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EC number: 241-379-4 | CAS number: 17354-14-2
- 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
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:
- 2014-08-26 till 2014-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-bis(butylamino)anthraquinone
- EC Number:
- 241-379-4
- EC Name:
- 1,4-bis(butylamino)anthraquinone
- Cas Number:
- 17354-14-2
- Molecular formula:
- C22H26N2O2
- IUPAC Name:
- 1,4-bis(butylamino)anthraquinone
- Details on test material:
- Purity: 99.2 % (w/w)
Expiry Date: 25 June 2024
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: suspended in DMSO
- Justification for choice of solvent/vehicle: Better than others
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- in strain TA 98 with metabolic activation
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Water solubility: unsoluble
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate. No precipitation of the test item was observed on the incubated agar plates. The undissolved particles had no influence on the data recording.
- Other confounding effects: none
COMPARISON WITH HISTORICAL CONTROL DATA: performed
The data in the untreated control of strain TA 1535 were slightly above our historical control range in the absence of metabolic activation. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed normal back¬ground growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabol¬ic activation. - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Study Name: 1652800 |
Study Code: Harlan CCR 1652800 |
Experiment: 1652800 VV Plate |
Date Plated: 26/08/2014 |
Assay Conditions: |
Date Counted: 29/08/2014 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
26 ± 4B M |
7 ± 2 |
21 ± 7 |
174 ± 10 |
35 ± 13 |
Untreated |
|
|
28 ± 3B M |
10 ± 3 |
22 ± 6 |
162 ± 30 |
48 ± 5 |
|
Fat Blue B 01 |
3 µg |
|
27 ± 4B M |
10 ± 4 |
28 ± 1 |
177 ± 2 |
42 ± 0 |
|
|
10 µg |
|
26 ± 2B M |
8 ± 2 |
19 ± 4 |
166 ± 9 |
39 ± 5 |
|
|
33 µg |
|
30 ± 2B M |
8 ± 1 |
22 ± 3 |
191 ± 2 |
44 ± 6 |
|
|
100 µg |
|
26 ± 1B M |
7 ± 1 |
17 ± 2 |
216 ± 16 |
41 ± 4 |
|
|
333 µg |
|
28 ± 2B M |
9 ± 1 |
19 ± 9 |
185 ± 16 |
54 ± 9 |
|
|
1000 µg |
|
28 ± 1B D M |
7 ± 1D |
21 ± 1D |
173 ± 10D |
44 ± 9D |
|
|
2500 µg |
|
26 ± 5B D M |
6 ± 2D M |
21 ± 4D M |
174 ± 11D M |
32 ± 4D M |
|
|
5000 µg |
|
28 ± 2B D M |
6 ± 1D M |
17 ± 2D M |
176 ± 13D M |
27 ± 4D M |
|
NaN3 |
10 µg |
|
2459 ± 235 |
|
|
1835 ± 57 |
|
|
4-NOPD |
10 µg |
|
|
|
395 ± 13 |
|
|
|
4-NOPD |
50 µg |
|
|
80 ± 8 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
1107 ± 49 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
13 ± 6 |
15 ± 2 |
30 ± 10 |
123 ± 23 |
55 ± 4 |
Untreated |
|
|
14 ± 7 |
12 ± 5 |
38 ± 6 |
175 ± 4 |
57 ± 14 |
|
Fat Blue B 01 |
3 µg |
|
19 ± 5 |
20 ± 1 |
41 ± 1 |
155 ± 7 |
41 ± 4 |
|
|
10 µg |
|
18 ± 2 |
18 ± 5 |
32 ± 3 |
146 ± 5 |
54 ± 6 |
|
|
33 µg |
|
17 ± 0 |
19 ± 4 |
37 ± 13 |
155 ± 4 |
53 ± 2 |
|
|
100 µg |
|
16 ± 4 |
16 ± 1 |
42 ± 2 |
163 ± 16 |
51 ± 5 |
|
|
333 µg |
|
13 ± 5 |
22 ± 4 |
73 ± 3 |
148 ± 16 |
50 ± 2 |
|
|
1000 µg |
|
14 ± 3D |
20 ± 5D |
117 ± 13D |
151 ± 18D |
46 ± 5D |
|
|
2500 µg |
|
13 ± 2D M |
21 ± 2D M |
172 ± 33D M |
168 ± 6D M |
49 ± 10D M |
|
|
5000 µg |
|
13 ± 3D M |
18 ± 2D M |
192 ± 7D M |
179 ± 5D M |
34 ± 3D M |
|
2-AA |
2.5 µg |
|
454 ± 13 |
310 ± 18 |
2167 ± 35 |
4272 ± 129 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
212 ± 10 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
D M B |
Densely coloured plate Manual count Extensive bacterial growth |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive in strain TA 98 with metabolic activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frameshifts in the genome of strain TA 98 with S9 mix. - Executive summary:
The test item Fat Blue B 01 was assessed for its potential to induce gene mutations according to the plate incorporation test using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed with and without liver microsomal activation. Each concentration and the controls, were tested in triplicate. The test item was tested at the following concentrations:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate. No precipitation of the test item was observed on the incubated agar plates. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the fivetester strains was observed following treatment with Fat Blue B 01 at any dose level in the absence of metabolic activation (S9 mix).
In the presence of metabolic activation a substantial and dose dependent increase was observed in strain TA 98.The number of colonies exceeded the threshold of twice the number of the corresponding solvent control at concentrations from 333 µg/plate to 5000 µg/plate
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
The data in the untreated control of strain TA 1535 were slightly above our historical control range in the absence of metabolic activation. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies.
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