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EC number: 821-885-7 | CAS number: 1820028-80-5
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar 08 - Jul 15, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- 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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: bulk
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- without S9 mix: 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
with S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate - Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; pre-incubation
DURATION:
Preincubation period: 60 Minutes
exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at more than one concentration.
An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Slight toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in strain TA 100 at the highest applied concentration of 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not tested
Precipitation: Precipitation of the test item in the overlay agar on the incubated agar plates was observed starting at 100 μg/plate without S9 mix and at 333 μg/plate and above with S9 mix in experiment I. In experiment II precipitation on the plates was found at concentrations ranging from 100 μg/plate to 5000 μg/plate independently from the S9 mix supplementation.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Slight toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in strain TA 100 at the highest applied concentration of 5000 μg/plate (without S9 mix in experiment II).. - Remarks on result:
- other: reverse mutation assay migrated from the field Test System
Any other information on results incl. tables
Summary of Experiment I
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
13 ± 2 |
10 ± 2 |
22 ± 3 |
124 ± 5 |
44 ± 8 |
Untreated |
|
11 ± 4 |
11 ± 1 |
27 ± 4 |
127 ± 6 |
46 ± 2 |
|
Test material |
3 µg |
13 ± 2 |
11 ± 1 |
22 ± 7 |
113 ± 8 |
46 ± 13 |
|
10 µg |
13 ± 2 |
11 ± 3 |
24 ± 8 |
122 ± 9 |
49 ± 8 |
||
|
33 µg |
13 ± 3 |
12 ± 2 |
25 ± 4 |
102 ± 5 |
48 ± 9 |
|
|
100 µg |
12 ± 2 P |
12 ± 2 P |
24 ± 3 P |
85 ± 15 P |
48 ± 3 P |
|
|
333 µg |
10 ± 4 P |
9 ± 3 P |
23 ± 4 P |
78 ± 11 P |
37 ± 5 P |
|
|
1000 µg |
9 ± 3 P M |
7 ± 2 P M |
25 ± 6 P |
70 ± 10 P M |
38 ± 8 P M |
|
|
2500 µg |
13 ± 2 P M |
8 ± 1 P M |
19 ± 4 P M |
67 ± 11 P M |
34 ± 3 P M |
|
|
5000 µg |
13 ± 3 P M |
8 ± 2 P M |
17 ± 1 P M |
61 ± 7 P M |
29 ± 3 P M |
|
NaN3 |
10 µg |
1103 ± 194 |
|
|
2098 ± 44 |
|
|
4-NOPD |
10 µg |
|
|
473 ± 20 |
|
|
|
4-NOPD |
50 µg |
|
79 ± 5 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
927 ± 71 |
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
13 ± 2 |
15 ± 1 |
38 ± 4 |
156 ± 5 |
53 ± 2 |
Untreated |
|
12 ± 3 |
20 ± 4 |
33 ± 6 |
193 ± 23 |
56 ± 3 |
|
Test material |
3 µg |
13 ± 2 |
13 ± 2 |
41 ± 6 |
153 ± 15 |
48 ± 4 |
|
10 µg |
12 ± 2 |
14 ± 3 |
36 ± 5 |
141 ± 1 |
51 ± 5 |
||
|
33 µg |
13 ± 2 |
13 ± 3 |
37 ± 6 |
140 ± 13 |
46 ± 7 |
|
|
100 µg |
13 ± 1 |
14 ± 5 |
40 ± 6 |
149 ± 11 |
58 ± 6 |
|
|
333 µg |
10 ± 1 P |
15 ± 4 P |
35 ± 5 P |
125 ± 21 P |
52 ± 6 P |
|
|
1000 µg |
10 ± 1 P M |
14 ± 1 P M |
34 ± 11 P |
118 ± 7 P |
54 ± 9 P M |
|
|
2500 µg |
12 ± 2 P M |
12 ± 2 P M |
25 ± 4 P M |
112 ± 6 P M |
44 ± 8 P M |
|
|
5000 µg |
9 ± 2 P M |
9 ± 2 P M |
23 ± 2 P M |
97 ± 6 P M |
47 ± 6 P M |
|
2-AA |
2.5 µg |
501 ± 47 |
206 ± 15 |
3057 ± 413 |
4984 ± 79 |
|
|
2-AA |
10.0 µg |
|
|
|
|
320 ± 24 |
Summary of Experiment II
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
11 ± 1 |
11 ± 5 |
24 ± 3 |
103 ± 6 |
46 ± 15 |
Untreated |
|
15 ± 1 |
9 ± 3 |
22 ± 3 |
105 ± 2 |
55 ± 7 |
|
Test material |
10 µg |
10 ± 4 |
8 ± 1 |
25 ± 2 |
95 ± 8 |
47 ± 5 |
|
33 µg |
10 ± 5 |
9 ± 1 |
23 ± 6 |
86 ± 15 |
46 ± 4 |
||
|
100 µg |
11 ± 2 P |
9 ± 0 P |
20 ± 7 P |
73 ± 10 P |
35 ± 6 P |
|
|
333 µg |
9 ± 2 P |
9 ± 5 P |
25 ± 4 P |
59 ± 7 P M |
46 ± 12 P |
|
|
1000 µg |
11 ± 1 P |
12 ± 3 P |
20 ± 3 P M |
50 ± 3 P M |
40 ± 12 P |
|
|
2500 µg |
11 ± 2 P M |
13 ± 3 P M |
22 ± 3 P M |
50 ± 9 P M |
35 ± 4 P M |
|
|
5000 µg |
10 ± 1 P M |
12 ± 3 P M |
21 ± 3 P M |
40 ± 9 P M |
36 ± 1 P M |
|
NaN3 |
10 µg |
986 ± 67 |
|
|
1730 ± 77 |
|
|
4-NOPD |
10 µg |
|
|
472 ± 18 |
|
|
|
4-NOPD |
50 µg |
|
94 ± 10 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
842 ± 61 |
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
13 ± 4 |
14 ± 2 |
29 ± 7 |
100 ± 5 |
54 ± 12 |
Untreated |
|
13 ± 4 |
15 ± 5 |
42 ± 10 |
99 ± 15 |
60 ± 11 |
|
Test material |
33 µg |
11 ± 4 |
13 ± 3 |
25 ± 2 |
108 ± 16 |
55 ± 10 |
|
100 µg |
13 ± 2 P |
14 ± 4 P |
36 ± 2 P |
116 ± 11 P |
50 ± 2 P |
||
|
333 µg |
13 ± 3 P |
13 ± 3 P |
30 ± 3 P |
106 ± 12 P |
49 ± 4 P |
|
|
1000 µg |
15 ± 3 P |
13 ± 2 P |
33 ± 3 P |
107 ± 17 P |
50 ± 2 P |
|
|
2500 µg |
15 ± 2 P M |
11 ± 4 P M |
30 ± 2 P M |
80 ± 2 P M |
44 ± 6 P M |
|
|
5000 µg |
12 ± 1 P M |
11 ± 2 P M |
27 ± 3 P M |
75 ± 6 P M |
43 ± 7 P M |
|
2-AA |
2.5 µg |
338 ± 24 |
196 ± 25 |
3697 ± 517 |
2567 ± 149 |
|
|
2-AA |
10.0 µg |
|
|
|
|
259 ± 12 |
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, the test material is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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