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EC number: 939-039-1 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 august 2009 - 26 August 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): 20231250
- Physical state: white powder
- Storage condition of test material: room temperature (ca. 20°C) in the dark
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: see table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from SD derived rats, dosed with phenobarbital and 5,6-benzoflavone, purchased from a commercial source (Moltox; Lot No. 2416).
- Test concentrations with justification for top dose:
- Test 1 and 2: 5; 15; 50; 150; 500; 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test item soluble in dimethyl sulphoxide (DMSO, ACS spectrophotometric grade)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- plates without bacteria to assess the sterility of the test substance, S9 mix and PBS
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- see Table 7.6.1/2
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- Without S9 mix
- Untreated negative controls:
- no
- Remarks:
- plates without bacteria to assess the sterility of the test substance, S9 mix and PBS
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- see Table 7.6.1/2
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) in the first experiment and in the second experiment with S9 mix; preincubation in the second experiment withour S9 mix (30 min at 37°C)
DURATION
- Preincubation period: 30 min
- Exposure duration: 72 hours approximately
NUMBER OF REPLICATIONS: 3 plates/concentrations, 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Any toxic effects of the test substance would be detected by a substantial reduction in mean revertant colony counts or by a sparse or absent background bacterial lawn. - Evaluation criteria:
- Acceptance criteria:
For a test to be considered valid, the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 10E9/mL.
Criteria for assessing mutagenic potential:
If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it is considered to exhibit mutagenic activity in this test system. No statistical analysis is performed. If exposure to a test substance does not produce a reproducible increase in revertant colony numbers, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed. If the results obtained fail to satisfy the criteria for a clear “positive” or “negative” response, even after additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers. The statistical procedures used are those described by Mahon et al (1989) and are usually Dunnett’s test followed, if appropriate, by trend analysis. Biological importance should always be considered along with statistical significance. In general, treatment-associated increases in revertant colony numbers below two or three times the vehicle controls (as described above) are not considered biologically important. - Statistics:
- none
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- see tables 7.6.1/3 to 7.6.1/6
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitate observed on all plates containing the test item at 1500 and 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: no data
- Effects of osmolality: nodata
- Evaporation from medium: none
- Water solubility: not soluble in water but in DMSO
- Precipitation: in both experiments, precipitate observed on all plates containing the test item at 1500 and 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES: not applicable
COMPARISON WITH HISTORICAL CONTROL DATA: The mean revertant colony counts for the vehicle controls were within or close to the 99%
confidence limits of the current historical control range of the laboratory.
Any other information on results incl. tables
7.6.1/3: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation in the first test (direct plate incorporation method)
20231250 Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
E. coli WP2 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
26.7 |
2.5 |
13.3 |
2.9 |
39.0 |
1.0 |
161.7 |
6.7 |
170.3 |
5.7 |
5 |
27.7 |
4.7 |
17.3 |
2.5 |
35.0 |
6.1 |
169.7 |
20.4 |
153.3 |
9.8 |
15 |
30.0 |
10.4 |
19.3 |
2.1 |
34.3 |
2.5 |
159.7 |
19.4 |
167.7 |
13.1 |
50 |
28.0 |
7 |
16.7 |
2.9 |
45.3 |
4.2 |
153.3 |
18.7 |
177.3 |
5.5 |
150 |
22.0 |
3.5 |
15.0 |
1.7 |
42.0 |
4.4 |
152.0 |
11.1 |
169.3 |
7.6 |
500 |
26.0 |
3.6 |
21.0 |
1.0 |
47.3 |
4.7 |
146.0 |
7.9 |
160.3 |
10.1 |
1500 |
25.3 |
2.9 |
13.3 |
4.0 |
34.0 |
2.0 |
161.3 |
22.7 |
178.3 |
11.0 |
5000 |
24.0 |
3.6 |
9.7 |
1.5 |
28.7 |
5.5 |
155.3 |
4.5 |
164.7 |
8.1 |
Positive control |
1063.7 |
79.7 |
913.0 |
138.4 |
256.3 |
114.6 |
961.3 |
79.0 |
2531.0 |
132.7 |
*Solvent control = negative control: 100 µL DMSO
7.6.1/4: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation in the first test (direct plate incorporation method)
20231250 Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
E. coli WP2 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
27.3 |
0.6 |
28.7 |
3.1 |
54.7 |
6.7 |
197.7 |
11.1 |
196.3 |
3.1 |
5 |
24.0 |
3.5 |
27.3 |
5.8 |
51.7 |
6.1 |
151.3 |
13.0 |
211.3 |
28.5 |
15 |
23.3 |
2.3 |
21.3 |
4.6 |
50.0 |
6.6 |
158.7 |
11.0 |
180.7 |
23.1 |
50 |
25.0 |
2.6 |
30.3 |
5.8 |
50.7 |
5.0 |
166.7 |
12.7 |
196.3 |
4.9 |
150 |
21.7 |
2.1 |
34.0 |
4.6 |
55.0 |
4.0 |
175.7 |
6.5 |
203.0 |
15.7 |
500 |
27.0 |
4.6 |
32.7 |
2.1 |
54.3 |
5.1 |
176.3 |
14.4 |
167.0 |
13.5 |
1500 |
26.7 |
3.1 |
27.3 |
3.8 |
39.7 |
7.8 |
182.0 |
13.1 |
165.3 |
12.1 |
5000 |
22.7 |
2.1 |
25.3 |
1.2 |
46.0 |
2.0 |
156.7 |
10.7 |
159.0 |
10.5 |
Positive control |
307.3 |
23.9 |
193.0 |
12.5 |
206.7 |
17.5 |
3014.7 |
216.5 |
601.3 |
24.8 |
*Solvent control = negative control: 100 µL DMSO
7.6.1/5: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation in the second test (preincubation method)
20231250 Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
E. coli WP2 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
23.0 |
0.0 |
14.0 |
1.7 |
41.0 |
2.6 |
161.0 |
18.7 |
195.7 |
7.5 |
5 |
20.3 |
3.8 |
16.3 |
0.6 |
37.0 |
1.7 |
172.3 |
15.6 |
160.7 |
22.6 |
15 |
15.3 |
3.8 |
16.7 |
1.5 |
38.0 |
2.6 |
150.0 |
12.8 |
182.0 |
21.8 |
50 |
16.0 |
1.7 |
18.0 |
3.5 |
42.0 |
8.0 |
139.3 |
12.2 |
194.7 |
15.3 |
150 |
24.3 |
2.9 |
16.0 |
1.0 |
43.0 |
2.6 |
137.3 |
6.0 |
188.7 |
6.7 |
500 |
22.3 |
4.0 |
13.0 |
1.7 |
39.7 |
9.0 |
121.3 |
3.2 |
173.7 |
2.3 |
1500 |
20.7 |
1.5 |
12.7 |
1.5 |
34.7 |
2.5 |
139.7 |
5.5 |
157.3 |
22.1 |
5000 |
16.7 |
2.1 |
11.3 |
1.5 |
27.0 |
6.9 |
138.7 |
15.0 |
189.0 |
11.5 |
Positive control |
987.0 |
23.4 |
918.3 |
74.7 |
378.3 |
35.1 |
802.0 |
18.0 |
1878.0 |
162.4 |
*Solvent control = negative control: 100 µL DMSO
Table 7.6.1/6: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation in the second test (preincubation method)
20231250 Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
E. coli WP2 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
19.0 |
2.6 |
27.3 |
1.5 |
49.3 |
1.2 |
195.7 |
23.4 |
220.0 |
10.1 |
5 |
14.3 |
3.8 |
29.7 |
2.1 |
52.7 |
5.8 |
193.0 |
23.5 |
221.3 |
36.6 |
15 |
21.7 |
2.1 |
29.0 |
5.0 |
51.0 |
10.8 |
174.3 |
16.8 |
205.3 |
19.4 |
50 |
18.3 |
4.6 |
30.7 |
2.3 |
55.0 |
10.5 |
156.0 |
3.6 |
202.7 |
24.1 |
150 |
17.7 |
5.9 |
24.7 |
2.3 |
54.0 |
1.0 |
171.3 |
5.0 |
190.3 |
39.7 |
500 |
17.7 |
5.5 |
36.7 |
4.7 |
51.3 |
10.0 |
171.0 |
2.6 |
188.3 |
13.2 |
1500 |
17.3 |
3.1 |
24.0 |
2.6 |
44.7 |
2.3 |
149.7 |
9.9 |
170.0 |
15.7 |
5000 |
15.0 |
2.6 |
20.0 |
6.6 |
42.0 |
6.2 |
129.3 |
26.1 |
158.3 |
10.2 |
Positive control |
287.3 |
26.1 |
138.0 |
28.6 |
187.7 |
9.9 |
4437.7 |
129.6 |
713.0 |
55.1 |
*Solvent control = negative control: 100 µL DMSO
Applicant's summary and conclusion
- Conclusions:
- The test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and E.coli WP2, either in the presence or in the absence of a rat liver metabolizing system.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD No.471 and EC No.B13/14 guidelines, and in compliance with the GLP, Salmonella typhimurium strains TA1535, TA1537, TA100, TA98 and E. Col WP2 were exposed to the test item diluted in DMSO at concentrations of 5; 15; 50; 150; 500; 1500 and 5000 µg/plate (triplicates) in the presence and absence of mammalian metabolic activation (fraction of S9from the liver of rats treated with phenobarbital and 5,6-benzoflavone). Both methods of direct incorporation or with a preincubation step were tested during two independent experiments. The negative control was the vehicle DMSO. Positive controls were used for each strain with and without metabolic activation and induced the appropriate responses in the corresponding strains.
No cytotoxicity was observed in any experiments. Precipitate was observed in all strains in both experiments from 1500 µg/plate. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to the test item at any concentration up to 5000 µg/plate in either the presence or absence of S9 mix.
The test item did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli as there was no evidence of induced mutant colonies over background.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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