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EC number: 619-290-0 | CAS number: 97780-06-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid: crystalline
- Details on test material:
- Purity: > 98%
Constituent 1
Method
- Target gene:
- his+
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA1535, TA1538, TA98, TA1535, and TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix liver homogenates from Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- 1, 3.3, 10, 33.3, 100, 333, 1000, 3330, and 5000 µg/plate; 5000 μg/plate is the maximum test substance concentration that should be used according to EEC guidelines
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylenediamine, daunomycine, 2-aminoanthracene
- Details on test system and experimental conditions:
- plate-incorporation assay
- Evaluation criteria:
- Criteria for a positive response: A chemical was judged to have induced a positive response when a dose -related increase in revertants was observed in which the number of revertants exceeded the control values by at least two-fold in at least two successive concentrations of the test chemical
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA1535, TA1537, TA1538, TA98, AND TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- other: Due to the short incubation period (3 hours) the positive control chemicals did not produce mean plate counts of at least two times the concurrent vehicle control group mean in all tester strains.
- Additional information on results:
- Nine serial dilutions of the test substance, in approximately half-log steps, were plated with an appropriately diluted TA100 culture (equal numbers of bacterial cells/plate) onto non-selective agar (viability determination). The percentage survival of the TA100 culture is determined by comparing the number of colonies on the solvent control plate with those on the plates containing the test substance. However, even at the highest test substance concentration used, the survival of strain TA100 is not reduced (see Table 2 in the “Other information about results including tables" section).
Based on these data, the test substance was tested up to a concentration of 5000 μg/plate, which is the maximum test substance concentration that should be used according to the EEC guidelines. However, in the direct plate incorporation test (almost) no revertant colonies were present on the plates with test substance treated bacteria. The negative and strain specific positive control values fell within our laboratory historical ranges and the condition of the bacterial background lawn was normal. This result was reproducible in an independently repeated experiment. The results might indicate that the test substance is selectively cytotoxic for His+ revertant bacteria.
To investigate the possible selective cytotoxicity of the test substance, a second toxicity determination was performed in TA100 with 10(8) bacteria per selective agar plate (see Table 3 in the “Other information about results including tables" section).
It is clearly demonstrated that the test substance is more toxic for His+ revertants than for His- bacteria. A direct plate incorporation test with concentrations up to 100 μg/plate showed that the test substance was even more toxic to revertants from strains other than TA100 (see Table 4 in the “Other information about results including tables" section). It should be noted that no increase in the number of revertants was observed at any test substance concentration in any strain.
To avoid the toxic action of the test substance on His+ revertants, a liquid incubation test was performed in which bacteria were incubated in the presence of test substance for three hours, followed by extensive washing to remove the test substance. Subsequently, bacteria were plated in the absence of test substance. Using this assay high concentrations of test substance (up to 5000 μg/plate) could be used (see Table 1 the “Other information about results including tables" section).
All bacterial strains showed negative responses over the entire dose range of the test substance, i.e., no dose-related increase in the number of revertants. Due to the short incubation period the positive control chemicals did not produce mean plate counts of at least two times the concurrent
vehicle control group mean in all tester strains. The negative control values fell within our laboratory background historical ranges.
Based on these results, the test substance can be considered as not mutagenic under the experimental conditions described in this report.
Any other information on results incl. tables
Table 1. Mutagenic response of A7881 in the Ames Salmonella/microsome plate test
Treatment |
µg/plate |
Mean number of revertant (His+) colonies/3 replicate plates(±S.D.) |
||||
|
TA1535 |
TA1537 |
TA1538 |
TA98 |
TA100 |
|
Without S9-mix |
||||||
DMSO |
8 ± 1 |
8 ± 0 |
7 ± 3 |
34 ± 5 |
63 ± 5 |
|
A7881 |
100 |
12 ± 1 |
8 ± 2 |
5 ± 2 |
40 ± 9 |
53 ± 4 |
A7881 |
333 |
12 ± 1 |
3 ± 1 |
3 ± 2 |
27 ± 5 |
44 ± 12 |
A7881 |
1000 |
10 ± 1 |
7 ± 1 |
7 ± 3 |
38 ± 1 |
51 ± 4 |
A7881 |
3330 |
9 ± 4 |
12 ± 11 |
2 ± 1 |
35 ± 10 |
43 ± 6 |
A7881 |
5000 |
2 ± 2 |
4 ± 2 |
0 ± 0 |
41 ± 10 |
36 ± 2 |
Positive control (see list below) |
10 ± 1 |
4 ± 1 |
77 ± 1 |
498 ± 50 |
45 ± 5 |
|
With S9-mix |
||||||
DMSO |
11 ± 3 |
6 ± 2 |
4 ± 3 |
30 ± 4 |
69 ± 14 |
|
A7881 |
100 |
15 ± 4 |
7 ± 3 |
5 ± 2 |
32 ± 5 |
73 ± 2 |
A7881 |
330 |
16 ± 3 |
4 ± 2 |
9 ± 4 |
25 ± 5 |
65 ± 5 |
A7881 |
1000 |
13 ± 4 |
4 ± 2 |
7 ± 3 |
32 ± 9 |
67 ± 6 |
A7881 |
3330 |
10 ± 5 |
3 ± 3 |
0 ± 1 |
24 ± 2 |
78 ± 7 |
A7881 |
5000 |
5 ± 3 |
1 ± 2 |
0 ± 0 |
31 ± 6 |
62 ± 4 |
DMN-B |
13 ± 4 |
4 ± 1 |
4 ± 2 |
35 ± 4 |
74 ± 6 |
|
DMN-A |
|
25 ± 3 |
5 ± 1 |
5 ± 2 |
25 ± 1 |
77 ± 4 |
Positive controls without S9-rnix
For TA1535: 5 μg Sodium azide (SA)/5 rnL exposition solution
For TA1537: 300 μg 9-Aminoacridine (9AC)/ 5 rnL exposition solution
For TA1538: 50 μg 4-Nitro-o-phenylenediamine (4NPD)/ 5 rnL exposition solution
For TA98: 20 μg Daunomycine (OM)/ 5 rnL exposition solution
For TA100: 3250 μg methylmethanesulfonate (MMS)/ 5 rnL exposition solution
Positive controls with S9-rnix for all strains: Dimethylnitrosamine (DMN);
DMN-A = 18500 μg/ 5 mL exposition solution and DMN-B = 9250 μg/ 5 mL exposition solution
Table 2 - Preliminary toxicity determination of the test substance in TA100
Concentration (μg/plate) Viable counts/plate (duplicate plates)
Without S9-mix With S9-mix
Solvent control (DMSO) 476;543 550;580
1. 0 536;500 600:667
3.3 610:616 607;618
10.0 582;642 605;707
33.3 553;600 695;608
100 570:453 652:659
333 514;545 601;579
1000 630;571 686;648
3330 581:571 585;640
5000 499;445 410;568
Table 3 - Toxicity determination of the test substance in TA100
Concentration (μg/plate) Viable counts/plate (duplicate plates)
Without S9-mix With S9-mix
Solvent control (DMSO) 69; 95 99; 88
1. 0 121; 81 84; 95
3.3 75; 90 76; 72
10.0 89; 64 85; 86
33.3 44; 61 70; 65
100 26; 48 41; 51
333 29; 26 39; 39
1000 0; 0 11; 10
3330 0; 0 0; 0
5000 0; 0 0; 0
Table 4- Mutagenic response of A7881 in the Ames Salmonella/microsome plate test
Treatment |
µg/plate |
Mean number of revertant (His+) colonies/3 replicate plates(±S.D.) |
||||
|
TA1535 |
TA1537 |
TA1538 |
TA98 |
TA100 |
|
Without S9-mix |
||||||
DMSO |
9 ± 6 |
7 ± 3 |
12 ± 4 |
23 ± 1 |
79 ± 19 |
|
A7881 |
1 |
11 ± 1 |
2 ± 1 |
4 ± 1 |
27 ± 6 |
105 ± 21 |
A7881 |
3.3 |
7 ± 5 |
2 ± 4 |
0 ± 0 |
21 ± 5 |
75 ± 3 |
A7881 |
10 |
3 ± 3 |
1 ± 2 |
0 ± 0 |
4 ± 5 |
52 ± 7 |
A7881 |
100 |
Microcolonies |
0 ± 0 |
0 ± 0 |
1 ± 1 |
23 ± 6 |
Positive control |
200 ± 16 |
7 ± 2 |
1912 ± 16 |
1979 ± 69 |
801 ± 20 |
|
With S9-mix |
||||||
DMSO |
16 ± 4 |
8 ± 5 |
23 ± 4 |
29 ± 8 |
96 ± 4 |
|
A7881 |
1 |
13 ± 2 |
6 ± 1 |
8 ± 4 |
29 ± 5 |
93 ± 1 |
A7881 |
3.3 |
6 ± 2 |
1 ± 2 |
2 ± 2 |
23 ± 4 |
71 ± 5 |
A7881 |
10 |
Plate infected with other bacteria |
0 ± 1 |
0 ± 0 |
7 ± 5 |
23 ± 6 |
A7881 |
33.3 |
2 ± 2 |
0 ± 0 |
0 ± 0 |
6 ± 4 |
33 ± 12 |
A7881 |
100 |
1 ± 2 |
0 ± 0 |
1 ± 1 |
1 ± 1 |
25 ± 9 |
Positive control |
114 ± 6 |
89 ± 4 |
694 ± 49 |
866 ± 75 |
1145 ± 48 |
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic.
- Executive summary:
The test substance was tested in the Ames Salmonella/microsome test up to 5000 μg/plate according to OECD Guideline 471. The test substance did not induce a dose-related increase in the number of revertant (His+) colonies in any of the tester strains (TA1535, TA1537, TA1538, TA98 and TA100), neither in a direct plate incorporation test, nor in a liquid incubation test. The test substance can, therefore, be considered as not mutagenic under the experimental conditions described in this report.
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