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EC number: 811-773-6 | CAS number: 1713250-52-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1991-05-29 and 1991-07-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: in accordance to OECD Guideline and EU method, GLP-conform
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- FAT 11181/K
- IUPAC Name:
- FAT 11181/K
- Test material form:
- other: solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. Typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver microsomal fraction induced by 500 mg/kg bw Aroclor 1254
- Test concentrations with justification for top dose:
- 10.0; 100.0; 333.3; 1000.0; and 5000.0 ug/plate
- Vehicle / solvent:
- - Vehicle/solvent used: aqua bidest.
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity for the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua dest. and DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-aminoanthracene (strain: TA1535, TA1537, TA1538, TA98, T100); without S9: sodium azide (strain: TA1535, TA100), 4-nitro-o-phenylene-diamine (strain: TA1537, TA1538, TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
PRECULTURE: From the thawed ampoules of the strains 0.5 mL bacterial suspension was transferred to 250 mL Erlenmeyer flasks containing 20 mL nutrient medium. The bacterial culture was incubated in a shaking water bath for 10 hours at 37° C.
DURATION
- Exposure duration: 48 hours at 37°C in the dark
SELECTION AGENT: 2.0 % Vogel-Bonner-Glucose-Minimal-Agar
NUMBER OF REPLICATIONS: three plates per strain and dose level; 2 independent experiments
DATA RECORDING: The colonies were counted by using the BIOTRAN III counter (BIOTRONIK, D-6000 Frankfurt, F.R.G,). If precipitation of the test article precluded automatic counting the revertant colonies were counted by hand. - Evaluation criteria:
- A test article is considered as positive if either a significant dose-related increase in the number of revertants or a significant and reproducible increase for at least one test concentration is induced. A significant response is described as follows:
A test article is considered as mutagenic if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The plates with the test article showed normal background growth up to 5000.0 µg/plate in strain TA 98 and TA 100, respectively. According to the dose selection criteria, the test article was tested at the following concentrations:
10.0; 100.0; 333.3; 1000.0; and 5000.0 µg/plate
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects occurred in the test groups with and without metabolic activation in experiment I and II in all strains used. - Remarks on result:
- other: strain/cell type: TA 1537 and TA 1538
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The results of the main study are shown in table 1 (without S9 mix) and table 2 (with S9 mix).
Table 1: without S9 mix
Revertants/plate (mean from three plates)
Dose µg/plate I/II |
TA 1535 |
TA 1537 |
TA1538 |
TA98 |
TA100 |
|||||
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
|
Neg. contr. |
7 |
15 |
10 |
8 |
12 |
15 |
20 |
23 |
77 |
78 |
Solv. contr |
11 |
14 |
9 |
9 |
11 |
12 |
22 |
22 |
85 |
81 |
10.0 |
11 |
12 |
11 |
11 |
13 |
13 |
18 |
28 |
79 |
76 |
100.0 |
14 |
18 |
9 |
14 |
23 |
27 |
31 |
32 |
80 |
66 |
333.3 |
10 |
13 |
13 |
17 |
44 |
49 |
35 |
44 |
77 |
79 |
1000.0 |
10 |
11 |
26 |
21 |
73 |
83 |
49 |
63 |
90 |
91 |
5000.0 |
11 |
15 |
62 |
67 |
162 |
156 |
123 |
100 |
87 |
94 |
Pos. contr. |
|
|
|
|
|
|
|
|
|
|
Sodium azide (10 µg/plate) |
1129 |
932 |
|
|
|
|
|
|
901 |
714 |
4-Nitro-o-phenylene-diamine (50 µg/plate) |
|
|
158 |
186 |
1635 |
1451 |
1721 |
1509 |
|
|
Table 2: with S9 mix
Revertants/plate (mean from three plates)
Dose µg/plate I/II |
TA 1535 |
TA 1537 |
TA1538 |
TA98 |
TA100 |
|||||
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
|
Neg. contr. |
12 |
15 |
9 |
13 |
22 |
18 |
27 |
34 |
113 |
93 |
Solv. contr |
11 |
11 |
8 |
9 |
14 |
14 |
26 |
36 |
114 |
80 |
10.0 |
10 |
12 |
7 |
10 |
15 |
15 |
27 |
30 |
114 |
84 |
100.0 |
11 |
14 |
8 |
12 |
14 |
20 |
26 |
34 |
101 |
84 |
333.3 |
10 |
13 |
8 |
8 |
29 |
31 |
27 |
29 |
120 |
76 |
1000.0 |
11 |
13 |
12 |
16 |
29 |
31 |
29 |
32 |
112 |
92 |
5000.0 |
12 |
16 |
26 |
31 |
93 |
83 |
76 |
56 |
125 |
100 |
Pos. contr. |
|
|
|
|
|
|
|
|
|
|
2-Amino-anthracene (2.5 µg/plate) |
305 |
288 |
140 |
226 |
998 |
934 |
347 |
1418 |
475 |
998 |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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