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EC number: - | 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:
- 23 November, 1993 to 16 June, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
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)
- Version / remarks:
- 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Version / remarks:
- 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
- EC Number:
- 271-352-2
- EC Name:
- [4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
- Cas Number:
- 68541-72-0
- Molecular formula:
- C20H13CrN4O5S
- IUPAC Name:
- [4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 20042/D (Neolan Rosa BE ZP feucht)
Batch No.: 276
Purity: Approx. 50 %
Appearance: Black-reddish humid pieces
Expiry date: October 1998
Storage: Room temperature
Material submitted by: CIBA-GEIGY Limited, Dyestuffs Division, Basle, Switzerland
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Original and confirmatory experiment- 123.46, 370.37, 1111.11, 3333.33 and 10000.00 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- other: same as solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: all strains (except TA 1535) with S9: 2-aminoanthracene; for TA 1535 with S9: cyclophosphamide; for TA 100 and 1535 without S9: sodium azide, for TA 102 without S9: mitomycin-C; for TA 98 without S9: 2 nitrofluorene, for TA1537 without S9: 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 per test substance concentration and controls
OTHER EXAMINATIONS:
- Colonies were counted electronically using an Artek Colony Counter (Fisher Scientific), or manually where minor agar damage or test chemical precipitates might have interfered with automating counting. The results were sent on line to a computer. They were checked on a random basis by the operator. Observations indicating precipitates of the test substance in the top agar or a reduced or absent bacterial background lawn were registered additionally. Means for all mutagenicity assays were calculated and included in the Results section. - Rationale for test conditions:
- None
- Evaluation criteria:
- Assay acceptance criteria: A test is considered acceptable if the mean colony counts of the control values of all strains are within the acceptable ranges and if the results of the positive controls meet the criteria for a positive response.
- Statistics:
- A statistical analysis of the test data was not performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- 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:
- not examined
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Range finding test
Normal background growth was observed. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 10000 µg/plate with and without metabolic activation (since the purity of the test substance is about 50%, this corresponds to a concentration of 5000 µg/plate).
Mutagenicity test, original experiment
In the experiment performed without metabolic activation, treatment of strain TA 98 with FAT 20042/D (Neolan Rosa BE ZP feucht) led to a slight increase in the number of back-mutant colonies at the highest concentration. A marginal increase at two intermediate concentrations was also registered with strain TA 102 in both, the experiment with and without metabolic activation. No effects were observed with the other strains.
Mutagenicity test, confirmatory experiment
In the experiment performed without metabolic activation, again after treatment of strain TA 98 with FAT 20042/D (Neolan Rosa BE ZP feucht) a slight increase in the incidence of histidineprototrophic mutants was observed in comparison with the negative control. The slight increase in the number of revenants in the experiment without activation on strain TA 1535 at the concentration of 3333.3 µg/plate was not observed in the original experiment conducted on this strain and is attributed to spontaneously occurring back-mutants. No effects at all occurred and in the experiments with activation on strains TA 98 and TA 1535 and with the other strains.
The slight effect observed with strain TA 102 in the original experiment also is attributed to fluctuations in the incidence of spontaneously occurring back-mutant colonies.
In the mutagenicity tests normal background growth was observed with all strains at all concentrations. The numbers of revertant colonies were occasionally reduced at the upper concentrations.
There were no known circumstances or occurrences in this study that were considered to have affected the quality or integrity of the test data.
Any other information on results incl. tables
-
Original
experiments with metabolic activation
Strain
Treatment
Mean counts
TA 100
Negative control
124.00
123.46 µg/plate
110.33
370.37 µg/plate
111.00
1111.11 µg/plate
113.67
3333.33 µg/plate
131.67
10000.00 µg/plate
122.00
Positive control
2303.33
Strain
Treatment
Mean counts
TA 1535
Negative control
15.33
123.46 µg/plate
17.33
370.37 µg/plate
17.67
1111.11 µg/plate
16.00
3333.33 µg/plate
17.67
10000.00 µg/plate
14.00
Positive control
352.33
Strain
Treatment
Mean counts
TA 98
Negative control
28.33
123.46 µg/plate
32.00
370.37 µg/plate
35.67
1111.11 µg/plate
30.67
3333.33 µg/plate
44.33
10000.00 µg/plate
31.00
Positive control
2263.67
Strain
Treatment
Mean counts
TA 1537
Negative control
8.00
123.46 µg/plate
6.33
370.37 µg/plate
8.00
1111.11 µg/plate
6.67
3333.33 µg/plate
7.00
10000.00 µg/plate
8.33
Positive control
268.00
Strain
Treatment
Mean counts
TA 102
Negative control
254.33
123.46 µg/plate
323.67
370.37 µg/plate
363.33
1111.11 µg/plate
395.33
3333.33 µg/plate
376.33
10000.00 µg/plate
256.33
Positive control
2453.67
-
Original experiments without metabolic
activation
Strain
Treatment
Mean counts
TA 100
Negative control
111.67
123.46 µg/plate
119.00
370.37 µg/plate
112.33
1111.11 µg/plate
137.67
3333.33 µg/plate
126.00
10000.00 µg/plate
113.67
Positive control
1090.67
Strain
Treatment
Mean counts
TA 1535
Negative control
14.67
123.46 µg/plate
14.33
370.37 µg/plate
11.33
1111.11 µg/plate
12.33
3333.33 µg/plate
11.67
10000.00 µg/plate
15.33
Positive control
1127.00
Strain
Treatment
Mean counts
TA 98
Negative control
17.67
123.46 µg/plate
19.67
370.37 µg/plate
20.67
1111.11 µg/plate
21.33
3333.33 µg/plate
24.00
10000.00 µg/plate
35.33
Positive control
1460.00
Strain
Treatment
Mean counts
TA 1537
Negative control
8.00
123.46 µg/plate
8.00
370.37 µg/plate
9.00
1111.11 µg/plate
10.00
3333.33 µg/plate
9.67
10000.00 µg/plate
9.33
Positive control
2477.00
Strain
Treatment
Mean counts
TA 102
Negative control
204.33
123.46 µg/plate
282.00
370.37 µg/plate
191.67
1111.11 µg/plate
323.67
3333.33 µg/plate
305.67
10000.00 µg/plate
127.67
Positive control
1416.67
- Original experiments without metabolic activation
SUMMARY OF THE MUTAGENICITY EXPERIMENTS
Strain |
Treatment |
Mean counts |
TA 100 |
Negative control |
145.00 |
123.46 µg/plate |
128.67 |
|
370.37 µg/plate |
141.67 |
|
1111.11 µg/plate |
143.00 |
|
3333.33 µg/plate |
152.33 |
|
10000.00 µg/plate |
147.67 |
|
Positive control |
2587.00 |
Strain |
Treatment |
Mean counts |
TA 1535 |
Negative control |
12.33 |
123.46 µg/plate |
13.00 |
|
370.37 µg/plate |
19.00 |
|
1111.11 µg/plate |
15.00 |
|
3333.33 µg/plate |
15.67 |
|
10000.00 µg/plate |
9.00 |
|
Positive control |
327.33 |
Strain |
Treatment |
Mean counts |
TA 98 |
Negative control |
45.00 |
123.46 µg/plate |
41.33 |
|
370.37 µg/plate |
35.67 |
|
1111.11 µg/plate |
38.00 |
|
3333.33 µg/plate |
50.67 |
|
10000.00 µg/plate |
45.67 |
|
Positive control |
1992.33 |
Strain |
Treatment |
Mean counts |
TA 1537 |
Negative control |
14.67 |
123.46 µg/plate |
9.00 |
|
370.37 µg/plate |
15.67 |
|
1111.11 µg/plate |
12.00 |
|
3333.33 µg/plate |
16.00 |
|
10000.00 µg/plate |
7.67 |
|
Positive control |
309.67 |
Strain |
Treatment |
Mean counts |
TA 102 |
Negative control |
222.33 |
123.46 µg/plate |
248.33 |
|
370.37 µg/plate |
239.33 |
|
1111.11 µg/plate |
197.00 |
|
3333.33 µg/plate |
24.00 |
|
10000.00 µg/plate |
127.67 |
|
Positive control |
1600.33 |
Confirmatory experiments without metabolic activation
Strain |
Treatment |
Mean counts |
TA 100 |
Negative control |
139.67 |
123.46 µg/plate |
130.33 |
|
370.37 µg/plate |
135.67 |
|
1111.11 µg/plate |
124.67 |
|
3333.33 µg/plate |
134.67 |
|
10000.00 µg/plate |
146.00 |
|
Positive control |
1197.00 |
Strain |
Treatment |
Mean counts |
TA 1535 |
Negative control |
12.00 |
123.46 µg/plate |
19.33 |
|
370.37 µg/plate |
20.00 |
|
1111.11 µg/plate |
21.67 |
|
3333.33 µg/plate |
24.00 |
|
10000.00 µg/plate |
8.33 |
|
Positive control |
947.00 |
Strain |
Treatment |
Mean counts |
TA 98 |
Negative control |
28.00 |
123.46 µg/plate |
24.67 |
|
370.37 µg/plate |
29.33 |
|
1111.11 µg/plate |
26.33 |
|
3333.33 µg/plate |
40.33 |
|
10000.00 µg/plate |
59.00 |
|
Positive control |
1750.00 |
Strain |
Treatment |
Mean counts |
TA 1537 |
Negative control |
8.67 |
123.46 µg/plate |
12.33 |
|
370.37 µg/plate |
13.67 |
|
1111.11 µg/plate |
9.33 |
|
3333.33 µg/plate |
10.67 |
|
10000.00 µg/plate |
12.67 |
|
Positive control |
2836.33 |
Strain |
Treatment |
Mean counts |
TA 102 |
Negative control |
291.33 |
123.46 µg/plate |
299.00 |
|
370.37 µg/plate |
381.33 |
|
1111.11 µg/plate |
354.67 |
|
3333.33 µg/plate |
331.00 |
|
10000.00 µg/plate |
228.00 |
|
Positive control |
1543.67 |
Applicant's summary and conclusion
- Conclusions:
- FAT 20042/D (Neolan Rosa BE ZP feucht) exerted a marginal mutagenic effect on strain TA 98 of Salmonella typhimurium without metabolic activation only.
- Executive summary:
FAT 20042/D, identified as black-reddish humid pieces, purity approx. 50 %, batch no. 276, was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimurium. The following strains of Salmonella typhimurium were used: TA 98, TA 100, TA 102, TA 1535 and TA 1537. The test was performed with and without the addition of rat-liver post mitochondrial supernatant (S9 fraction) as an extrinsic metabolic activation system. The compound was dissolved in DMSO and tested at five concentrations in the range of 123.5 to 10000 µg/plate in the presence and absence of a metabolic activation system. In order to confirm the results, the experiments were repeated with and without metabolic activation at five concentrations in the range of 123.5 to 10000 µg/plate. Each strain was additionally tested in the presence and in the absence of a metabolic activation system with a suitable, known mutagen as positive control. FAT 20042/D led to a slight increase in the incidence of histidine-prototrophic mutants in comparison to the negative control in strain TA 98 at the highest concentration in both original as well as confirmatory experiments when tested in absence of metabolic activation. No relevant effects occurred with the other strains. Based on the results of these experiments and using standard evaluation criteria, it is concluded that FAT 20042/D (Neolan Rosa BE ZP feucht) exerted a marginal mutagenic effect on strain TA 98 of Salmonella typhimurium without metabolic activation only.
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