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EC number: 237-655-9 | CAS number: 13887-98-4
- 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
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- 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
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- Endpoint summary
- Stability
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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
The test substance was not mutagenic in the Ames test.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1990-11-27 to 1990-12-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D 269
- Expiration date of the lot/batch: stable until December 1991
- Purity test date: 1990-07-16
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dark at approximately 5 °C
- Stability under test conditions: stable until December 1991, stability in solvent proved for 4 hours - Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA1535, TA100) and frameshift (TA1537, TA98) mutations.
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix, Aroclor 1254 induced
- Test concentrations with justification for top dose:
- The test compound was tested at doses of 4 to 10000 microgram/plate and proved to be toxic to the bacterial strains at doses of 2500 microgram/ plate. Thinning of the bacterial lawn and a reduction in the number of colonies have been observed at this dose.
Concentrations: 0, 4, 20, 100, 500, 2500, 5000, 10000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: water
- Justification for choice of solvent/vehicle: soluble in water - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- 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 (plate incorporation)
DURATION
- Exposure duration: 48 h
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all revertant colonies were counted
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- standard test conditions for this assay
- Evaluation criteria:
- A test article is classified mutagenic if either of the following conditions under a) and b) is achieved:
a) a test article produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) a test article induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.
The test results must be reproducible. - Statistics:
- Statistical analysis is not neccessary as only the number of colonies has to be compared to the controls.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed at doses of 2500 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed in the preliminary experiment at doses of 2500 µg/plate and above.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed at doses of 2500 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed at doses of 2500 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed at doses of 2500 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The test substance was not mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The test item was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium.
The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate (S9 mix, Aroclor 1254 induced). A dose range of 6 different doses from 4 microgram/plate to 10000 microgram/plate was used.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies. The test compound proved to be toxic to the bacterial strains at 2500 microgram/plate. In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test item did not result in relevant increases in the number of revertant colonies. Summarizing, it can be stated that the test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-07-18 to 2017-07-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- only one bacterial strain tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- yes
- Remarks:
- only one bacterial strain tested
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 03/2016_R_JM
- Expiration date of the lot/batch: 26.06.2018
- Purity test date: 03.02.2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (15-25 °C)
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable
OTHER SPECIFICS:
The test item used in this assay with a purity of 80.8 % consists of 11 % water as a constituent. The substance that is to be registered (dried test item with only 1 % water left) has a purity of 92.3 %. Drying process of the substance is only limited technically feasible. Therefore, at the preparation of test item stock solutions (for Initial and Confirmatory Mutation Tests) a correction factor of 1.14 (92.3/80.8=1.14) was applied in order to take the test item purity into account. - Target gene:
- trpE,
in addition to tryptophan mutation, the Escherichia coli WP2 uvrA strain has additional mutations which enhance its sensitivity to mutagens. The uvrA strains are defective in excision repair. - Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: bacterial disc cultures from Trinova Biochem GmbH (Rathenau Str. 2),
35394 Giessen, Germany
- Cell cycle length, doubling time or proliferation index:
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
Ready-to-use minimal glucose agar (MGA) plates were used in the study. The origin of the ready-to use MGA plates: VWR International, Merck Life Science GmbH, Germany,
Tryptophan overlay agar (Agar Bacteriological, NaCl, Nutrient Broth, L-Tryptophan) - Additional strain / cell type characteristics:
- other: defective in excision repair
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of Phenobarbital (PB) and β-naphthoflavone (BNF) induced rat liver
- Test concentrations with justification for top dose:
- 16, 50, 160, 500, 1600, 5000 µg/plate
The toxicity of the test item was determined with Escherichia coli WP2 uvrA in a pre-experiment. 7 concentrations were tested for toxicity and mutation induction with 3 plates each. The experimental conditions in this pre-experiment were the same as described below for the main experiment I (plate incorporation test) and included non-activated and S9 activated test conditions with appropriate positive and negative controls. The test item concentrations, including the controls (untreated, vehicle and positive reference) were tested in triplicate. In the toxicity test the concentrations examined were: 5000, 1600, 500, 160, 50, 16 and 5 μg/plate. - Vehicle / solvent:
- - Vehicle/solvent used: water
- Justification for choice of solvent/vehicle: soluble in water - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ultrapure water was applied as vehicle of the test item and the positive control substance MMS
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ultrapure water was applied as vehicle of the test item and the positive control substance MMS and DMSO was applied as vehicle for positive control substance 2AA.
- 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 (plate incorporation) (experiment 1) and preincubation test (experiment 2)
DURATION
- Exposure duration: 20 min
- Expression time (cells in growth medium): appr. 48 h
SELECTION AGENT (mutation assays): agar plates containing trypthophan
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all colonies were counted
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- according to guideline
- Evaluation criteria:
- The tests (initial and confirmatory mutation experiments) are considered to be valid if:
- The Escherichia WP2 uvrA culture demonstrates the deletion in the uvrA gene.
- The bacterial cultures demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls.
- The tester strain culture titer is in the 10^9 cells/mL order.
- The batch of S9 used in this study shows the appropriate biological activity.
- The reference mutagens show the expected increase (at least a 3.0-fold increase) in induced revertant colonies over the mean value of the respective vehicle control.
- There are at least five analyzable concentrations (at the tester strain) (a minimum of three non-toxic dose levels is required to evaluate assay data).
A dose level is considered toxic if
- the reduced revertant colony numbers are observed as compared to the mean vehicle control value and the reduction shows a dose-dependent relationship, and / or
- the reduced revertant colony numbers are below the historical control data range and / or
- pinpoint colonies appear and / or
- clearing or diminution of the background lawn (reduced background lawn development occurs).
A test item is considered mutagenic if:
- a dose-related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response (the number of reversions is at least three times higher than the reversion rate of the vehicle control) for at least one of the dose groups occurs in the examined strain with or without metabolic activation.
Criteria for a Negative Response:
A test item is considered non-mutagenic in this bacterial reverse mutation assay if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- The colony numbers on the controls (untreated, vehicle, positive) and the test item plates were determined (counted manually, evaluated by unaided eye), the mean values and appropriate standard deviations and mutation rates were calculated.
- 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 applicable
- Positive controls validity:
- valid
- Conclusions:
- The test item is not mutagenic in Escherichia coli WP2 uvrA.
- Executive summary:
The Escherichia coli WP2 uvrA tester strain was used to investigate the mutagenic potential of the test item in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (±S9 Mix, Phenobarbital (PB) and β-naphthoflavone (BNF) induced). The concentrations, including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently. No substantial increases were observed in revertant colony numbers of the investigated Escherichia coli WP2 uvrA tester strain following treatment at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. Sporadic increases in revertant colony numbers compared to the vehicle control values mostly within the actual historical control data ranges were observed in both independently performed main experiments. However, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments. In the performed experiments inhibitory effect of the test item (decreased number of revertant colony numbers and/or affected background lawn development) was not observed in any case. No precipitation of the test item was observed on the plates in the examined bacterial strain at any examined concentration level (±S9 Mix) throughout the study. As a conclusion the test item is considered non-mutagenic in this bacterial reverse mutation assay.
Referenceopen allclose all
Table 1: Number of revertants per plate (mean of three plates), Experiment 1
strain TA 100 |
strain TA 1535 |
Strain TA 1537 |
strain TA 1538 |
strain TA 98 |
||||||
conc. [µg] per plate |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
0 |
171 |
169 |
10 |
9 |
5 |
5 |
12 |
14 |
19 |
28 |
4 |
158 |
161 |
8 |
9 |
4 |
4 |
13 |
19 |
14 |
27 |
20 |
163 |
170 |
9 |
11 |
5 |
7 |
13 |
10 |
19 |
26 |
100 |
158 |
166 |
10 |
9 |
6 |
8 |
15 |
14 |
18 |
23 |
500 |
158 |
163 |
7 |
9 |
6 |
10 |
11 |
10 |
20 |
24 |
2500 |
140 |
144 |
9 |
12 |
8 |
6 |
14 |
15 |
15 |
25 |
10000 |
123 |
153 |
8 |
9 |
12 |
6 |
8 |
12 |
21 |
25 |
Sodium azide 1 µg |
558 |
|
434 |
|
|
|
|
|
|
|
9-Aminoacridine 50 µg |
|
|
|
|
282 |
|
|
|
|
|
2-Nitrofluorene 2.5 µg |
|
|
|
|
|
|
1234 |
|
1019 |
|
2-Aminoanthracene 0.5 µg (TA 100, TA1538, TA98) 1µg (TA1535, TA1537) |
|
725 |
|
178 |
|
124 |
|
474 |
|
484 |
Benzo[a]pyrene 10 µg |
|
1316 |
|
35 |
|
128 |
|
202 |
|
588 |
Table 2: Number of revertants per plate (mean of three plates), Experiment 2
strain TA 100 |
strain TA 1535 |
Strain TA 1537 |
strain TA 1538 |
strain TA 98 |
||||||
conc. [µg] |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
0 |
111 |
124 |
9 |
9 |
8 |
10 |
16 |
19 |
18 |
25 |
4 |
105 |
124 |
6 |
11 |
11 |
13 |
13 |
21 |
20 |
27 |
20 |
99 |
124 |
8 |
8 |
8 |
9 |
12 |
24 |
25 |
25 |
100 |
116 |
124 |
10 |
9 |
9 |
7 |
14 |
20 |
22 |
28 |
500 |
115 |
124 |
10 |
8 |
7 |
12 |
10 |
22 |
21 |
22 |
2500 |
113 |
105 |
6 |
12 |
7 |
6 |
11 |
25 |
28 |
18 |
10000 |
105 |
100 |
7 |
8 |
7 |
7 |
17 |
20 |
24 |
23 |
Sodium azide 1 µg |
494 |
|
375 |
|
|
|
|
|
|
|
9-Aminoacridine 50 µg |
|
|
|
|
246 |
|
|
|
|
|
2-Nitrofluorene 2.5 µg |
|
|
|
|
|
|
874 |
|
652 |
|
2-Aminoanthracene 0.5 µg (TA 100, TA1538, TA98) 1µg (TA1535, TA1537) |
|
570 |
|
130 |
|
121 |
|
323 |
|
347 |
Benzo[a]pyrene 10 µg |
|
1198 |
|
18 |
|
126 |
|
131 |
|
616 |
Table 1: Number of revertants per plate (mean of three plates), Experiment 1(plate incorporation test)
Initial Mutation Test (Plate Incorporation Test) |
|||||
Concentrations (μg/plate) |
Escherichia coliWP2uvrA |
||||
-S9 |
+S9 |
||||
Mean values of revertants per plate and Mutation rate (MR) |
Mean |
MR |
Mean |
MR |
|
Untreated Control |
31.3 |
0.84 |
43.3 |
1.10 |
|
DMSO Control |
– |
– |
32.3 |
1.00 |
|
Ultrapure Water Control |
37.3 |
1.00 |
39.3 |
1.00 |
|
5000 |
46.3 |
1.24 |
45.0 |
1.14 |
|
1600 |
36.0 |
0.96 |
51.0 |
1.30 |
|
500 |
41.7 |
1.12 |
47.0 |
1.19 |
|
160 |
40.7 |
1.09 |
52.0 |
1.32 |
|
50 |
39.7 |
1.06 |
44.3 |
1.13 |
|
16 |
34.0 |
0.91 |
51.0 |
1.30 |
|
MMS (2μL) |
765.3 |
20.50 |
– |
– |
|
2AA (50 μg) |
– |
– |
223.0 |
6.90 |
|
Table 2: Number of revertants per plate (mean of three plates), Experiment 2(Pre-Incubation Test)
Confirmatory Mutation Test (Pre-Incubation Test) |
|||||
Concentrations (μg/plate) |
Escherichia coliWP2uvrA |
||||
-S9 |
+S9 |
||||
Mean values of revertants per plate and Mutation rate (MR) |
Mean |
MR |
Mean |
MR |
|
Untreated Control |
26.7 |
1.03 |
35.0 |
0.95 |
|
DMSO Control |
– |
– |
35.0 |
1.00 |
|
Ultrapure Water Control |
26.0 |
1.00 |
36.7 |
1.00 |
|
5000 |
31.3 |
1.21 |
34.3 |
0.94 |
|
1600 |
27.3 |
1.05 |
39.7 |
1.08 |
|
500 |
34.7 |
1.33 |
33.7 |
0.92 |
|
160 |
33.0 |
1.27 |
35.3 |
0.96 |
|
50 |
26.0 |
1.00 |
35.3 |
0.96 |
|
16 |
31.3 |
1.21 |
38.3 |
1.05 |
|
MMS (2μL) |
1168.0 |
44.92 |
– |
– |
|
2AA (50 μg) |
– |
– |
273.0 |
7.80 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames test (Salmonella typhimurium strains)
The test item was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate (S9 mix, Aroclor 1254 induced). A dose range of 6 different doses from 4 microgram/plate to 10000 microgram/plate was used. Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies. The test compound proved to be toxic to the bacterial strains at 2500 microgram/plate. In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test item did not result in relevant increases in the number of revertant colonies. Summarizing, it can be stated that the test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
Ames test (Echerichia coli WP2 uvrA)
The Escherichia coli WP2 uvrA tester strain was used to investigate the mutagenic potential of the test item in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (± rat liver S9 Mix, Phenobarbital (PB) and β-naphthoflavone (BNF) induced). The concentrations, including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently. No substantial increases were observed in revertant colony numbers of the investigated Escherichia coli WP2 uvrA tester strain following treatment at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. Sporadic increases in revertant colony numbers compared to the vehicle control values mostly within the actual historical control data ranges were observed in both independently performed main experiments. However, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments. In the performed experiments inhibitory effect of the test item (decreased number of revertant colony numbers and/or affected background lawn development) was not observed in any case. No precipitation of the test item was observed on the plates in the examined bacterial strain at any examined concentration level (±S9 Mix) throughout the study. As a conclusion the test item is considered non-mutagenic in this bacterial reverse mutation assay.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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