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EC number: - | 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- 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
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- 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
- Sensitisation
- 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
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:
- From 25 Apr 2018 to 08 Aug 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- yes
- Remarks:
- No solubility test was performed. DMSO was selected as solvent based on the solubility findings in Charles River Laboratories Study No. 519589. This deviation is of no influence on the study results
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 31, 2008
- Deviations:
- yes
- Remarks:
- No solubility test was performed. DMSO was selected as solvent based on the solubility findings in Charles River Laboratories Study No. 519589. This deviation is of no influence on the study results
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- liquid
- Details on test material:
- Lot: 6420
Expiration date: 07/18/2019
Store under nitrogen
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: E. coli WP2 uvrA: The sensitivity of the strain to a wide variety of mutagens has been enhanced by permeabilization of the strain using Tris-EDTA treatment
- Metabolic activation:
- with and without
- Metabolic activation system:
- Due to migration, the value was transferred to one of the current document's attachments
- Test concentrations with justification for top dose:
- dose-range finding test: 1.7, 5.4, 17, 52, 164, 512, 1600, 5000 µg/plate.
main study, direct plate assay: 52, 164, 512, 1600, 5000 µg/plate.
main study, pre-incubation assay: 17, 52, 164, 512, 1600, 5000 µg/plate.
maximum test concentration for soluble non-cytotoxic substances according to guideline - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulfoxide (DMSO, Merck, Darmstadt, Germany)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA1535), ICR-191(TA1537), 2-nitrofluorene (TA1537, TA98), Methylmethanesulfonate (TA100), 4-nitroquinoline N-oxide (WP2 uvrA)
- Remarks:
- without metabolic activtion
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar with and without preincubation
DURATION
- Preincubation period: none or 30 +/- 2 min at 37 °C
- Exposure duration: 48 +/- 4 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 +/- 4 h
NUMBER OF REPLICATIONS: triplicates for each dose level
DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies are evaluated - Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP 2 uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP 2 uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535,TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment. - Statistics:
- Not performed
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Individual plate counts; (following pages)
LIST OF ABBREVIATIONS
n |
Normal bacterial background lawn |
a |
Bacterial background lawn absent |
NP |
No precipitate |
MP |
Moderate precipitate |
Dose range finding
Strain TA100
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
926 |
|
951 |
|
963 |
|
947 |
± |
19 |
solvent control |
93 |
|
128 |
|
99 |
|
107 |
± |
19 |
1.7 |
122 |
|
82 |
|
118 |
|
107 |
± |
22 |
5.4 |
103 |
|
102 |
|
101 |
|
102 |
± |
1 |
17 |
125 |
|
95 |
|
113 |
|
111 |
± |
15 |
52 |
110 |
|
93 |
|
105 |
|
103 |
± |
9 |
164 |
127 |
|
127 |
|
128 |
|
127 |
± |
1 |
512 |
98 |
|
91 |
|
103 |
|
97 |
± |
6 |
1600 |
107 |
|
122 |
|
102 |
|
110 |
± |
10 |
5000 |
173 |
n NP |
166 |
n NP |
155 |
n NP |
165 |
± |
9 |
|
|
|
|
|
|
|
|
|
|
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
1144 |
|
1277 |
|
1190 |
|
1204 |
± |
68 |
solvent control |
102 |
|
116 |
|
113 |
|
110 |
± |
7 |
1.7 |
95 |
|
93 |
|
114 |
|
101 |
± |
12 |
5.4 |
87 |
|
94 |
|
105 |
|
95 |
± |
9 |
17 |
76 |
|
97 |
|
105 |
|
93 |
± |
15 |
52 |
102 |
|
125 |
|
112 |
|
113 |
± |
12 |
164 |
117 |
|
120 |
|
118 |
|
118 |
± |
2 |
512 |
144 |
|
148 |
|
133 |
|
142 |
± |
8 |
1600 |
125 |
|
146 |
|
150 |
|
140 |
± |
13 |
5000 |
152 |
n NP |
147 |
n NP |
166 |
n NP |
155 |
± |
10 |
|
|
|
|
|
|
|
|
|
|
Dose range finding
Strain WP2uvrA
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
1560 |
|
1284 |
|
1072 |
|
1305 |
± |
245 |
solvent control |
39 |
|
33 |
|
24 |
|
32 |
± |
8 |
1.7 |
39 |
|
35 |
|
29 |
|
34 |
± |
5 |
5.4 |
34 |
|
42 |
|
30 |
|
35 |
± |
6 |
17 |
22 |
|
18 |
|
34 |
|
25 |
± |
8 |
52 |
41 |
|
31 |
|
38 |
|
37 |
± |
5 |
164 |
26 |
|
45 |
|
37 |
|
36 |
± |
10 |
512 |
35 |
|
20 |
|
24 |
|
26 |
± |
8 |
1600 |
30 |
|
24 |
|
31 |
|
28 |
± |
4 |
5000 |
33 |
n NP |
24 |
n NP |
39 |
n NP |
32 |
± |
8 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
429 |
|
426 |
|
381 |
|
412 |
± |
27 |
solvent control |
45 |
|
27 |
|
31 |
|
34 |
± |
9 |
1.7 |
44 |
|
27 |
|
23 |
|
31 |
± |
11 |
5.4 |
41 |
|
35 |
|
29 |
|
35 |
± |
6 |
17 |
44 |
|
39 |
|
42 |
|
42 |
± |
3 |
52 |
41 |
|
41 |
|
38 |
|
40 |
± |
2 |
164 |
38 |
|
38 |
|
38 |
|
38 |
± |
0 |
512 |
46 |
|
58 |
|
44 |
|
49 |
± |
8 |
1600 |
39 |
|
42 |
|
29 |
|
37 |
± |
7 |
5000 |
50 |
n NP |
45 |
n NP |
54 |
n NP |
50 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
Experiment 1
Strain TA1535
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
767 |
|
811 |
|
784 |
|
787 |
± |
22 |
solvent control |
7 |
|
8 |
|
11 |
|
9 |
± |
2 |
52 |
12 |
|
10 |
|
7 |
|
10 |
± |
3 |
164 |
10 |
|
3 |
|
5 |
|
6 |
± |
4 |
512 |
14 |
|
11 |
|
15 |
|
13 |
± |
2 |
1600 |
4 |
|
12 |
|
11 |
|
9 |
± |
4 |
5000 |
12 |
n NP |
14 |
n NP |
19 |
n NP |
15 |
± |
4 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
267 |
|
291 |
|
294 |
|
284 |
± |
15 |
solvent control |
10 |
|
15 |
|
12 |
|
12 |
± |
3 |
52 |
12 |
|
11 |
|
10 |
|
11 |
± |
1 |
164 |
7 |
|
8 |
|
19 |
|
11 |
± |
7 |
512 |
3 |
|
14 |
|
5 |
|
7 |
± |
6 |
1600 |
16 |
|
25 |
|
14 |
|
18 |
± |
6 |
5000 |
26 |
n NP |
18 |
n NP |
7 |
n NP |
17 |
± |
10 |
|
|
|
|
|
|
|
|
|
|
Experiment 1
Strain TA1537
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
854 |
|
883 |
|
909 |
|
882 |
± |
28 |
solvent control |
11 |
|
11 |
|
15 |
|
12 |
± |
2 |
52 |
5 |
|
7 |
|
4 |
|
5 |
± |
2 |
164 |
8 |
|
14 |
|
7 |
|
10 |
± |
4 |
512 |
11 |
|
11 |
|
8 |
|
10 |
± |
2 |
1600 |
12 |
n |
3 |
n |
3 |
n |
6 |
± |
5 |
50001 |
0 |
a NP |
0 |
a NP |
0 |
a NP |
0 |
± |
0 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
438 |
|
408 |
|
463 |
|
436 |
± |
28 |
solvent control |
18 |
|
12 |
|
8 |
|
13 |
± |
5 |
52 |
4 |
|
7 |
|
5 |
|
5 |
± |
2 |
164 |
10 |
|
3 |
|
4 |
|
6 |
± |
4 |
512 |
18 |
|
10 |
|
5 |
|
11 |
± |
7 |
1600 |
19 |
n |
16 |
n |
19 |
n |
18 |
± |
2 |
50001 |
0 |
a NP |
0 |
a NP |
0 |
a NP |
0 |
± |
0 |
|
|
|
|
|
|
|
|
|
|
1 No bacteria plated, not reported
Experiment 1A (repeat experiment, since no bacteria plated in the highest concentration of Experiment 1)
Strain TA1537
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
332 |
|
325 |
|
412 |
|
356 |
± |
48 |
solvent control |
0 |
n |
3 |
|
0 |
n |
1 |
± |
2 |
5000 |
4 |
n MP |
2 |
n MP |
2 |
n MP |
3 |
± |
1 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
781 |
|
903 |
|
882 |
|
855 |
± |
65 |
solvent control |
3 |
|
4 |
|
1 |
|
3 |
± |
2 |
5000 |
4 |
n MP |
3 |
n MP |
2 |
n MP |
3 |
± |
1 |
|
|
|
|
|
|
|
|
|
|
Experiment 1
Strain TA98
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
966 |
|
891 |
|
956 |
|
938 |
± |
41 |
solvent control |
30 |
|
23 |
|
22 |
|
25 |
± |
4 |
52 |
15 |
|
16 |
|
22 |
|
18 |
± |
4 |
164 |
31 |
|
14 |
|
10 |
|
18 |
± |
11 |
512 |
14 |
|
14 |
|
10 |
|
13 |
± |
2 |
1600 |
14 |
|
10 |
|
18 |
|
14 |
± |
4 |
5000 |
18 |
n NP |
16 |
n NP |
12 |
n NP |
15 |
± |
3 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
997 |
|
914 |
|
899 |
|
937 |
± |
53 |
solvent control |
37 |
|
20 |
|
19 |
|
25 |
± |
10 |
52 |
27 |
|
30 |
|
19 |
|
25 |
± |
6 |
164 |
15 |
|
27 |
|
24 |
|
22 |
± |
6 |
512 |
8 |
|
29 |
|
30 |
|
22 |
± |
12 |
1600 |
15 |
|
8 |
|
20 |
|
14 |
± |
6 |
5000 |
23 |
n NP |
33 |
n NP |
26 |
n NP |
27 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
Experiment 2
Strain TA1535
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
1175 |
|
1303 |
|
1257 |
|
1245 |
± |
65 |
solvent control |
12 |
|
7 |
|
12 |
|
10 |
± |
3 |
17 |
8 |
|
7 |
|
12 |
|
9 |
± |
3 |
52 |
12 |
|
11 |
|
10 |
|
11 |
± |
1 |
164 |
5 |
|
10 |
|
8 |
|
8 |
± |
3 |
512 |
7 |
|
8 |
|
10 |
|
8 |
± |
2 |
1600 |
10 |
|
4 |
|
7 |
|
7 |
± |
3 |
5000 |
7 |
n NP |
11 |
n NP |
10 |
n NP |
9 |
± |
2 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
307 |
|
252 |
|
306 |
|
288 |
± |
31 |
solvent control |
5 |
|
15 |
|
8 |
|
9 |
± |
5 |
17 |
8 |
|
7 |
|
10 |
|
8 |
± |
2 |
52 |
20 |
|
7 |
|
14 |
|
14 |
± |
7 |
164 |
5 |
|
15 |
|
14 |
|
11 |
± |
6 |
512 |
12 |
|
10 |
|
12 |
|
11 |
± |
1 |
1600 |
7 |
|
8 |
|
12 |
|
9 |
± |
3 |
5000 |
14 |
n NP |
15 |
n NP |
24 |
n NP |
18 |
± |
6 |
|
|
|
|
|
|
|
|
|
|
Experiment 2
Strain TA1537
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
158 |
|
151 |
|
141 |
|
150 |
± |
9 |
solvent control |
7 |
|
4 |
|
3 |
|
5 |
± |
2 |
17 |
3 |
|
1 |
|
5 |
|
3 |
± |
2 |
52 |
16 |
|
10 |
|
5 |
|
10 |
± |
6 |
164 |
1 |
|
3 |
|
5 |
|
3 |
± |
2 |
512 |
10 |
|
8 |
|
4 |
|
7 |
± |
3 |
1600 |
1 |
|
7 |
|
3 |
|
4 |
± |
3 |
5000 |
3 |
n NP |
4 |
n NP |
5 |
n NP |
4 |
± |
1 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
241 |
|
246 |
|
245 |
|
244 |
± |
3 |
solvent control |
5 |
|
10 |
|
8 |
|
8 |
± |
3 |
17 |
1 |
|
4 |
|
3 |
|
3 |
± |
2 |
52 |
11 |
|
8 |
|
8 |
|
9 |
± |
2 |
164 |
4 |
|
5 |
|
4 |
|
4 |
± |
1 |
512 |
3 |
|
10 |
|
4 |
|
6 |
± |
4 |
1600 |
8 |
|
8 |
|
4 |
|
7 |
± |
2 |
5000 |
2 |
n NP |
7 |
n NP |
5 |
n NP |
5 |
± |
3 |
|
|
|
|
|
|
|
|
|
|
Experiment 2
Strain TA98
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
1598 |
|
1054 |
|
1445 |
|
1366 |
± |
281 |
solvent control |
18 |
|
10 |
|
12 |
|
13 |
± |
4 |
17 |
20 |
|
7 |
|
10 |
|
12 |
± |
7 |
52 |
14 |
|
14 |
|
14 |
|
14 |
± |
0 |
164 |
10 |
|
23 |
|
12 |
|
15 |
± |
7 |
512 |
10 |
|
14 |
|
12 |
|
12 |
± |
2 |
1600 |
18 |
|
15 |
|
19 |
|
17 |
± |
2 |
5000 |
18 |
n NP |
10 |
n NP |
18 |
n NP |
15 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
577 |
|
623 |
|
726 |
|
642 |
± |
76 |
solvent control |
18 |
|
15 |
|
7 |
|
13 |
± |
6 |
17 |
20 |
|
18 |
|
18 |
|
19 |
± |
1 |
52 |
27 |
|
20 |
|
19 |
|
22 |
± |
4 |
164 |
14 |
|
18 |
|
22 |
|
18 |
± |
4 |
512 |
23 |
|
24 |
|
27 |
|
25 |
± |
2 |
1600 |
30 |
|
15 |
|
18 |
|
21 |
± |
8 |
5000 |
15 |
n NP |
24 |
n NP |
20 |
n NP |
20 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
Experiment 2
Strain TA100
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
909 |
|
880 |
|
880 |
|
890 |
± |
17 |
solvent control |
103 |
|
106 |
|
110 |
|
106 |
± |
4 |
17 |
99 |
|
107 |
|
121 |
|
109 |
± |
11 |
52 |
122 |
|
107 |
|
102 |
|
110 |
± |
10 |
164 |
97 |
|
114 |
|
102 |
|
104 |
± |
9 |
512 |
117 |
|
146 |
|
102 |
|
122 |
± |
22 |
1600 |
112 |
|
128 |
|
122 |
|
121 |
± |
8 |
5000 |
132 |
n NP |
122 |
n NP |
128 |
n NP |
127 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
1864 |
|
1963 |
|
2075 |
|
1967 |
± |
106 |
solvent control |
110 |
|
103 |
|
101 |
|
105 |
± |
5 |
17 |
94 |
|
132 |
|
103 |
|
110 |
± |
20 |
52 |
101 |
|
98 |
|
99 |
|
99 |
± |
2 |
164 |
106 |
|
107 |
|
95 |
|
103 |
± |
7 |
512 |
113 |
|
107 |
|
106 |
|
109 |
± |
4 |
1600 |
105 |
|
140 |
|
139 |
|
128 |
± |
20 |
5000 |
152 |
n NP |
143 |
n NP |
151 |
n NP |
149 |
± |
5 |
|
|
|
|
|
|
|
|
|
|
Experiment 2
Strain WP2uvrA
|
|||||||||
WITHOUT S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
392 |
|
310 |
|
412 |
|
371 |
± |
54 |
solvent control |
29 |
|
30 |
|
24 |
|
28 |
± |
3 |
17 |
37 |
|
26 |
|
34 |
|
32 |
± |
6 |
52 |
26 |
|
48 |
|
24 |
|
33 |
± |
13 |
164 |
37 |
|
41 |
|
39 |
|
39 |
± |
2 |
512 |
27 |
|
29 |
|
33 |
|
30 |
± |
3 |
1600 |
38 |
|
35 |
|
30 |
|
34 |
± |
4 |
5000 |
31 |
n NP |
34 |
n NP |
45 |
n NP |
37 |
± |
7 |
|
|
|
|
|
|
|
|
|
|
WITH S9-MIX |
|||||||||
plate |
1 |
|
2 |
|
3 |
|
MEAN |
|
SD |
|
|
|
|
|
|
|
|
|
|
dose (µg/plate) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
positive control |
559 |
|
566 |
|
560 |
|
562 |
± |
4 |
solvent control |
37 |
|
38 |
|
34 |
|
36 |
± |
2 |
17 |
49 |
|
58 |
|
30 |
|
46 |
± |
14 |
52 |
39 |
|
41 |
|
45 |
|
42 |
± |
3 |
164 |
46 |
|
39 |
|
45 |
|
43 |
± |
4 |
512 |
31 |
|
52 |
|
29 |
|
37 |
± |
13 |
1600 |
41 |
|
56 |
|
56 |
|
51 |
± |
9 |
5000 |
49 |
n NP |
39 |
n NP |
37 |
n NP |
42 |
± |
6 |
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that the test material is not mutagenic in the bacterial reverse mutation assay with Salmonella typhimurium and Escherichia coli strains.
- Executive summary:
A bacterial mutagenicity test (according to guideline OECD 471) in Salmonella typhimurium strains TA 1537, TA 1535, TA100, TA98 as well as Escherichia coli strain WP2 uvrA was performed with the test material in concentrations up to 5000 µg/plate with and without metabolic activation.
All bacterial strains showed negative responses over the entire dose-range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
The negative (vehicle) control values were within the laboratory historical control data ranges, except the response for TA1537 in the absence of S9-mix, in the repeat of the first experiment. However since the mean number of revertant colonies showed a characteristic number of revertant colonies (1 revertant colony) when compared against relevant historical control data (3 revertant colonies), the validity of the test was considered to be not affected.
In conclusion, the test item Step 2 Catalyst revealed no mutagenic activity under the conditions of this bacterial reverse mutation assay with Salmonella typhimurium and Escherichia coli strains.
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