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EC number: 471-920-1 | 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:
- 2005/10/28 to 2005/11/10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study done according to OECD 471 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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
- Details on test material:
- - Physical state: dark amber slightly viscous liquid
- Analytical purity: >99%
- Storage condition of test material: room temprature in the dark
Constituent 1
Method
- Target gene:
- Histidine and tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/beta-naphthoflavone induced S9
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500 and 5000 ug/plate
- Vehicle / solvent:
- Acetone
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: 2 ug/plate for WP2 uvr A, 3 ug/plate fro TA100 and 5 ug/plate for TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: 80ug/plate for TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: 0.2 ug/plate for TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1 ug/plate fro TA100, 2 ug/plate for TA1535 and TA1537, 10 ug/plate for WP2 uvr A
- Remarks:
- 2-aminoanthracene (2AA)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: 5 ug/plate for TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicate plates per dose level, experiment repeated on seperate occasion.
DETERMINATION OF CYTOTOXICITY
- Method: Evaluation of growth of background lawn of bacteria and numbers of revertant colonies - Evaluation criteria:
- A dose-related increase in revertant frequency over the dose-range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolica activation. Biological relevance of the results will be considered first, statistical methods also used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
- Statistics:
- Dunnett's t-test, as recommended by the UKEMS (1989).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Not soluble in water
- Precipitation: Observed at upper three dose levels but did not interfere with the test
RANGE-FINDING/SCREENING STUDIES: A prelimiary test was performed using a dose range of 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 ug/plate
COMPARISON WITH HISTORICAL CONTROL DATA: Control data were within the range of the historical dataset. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1 – Mean colony counts of triplicate plates
|
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
S9 |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
0 |
111 |
104 |
29 |
16 |
19 |
26 |
24 |
21 |
13 |
19 |
50 |
104 |
97 |
33 |
12 |
18 |
27 |
23 |
20 |
10 |
20 |
150 |
111 |
97 |
30 |
11 |
19 |
19 |
20 |
19 |
16 |
18 |
500 |
112 |
104 |
34 |
12 |
19 |
20 |
20 |
24 |
9 |
24 |
1500 |
106 |
85 |
33 |
11 |
17 |
24 |
21 |
21 |
13 |
24 |
5000 |
107 |
86 |
25 |
13 |
20 |
29 |
22 |
19 |
10 |
18 |
Positive |
657 |
517 |
413 |
194 |
977 |
673 |
234 |
162 |
905 |
413 |
Experiment 2 – Mean colony counts of triplicate plates
|
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
S9 |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
0 |
111 |
99 |
26 |
10 |
19 |
21 |
18 |
23 |
14 |
13 |
50 |
110 |
90 |
21 |
8 |
18 |
29 |
17 |
19 |
17 |
11 |
150 |
110 |
106 |
23 |
12 |
19 |
25 |
16 |
21 |
19 |
9 |
500 |
115 |
105 |
18 |
12 |
18 |
26 |
18 |
13 |
15 |
7 |
1500 |
117 |
99 |
25 |
12 |
17 |
22 |
18 |
19 |
10 |
8 |
5000 |
105 |
89 |
21 |
19 |
24 |
28 |
20 |
13 |
10 |
10 |
Positive |
421 |
1417 |
245 |
251 |
616 |
712 |
152 |
233 |
481 |
503 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test, at up to the maximum recommended dose level and beyond the precipitating limit. - Executive summary:
Introduction. The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF. It also meets the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B 13/14 of Commission Directive 2000/32/EC and the USA, EPA (TSCA) OPPTS harmonised guidelines.
Methods. Salmonella typhimurium strains TAl535, TA1537, TA98 and TAl00 and Escherichia coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-fmding test was determined in a preliminary toxicity assay and was 50 to 5000 ug/plate. The experiment was repeated on a separate day using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.
Results. The vehicle (acetone) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 pg/plate. A precipitate (oily in appearance) was observed at and above 500 ug/plate, this did not prevent the scoring of revertant colonies. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
Conclusion. The test material was considered to be non-mutagenic under the conditions of this test.
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