 |
1580 |
31 |
3.5 |
29, 29, 35 |
|||
2500 |
31.7 |
4 |
28, 31, 36 |
|||
5000 |
25 |
2.6 |
28, 23, 24 |
|||
7500 |
5 T |
5 |
5, 0, 10 |
|||
10000 |
5.7 T |
9 |
16, 1, 0 |
|||
|
+ |
0 |
20 |
37.7 |
2.5 |
35, 40, 38 |
1580 |
36.5 |
2.1 |
38, 35, ND |
|||
2500 |
35.3 |
2.3 |
34, 38, 34 |
|||
5000 |
25 |
2.6 |
27, 22, 26 |
|||
7500 |
6.3 T |
7.6 |
3, 1, 15 |
|||
10000 |
0.7 T |
1.2 |
0, 2, 0 |
|||
Untreated |
0 |
29.7 |
13.3 |
45, 22, 22 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
38.7 |
3.1 |
38, 42, 36 |
2AA |
|
2 |
|
1986.3 |
179.6 |
2096, 2084, 1779 |
DMSO |
+ |
|
10 |
33 |
5.6 |
34, 27, 38 |
2AA |
|
2 |
|
2101 |
178.3 |
2285, 2089, 1929 |
S.D. = standard deviation T = toxic dose level |
S.D. = standard deviation T = toxic dose level |
|||||
2-AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
|
||||||
Table 4: Mutagenicity Assay Results Test 1 – TA1535 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1535 |
- |
0 |
5 |
9 |
4 |
9, 5, 11 |
1580 |
6.7 |
3.8 |
5, 11, 4 |
|||
2500 |
12.7 |
1.5 |
13, 14, 11 |
|||
5000 |
7 |
2.6 |
4, 9, 8 |
|||
7500 |
7.7 |
4.6 |
5, 5, 13 |
|||
10000 |
6.3 |
1.5 |
5, 6, 8 |
|||
- |
0 |
10 |
8 |
2.6 |
6, 7, 11 |
|
1580 |
7 |
2 |
9, 7, 5 |
|||
2500 |
8 |
3 |
11, 5, 8 |
|||
5000 |
9.7 |
1.2 |
9, 9, 11 |
|||
7500 |
6.7 |
3.8 |
4, 5, 11 |
|||
10000 |
3.7 |
1.2 |
5, 3, 3 |
|||
- |
0 |
20 |
10.7 |
1.5 |
9, 12, 11 |
|
1580 |
4.7 |
2.1 |
7, 3, 4 |
|||
2500 |
5 |
1.7 |
6, 3, 6 |
|||
5000 |
7.3 |
3.2 |
6, 11, 5 |
|||
7500 |
6.3 |
4.9 |
4, 12, 3 |
|||
10000 |
8 |
5.3 |
4, 14, 6 |
|||
Untreated |
0 |
6.3 |
2.5 |
6, 4, 9 |
||
+ |
0 |
5 |
7.3 |
1.2 |
8, 8, 6 |
|
1580 |
9.3 |
3.8 |
5, 12, 11 |
|||
2500 |
7.3 |
2.1 |
9, 8, 5 |
|||
5000 |
8.3 |
3.2 |
12, 7, 6 |
|||
7500 |
3 T |
1.7 |
1, 4, 4 |
|||
10000 |
3.3 T |
1.5 |
2, 3, 5 |
|||
+ |
0 |
10 |
10.3 |
2.1 |
8, 11, 12 |
|
1580 |
13.3 |
2.5 |
13, 11, 16 |
|||
2500 |
8 |
1 |
9, 7, 8 |
|||
5000 |
5.3 T |
1.5 |
7, 4, 5 |
|||
7500 |
3.7 T |
3.8 |
8, 1, 2 |
|||
10000 |
2.3 T |
1.5 |
4, 2, 1 |
|||
+ |
0 |
20 |
6.7 |
0.6 |
6, 7, 7 |
|
1580 |
8.7 |
3.8 |
7, 6, 13 |
|||
2500 |
6 |
1 |
7, 6, 5 |
|||
5000 |
8 |
3.6 |
12, 5, 7 |
|||
7500 |
2 T |
3.5 |
0, 6, 0 |
|||
10000 |
3.3 T |
0.6 |
3, 4, 3 |
|||
Untreated |
0 |
3.7 |
2.1 |
2, 3, 6 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
38.7 |
3.1 |
38, 42, 36 |
2AA |
|
2 |
|
1986.3 |
179.6 |
2096, 2084, 1779 |
DMSO |
+ |
|
10 |
33 |
5.6 |
34, 27, 38 |
2AA |
|
2 |
|
2101 |
178.3 |
2285, 2089, 1929 |
S.D. = standard deviation T = toxic dose level |
S.D. = standard deviation T = toxic dose level |
|||||
2-AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 5: Mutagenicity Assay Results Test 1 – TA100 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA100 |
- |
0 |
5 |
105.3 |
15.5 |
94, 123, 99 |
1580 |
98 |
17.3 |
108, 108, 78 |
|||
2500 |
94.3 |
20.5 |
118, 82, 83 |
|||
5000 |
83.7 |
1.1 |
85, 83, 83 |
|||
7500 |
90 |
2.6 |
89, 88, 93 |
|||
10000 |
82.7 |
12.6 |
96, 71, 81 |
|||
|
- |
0 |
10 |
105.3 |
15.7 |
100, 93, 123 |
1580 |
114.3 |
13.2 |
117, 100, 126 |
|||
2500 |
121.7 |
6.7 |
120, 116, 129 |
|||
5000 |
103 |
3 |
106, 100, 103 |
|||
7500 |
107.7 |
29.4 |
121, 128, 74 |
|||
10000 |
101.3 |
4 |
99, 106, 99 |
|||
|
- |
0 |
20 |
122.3 |
4.2 |
119, 121, 127 |
1580 |
120.3 |
18 |
139, 119, 103 |
|||
2500 |
103.7 |
4 |
108, 103, 100 |
|||
5000 |
102.3 |
14.5 |
119, 95, 93 |
|||
7500 |
111.3 |
10.4 |
108, 103, 123 |
|||
10000 |
127.7 |
13.4 |
143, 122, 118 |
|||
Untreated |
0 |
55.3 |
12.7 |
49, 47, 70 |
||
|
+ |
0 |
5 |
109.7 |
16.4 |
116, 91, 122 |
1580 |
126.7 |
4.2 |
128, 130, 122 |
|||
2500 |
127.3 |
2.9 |
129, 129, 124 |
|||
5000 |
103.3 |
2.1 |
101, 105, 104 |
|||
7500 |
83 |
10.6 |
95, 75, 79 |
|||
10000 |
0 T |
|
|
|||
|
+ |
0 |
10 |
117.3 |
20.1 |
123, 134, 95 |
1580 |
121 |
20.5 |
120, 101, 142 |
|||
2500 |
122.7 |
4.1 |
127, 119, 122 |
|||
5000 |
94.7 |
13.8 |
79, 105, 100 |
|||
7500 |
63.3 |
24.5 |
35, 78, 77 |
|||
10000 |
52 T |
20.3 |
70, 56, 30 |
|||
|
+ |
0 |
20 |
130 |
8.9 |
123, 140, 127 |
1580 |
123.7 |
9.9 |
117, 119, 135 |
|||
2500 |
114.3 |
10.8 |
119, 122, 102 |
|||
5000 |
94.7 |
5.5 |
95, 89, 100 |
|||
7500 |
76 |
14.8 |
69, 66, 93 |
|||
10000 |
0.3 T |
0.6 |
1, 0, 0 |
|||
Untreated |
0 |
115.7 |
8.5 |
122, 106, 119 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
-
|
|
10 |
38.7 |
3.1 |
38, 42, 36 |
2AA |
|
2 |
|
1986.3 |
179.6 |
2096, 2084, 1779 |
DMSO |
+ |
|
10 |
33 |
5.6 |
34, 27, 38 |
2AA |
|
2 |
|
2101 |
178.3 |
2285, 2089, 1929 |
S.D. = standard deviation T = toxic dose level |
S.D. = standard deviation T = toxic dose level |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 6: Mutagenicity Assay Results Test 2 – TA1537 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1537 |
- |
0 |
5 |
6.3 |
2.5 |
9, 4, 6 |
1580 |
6 |
1 |
6, 5, 7 |
|||
2500 |
9.3 |
4.6 |
12, 4, 12 |
|||
5000 |
5 |
2 |
3, 7, 5 |
|||
7500 |
8 |
1 |
7, 9, 8 |
|||
10000 |
2 T |
1 |
3, 1, 2 |
|||
- |
0 |
10 |
7.7 |
1.2 |
7, 9, 7 |
|
1580 |
7 |
1 |
8, 7, 6 |
|||
2500 |
6.3 |
1.2 |
7, 7, 5 |
|||
5000 |
6 |
3.6 |
7, 2, 9 |
|||
7500 |
5.3 |
1.5 |
5, 7, 4 |
|||
10000 |
2.7 |
1.5 |
3, 1, 4 |
|||
- |
0 |
20 |
12 |
5.6 |
7, 11, 18 |
|
1580 |
9.3 |
3.2 |
8, 13, 7 |
|||
2500 |
5.7 |
1.2 |
5, 7, 5 |
|||
5000 |
7.7 |
1.5 |
8, 9, 6 |
|||
7500 |
6 |
2 |
8, 6, 4 |
|||
10000 |
6.7 |
1.5 |
7, 8, 5 |
|||
Untreated |
0 |
6.3 |
1.2 |
7, 5, 7 |
||
+ |
0 |
5 |
5.3 |
2.3 |
8, 4, 4 |
|
1580 |
7 |
1.7 |
5, 8, 8 |
|||
2500 |
8.3 |
2.5 |
11, 8, 6 |
|||
5000 |
6.3 |
2.9 |
3, 8, 8 |
|||
7500 |
1.3 T |
1.5 |
1, 3, 0 |
|||
10000 |
3.3 T |
3.2 |
1, 7, 2 |
|||
+ |
0 |
10 |
6.3 |
2.1 |
8, 4, 7 |
|
1580 |
4.3 |
1.2 |
5, 5, 3 |
|||
2500 |
5.3 |
2.9 |
2, 7, 7 |
|||
5000 |
7 |
1 |
6, 7, 8 |
|||
7500 |
4.7 |
1.5 |
6, 5, 3 |
|||
10000 |
2.3 T |
1.2 |
1, 3, 3 |
|||
+ |
0 |
20 |
10 |
4.6 |
5, 14, 11 |
|
1580 |
9.3 |
2.3 |
8, 8, 12 |
|||
2500 |
8.3 |
3.2 |
7, 12, 6 |
|||
5000 |
1 T |
1.7 |
3, 0, 0 |
|||
7500 |
3 T |
3 |
3, 0, 6 |
|||
10000 |
1.7 T |
1.2 |
3, 1, 1 |
|||
Untreated |
0 |
7.7 |
2.9 |
6, 6, 11 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
-
|
|
10 |
7.7 |
1.2 |
7, 9, 7 |
2AA |
2 |
|
499 |
18.1 |
480, 516, 501 |
|
DMSO |
+ |
|
10 |
6.3 |
2.1 |
8, 4, 7 |
2AA |
2 |
|
415 |
27.8 |
401, 447, 397 |
|
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 7: Mutagenicity Assay Results Test 2 – TA1538 Strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1538 |
- |
0 |
5 |
32.3 |
7.4 |
38, 35, 24 |
1580 |
21.7 |
1.5 |
23, 20, 22 |
|||
2500 |
28 |
2.6 |
29, 25, 30 |
|||
5000 |
27.3 |
7 |
28, 20, 34 |
|||
7500 |
24.3 |
4.7 |
26, 19, 28 |
|||
10000 |
26 |
9.5 |
25, 17, 36 |
|||
- |
0 |
10 |
28.3 |
12.1 |
17, 27, 41 |
|
1580 |
24 |
4.6 |
19, 25, 28 |
|||
2500 |
24.7 |
6.7 |
17, 28, 29 |
|||
5000 |
30 |
3 |
33, 27, 30 |
|||
7500 |
27.3 |
6.7 |
23, 35, 24 |
|||
10000 |
29.7 |
4.7 |
35, 26, 28 |
|||
- |
0 |
20 |
23.3 |
6.7 |
25, 29, 16 |
|
1580 |
|
21.3 |
5.1 |
27, 20, 17 |
||
2500 |
|
26 |
8.5 |
17, 27, 34 |
||
5000 |
|
25 |
12.2 |
39, 19, 17 |
||
7500 |
|
25.3 |
3.5 |
29, 22, 25 |
||
10000 |
|
24.3 |
3.8 |
27, 20, 26 |
||
Untreated |
0 |
15.7 |
2.5 |
13, 18, 16 |
||
+ |
0 |
5 |
22.7 |
5.5 |
29, 20, 19 |
|
1580 |
25.7 |
7 |
33, 19, 25 |
|||
2500 |
23 |
9.2 |
13, 25, 31 |
|||
5000 |
23.3 |
4.2 |
20, 28, 22 |
|||
7500 |
20.7 |
4.2 |
16, 24, 22 |
|||
10000 |
18.3 |
1.2 |
19, 17, 19 |
|||
+ |
0 |
|
32 |
3.6 |
35, 28, 33 |
|
1580 |
|
28.7 |
4 |
25, 28, 33 |
||
2500 |
10 |
27.7 |
5 |
27, 23, 33 |
||
5000 |
|
24.7 |
4.9 |
28, 19, 27 |
||
7500 |
|
21.7 |
4.7 |
20, 18, 27 |
||
10000 |
|
14 T |
13.1 |
26, 16, 0 |
||
+ |
0 |
|
25 |
3 |
22, 28, 25 |
|
1580 |
|
28.7 |
5.5 |
25, 35, 26 |
||
2500 |
20 |
27.7 |
4.2 |
29, 23, 31 |
||
5000 |
|
23.3 |
4.2 |
22, 20, 28 |
||
7500 |
|
2 T |
2.6 |
5, 0, 1 |
||
10000 |
|
0 T |
|
|
||
Untreated |
0 |
26.3 |
9.1 |
16, 33, 30 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
28.3 |
12.1 |
17, 27, 41 |
2AA |
|
2 |
|
1930.7 |
73.7 |
1929, 1858, 2005 |
DMSO |
+ |
|
10 |
32 |
3.6 |
35, 28, 33 |
2AA |
|
2 |
|
2176.7 |
98.3 |
2063, 2235, 2232 |
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 8: Mutagenicity Assay Results Test 2 – TA98 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA98 |
- |
0 |
5 |
36.7 |
8.6 |
46, 29, 35 |
1580 |
25.3 |
4.7 |
29, 20, 27 |
|||
2500 |
30.7 |
2.1 |
33, 30, 29 |
|||
5000 |
32.7 |
4.5 |
28, 33, 37 |
|||
7500 |
32.3 |
5 |
27, 33, 37 |
|||
10000 |
31 |
11.5 |
44, 27, 22 |
|||
|
- |
0 |
10 |
38.7 |
2.1 |
37, 38, 41 |
1580 |
43.3 |
5.9 |
39, 41, 50 |
|||
2500 |
33.7 |
5.8 |
27, 37, 37 |
|||
5000 |
36.7 |
7.4 |
31, 34, 45 |
|||
7500 |
29 |
5.6 |
30, 23, 34 |
|||
10000 |
39.3 |
3.8 |
42, 35, 41 |
|||
|
- |
0 |
20 |
44.7 |
11.1 |
33, 46, 55 |
1580 |
37 |
5.3 |
41, 39, 31 |
|||
2500 |
42 |
7.2 |
44, 48, 34 |
|||
5000 |
41.3 |
7.1 |
49, 35, 40 |
|||
7500 |
41 |
5.2 |
38, 47, 38 |
|||
10000 |
34.3 |
5.7 |
28, 36, 39 |
|||
Untreated |
0 |
42.3 |
7.5 |
35, 50, 42 |
||
|
+ |
0 |
5 |
37.7 |
11 |
27, 37, 49 |
1580 |
36.7 |
4 |
41, 36, 33 |
|||
2500 |
35 |
5.3 |
33, 41, 31 |
|||
5000 |
26.3 |
2.9 |
28, 28, 23 |
|||
7500 |
28 |
3 |
31, 28, 25 |
|||
10000 |
14.7 |
10.8 |
27, 7, 10 |
|||
|
+ |
0 |
10 |
34.7 |
4 |
37, 37, 30 |
1580 |
31.3 |
3.8 |
34, 27, 33 |
|||
2500 |
35.3 |
2.5 |
35, 38, 33 |
|||
5000 |
26.3 |
9 |
35, 17, 27 |
|||
7500 |
8.7 T |
8.1 |
10, 16, 0 |
|||
10000 |
2.7 T |
3.8 |
0, 1, 7 |
|||
|
+ |
0 |
20 |
34.3 |
0.6 |
35, 34, 34 |
1580 |
37.7 |
1.2 |
39, 37, 37 |
|||
2500 |
36.3 |
3.1 |
33, 39, 37 |
|||
5000 |
23.7 |
1.2 |
23, 23, 25 |
|||
7500 |
21.3 |
4 |
22, 25, 17 |
|||
10000 |
0 T |
|
|
|||
Untreated |
0 |
42.7 |
3.8 |
47, 40, 41 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
38.7 |
2.1 |
37, 38, 41 |
2AA |
|
2 |
|
1645 |
54.8 |
1704, 1635, 1596 |
DMSO |
+ |
|
10 |
34.7 |
4 |
37, 37, 30 |
2AA |
|
2 |
|
1599.3 |
77.9 |
1511, 1629, 1658 |
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 9: Mutagenicity Assay Results Test 2 – TA1535 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA1535 |
- |
0 |
5 |
8.3 |
4 |
4, 12, 9 |
1580 |
11 |
5.3 |
17, 9, 7 |
|||
2500 |
11 |
2.6 |
8, 12, 13 |
|||
5000 |
9.7 |
2.1 |
9, 8, 12 |
|||
7500 |
10 |
2.6 |
9, 8, 13 |
|||
10000 |
6.3 |
0.6 |
6, 6, 7 |
|||
- |
0 |
10 |
8.7 |
3.8 |
6, 7, 13 |
|
1580 |
7 |
0 |
7, 7, 7 |
|||
2500 |
8.7 |
6.7 |
3, 7, 16 |
|||
5000 |
8.7 |
4 |
11, 4, 11 |
|||
7500 |
5.3 |
1.5 |
7, 5, 4 |
|||
10000 |
7.3 |
2.1 |
9, 8, 5 |
|||
- |
0 |
20 |
14.3 |
2.5 |
14, 17, 12 |
|
1580 |
8.7 |
2.1 |
7, 8, 11 |
|||
2500 |
9.3 |
3.5 |
9, 6, 13 |
|||
5000 |
11.3 |
2.1 |
9, 13, 12 |
|||
7500 |
7.7 |
4.2 |
9, 3, 11 |
|||
10000 |
9 |
2 |
11, 9, 7 |
|||
Untreated |
0 |
9.3 |
1.5 |
9, 8, 11 |
||
+ |
0 |
5 |
7.7 |
2.1 |
6, 10, 7 |
|
1580 |
12.7 |
2.9 |
16, 11, 11 |
|||
2500 |
6.3 |
1.5 |
5, 6, 8 |
|||
5000 |
7.3 |
1.2 |
8, 8, 6 |
|||
7500 |
6.7 |
1.2 |
6, 6, 8 |
|||
10000 |
1.7 T |
2.9 |
0, 5, 0 |
|||
+ |
0 |
10 |
6.3 |
1.2 |
7, 5, 7 |
|
1580 |
11 |
5 |
11, 16, 6 |
|||
2500 |
8 |
3.5 |
12, 6, 6 |
|||
5000 |
7 |
2 |
9, 7, 5 |
|||
7500 |
2 T |
2 |
4, 0, 2 |
|||
10000 |
1.7 T |
1.2 |
1, 1, 3 |
|||
+ |
0 |
20 |
11.3 |
3.8 |
7, 13, 14 |
|
1580 |
8.3 |
2.5 |
6, 11, 8 |
|||
2500 |
10 |
2.6 |
8, 13, 9 |
|||
5000 |
10.7 |
3.2 |
7, 12, 13 |
|||
7500 |
1.3 T |
2.3 |
0, 0, 4 |
|||
10000 |
3.7 T |
3.2 |
0, 5, 6 |
|||
Untreated |
0 |
11 |
2.6 |
8, 13, 12 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
8.7 |
3.8 |
6, 7, 13 |
2AA |
|
2 |
|
75.7 |
10.4 |
64, 84, 79 |
DMSO |
+ |
|
10 |
6.3 |
1.2 |
7, 5, 7 |
2AA |
|
2 |
|
137.3 |
11.8 |
130, 131, 151 |
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 10: Mutagenicity Assay Results Test 2 – TA100 strain |
||||||
Strain |
+/- pre-incubation |
Dose level (µg/ml) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
TA100 |
- |
0 |
5 |
130.3 |
3.1 |
131, 133, 127 |
1580 |
140 |
14.1 |
142, 153, 125 |
|||
2500 |
126.7 |
14.2 |
119, 143, 118 |
|||
5000 |
111.7 |
11.9 |
125, 108, 102 |
|||
7500 |
111 |
15.1 |
106, 99, 128 |
|||
10000 |
112.7 |
10.7 |
125, 107, 106 |
|||
|
- |
0 |
10 |
139 |
6.6 |
132, 140, 145 |
1580 |
130 |
10.6 |
118, 138, 134 |
|||
2500 |
121.7 |
18.1 |
105, 141, 119 |
|||
5000 |
111.3 |
10.3 |
114, 120, 100 |
|||
7500 |
123.7 |
9.1 |
114, 132, 125 |
|||
10000 |
116.7 |
3.8 |
121, 114, 115 |
|||
|
- |
0 |
20 |
131.3 |
6 |
132, 137, 125 |
1580 |
131.3 |
23.9 |
148, 104, 142 |
|||
2500 |
120.7 |
16.7 |
102, 134, 126 |
|||
5000 |
131.3 |
10.3 |
140, 134, 120 |
|||
7500 |
133.3 |
4.5 |
133, 138, 129 |
|||
10000 |
117.3 |
15.5 |
117, 133, 102 |
|||
Untreated |
0 |
145.3 |
11.8 |
138, 159, 139 |
||
|
+ |
0 |
5 |
118.7 |
10.7 |
121, 107, 128 |
1580 |
130 |
21.6 |
106, 148, 136 |
|||
2500 |
129 |
15 |
114, 144, 129 |
|||
5000 |
93.3 |
14.6 |
95, 78, 107 |
|||
7500 |
82.3 |
2.5 |
82, 85, 80 |
|||
10000 |
46.7 T |
34 |
60, 8, 72 |
|||
|
+ |
0 |
10 |
109.7 |
8.4 |
115, 100, 114 |
1580 |
129 |
9 |
129, 138, 120 |
|||
2500 |
124 |
19.3 |
145, 120, 107 |
|||
5000 |
94 |
21.7 |
81, 119, 82 |
|||
7500 |
62.7 T |
19.6 |
41, 79, 68 |
|||
10000 |
26 T |
22.7 |
36, 42, 0 |
|||
|
+ |
0 |
20 |
130 |
10.1 |
139, 132, 119 |
1580 |
138 |
6.6 |
137, 145, 132 |
|||
2500 |
122 |
1.8 |
120, 123, 123 |
|||
5000 |
105.3 |
24.5 |
77, 119, 120 |
|||
7500 |
51.3 T |
40.3 |
71, 5, 78 |
|||
10000 |
21.7 T |
31.7 |
0, 58, 7 |
|||
Untreated |
0 |
139.7 |
18.6 |
138, 122, 159 |
||
Positive control |
+/- pre-incubation |
Concentration (µg/plate) |
% S9 |
Mean Revertant Colony Counts |
S.D. |
Individual Revertant Colony Counts |
DMSO |
- |
|
10 |
139 |
6.6 |
132, 140, 145 |
2AA |
|
2 |
|
1850 |
125.7 |
1728, 1979, 1843 |
DMSO |
+ |
|
10 |
34.7 |
4 |
37, 37, 30 |
2AA |
|
2 |
|
1599.3 |
77.9 |
1511, 1629, 1658 |
S.D. = standard deviation T = toxic dose level |
+ = with pre-incubation - = without pre-incubation |
|||||
2AA = 2-aminoanthracene administered with DMSO as a vehicle |
||||||
Table 1. Toxicity of test material – WS-23 towards different strains of Salmonella Typhimurium |
||||||
Amount of material per plate (µg) |
Metabolic activation (% S9) |
% Survival (+/-95% C.L.) |
||||
TA1535 |
TA1537 |
TA100 |
TA1538 |
TA98 |
||
DMSO |
|
100 |
100 |
100 |
100 |
100 |
0.5 |
|
90.2 (9.2) |
97.6 (14.6) |
98.6 (17.3) |
104.5 (7.8) |
92.9 (15.2) |
5 |
10 |
90.8 (9.6) |
98.1 (15.4) |
102.3 (16) |
92.7 (7.2) |
89.8 (18.1) |
50 |
|
94.4 (9.6) |
91.9 (15.9) |
92.6 (3.1) |
101 (9.1) |
95.5 (16.2) |
500 |
|
90.1 (9.9) |
92.6 (11.3) |
110.2 (14.4) |
106.1 (8.3) |
93.6 (15.3) |
5000 |
|
40.6 (16.1) |
45.4 (9) |
95.2 (22.6) |
18 (2) |
48.4 (8.1) |
DMSO |
|
100 |
100 |
100 |
100 |
100 |
0.5 |
|
98.8 (5.1) |
89.6 (13.8) |
89.6 (11) |
80.9 (26.6) |
75.9 (14.7) |
5 |
0 |
96.7 (10.4) |
90.7 (9.2) |
95 (10.9) |
103.7 (42.4) |
87.6 (14.9) |
50 |
|
106.4 (8.6) |
89.5 (9.1) |
90.5 (6.1) |
122 (15.4) |
69.2 (14.4) |
500 |
|
97.8 (3.3) |
92.4 (13.3) |
91.4 (10.7) |
96.8 (32.3) |
82.3 (12) |
5000 |
|
79.8 (5) |
24.5 (3.6) |
51.5 (7.8) |
11 (2.1) |
9.7 (3.8) |
C.L. = confidence limit Figures correct to one decimal place |
||||||
Table 2. Mutagenicity of test material – WS-23 towards Salmonella TyphimuriumTA1535
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
Individual plates |
Mean |
S.D. (+/-) |
||
DMSO |
10 |
11, 7, 14 |
10.7 |
3.5 |
50 |
13, 13, 8 |
11.3 |
2.9 |
|
158 |
11, 6, 11 |
9.3 |
2.9 |
|
500 |
9, 15, 22 |
12 |
3 |
|
1580 |
12, 9, 15 |
12 |
3 |
|
5000 |
7, 11, 12 |
10 |
2.6 |
|
DMSO |
0 |
8, 11, 14 |
11 |
3 |
50 |
15, 12, 14 |
13.7 |
1.5 |
|
158 |
9, 14, 6 |
9.7 |
4 |
|
500 |
9, 15, 19 |
14.3 |
5 |
|
1580 |
18, 11, 16 |
15 |
3.6 |
|
5000 |
16, 20, 20 |
18.7 |
2.3 |
|
Positive control mutagens |
||||
DMSO |
|
11, 7, 14 |
10.7 |
3.5 |
2AA (0.63) |
10 |
123, 78, 73 |
91.3 |
27.5* |
2AA (2.0) |
|
147, 151, 155 |
151 |
4* |
Water |
|
12, 6, 11 |
9.7 |
3.2 |
NAAZ (5.0) |
0 |
619, 649, 670 |
646 |
25.6* |
NAAZ (10.0) |
|
889, 958, 927 |
924.7 |
34.6* |
2AA = 2-aminoanthracene NAAZ = sodium azide C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 3. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA1535
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
Individual plates |
Mean |
S.D. (+/-) |
||
DMSO |
10 |
12, 15, 12 |
13 |
1.7 |
50 |
15, 17, 17 |
16.3 |
1.2 |
|
158 |
6, 8, 9 |
7.7 |
1.5 |
|
500 |
9, 9, 12 |
10 |
1.7 |
|
1580 |
9, 9, 15 |
11 |
3.5 |
|
5000 |
8, 8, 15 |
10.3 |
4 |
|
DMSO |
0 |
16, 13, 17 |
15.3 |
2.1 |
50 |
19, 15, C |
17 |
2.8 |
|
158 |
16, 9, 16 |
13.7 |
4 |
|
500 |
12, 18, 13 |
14.3 |
3.2 |
|
1580 |
C, 18, 9 |
13.5 |
6.4 |
|
5000 |
9, 9, 5 |
7.7 |
2.3 |
|
Positive control mutagens |
||||
DMSO |
|
12, 15, 12 |
13 |
1.7 |
2AA (0.63) |
10 |
135, 120, 141 |
132 |
10.8* |
2AA (2.0) |
|
185, 171, 184 |
180 |
7.8* |
Water |
|
C, 12, 15 |
13.5 |
2.1 |
NAAZ (5.0) |
0 |
600, 645, 637 |
627.3 |
24 |
NAAZ (10.0) |
|
804, 907, 902 |
871 |
58.1 |
2AA = 2-aminoanthracene NAAZ = sodium azide C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 4. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA1537
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
7, 8, 9 |
8 |
1 |
50 |
|
5, 12, 6 |
7.7 |
3.8 |
158 |
|
14, 9, 4 |
9 |
5 |
500 |
|
7, 6, 12 |
8.3 |
3.2 |
1580 |
|
13, 9, 4 |
8.7 |
4.5 |
5000 |
|
8, 4, 3 |
5 |
2.6 |
DMSO |
0 |
7, 9, 5 |
7 |
2 |
50 |
|
9, 8, 7 |
8 |
1 |
158 |
|
12, 7, 11 |
10 |
2.6 |
500 |
|
7, 7, 3 |
5.7 |
2.3 |
1580 |
|
6, 9, 6 |
7 |
1.7 |
5000 |
|
2, 4, 5 |
3.7 |
1.5 |
Positive control mutagens |
||||
DMSO |
|
7, 8, 9 |
8 |
1 |
2AA (0.63) |
10 |
236, 222, 219 |
225.7 |
9.1* |
2AA (2.0) |
|
537, 562, 532 |
543.7 |
16* |
Water |
|
7, 9, 5 |
7 |
2 |
9AA (20.0) |
0 |
38, 31, 48 |
39 |
8.5* |
9AA (40.0) |
|
541, 841, 591 |
657.7 |
160.7* |
2AA = 2-aminoanthracene 9AA = 9-aminoacridine C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 5. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA1537 |
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
9, 9, 9 |
9 |
0 |
50 |
|
7, 5, 5 |
5.7 |
1.2 |
158 |
|
7, 7, 5 |
6.3 |
1.2 |
500 |
|
5, 13, 8 |
8.7 |
4 |
1580 |
|
8, 6, 6 |
6.7 |
1.2 |
5000 |
|
8, 6, 7 |
7 |
1 |
DMSO |
0 |
8, 5, 9 |
7.3 |
2.1 |
50 |
|
5, 4, 4 |
4.3 |
0.6 |
158 |
|
6, 5, 3 |
4.7 |
1.5 |
500 |
|
13, 8, 3 |
8 |
5 |
1580 |
|
9, 6, 8 |
7.7 |
1.5 |
5000 |
|
9, 6, 7 |
7.3 |
1.5 |
Positive control mutagens |
||||
DMSO |
|
9, 9, 9 |
9 |
0 |
2AA (0.63) |
10 |
234, 180, 228 |
214 |
29.6* |
2AA (2.0) |
|
733, 714, 714 |
720.3 |
11* |
Water |
|
8, 5, 9 |
7.3 |
2.1 |
9AA (20.0) |
0 |
29, 29, 25 |
27.7 |
2.3* |
9AA (40.0) |
|
497, 377, 422 |
432 |
60.6* |
2AA = 2-aminoanthracene 9AA = 9-aminoacridine C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 6. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA100
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
107, 106, 123 |
112 |
9.5 |
50 |
|
88, 135, 135 |
119.3 |
27.1 |
158 |
|
86, 101, 107 |
98 |
10.8 |
500 |
|
101, 107, 110 |
106 |
4.6 |
1580 |
|
86, 120, 119 |
108.3 |
19.3 |
5000 |
|
93, 103, 90 |
95.3 |
6.8 |
DMSO |
0 |
126, 91, 86 |
101 |
21.8 |
50 |
|
85, 91, 91 |
89 |
3.5 |
158 |
|
100, 108, 118 |
108.7 |
9 |
500 |
|
118, 95, C |
106.5 |
16.3 |
1580 |
|
129, 93, 99 |
107 |
19.3 |
5000 |
|
119, 122, 120 |
120.3 |
1.5 |
Positive control mutagens |
||||
DMSO |
|
107, 106, 123 |
112 |
9.5 |
2AA (2.0) |
10 |
2605, 2619, 2610 |
2611.3 |
6.5* |
2AA (4.0) |
|
2000, 2040, 2123 |
2054.3 |
62.9* |
Water |
|
100, 143, 126 |
123 |
21.7 |
NAAZ (5.0) |
0 |
714, 662, 693 |
689.7 |
26.1* |
NAAZ (10.0) |
|
941, 964, 867 |
924 |
50.7* |
2AA = 2-aminoanthracene NAAZ = sodium azide C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 7. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA100
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
129, 128, 137 |
131.3 |
4.9 |
50 |
|
133, 113, C |
123 |
14.1 |
158 |
|
132, 125, C |
128.5 |
5 |
500 |
|
116, 100, 125 |
113.7 |
12.7 |
1580 |
|
152, 125, 126 |
134.3 |
15.3 |
5000 |
|
102, C, 112 |
107 |
7.1 |
DMSO |
0 |
112, 97, C |
104.5 |
10.6 |
50 |
|
117, 126, 98 |
113.7 |
14.3 |
158 |
|
101, 111, 91 |
101 |
10 |
500 |
|
110, 111, 115 |
112 |
2.7 |
1580 |
|
108, 105, 115 |
109.3 |
5.1 |
5000 |
|
104, 101, 81 |
95.3 |
12.5 |
Positive control mutagens |
||||
DMSO |
|
129, 128, 137 |
131.3 |
4.9 |
2AA (2.0) |
10 |
2064, 2144, 2162 |
2123.3 |
51.9* |
2AA (4.0) |
|
1644, 1578, 1409 |
1543.7 |
121.2* |
Water |
|
C, 129, 120 |
124.5 |
6.4 |
NAAZ (5.0) |
0 |
577, 572, 519 |
556 |
32.1* |
NAAZ (10.0) |
|
770, 762, 829 |
787 |
36.6* |
2AA = 2-aminoanthracene NAAZ = sodium azide C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 8. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA1538
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
24, 31, 19 |
24.7 |
6 |
50 |
|
25, 29, 27 |
27 |
2 |
158 |
|
15, 25, 28 |
22.7 |
6.8 |
500 |
|
28, 20, 25 |
24.3 |
4 |
1580 |
|
26, 22, 30 |
22.7 |
3.1 |
5000 |
|
20, 24, 30 |
24.7 |
5 |
DMSO |
0 |
13, 9, 14 |
12 |
2.6 |
50 |
|
16, 13, 11 |
13.3 |
2.5 |
158 |
|
17, 15, 22 |
18 |
3.6 |
500 |
|
14, 13, 13 |
13.3 |
0.6 |
1580 |
|
13, 9, 11 |
11 |
2 |
5000 |
|
11, 17, 16 |
14.7 |
3.2 |
Positive control mutagens |
||||
DMSO |
|
24, 31, 9 |
24.7 |
6 |
2AA (2.0) |
10 |
2132, 2301, 2206 |
2213 |
84.6* |
2AA (4.0) |
|
194, 165, 157 |
172 |
19.5* |
DMSO |
|
13, 9, 14 |
12 |
2.6 |
2NF (10.0) |
0 |
1199, 1197, 1086 |
1160.7 |
64.6* |
2AA = 2-aminoanthracene 2NF= 2-nitrofluorene C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 9. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA1538
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
Individual plates |
Mean |
S.D. (+/-) |
||
DMSO |
10 |
28, 27, 18 |
24.3 |
5.5 |
50 |
24, 31, 32 |
29 |
4.4 |
|
158 |
19, 27, 21 |
22.3 |
4.2 |
|
500 |
17, 14, 25 |
18.7 |
5.7 |
|
1580 |
24, 17, 21 |
20.7 |
3.5 |
|
5000 |
19, 24, 25 |
22.7 |
3.2 |
|
DMSO |
0 |
14, 5, 16 |
11.7 |
5.9 |
50 |
17, 14, 12 |
14.3 |
2.5 |
|
158 |
15, 9, 16 |
13.3 |
3.8 |
|
500 |
14, 5, 13 |
10.7 |
4.9 |
|
1580 |
12, 17, 16 |
15 |
2.6 |
|
5000 |
13, 8, 12 |
11 |
2.6 |
|
Positive control mutagens |
||||
DMSO |
|
28, 27, 18 |
24.3 |
5.5 |
2AA (2.0) |
10 |
1800, 1884, 1926 |
1870 |
64.2* |
2AA (4.0) |
|
115, 122, 129 |
122 |
7* |
DMSO |
|
14, 5, 16 |
11.7 |
5.9 |
2NF (10.0) |
0 |
1327, 1268, 1370 |
1321.7 |
51 |
2AA = 2-aminoanthracene 2NF= 2-nitrofluorene C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 10. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA98
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
48, 38, 33 |
39.7 |
7.6 |
50 |
|
35, 38, 34 |
35.7 |
2.1 |
158 |
|
40, 29, 37 |
35.3 |
5.7 |
500 |
|
30, 31, 34 |
31.7 |
2.1 |
1580 |
|
39, 41, 36 |
38.7 |
2.5 |
5000 |
|
C, 45, 35 |
40 |
7.1 |
DMSO |
0 |
22, 23, 27 |
24 |
2.6 |
50 |
|
30, 29, 20 |
26.3 |
5.5 |
158 |
|
23, 29, 30 |
27.3 |
3.8 |
500 |
|
25, 20, 28 |
24.3 |
4 |
1580 |
|
34, 22, 20 |
25.3 |
7.6 |
5000 |
|
C, 19, 22 |
20.5 |
2.1 |
Positive control mutagens |
||||
DMSO |
|
48, 38, 33 |
39.7 |
7.6 |
2AA (2.0) |
10 |
2512, 2592, 2370 |
2491.3 |
112.2* |
2AA (4.0) |
|
2037, 2007, 2007 |
2017 |
17.8 |
DMSO |
|
22, 23, 27 |
24 |
2.6 |
2NF (10.0) |
0 |
718, 726, 729 |
724.3 |
5.8* |
2AA = 2-aminoanthracene 2NF = 2-nitrofluorene C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Table 11. Mutagenicity of test material – WS-23 towards Salmonella Typhimurium TA98
|
||||
Amount of test material per plate (µg) |
Metabolic activation (% S9) |
Revertant colony counts |
||
|
|
Individual plates |
Mean |
S.D. (+/-) |
DMSO |
10 |
45, C, 33 |
39 |
8.5 |
50 |
|
32, 39, 31 |
34 |
4.4 |
158 |
|
38, 38, 38 |
38 |
0 |
500 |
|
41, 48, 31 |
40 |
8.5 |
1580 |
|
25, 29, 17 |
23.7 |
6.1 |
5000 |
|
25, 27, 28 |
26.7 |
1.5 |
DMSO |
0 |
24, 33, 20 |
25.7 |
6.7 |
50 |
|
25, 20, 18 |
21 |
3.6 |
158 |
|
19, 20, 37 |
25.3 |
10.1 |
500 |
|
29, 17, 32 |
26 |
7.9 |
1580 |
|
15, 25, 20 |
20 |
5 |
5000 |
|
21, 9, 14 |
14.7 |
6 |
Positive control mutagens |
||||
DMSO |
|
45, C, 33 |
39 |
8.5 |
2AA (2.0) |
10 |
1876, 1724, 1911 |
1870.3 |
130.9* |
2AA (4.0) |
|
1804, 1591, 1673 |
1689.3 |
107.5* |
DMSO |
|
24, 33, 20 |
25.7 |
6.7 |
2NF (10.0) |
0 |
744, 684, 793 |
740.3 |
54.6* |
2AA = 2-aminoanthracene 2NF= 2-nitrofluorene C = contaminated N.D. = not done S.D. = standard deviation * = doubling of negative value Figures correct to one decimal place |
||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the negative results of two in vitro AMES assays (equivalent or similar to OECD TG 471) and in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, it is concluded that WS-23 does not have a mutagenic potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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.
