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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item was tested in the Bacterial reverse mutation assay with five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537). The study procedures described in this report were based on the most recent Guideline OECD 471 (2020) and EU Method B.13/14 (2008). The test was performed with +S9 standing for the presence of a metabolic activation, and -S9 standing for absence of metabolic activation.
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:
- 2020-2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Trinova Biochem GmbH, Gießen. Produced from the livers of male Sprague-Dawley rats which were treated with Phenobarbital/5,6-Benzoflavone
- concentration or volume of S9 mix and S9 in the final culture medium: Phosphate buffer 22.5 mL; 0.1M NADP-solution 1.0 mL; 1M G6P-solution 0.125 mL; Salt solution 0.5 mL; Rat liver S9 1.0 mL - Test concentrations with justification for top dose:
- Experiment 1: Test concentrations 5, 1.5, 0.5, 0.15, 0.05 µL/plate.
Experiment 1b: Test concentrations 5, 1.5, 0.5, 0.15, 0.05, 0.015, 0.005 µL/plate.
Experiment 2: Test concentrations 5, 2.5, 1.25, 0.63, 0.31, 0.16, 0.08 µL/plate.
S. typhimurium TA 102 was not tested in Experiment 1.
Top dose of 5 µL/plate as recommended on the OECD Guideline - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test material was sufficiently soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations
- Justification for percentage of solvent in the final culture medium: The test material is soluble in a concentration of 50 mL/L in DMSO. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 4-Nitro-1,2-phenylene diamine
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
Number of replicates: 3 replicates per bacteria strain with (+S9) and 3 replicates per bacteria strain without metabolic activation(-S9)
- Number of independent experiments: 3, Experiment 1, 1b and 2
Three valid experiments were performed; the initial experiment had to be repeated with ad-ditional lower concentrations due to an insufficient number of analyzable non-toxic concentrations as indicated in the guideline.
For TA100 (+/-S9) experiment 1 was invalid, because the values of spontaneous revertants of the solvent controls demin. water and DMSO did not meet the historical control data range.
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; Agar. Experiment 1 and Experiment 1b used the plate incorporation method. Experiment 2 used the pre-incubation method
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
- Exposure duration/duration of treatment: 48h - Rationale for test conditions:
- The test was conducted in compliance with the following guidelines:
- OECD Guidelines for the Testing of Chemicals Part 471, adopted 26. Jun. 2020 “Bacterial Reverse Mutation Test“
- Commission Regulation (EC) No. 440 2008, EU-Method B.13/14 adopted 30. May 2008 “Mutagenicity –Reverse mutation test using bacteria”.
Three valid experiments were performed; the initial experiment had to be repeated with additional lower concentrations due to an insufficient number of analyzable non-toxic concentrations as indicated in the guideline. - Evaluation criteria:
- A result is considered positive if a clear and dose-related increase in the number of revertants occurs and/or a biologically relevant positive response for at least one of the concentrations occurs in at least one tested strain with or without metabolic activation.
A biologically relevant increase is described as follows:
• if in the bacteria strains S. typhimurium TA98, TA100, TA102 the number of revertants is at least twice as high than the reversion rate of the negative controls (increase fac-tor of at least 2.0)
• if in the bacteria strains S. typhimurium TA1535 and TA1537 the number of revertants is at least three times higher than the reversion rate of the negative controls (increase factor of at least 3.0).
A substance is not mutagenic if it does not meet the criteria above.
If the criteria listed above are not clearly met, the results will be assessed as equivocal and will be discussed. - Statistics:
- Statistical analysis was not performed for this test
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Based on the results of this study it is concluded that the test item is mutagenic in the Salmonella typhimurium strains TA100 in the presence and absence of metabolic activation and TA1535 in the presence of metabolic activation under the experimental conditions in this study.
- Executive summary:
The test item was tested in the Bacterial reverse mutation assay with five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537). The study procedures described in this report were based on the most recent Guideline OECD 471 (2020) and EU Method B.13/14 (2008). The test was performed with +S9 standing for the presence of a metabolic activation, and -S9 standing for absence of metabolic activation. Three valid experiments were performed; the initial experiment had to be repeated with additional lower concentrations due to an insufficient number of analyzable non-toxic concentrations as indicated in the guideline. It was concluded that the test item is mutagenic in the Salmonella typhimuriumstrains TA100 in the presence and absence of metabolic activation and TA1535 in the presence of metabolic activation.
Reference
Mean Revertants Experiment 1
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
12 |
14 |
iv |
iv |
- |
- |
6 |
7 |
7 |
4 |
sd |
1.0 |
1.5 |
iv |
iv |
- |
- |
1.0 |
2.1 |
0.0 |
1.5 |
|
DMSO |
Mean |
9 |
16 |
iv |
iv |
- |
- |
9 |
6 |
5 |
5 |
sd |
1.0 |
2.6 |
iv |
iv |
- |
- |
2.1 |
1.0 |
2.0 |
1.7 |
|
Positive |
Mean |
576 |
128 |
iv |
iv |
- |
- |
309 |
297 |
59 |
17 |
sd |
16.0 |
7.6 |
iv |
iv |
- |
- |
14.0 |
8.3 |
1.0 |
6.0 |
|
f(I) |
64.00 |
8.00 |
iv |
iv |
- |
- |
51.50 |
49.50 |
11.80 |
3.40 |
|
5 µL/plate |
Mean |
0 |
3 |
iv |
iv |
- |
- |
3 |
10 |
0 |
0 |
sd |
0.0 |
3.0 |
iv |
iv |
- |
- |
2.0 |
3.5 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.19 |
iv |
iv |
- |
- |
0.33 |
1.67 |
0.00 |
0.00 |
|
1.5 µL/plate |
Mean |
12 |
11 |
iv |
iv |
- |
- |
19 |
19 |
5 |
7 |
sd |
2.5 |
3.8 |
iv |
iv |
- |
- |
7.0 |
1.5 |
1.5 |
1.7 |
|
f(I) |
1.33 |
0.69 |
iv |
iv |
- |
- |
2.11 |
3.17 |
1.00 |
1.40 |
|
0.5 µL/plate |
Mean |
13 |
8 |
iv |
iv |
- |
- |
12 |
17 |
7 |
4 |
sd |
3.8 |
2.6 |
iv |
iv |
- |
- |
3.6 |
2.1 |
0.6 |
3.5 |
|
f(I) |
1.44 |
0.50 |
iv |
iv |
- |
- |
1.33 |
2.83 |
1.40 |
0.80 |
|
0.15 µL/plate |
Mean |
9 |
15 |
iv |
iv |
- |
- |
6 |
9 |
3 |
4 |
sd |
1.5 |
4.6 |
iv |
iv |
- |
- |
4.0 |
3.1 |
2.5 |
1.7 |
|
f(I) |
1.00 |
0.94 |
iv |
iv |
- |
- |
0.67 |
1.50 |
0.60 |
0.80 |
|
0.05 µL/plate |
Mean |
9 |
12 |
iv |
iv |
- |
- |
10 |
4 |
3 |
5 |
sd |
0.6 |
3.2 |
iv |
iv |
- |
- |
4.4 |
0.6 |
1.7 |
2.1 |
|
f(I) |
1.00 |
0.75 |
iv |
iv |
- |
- |
1.11 |
0.67 |
0.60 |
1.00 |
sd = standard deviation±
* Different positive controls were used, see table under 'Any other information on materials and methos incl tables' section
f(I) = increase factor, calculation [mean revertants divide by means spontaneous revrtants]
iv = invalid
- = not tested
Mean Revertants Experiment 1b
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
19 |
22 |
73 |
82 |
260 |
247 |
5 |
6 |
3 |
6 |
sd |
3.1 |
1.5 |
7.0 |
5.7 |
18.3 |
12.2 |
1.5 |
2.5 |
2.5 |
0.6 |
|
DMSO |
Mean |
14 |
16 |
74 |
76 |
247 |
243 |
6 |
5 |
3 |
3 |
sd |
1.5 |
3.0 |
13.6 |
13.7 |
15.1 |
22.0 |
1.5 |
1.5 |
1.5 |
2.1 |
|
0.9% NaCl |
Mean |
- |
- |
- |
- |
245 |
- |
- |
- |
- |
- |
sd |
- |
- |
- |
- |
8.3 |
- |
- |
- |
- |
- |
|
Positive |
Mean |
601 |
149 |
573 |
2003 |
581 |
737 |
356 |
145 |
33 |
88 |
sd |
28.1 |
4.2 |
31.1 |
164.2 |
24.4 |
31.1 |
22.3 |
10.0 |
14.2 |
7.2 |
|
f(I) |
42.93 |
9.31 |
7.85 |
26.36 |
2.37 |
3.03 |
71.20 |
29.00 |
11.00 |
29.33 |
|
5 µL/plate |
Mean |
3 |
6 |
0 |
81 |
233 |
249 |
7 |
10 |
1 |
1 |
sd |
2.5 |
1.2 |
0.0 |
9.3 |
6.1 |
16.7 |
2.1 |
1.5 |
1.2 |
1.0 |
|
f(I) |
0.21 |
0.38 |
0.00 |
1.07 |
0.94 |
1.02 |
1.17 |
2.00 |
0.33 |
0.33 |
|
1.5 µL/plate |
Mean |
11 |
10 |
85 |
93 |
241 |
233 |
13 |
12 |
3 |
3 |
sd |
2.1 |
4.6 |
12.7 |
6.7 |
15.1 |
19.7 |
3.0 |
3.2 |
2.1 |
1.7 |
|
f(I) |
0.79 |
0.63 |
1.15 |
1.22 |
0.98 |
0.96 |
2.17 |
2.40 |
1.00 |
1.00 |
|
0.5 µL/plate |
Mean |
12 |
14 |
89 |
84 |
224 |
233 |
13 |
10 |
2 |
5 |
sd |
2.0 |
4.0 |
9.0 |
9.7 |
6.9 |
6.1 |
3.1 |
1.0 |
1.7 |
3.2 |
|
f(I) |
0.86 |
0.88 |
1.20 |
1.11 |
0.91 |
0.96 |
2.17 |
2.00 |
0.67 |
1.67 |
|
0.15 µL/plate |
Mean |
12 |
13 |
82 |
78 |
244 |
233 |
8 |
7 |
2 |
2 |
sd |
3.2 |
1.7 |
11.1 |
8.7 |
14.4 |
9.2 |
0.6 |
2.6 |
1.5 |
2.1 |
|
f(I) |
0.86 |
0.81 |
1.11 |
1.03 |
0.99 |
0.96 |
1.33 |
1.40 |
0.67 |
0.67 |
|
0.05 µL/plate |
Mean |
15 |
16 |
78 |
84 |
255 |
232 |
7 |
4 |
2 |
4 |
sd |
2.6 |
2.6 |
3.1 |
13.0 |
4.6 |
6.9 |
2.1 |
1.2 |
0.6 |
2.1 |
|
f(I) |
1.07 |
1.00 |
1.05 |
1.11 |
1.03 |
0.95 |
1.17 |
0.80 |
0.67 |
1.33 |
|
0.015 µL/plate |
Mean |
14 |
18 |
76 |
75 |
257 |
260 |
3 |
5 |
2 |
4 |
sd |
3.6 |
4.9 |
7.2 |
1.5 |
18.0 |
10.6 |
2.0 |
1.2 |
1.5 |
2.6 |
|
f(I) |
1.00 |
1.13 |
1.03 |
0.99 |
1.04 |
1.07 |
0.50 |
1.00 |
0.67 |
1.33 |
|
0.005 µL/plate |
Mean |
14 |
18 |
86 |
86 |
241 |
240 |
8 |
5 |
3 |
4 |
sd |
1.7 |
1.5 |
5.5 |
9.6 |
2.3 |
10.6 |
2.5 |
2.3 |
1.0 |
1.5 |
|
f(I) |
1.00 |
1.13 |
1.16 |
1.13 |
0.98 |
0.99 |
1.33 |
1.00 |
1.00 |
1.33 |
sd = standard deviation±
* Different positive controls were used, see 'Any other information on materials and methos incl tables' section
f(I) = increase factor, calculation [mean revertants divide by means spontaneous revrtants]
- = not tested
Mean Revertants Experiment 2
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
38 |
38 |
63 |
59 |
244 |
232 |
8 |
9 |
5 |
5 |
sd |
6.0 |
5.9 |
5.1 |
3.5 |
8.0 |
17.4 |
1.0 |
1.0 |
1.0 |
1.0 |
|
DMSO |
Mean |
33 |
38 |
58 |
57 |
236 |
249 |
8 |
7 |
6 |
5 |
sd |
3.2 |
0.6 |
2.0 |
3.5 |
10.6 |
8.3 |
0.6 |
0.6 |
1.0 |
0.0 |
|
0.9% NaCl |
Mean |
- |
- |
- |
- |
235 |
- |
- |
- |
- |
- |
sd |
- |
- |
- |
- |
8.3 |
- |
- |
- |
- |
- |
|
Positive |
Mean |
1096 |
118 |
416 |
1720 |
809 |
996 |
359 |
231 |
56 |
79 |
sd |
52.5 |
4.7 |
18.3 |
38.2 |
18.9 |
32.7 |
32.3 |
12.2 |
4.6 |
2.6 |
|
f(I) |
33.21 |
3.11 |
6.60 |
30.18 |
3.44 |
4.00 |
44.88 |
33.00 |
9.33 |
15.80 |
|
5 µL/plate |
Mean |
0 |
0 |
0 |
0 |
165 |
219 |
1 |
3 |
0 |
0 |
sd |
0.0 |
0.0 |
0.0 |
0.0 |
16.2 |
8.3 |
0.6 |
1.5 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.70 |
0.88 |
0.13 |
0.43 |
0.00 |
0.00 |
|
2.5 µL/plate |
Mean |
6 |
17 |
0 |
61 |
241 |
239 |
12 |
18 |
0 |
4 |
sd |
3.1 |
1.2 |
0.0 |
3.2 |
12.9 |
16.2 |
5.8 |
4.0 |
0.0 |
2.0 |
|
f(I) |
0.18 |
0.45 |
0.00 |
1.07 |
1.02 |
0.96 |
1.50 |
2.57 |
0.00 |
0.80 |
|
1.25 µL/plate |
Mean |
32 |
29 |
60 |
126 |
240 |
240 |
11 |
12 |
5 |
5 |
sd |
4.4 |
1.5 |
1.0 |
8.7 |
8.0 |
12.0 |
3.2 |
3.2 |
2.5 |
2.3 |
|
f(I) |
0.97 |
0.76 |
1.03 |
2.21 |
1.02 |
0.96 |
1.38 |
1.71 |
0.83 |
1.00 |
|
0.63 µL/plate |
Mean |
34 |
31 |
138 |
80 |
235 |
239 |
13 |
5 |
4 |
6 |
sd |
1.5 |
4.6 |
2.0 |
8.5 |
12.2 |
8.3 |
3.5 |
2.5 |
1.0 |
0.6 |
|
f(I) |
1.03 |
0.82 |
2.38 |
1.40 |
1.00 |
0.96 |
1.63 |
0.71 |
0.67 |
1.20 |
|
0.31 µL/plate |
Mean |
33 |
38 |
121 |
70 |
237 |
237 |
7 |
8 |
4 |
5 |
sd |
7.6 |
4.9 |
3.0 |
1.5 |
8.3 |
6.1 |
4.9 |
2.9 |
0.6 |
0.6 |
|
f(I) |
1.00 |
1.00 |
2.09 |
1.23 |
1.00 |
0.95 |
0.88 |
1.14 |
0.67 |
1.00 |
|
0.16 µL/plate |
Mean |
32 |
37 |
74 |
65 |
236 |
243 |
11 |
5 |
5 |
5 |
sd |
4.4 |
1.5 |
0.0 |
1.5 |
4.0 |
10.1 |
2.9 |
1.5 |
1.2 |
2.5 |
|
f(I) |
0.97 |
0.97 |
1.28 |
1.14 |
1.00 |
0.98 |
1.38 |
0.71 |
0.83 |
1.00 |
|
0.08 µL/plate |
Mean |
27 |
39 |
58 |
59 |
237 |
237 |
5 |
7 |
4 |
6 |
sd |
3.0 |
2.6 |
3.2 |
1.5 |
9.2 |
14.0 |
0.6 |
2.1 |
1.0 |
0.0 |
|
f(I) |
0.82 |
1.03 |
1.00 |
1.04 |
1.00 |
0.95 |
0.63 |
1.00 |
0.67 |
1.20 |
sd = standard deviation±
* Different positive controls were used, see 'Any other information on materials and methos incl tables' section
f(I) = increase factor, calculation [mean revertants divide by means spontaneous revrtants]
- = not tested
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Justification for classification or non-classification
It was concluded that the test item is mutagenic in the Salmonella typhimurium strains TA100 in the presence and absence of metabolic activation and TA1535 in the presence of metabolic activation.
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