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EC number: 920-684-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed at a registered GLP site and reported a high standard andis in compliance with recognised OECD standards with no deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- The purpose of the study was to evaluate 11-KN for the ability to induce reverse mutations, either directly or after metabolic activation, at the histidine or tryptophan locus in the genome of five strains of bacteria.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 1537 Genotype : his C 3076; rfa¯; uvrB¯: TA98 Genotype : his D 3052; rfa¯; uvrB¯; R-factor TAI535 Genotype : his G 46; rfa¯; uvrB¯: TA100 Genotype : his G 46; rfa¯; uvrB¯; R-factor
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: Genotype : trp¯; uvrA¯:
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, SOD, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test item was insoluble in sterile distilled water at 50 mg/mL and acetone at 100 mg/mL but was fully soluble in dimethyl sulphoxide at 50 mg/mL in solubility checks performed in-house. Dimethyl sulphoxide was therefore selected as the vehicle. - Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
Test Procedure
Test for Mutagenicity (Experiment 1) - Plate Incorporation Method
Dose selection
Test items that are not deemed particularly toxic or do not belong to a class of compounds known for their toxicity were tested using the following method. The maximum concentration was 5000 µg/plate (the maximum recommended dose level). Eight concentrations of the test item (1.5, 5, 15, 50, 150, SOD, 1500 and 5000 µg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.
Without Metabolic Activation
0.1 mL of the appropriate concentration of test item, vehicle or appropriate positive control was added to 2 mL of trace amino-acid supplemented media (at approximately 45°C) containing 0.1 mL of one of the bacterial strain cultures and 0.5 mL of phosphate buffer. These were then mixed and overlayed onto a Vogel-Bonner agar plate. Each concentration of the test item, appropriate positive control, and each bacterial strain, was assayed using triplicate plates.
With Metabolic Activation
The procedure was the same as described previously (see 3.5.1.2) except that following the addition of the test item formulation and bacterial culture, 0.5 mL of S9-mix was added to the trace amino-acid supplemented media instead of phosphate buffer.
All of the plates were incubated at 37 °C ± 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). Manual counts were performed at and above 1500 µg/plate because of excessive test item precipitation.
Test for Mutagenicity (Experiment 2) - Pre-Incubation Method
As Experiment 1 was deemed negative, Experiment 2 was performed using the pre-incubation method in the presence and absence of metabolic activation.
Dose selection
The dose range used for Experiment 2 was determined by the results of Experiment 1 and was 50 to 5000 µg/plate.
Without Metabolic Activation
0.1 mL of the appropriate bacterial strain culture, 0.5 mL of phosphate buffer and 0.1 mL of the test item formulation, vehicle or 0.1 mL of appropriate positive control were incubated at 37 °C± 3 °C for 20 minutes (with shaking) prior to addition of 2 mL of amino-acid supplemented media and subsequent plating onto Vogel-Bonner plates. All testing for this experiment was performed in triplicate.
With metabolic activation
The procedure was the same as described previously (see 3.5.2.2) except that following the addition of the test item formulation and bacterial strain culture, 0.5 mL of S9-mix was added to the tube instead of phosphate buffer, prior to incubation at 37 °C± 3° C for 20 minutes (with shaking) and addition of amino-acid supplemented media. All testing for this experiment was performed in triplicate.
All of the plates were incubated at 37 °C± 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). Manual counts were performed at and above 1500 ~g/plate because of excessive test item precipitation. - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et aI., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response Cariello and Piegorsch, 1996).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). These data are not given in the report. The amino acid supplemented top agar and the S9-mix used in both experiments was shown to be sterile.
Results for the negative controls (spontaneous mutation rates) are presented in Table 1 and were considered to be acceptable. These data are for concurrent untreated control plates performed on the same day as the Mutation Test.
The individual plate counts, the mean number of revertant colonies and the standard deviations, for the test item, positive and vehicle controls, both with and without metabolic activation, are presented in Table 2 and Table 3 for Experiment 1 and Table 4 and Table 5 for Experiment 2.
The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. A test item precipitate (white and powdery) was observed at and above 500 µg/plate, this observation did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation or exposure method.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains. - Conclusions:
- Interpretation of results (migrated information):
negative
11-KN was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Introduction
The test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLWand MAFF, the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC) number 440/2008 of 30 May 2008 and the USA, EPA
(TSCA) OCSPP harmonized guidelines.
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors).
The dose range for Experiment 1 was predetermined and was 1.5 to 5000 µg/plate. The experiment was repeated on a separate day (pre-incubation method) using fresh cultures of the bacterial strains and fresh test item formulations. The dose range was amended following the results of Experiment 1 and was 50 to 5000 µg/plate.
Results
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of
5000 µg/plate. A test item precipitate (white and powdery) was observed at and above 500 µg/plate, this observation did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
Conclusion
11-KN was considered to be non-mutagenic under the conditions of this test.
Reference
Table 1
Experiment 1 | |||||||||
Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||
100 | (105) | 26 | (29) | 29 | (29) | 16 | (15) | 13 | (20) |
119 | 19 | 27 | 12 | 24 | |||||
95 | 23 | 31 | 17 | 23 | |||||
Experiment 2 | |||||||||
Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||
87 | (85) | 25 | (22) | 29 | (28) | 16 | (16) | 7 | (8) |
98 | 20 | 35 | 15 | 8 | |||||
69 | 20 | 21 | 17 | 6 |
Table 2
Test Period | From: 05 April 2013 | To: 08 April 2013 | |||||||||
S9-Mix (-) |
Dose level Per Plate |
Number of revertants (mean) +/- SD | |||||||||
Base-pair substitution strains | Frameshift strains | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
Solvent Control (DMSO) |
91 | (89) 4.0# |
28 | (23) 4.7 |
21 | (18) 3.1 |
11 | (18) 6.6 |
15 | (16) 2.3 |
|
91 | 19 | 19 | 24 | 15 | |||||||
84 | 21 | 15 | 19 | 19 | |||||||
1.5 µg | 91 | (97) 11.8 |
24 | (23) 1.7 |
21 | (20) 12.0 |
8 | (20) 12.0 |
11 | (10) 2.1 |
|
90 | 21 | 23 | 19 | 12 | |||||||
111 | 24 | 17 | 32 | 8 | |||||||
5 µg | 88 | (93) 5.6 |
28 | (21) 7.5 |
19 | (19) 0.6 |
9 | (11) 2.1 |
24 | (16) 6.7 |
|
92 | 21 | 19 | 13 | 13 | |||||||
99 | 13 | 20 | 12 | 12 | |||||||
15 µg | 91 | (92) 14.5 |
13 | (18) 4.2 |
11 | (18) 8.9 |
11 | (13) 2.5 |
11 | (13) 6.8 |
|
78 | 19 | 28 | 13 | 21 | |||||||
107 | 21 | 15 | 16 | 8 | |||||||
50 µg | 108 | (109) 3.1 |
19 | (20) 1.2 |
17 | (18) 1.2 |
13 | (14) 1.7 |
15 | (10) 4.2 |
|
106 | 21 | 19 | 16 | 7 | |||||||
112 | 21 | 17 | 13 | 9 | |||||||
150 µg | 76 | (88) 25.8 |
27 | (24) 3.1 |
16 | (19) 2.9 |
21 | (17) 3.5 |
8 | (9) 1.5 |
|
118 | 25 | 21 | 15 | 9 | |||||||
71 | 21 | 21 | 15 | 11 | |||||||
500 µg | 90 P | (91) 0.6 |
20 P | (24) 4.0 |
21 P | (18) 4.6 |
25 P | (20) 4.6 |
12 P | (14) 4.0 |
|
91 P | 24 P | 21 P | 17 P | 12 P | |||||||
91 P | 28 P | 13 P | 17 P | 19 P | |||||||
1500 µg | 98 P | (101) 19.2 |
19 P | (22) 2.5 |
18 P | (20) 1.7 |
17 P | (17) 0.6 |
12 P | (11) 1.0 |
|
122 P | 24 P | 21 P | 18 P | 10 P | |||||||
84 P | 22 P | 21 P | 17 P | 11 P | |||||||
5000 µg | 81 P | (88) 11.8 |
18 P | (22) 3.8 |
24 P | (23) 0.6 |
12 P | (16) 5.1 |
14 P | (13) 1.2 |
|
82 P | 25 P | 23 P | 22 P | 12 P | |||||||
102 P | 24 P | 23 P | 15 P | 14 P | |||||||
Positive controls S9-Mix (-) |
Name Dose level No.of Revertants |
ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
3 µg | 5 µg | 2 µg | 0.2 µg | 80µg | |||||||
750 | (795) 45.5 |
599 | (706) 93.0 |
1002 | (953) 65.2 |
171 | (207) 58.1 |
523 | (700) 262.6 |
||
841 | 770 | 879 | 274 | 576 | |||||||
795 | 748 | 978 | 176 | 1002 |
ENNG = N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO = 4-Nitroquinoline-l-oxide
9AA = 9-Aminoacridine
P = Test item precipitate
# = Standard deviation
Table 3
Test Period | From: 05 April 2013 | To: 08 April 2013 | |||||||||
S9-Mix (+) |
Dose level Per Plate |
Number of revertants (mean) +/- SD | |||||||||
Base-pair substitution strains | Frameshift strains | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
Solvent Control (DMSO) |
103 | (97) 4.9# |
19 | (16) 3.1 |
41 | (35) 7.2 |
28 | (20) 6.7 |
21 | (14) 7.0 |
|
94 | 13 | 27 | 16 | 7 | |||||||
95 | 15 | 37 | 17 | 15 | |||||||
1.5 µg | 91 | (89) 6.2 |
15 | (14) 2.3 |
32 | (28) 7.5 |
12 | (21) 8.5 |
12 | (12) 0.6 |
|
94 | 15 | 32 | 21 | 12 | |||||||
82 | 11 | 19 | 29 | 13 | |||||||
5 µg | 92 | (100) 7.6 |
12 | (15) 4.4 |
29 | (31) 1.5 |
19 | (18) 2.6 |
11 | (15) 3.5 |
|
107 | 13 | 32 | 20 | 17 | |||||||
102 | 20 | 31 | 15 | 17 | |||||||
15 µg | 96 | (104) 10.6 |
13 | (12) 1.2 |
23 | (33) 8.7 |
24 | (21) 2.5 |
17 | (14) 3.1 |
|
116 | 11 | 37 | 21 | 11 | |||||||
100 | 11 | 39 | 19 | 13 | |||||||
50 µg | 104 | (96) 6.8 |
16 | (16) 1.0 |
19 | (27) 6.9 |
23 | (22) 2.1 |
13 | (12) 3.6 |
|
94 | 17 | 31 | 20 | 15 | |||||||
91 | 15 | 31 | 24 | 8 | |||||||
150 µg | 96 | (104) 7.2 |
19 | (16) 3.5 |
44 | (32) 10.8 |
19 | (21) 2.1 |
13 | (13) 0.6 |
|
106 | 16 | 29 | 20 | 12 | |||||||
110 | 12 | 23 | 23 | 13 | |||||||
500 µg | 108 | (98) 15.6 |
9 P | (12) 3.1 |
27 P | (30) 2.3 |
19 P | (19) 0.0 |
11 P | (11) 0.6 |
|
80 | 11 P | 31 P | 19 P | 11 P | |||||||
106 | 15 P | 31 P | 19 P | 10 P | |||||||
1500 µg | 74 P | (83) 8.5 |
11 P | (10) 1.2 |
25 P | (28) 4.2 |
20 P | (19) 2.3 |
14 P | (13) 1.2 |
|
91 P | 9 P | 27 P | 16 P | 12 P | |||||||
84 P | 11 P | 33 P | 20 P | 12 P | |||||||
5000 µg | 99 P | (97) 4.0 |
11 P | (12) 1.0 |
18 P | (22) 8.7 |
15 P | (22) 6.2 |
9 P | (9) 1.0 |
|
92 P | 12 P | 16 P | 24 P | 10 P | |||||||
99 P | 13 P | 32 P | 27 P | 8 P | |||||||
Positive controls S9-Mix (+) |
Name Dose level No.of Revertants |
2AA | 2AA | 2AA | BP | 2AA | |||||
1 µg | 2 µg | 10 µg | 5 µg | 2 µg | |||||||
1445 | (1450) 24.4 |
237 | (254) 23.4 |
262 | (283) 20.6 |
378 | (369) 12.1 |
354 | (301) 47.2 |
||
1429 | 245 | 303 | 373 | 287 | |||||||
1477 | 281 | 285 | 355 | 263 |
BP = Benzo(a)pyrene
2AA = 2-Aminoanthracene
P = Test item precipitate
# = Standard deviation
Table 4
Test Period | From: 05 April 2013 | To: 08 April 2013 | |||||||||
S9-Mix (-) |
Dose level Per Plate |
Number of revertants (mean) +/- SD | |||||||||
Base-pair substitution strains | Frameshift strains | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
Solvent Control (DMSO) |
75 | (75) 7.5# |
25 | (20) 6.4 |
27 | (24) 6.4 |
19 | (14) 5.0 |
3 | (7) 3.2 |
|
68 | 13 | 29 | 13 | 8 | |||||||
83 | 23 | 17 | 9 | 9 | |||||||
50 µg | 84 | (81) 5.8 |
29 | (23) 9.5 |
33 | (30) 2.3 |
19 | (18) 1.2 |
8 | (9) 2.3 |
|
74 | 12 | 29 | 17 | 8 | |||||||
84 | 28 | 29 | 17 | 12 | |||||||
150 µg | 87 | (77) 9.3 |
29 | (23) 5.2 |
25 | (28) 3.1 |
11 | (14) 3.1 |
8 | (7) 1.7 |
|
74 | 20 | 27 | 17 | 5 | |||||||
69 | 20 | 31 | 15 | 8 | |||||||
500 µg | 88 P | (84) 3.2 |
17 P | (19) 1.5 |
21 P | (23) 2.1 |
15 P | (15) 2.0 |
8 P | (9) 1.7 |
|
82 P | 20 P | 24 P | 13 P | 8 P | |||||||
83 P | 19 P | 25 P | 17 P | 11 P | |||||||
1500 µg | 72 | (80) 9.8 |
21 P | (23) 4.9 |
31 P | (25) 6.0 |
20 P | (17) 3.1 |
7 P | (11) 3.2 |
|
77 P | 20 P | 19 P | 16 P | 13 P | |||||||
91 P | 29 P | 25 P | 14 P | 12 P | |||||||
5000 µg | 68 P | (72) 5.1 |
18 P | (21) 6.1 |
26 P | (22) 3.6 |
15 P | (16) 1.2 |
11 P | (9) 3.8 |
|
71 P | 17 P | 19 P | 15 P | 5 P | |||||||
78 P | 28 P | 21 P | 17 P | 12 P | |||||||
Positive controls S9-Mix (-) |
Name Dose level No.of Revertants |
ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
3 µg | 5 µg | 2 µg | 0.2 µg | 80µg | |||||||
470 | (463) 17.0 |
345 | (536) 177.3 |
422 | (371) 45.2 |
239 | (207) 32.0 |
1658 | (1213) 386.5 |
||
476 | 695 | 335 | 206 | 961 | |||||||
444 | 569 | 357 | 175 | 1020 |
ENNG = N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO = 4-Nitroquinoline-l-oxide
9AA = 9-Aminoacridine
P = Test item precipitate
# = Standard deviation
Table 5
Test Period | From: 05 April 2013 | To: 08 April 2013 | |||||||||
S9-Mix (+) |
Dose level Per Plate |
Number of revertants (mean) +/- SD | |||||||||
Base-pair substitution strains | Frameshift strains | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
Solvent Control (DMSO) |
96 | (89) 18.1# |
24 | (21) 5.2 |
35 | (32) 3.6 |
23 | (19) 3.5 |
17 | (8) 7.8 |
|
68 | 15 | 28 | 17 | 4 | |||||||
102 | 24 | 33 | 17 | 3 | |||||||
50 µg | 88 | (83) 4.6 |
21 | (17) 4.0 |
33 | (28) 6.1 |
15 | (15) 2.0 |
9 | (11) 4.4 |
|
79 | 13 | 29 | 13 | 8 | |||||||
82 | 17 | 21 | 17 | 16 | |||||||
150 µg | 74 | (84) 13.1 |
17 | (20) 4.6 |
35 | (32) 3.5 |
17 | (20) 3.5 |
13 | (11) 5.7 |
|
99 | 25 | 28 | 20 | 5 | |||||||
80 | 17 | 32 | 24 | 16 | |||||||
500 µg | 90 P | (88) 1.5 |
16 P | (16) 0.6 |
24 P | (28) 3.6 |
11 P | (17) 6.0 |
9 P | (12) 3.6 |
|
88 P | 17 P | 29 P | 23 P | 16 P | |||||||
87 P | 16 P | 31 P | 17 P | 11 P | |||||||
1500 µg | 73 P | (70) 5.2 |
15 P | (20) 5.7 |
28 P | (31) 3.8 |
26 P | (25) 1.0 |
7 P | (7) 1.5 |
|
64 P | 26 P | 29 P | 25 P | 9 P | |||||||
73 P | 18 P | 35 P | 24 P | 6 P | |||||||
5000 µg | 84 P | (78) 6.0 |
13 P | (15) 3.2 |
33 P | (30) 6.4 |
17 P | (22) 6.4 |
11 P | (8) 2.5 |
|
79 P | 19 P | 23 P | 29 P | 8 P | |||||||
72 P | 14 P | 35 P | 19 P | 6 P | |||||||
Positive controls S9-Mix (+) |
Name Dose level No.of Revertants |
2AA | 2AA | 2AA | BP | 2AA | |||||
1 µg | 2 µg | 10 µg | 5 µg | 2 µg | |||||||
1148 | (1119) 29.0 |
374 | (375) 22.5 |
238 | (249) 9.3 |
203 | (205) 19.6 |
190 | (209) 24.8 |
||
1120 | 353 | 255 | 186 | 200 | |||||||
1090 | 398 | 253 | 255 | 237 |
BP = Benzo(a)pyrene
2AA = 2-Aminoanthracene
P = Test item precipitate
# = Standard deviation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Bacterial Reverse Mutation Test
The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
Justification for selection of genetic toxicity endpoint
In accordance with Annex VII, only the in vitro ames study has been carried out.
Justification for classification or non-classification
The available study data shows no significant evidence of mutagenicity, therefore the material should nt be classified.
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