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EC number: 458-430-3 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 July - 19 August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: Standards for Mutagenicity Test using Microorganisms (JMOL)
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Screening Toxicity Testing of Chemicals and Guidelines for Toxicity Testing of Chemicals (JMITI)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- tryptophan (E. coli strain) and histidine (Salmonella strains)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and 5,6-benzoflavone, S9 induced rat liver
- Test concentrations with justification for top dose:
- Preliminary test: 10, 50, 100, 500, 1000, 5000 µg/plate
Main test: 313, 625, 1250, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance was found to be soluble in DMSO and acetone, but not in water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- -MA: TA 100, WP2 uvrA - 0.01 µg/plate; TA 98 - 0.1 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- -MA: TA 1535 - 0.5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -MA: TA 1537 - 80.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-AA (2-Aminoanthracene)
- Remarks:
- +MA: TA 1535 - 2.0 µg/plate; WP2 uvrA - 10.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- +MA: TA 100, TA 98, TA 1537 - 5.0 µg/plate
- Details on test system and experimental conditions:
- ACTIVATION:
S9 mix per ml:
S9 fraction: 10 v/v%
MgCl2: 8 µmol
KCl: 33 µmol
G-6-P: 5 µmol
NADPH: 4 µmol
NADH: 4 µmol
0.5 ml S9 mix was added to a total volume of 2.7 ml, giving a final concentration of approximately 2% S9.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 37°C for 48 hours
SELECTION AGENT (mutation assays): minimum glucose agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- increase in number of revertant colonies - Evaluation criteria:
- The number of revertant colonies of each test group were compared with and analysed for a statistically significant increase (p<0.01) from that of the negative control group at each dose in each bacterial strain with and without metabolic activation.
- Statistics:
- Dunnett's multiple comparison (one-sided test)
Linear regression
Results and discussion
Test resultsopen allclose all
- Key result
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
The test substance produced neither toxic effects nor a statistically significant increase in the number of revertant colonies in any conditions in any bacterial strains.
All of the positive controls produced significant increases in the number of revertant colonies in all bacterial strains with and without metabolic activation. This shows the test method employed in the test is effective for the purpose. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 1: Preliminary test - number of revertants per plate (mean of 2 plates)
Dose (µg/plate) |
TA 100 |
TA 100 |
TA 1535 |
TA 1535 |
WP2 uvrA |
WP2 uvrA |
TA 98 |
TA 98 |
TA 1537 |
TA 1537 |
|
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
DMSO |
133 |
124 |
9 |
11 |
28 |
31 |
26 |
29 |
10 |
10 |
10 |
133 |
115 |
9 |
13 |
24 |
30 |
26 |
27 |
8 |
12 |
50 |
126 |
120 |
11 |
11 |
24 |
29 |
26 |
34 |
8 |
9 |
100 |
123 |
116 |
8 |
14 |
30 |
35 |
20 |
30 |
7 |
12 |
500 |
135 |
133 |
9 |
14 |
23 |
32 |
21 |
36 |
9 |
9 |
1000 |
127 |
139 |
12 |
10 |
30 |
32 |
22 |
27 |
6 |
10 |
5000 |
126 |
138 |
14 |
10 |
29 |
36 |
27 |
36 |
5 |
5 |
Positive control |
372 |
1227 |
301 |
413 |
99 |
733 |
497 |
277 |
730 |
53 |
Table 2: Main test 1 - number of revertants per plate (mean of 3 plates)
Dose (µg/plate) |
TA 100 |
TA 100 |
TA 1535 |
TA 1535 |
WP2 uvrA |
WP2 uvrA |
TA 98 |
TA 98 |
TA 1537 |
TA 1537 |
|
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
DMSO |
117 |
128 |
11 |
12 |
29 |
30 |
20 |
24 |
6 |
10 |
313 |
110 |
137 |
13 |
14 |
27 |
37 |
22 |
25 |
5 |
7 |
625 |
110 |
142 |
11 |
11 |
24 |
37 |
23 |
29 |
6 |
8 |
1250 |
111 |
128 |
9 |
12 |
29 |
31 |
21 |
32 |
8 |
8 |
2500 |
110 |
128 |
11 |
14 |
25 |
35 |
27 |
30 |
5 |
8 |
5000 |
116 |
116 |
10 |
12 |
27 |
37 |
23 |
25 |
5 |
6 |
Positive control |
354 |
1178 |
285 |
444 |
85 |
818 |
457 |
273 |
990 |
55 |
Table 3: Main test 2 - number of revertants per plate (mean of 3 plates)
Dose (µg/plate) |
TA 100 |
TA 100 |
TA 1535 |
TA 1535 |
WP2 uvrA |
WP2 uvrA |
TA 98 |
TA 98 |
TA 1537 |
TA 1537 |
|
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
DMSO |
115 |
122 |
11 |
12 |
25 |
33 |
2.5 |
28 |
7 |
11 |
313 |
112 |
121 |
10 |
11 |
29 |
34 |
2.3 |
31 |
8 |
10 |
625 |
124 |
135 |
9 |
12 |
30 |
36 |
1.5 |
30 |
8 |
8 |
1250 |
107 |
136 |
9 |
14 |
22 |
34 |
3.0 |
29 |
6 |
8 |
2500 |
119 |
117 |
9 |
10 |
27 |
33 |
6.0 |
23 |
8 |
9 |
5000 |
113 |
122 |
11 |
9 |
28 |
32 |
1.5 |
26 |
9 |
7 |
Positive control |
438 |
1334 |
223 |
437 |
111 |
1087 |
456 |
273 |
1077 |
56 |
Applicant's summary and conclusion
- Conclusions:
- The test substance has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471 and 472 and in compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WP2 uvrA in the initial or the repeat experiments up to limit concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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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