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EC number: 212-141-7 | CAS number: 765-14-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2006-10-07 to 2006-11-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study conducted under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: All Salmonella strains (rfa-minus) mutation, UV-sensitive "uvrB-minus"; For strain TA 98 and TA 100 R-factor plasmid pKM 101 (ampicillin resistance marker). E. coli WP2 uvrA with deficient excision repair.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 20 µg - 5000 µg/plate (dosel levels for Standard Plate Test and Preincubation Test)
- Vehicle / solvent:
- - Vehicle/solvent used: acetone
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, acetone was used as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available. - Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-aminoanthracene (TA 1535, TA 100, TA 1537, TA 98, E.coli WP2 uvrA); without S9: N-methyl-N'-nitro-N-nitrosoguanidine (TA 1535, TA 100), 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine (TA 1537), 4-nitroquinoline-N-oxide (E. coli WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
I) Standard plate test with Salmonella typhimurium
METHOD OF APPLICATION:
Test tubes containing 2-mL portions of soft agar (overlay agar), which consists of 100 mL agar (0.8% [w/v] agar + 0.6% [w/v] NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at about 42 - 45°C, and the remaining components are added in the following order:
0.1 mL test solution or vehicle
0.1 mL fresh bacterial suspension
0.5 mL S-9 mix (in tests with metabolic activation) or
0.5 mL phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
Composition of the minimal glucose agar:
980 mL purified water
20 mL Vogel-Bonner E medium
15 g Difco bacto agar
20 g D-glucose, monohydrate.
After incubation at 37°C for 48 – 72 hours in the dark, the bacterial colonies (his+ revertants) are counted.
DURATION:
- Exposure duration: After incubation at 37°C for 48 hours in the dark, the bacterial colonies (his+ revertants) are counted.
- SELECTION AGENT: his- medium
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
II) Standard plate test with Escherichia coli
METHOD OF APPLICATION:
Test tubes containing 2 mL portions of soft agar which consists of 100 mL agar (0.6% agar + 0.6% NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM tryptophan) are kept in a water bath at 45°C and the remaining components are added in the following order:
0.1 mL test solution or vehicle
0.1 mL bacterial suspension
0.5 mL S-9 mix (in tests with metabolic activation) or
0.5 mL phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto minimal agar plates within approx. 30 seconds.
DURATION:
- Exposure duration: After incubation at 37°C for 48 hours in the dark, the bacterial colonies (trp+ revertants) are counted.
- SELECTION AGENT: trp- medium
III) Preincubation Test
METHOD OF APPLICATION:
0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL S9 mix (with metabolic activation) or phosphate buffer (without metabolic activation) are incubated at 37°C for the duration of about 20 minutes using a shaker. Subsequently, 2 mL of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx. 30 seconds.
DURATION:
After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies are counted.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A weak bacteriotoxic effect was occasionally observed in the standard plate test depending on the strain and test conditions at 5000 ug/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test substance was found from about 2500 ug/plate onward.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Reference
I. Standard plate test
Table 1: Revertants (mean of three plates), without S9 mix
Dose µg/plate |
TA1535 |
TA 100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|
Acetone |
15 |
114 |
9 |
31 |
33 |
|
20 µg |
16 |
116 |
10 |
28 |
31 |
|
100 µg |
16 |
108 |
6 |
28 |
28 |
|
500 µg |
14 |
96 |
8 |
30 |
37 |
|
2500 µg |
12 |
103 |
7 |
26 |
29 |
|
5000 µg |
8 |
90 |
4 |
24 |
29 |
|
Pos. contr. |
||||||
MNNG (5.0 µg) |
904 |
997 |
|
|
|
|
AAC (100 µg) |
|
|
424 |
|
|
|
NOPD (10 µg) |
|
|
|
595 |
|
|
4-NQO (5.0 µg) |
|
|
|
|
591 |
|
Table 2: Revertans (mean of three plates), with S9 mix
Dose µg/plate |
TA1535 |
TA 100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|
Acetone |
18 |
125 |
9 |
36 |
38 |
|
20 µg |
17 |
115 |
7 |
36 |
36 |
|
100 µg |
16 |
112 |
11 |
32 |
31 |
|
500 µg |
16 |
96 |
12 |
31 |
31 |
|
2500 µg |
14 |
101 |
8 |
30 |
32 |
|
5000 µg |
8 |
116 |
6 |
28 |
34 |
|
Pos. contr. |
||||||
2-AA (2.5 µg) |
129 |
878 |
145 |
758 |
|
|
2-AA (60 µg) |
|
|
|
|
243 |
|
II. Preincubation test
Table 3: Revertants (mean of three plates), without S9 mix
Dose µg/plate |
TA1535 |
TA 100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|
Acetone |
16 |
113 |
9 |
28 |
33 |
|
20 µg |
15 |
115 |
7 |
25 |
32 |
|
100 µg |
16 |
113 |
9 |
25 |
33 |
|
500 µg |
16 |
106 |
9 |
26 |
33 |
|
2500 µg |
16 |
100 |
9 |
24 |
31 |
|
5000 µg |
13 |
103 |
7 |
25 |
32 |
|
Pos. contr. |
||||||
MNNG (5.0 µg) |
642 |
848 |
|
|
|
|
AAC (100 µg) |
|
|
403 |
|
|
|
NOPD (10 µg) |
|
|
|
452 |
|
|
4-NQO (5.0 µg) |
|
|
|
|
550 |
|
Table 4: Revertants (mean of three plates), with S9 -mix
Dose µg/plate |
TA1535 |
TA 100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|
Acetone |
18 |
116 |
10 |
34 |
37 |
|
20 µg |
18 |
113 |
7 |
32 |
36 |
|
100 µg |
14 |
112 |
10 |
29 |
31 |
|
500 µg |
18 |
104 |
9 |
32 |
35 |
|
2500 µg |
15 |
110 |
9 |
29 |
36 |
|
5000 µg |
15 |
99 |
8 |
29 |
34 |
|
Pos. contr. |
||||||
2-AA (2.5 µg) |
130 |
773 |
128 |
620 |
|
|
2-AA (60 µg) |
|
|
|
|
227 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. Therefore, the strains TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA were exposed to the test material at five different concentrations ranging from 20 µg - 5000 µg/plate in the presence and absence of a metabolic activation system applying the standard plate incorporation method as well as the preincubation method. For the experiments 3 test plates per dose or per control were used. Each strain was additionally tested in the presence and in the absence of the metabolic activation system with a suitable, knwon mutagen as positive control. A toxicity test were performed by determining the relative total growth. A weak bacteriotoxic effect was occasionally observed in the standard plate test depending on the strain and test conditions at 5000 µg/plate. Concerning the mutagenicity, an increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. According to the results, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions choosen here.
Justification for selection of genetic toxicity endpoint
only one available study
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genotoxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be genotoxic under Regulation (EC) No 1272/2008,as amended for the sixth time in Directive EC 605/2014.
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