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Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes
EC number: 276-160-2 | CAS number: 71888-93-2
- 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
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:
- disregarded due to major methodological deficiencies
- Study period:
- 2001
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The test was performed without the modification according to Prival for azo-compounds, although the ligands contain azo-sturcutures. The purity of the test sample is not given
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No modification for azo compounds
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his- ~ his+ and trp· ~ trp+ reversions
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9mix
- Test concentrations with justification for top dose:
- 0; 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity of the test item results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. - Evaluation criteria:
- - regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information):
positive
Under the experimental conditions reported, the test item induced gene mutations by frameshifts in strain TA 98 at precipitating concentrations with and without metabolic activaation. - Executive summary:
This study was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed with and without rat liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: 3, 1 0; 33; 1 00; 333; 1 000; 2500; and 5000 µg/plate The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation. No relevant toxic effects, evident as a dose dependent reduction of the number of revertants below 0.5 times the corresponding solvent control, occurred in the test groups with and without metabolic activation. A dose dependent increase in revertant colony numbers was observed following treatment with the test item i
n strain TA 98 with and without metabolic activation. The threshold of twice the colony count of the corresponding solvent control was exceeded at 333 µg/plate and above in the absence - and at 1 000 µg/plate and above in the presence of metabolic activation. Precipitation of the test item occurred at the concentrations producing mutagenic effects above the threshold mentioned above. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Conclusion
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item induced gene mutations by frameshifts in the genome of the strain T A 98 in the precipitating concentration range. Therefore,
the test item i
s considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- This mammalian cell mutation assay system detects point mutations involving base substitutions, deletions, frameshifts and rearrangements within the locus. The enzyme hypoxanthine guanine phosphoribosyl transferase (hprt) catalyses phosphorylation of purines in one of the purine salvage pathways. The selective agent used in this assay, 6-Thioguanine (6-TG), is also a substrate for this enzyme and cells that retain the functional hprt enzyme are susceptible to the cytotoxic effects of 6-TG. Forward mutations that result in the loss of the functional hprt gene render cells resistant to 6-TG. These mutant cells can be quantitated after an expression period by cloning in culture medium supplemented with 6-TG, the selective agent.
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 homogenate
- Test concentrations with justification for top dose:
- A) 4 B) 15 C) 58 and D) 230 µg/mL (factor of 4)
- Vehicle / solvent:
- DMSO was used as the vehicle control.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Details on test system and experimental conditions:
- - Source of the Test System:
American Type Culture Collection, P. O. Box 1549, Manassas, VA 20108, USA
- Storage of Test System
Stock cultures of the CHO-K1 cell line were stored in the test facility as frozen permanents in liquid nitrogen. - Evaluation criteria:
- - Evaluation and Interpretation : When all the validity criteria are fulfilled:
a.A test chemical is considered to be clearly positive if, in any of the experimental conditions examined:
•At least one of the test concentrations exhibits a statistically significant increase in number of aberrations compared with the concurrent vehicle control
•The increase is dose-dependent when evaluated with an appropriate trend test
•Any of the results are outside the distribution of the historical vehicle control data
b.A test chemical is considered to be clearly negative if, in all experimental conditions examined:
•None of the test concentrations exhibits a statistically significant increase in number of aberrations compared with the concurrent vehicle control
•There is no concentration-related increase when evaluated with an appropriate trend test
•All results are inside the distribution of the historical vehicle control data
c.The test chemical is then considered unable to induce gene mutations in cultured mammalian cells in this test system. - Statistics:
- A power transformation procedure (Snee and Irr, 1981) was used with which, the observed mutant frequency was transformed.
Statistical analysis of the experimental data was carried out using validated copies of SYSTAT Statistical package version 12.0. In cases where analysis of variance was significant at p < 0.05, a Dunnett’s test was conducted, comparing each treatment group and the positive control to the vehicle control (p < 0.05). - Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that the test item, Savinyl-Feuerrot 3GLS (Savinyl Fire Red 3GLS) does not have the potential to induce gene mutation in CHO-K1 cells at the tested concentrations and under the conditions of testing employed. - Executive summary:
The genotoxic potential of the test item Savinyl-Feuerrot 3GLS (Savinyl Fire Red 3GLS) to induce gene mutation in mammalian cells was evaluated using Chinese Hamster ovary (CHO) cells.
The study consisted of a preliminary cytotoxicity test and a definitive gene mutation test. The gene mutation test comprised of two independent experiments, one each in the presence and absence of metabolic activation system (S9 fraction prepared from Aroclor 1254 induced rat liver).
Savinyl-Feuerrot 3GLS (Savinyl Fire Red 3GLS) was soluble in Dimethyl sulphoxide (DMSO) at 200 mg/mL.
In a preliminary cytotoxicity test for the selection of test concentrations for the gene mutation assay, the test item showed evidence of significant cell growth inhibition as Relative Survival between 128 and 320 µg/mL both in the presence and absence of metabolic activation. There was no colony formation at 800 and 2000 µg/mL both in the presence and absence of metabolic activation, due to test item toxicity. The test item precipitated in the test medium at and above 800 µg/mL, but did not show any appreciable change in the pH and osmolality of test medium. Based on these observations a maximum of 230 µg/mL was tested in the gene mutation assay.
In the gene mutation test, CHO-K1 cells were exposed to the test item in duplicate at concentrations of 4, 15, 58 and 230 µg/mL of the medium for 3 hours in the presence (Experiment 1) and absence (Experiment 2) of metabolic activation. In a similar way, a concurrent vehicle control (DMSO) and a positive control, 3-methylcholanthrene (Experiment 1) was also tested in duplicate.
There was no evidence of induction of gene mutations in any of the test item treated cultures either in the presence or absence of metabolic activation. In each of these experiments, the respective positive controls produced a statistically significant increase in the frequencies of mutants, under identical conditions.
The results of the forward gene mutation test at thehprtlocus with Savinyl-Feuerrot 3GLS (Savinyl Fire Red 3GLS) indicated that the test item was non-mutagenic under the conditions of this study.
Referenceopen allclose all
Strain: TA 1535 Activation: no
Concentration µg/plate |
Revertants/plate (mean of 3) |
SD |
Factor |
Negative Control |
11 |
2,1 |
- |
Solvent Control |
11 |
0,6 |
1,0 |
Positive control |
590 |
11,1 |
55,3 |
3 |
6 |
1,2 |
0,5 |
10 |
5 |
1,5 |
0,4 |
33 |
6 |
1,0 |
0,6 |
100 |
6 |
1,0 |
0,6 |
333 |
5 |
1,2 |
0,4 |
1000 |
7 |
1,2 |
0,7 |
2500 |
5 |
1,2 |
0,5 |
5000 |
7 |
1,5 |
0,6 |
Strain: TA 1535 Activation: S9 mix
Concentration µg/plate |
Revertants/plate |
SD |
Factor |
Negative Control |
10 |
1,0 |
- |
Solvent Control |
12 |
4,4 |
1,0 |
Positive control |
151 |
27,1 |
12,6 |
3 |
8 |
1,0 |
0,7 |
10 |
9 |
3,2 |
0,8 |
33 |
10 |
2,1 |
0,8 |
100 |
7 |
2,3 |
0,6 |
333 |
6 |
2,0 |
0,5 |
1000 |
5 |
3,2 |
0,4 |
2500 |
4 |
1,2 |
0,3 |
5000 |
7 |
2,6 |
0,6 |
Strain: TA 1537 Activation: no
Concentration µg/plate |
Revertants/plate (mean of 3) |
SD |
Factor |
Negative Control |
6 |
1,2 |
- |
Solvent Control |
5 |
1,0 |
1,0 |
Positive control |
43 |
1,7 |
8,6 |
3 |
4 |
1,2 |
0,7 |
10 |
3 |
2,3 |
0,7 |
33 |
3 |
1,5 |
0,7 |
100 |
5 |
1,7 |
1,0 |
333 |
4 |
1,5 |
0,7 |
1000 |
3 |
0 |
0,6 |
2500 |
10 |
1,2 |
2,1 |
5000 |
11 |
3,2 |
2,3 |
Strain: TA 1537 Activation: S9 mix
Concentration µg/plate |
Revertants/plate |
SD |
Factor |
Negative Control |
6 |
1,7 |
- |
Solvent Control |
5 |
1,2 |
1,0 |
Positive control |
80 |
11,8 |
17,1 |
3 |
4 |
0,6 |
0,8 |
10 |
5 |
1,2 |
1,0 |
33 |
5 |
1,5 |
1,1 |
100 |
5 |
2,3 |
1,0 |
333 |
7 |
1,5 |
1,4 |
1000 |
10 |
2,0 |
2,1 |
2500 |
7 |
0,6 |
1,6 |
5000 |
7 |
2,1 |
1,6 |
Strain: TA 98 Activation: no
Concentration µg/plate |
Revertants/plate (mean of 3) |
SD |
Factor |
Negative Control |
21 |
4,6 |
- |
Solvent Control |
17 |
2,5 |
1,0 |
Positive control |
184 |
11,6 |
10,6 |
3 |
17 |
3,1 |
1,0 |
10 |
19 |
5,9 |
1,1 |
33 |
19 |
2,3 |
1,1 |
100 |
20 |
3,1 |
1,1 |
333 |
41 |
7,5 |
2,3 |
1000 |
80 |
3,6 |
4,6 |
2500 |
126 |
9,9 |
7,2 |
5000 |
134 |
4,5 |
7,7 |
Strain: TA 98 Activation: S9 mix
Concentration µg/plate |
Revertants/plate |
SD |
Factor |
Negative Control |
21 |
5,0 |
- |
Solvent Control |
23 |
2,1 |
1,0 |
Positive control |
619 |
71,6 |
27,3 |
3 |
18 |
4,0 |
0,8 |
10 |
19 |
5,5 |
0,8 |
33 |
19 |
0,6 |
0,9 |
100 |
26 |
2,3 |
1,2 |
333 |
41 |
4,5 |
1,8 |
1000 |
63 |
7,9 |
2,8 |
2500 |
7 |
4,5 |
3,3 |
5000 |
135 |
6,0 |
6,0 |
Strain: TA 100 Activation: no
Concentration µg/plate |
Revertants/plate (mean of 3) |
SD |
Factor |
Negative Control |
120 |
5 |
- |
Solvent Control |
118 |
12 |
1,0 |
Positive control |
701 |
21 |
5,9 |
3 |
117 |
4 |
1,0 |
10 |
118 |
11 |
1,0 |
33 |
115 |
4 |
1,0 |
100 |
112 |
15 |
1,0 |
333 |
106 |
13 |
0,9 |
1000 |
134 |
11 |
1,1 |
2500 |
161 |
9 |
1,4 |
5000 |
164 |
24 |
1,4 |
Strain: TA 100 Activation: S9 mix
Concentration µg/plate |
Revertants/plate |
SD |
Factor |
Negative Control |
167 |
15 |
- |
Solvent Control |
140 |
20 |
1,0 |
Positive control |
1135 |
196 |
8,1 |
3 |
143 |
7 |
1,0 |
10 |
132 |
5 |
0,9 |
33 |
120 |
12 |
0,9 |
100 |
139 |
18 |
1,0 |
333 |
164 |
5 |
1,2 |
1000 |
178 |
6 |
1,3 |
2500 |
185 |
22 |
1,3 |
5000 |
172 |
14 |
1,2 |
Strain: WP2 uvrA Activation: no
Concentration µg/plate |
Revertants/plate (mean of 3) |
SD |
Factor |
Negative Control |
32 |
5,5 |
- |
Solvent Control |
37 |
5,3 |
1,0 |
Positive control |
573 |
16,6 |
15,5 |
3 |
34 |
8,1 |
0,9 |
10 |
33 |
1,2 |
0,9 |
33 |
41 |
9,3 |
1,1 |
100 |
36 |
2,1 |
1,0 |
333 |
30 |
2,9 |
0,8 |
1000 |
34 |
2,5 |
0,9 |
2500 |
3 |
1,2 |
0,8 |
5000 |
32 |
5,9 |
0,9 |
Strain: WP2 uvrA Activation: S9 mix
Concentration µg/plate |
Revertants/plate |
SD |
Factor |
Negative Control |
42 |
3,5 |
- |
Solvent Control |
39 |
6,1 |
1,0 |
Positive control |
175 |
6,4 |
4,5 |
3 |
33 |
6,7 |
0,9 |
10 |
39 |
1, |
1,0 |
33 |
36 |
7,0 |
0,9 |
100 |
43 |
0,6 |
1,1 |
333 |
40 |
5,5 |
1,0 |
1000 |
47 |
3,2 |
1,2 |
2500 |
43 |
2,1 |
1,1 |
5000 |
33 |
2,0 |
0,8 |
TABLE 3. Determination of pH of Test Medium
Treatment (mg/mL) |
pH at the beginning of exposure to treatment |
pH at the end of exposure to treatment |
||
With S9 |
Without S9 |
With S9 |
Without S9 |
|
DMSO |
7.10 |
7.03 |
7.00 |
7.20 |
4 |
7.07 |
7.10 |
7.09 |
7.15 |
8 |
7.11 |
7.12 |
7.10 |
7.13 |
20 |
7.15 |
7.09 |
7.00 |
7.14 |
50 |
7.19 |
7.14 |
7.12 |
7.10 |
128 |
7.20 |
7.18 |
7.15 |
7.07 |
320 |
7.15 |
7.21 |
7.13 |
7.09 |
800 |
7.13 |
7.20 |
7.12 |
7.10 |
2000 |
7.21 |
7.18 |
7.15 |
7.12 |
Note: The test item precipitated in the test medium at and above 800 µg/mL both in the presence and absence of metabolic activation at 3 hours post-treatment.
TABLE 2. Determination of Osmolality of Test Medium
Treatment (mg/mL) |
Osmolality at the beginning of exposure to treatment (OSMOL/kg) |
Osmolality at the end of exposure to treatment (OSMOL/kg) |
||
With S9 |
Without S9 |
With S9 |
Without S9 |
|
DMSO |
0.470 |
0.463 |
0.483 |
0.456 |
320 |
- |
- |
0.471 |
0.452 |
800 |
- |
- |
0.459 |
0.455 |
2000 |
0.439 |
0.440 |
0.460 |
0.434 |
TABLE 3. Results of Preliminary Cytotoxicity Test
Treatment (mg/mL) |
3-hour exposure with metabolic activation |
3-hour exposure without metabolic activation |
||||||
Cloning Efficiency (CE) |
Cells at end of treatment (x105/flask) |
Adjusted Cloning Efficiency (ACE) |
Relative Survival (%RS) |
Cloning Efficiency (CE) |
Cells at end of treatment (x105/flask) |
Adjusted Cloning Efficiency (ACE) |
Relative Survival (%RS) |
|
DMSO |
0.93 |
14.70 |
0.83 |
100 |
0.94 |
14.05 |
0.80 |
100 |
4 |
0.88 |
14.05 |
0.75 |
90 |
0.86 |
13.40 |
0.70 |
88 |
8 |
0.66 |
13.70 |
0.55 |
66 |
0.82 |
11.85 |
0.59 |
74 |
20 |
0.63 |
11.00 |
0.42 |
51 |
0.67 |
11.10 |
0.45 |
56 |
50 |
0.60 |
9.85 |
0.36 |
43 |
0.61 |
10.50 |
0.39 |
49 |
128 |
0.58 |
7.35 |
0.26 |
31 |
0.48 |
9.00 |
0.26 |
33 |
320 |
0.10 |
6.25 |
0.04 |
5 |
0.09 |
6.85 |
0.04 |
5 |
800 |
No colony growth |
No colony growth |
||||||
2000 |
Note: Baseline cell count (No. of cells at the beginning of treatment): 16.5 x 105cells/mL
CE and ACE values are rounded of 2 decimal points and RS values are rounded off to the nearest whole number
TABLE 4. Parallel Cytotoxicity Test Results from Experiment 1
Treatment µg/mL |
No. of Colonies /Flask |
CE* |
ACE |
RS % |
||
1 |
2 |
3 |
||||
DMSO |
191 |
182 |
190 |
0.95 |
0.93 |
100 |
196 |
184 |
193 |
||||
4 |
180 |
175 |
170 |
0.88 |
0.81 |
87 |
178 |
181 |
172 |
||||
15 |
131 |
128 |
130 |
0.67 |
0.56 |
60 |
141 |
137 |
132 |
||||
58 |
117 |
120 |
115 |
0.59 |
0.40 |
43 |
122 |
112 |
114 |
||||
230 |
60 |
65 |
62 |
0.32 |
0.18 |
19 |
71 |
59 |
61 |
||||
3-MCA |
152 |
150 |
147 |
0.77 |
0.55 |
59 |
157 |
161 |
152 |
TABLE 5. Parallel Cytotoxicity Test Results from Experiment 2
Treatment µg/mL |
No. of Colonies /Flask |
CE* |
ACE |
RS % |
||
1 |
2 |
3 |
||||
DMSO |
184 |
192 |
190 |
0.95 |
0.95 |
100 |
182 |
195 |
198 |
||||
4 |
170 |
184 |
169 |
0.88 |
0.79 |
83 |
179 |
182 |
164 |
||||
15 |
141 |
137 |
140 |
0.69 |
0.56 |
59 |
132 |
145 |
128 |
||||
58 |
110 |
118 |
112 |
0.58 |
0.40 |
42 |
117 |
120 |
115 |
||||
230 |
61 |
65 |
75 |
0.34 |
0.19 |
20 |
78 |
64 |
60 |
TABLE 6. Summary Results of the Gene Mutation Assay in the Presence of Metabolic Activation (Experiment 1)
Treatment µg/mL |
Mutation Assay Flasks |
Cloning Efficiency of Mutant Colonies |
Cloning Efficiency Flasks |
6-TG Mutants per 106Clonable Cells (MF) |
||||||||
TG Colonies/Flask |
No. of Colonies/Flask |
|||||||||||
1 |
2 |
3 |
4 |
5 |
Total |
1 |
2 |
3 |
CE* |
|||
DMSO |
3 |
0 |
3 |
1 |
2 |
17 |
0.0000085 |
189 |
191 |
184 |
0.92 |
9.24 |
1 |
3 |
1 |
1 |
2 |
178 |
175 |
185 |
|||||
4 |
3 |
1 |
1 |
0 |
2 |
16 |
0.000008 |
171 |
182 |
176 |
0.89 |
8.99 |
3 |
2 |
2 |
1 |
1 |
182 |
180 |
174 |
|||||
15 |
0 |
2 |
3 |
2 |
3 |
21
|
0.000011 |
170 |
168 |
184 |
0.86 |
12.21 |
3 |
2 |
0 |
4 |
2 |
182 |
167 |
165 |
|||||
58 |
3 |
1 |
3 |
1 |
1 |
21 |
0.000011 |
180 |
171 |
174 |
0.85 |
12.35 |
2 |
1 |
3 |
5 |
1 |
172 |
161 |
160 |
|||||
230 |
4 |
1 |
2 |
0 |
2 |
18
|
0.000009 |
158 |
160 |
157 |
0.80 |
11.25 |
2 |
2 |
3 |
2 |
0 |
164 |
155 |
161 |
|||||
3-MCA |
37 |
34 |
36 |
35 |
28 |
340 |
0.000170 |
147 |
156 |
155 |
0.77 |
220.78 |
36 |
30 |
38 |
32 |
34 |
153 |
160 |
157 |
TABLE 7. Summary Results of the Gene Mutation Assay in the Absence of Metabolic Activation (Experiment 2)
Treatment µg/mL |
Mutation Assay Flasks |
Cloning Efficiency of Mutant Colonies |
Cloning Efficiency Flasks |
6-TG Mutants per 106Clonable Cells (MF) |
||||||||
TG Colonies/Flask |
No. of Colonies/Flask |
|||||||||||
1 |
2 |
3 |
4 |
5 |
Total |
1 |
2 |
3 |
CE* |
|||
DMSO |
2 |
3 |
2 |
5 |
0 |
22 |
0.0000110 |
190 |
187 |
191 |
0.94 |
11.70 |
2 |
3 |
2 |
3 |
0 |
185 |
183 |
186 |
|||||
4 |
2 |
2 |
1 |
2 |
3 |
22 |
0.000011 |
177 |
180 |
174 |
0.88 |
12.50 |
2 |
3 |
2 |
2 |
3 |
184 |
170 |
172 |
|||||
15 |
3 |
2 |
2 |
1 |
1 |
16 |
0.000008 |
167 |
179 |
165 |
0.87 |
9.20 |
2 |
2 |
1 |
1 |
1 |
178 |
181 |
177 |
|||||
58 |
0 |
3 |
2 |
1 |
4 |
22 |
0.000011 |
160 |
172 |
158 |
0.83 |
13.25 |
2 |
3 |
2 |
4 |
1 |
177 |
162 |
164 |
|||||
230 |
2 |
0 |
4 |
4 |
3 |
20 |
0.000010 |
167 |
158 |
155 |
0.80 |
12.50 |
2 |
1 |
3 |
1 |
0 |
160 |
154 |
169 |
Vehicle Control: DMSO CE: Cloning Efficiency MF: Mutant Frequency
* calculated from the mean values of the replicates of each group and rounded off to two decimal places
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
The test item showed mutagenic activity in TA 98 with and without metabolic activation by rat liver S9 mix. The substance is considered a mutagen in bacterial cells. As however, these observations were not confirmed in a mutagenicity study using mammalian cells. The test material is therefore not considered to present a mutagenic hazard.
Justification for selection of genetic toxicity endpoint
All available valid studies.
Justification for classification or non-classification
No classification
According to 1272/2008 EU a single positive result in a bacterial test alone is not suffcient for classification.
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