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EC number: 212-668-2 | CAS number: 842-07-9
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Responses of the L5178Y Mouse Lymphoma Cell Forward Mutation Assay. V: 27 Coded Chemicals
- Author:
- Douglas B. McGregor, Alison G. Brown, Susan Howgate, Douglas McBride, Colin Riach, and William J. Caspary
- Year:
- 1 991
- Bibliographic source:
- Environmental and Molecular Mutagenesis 17:196 - 219 (1991)
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study was performed to determine the mutagenic potential of 1-(phenyldiazenyl)-2-naphthol in the L5178Y tk+/tk¯ mouse lymphoma cells
- GLP compliance:
- not specified
- Type of assay:
- other: Mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1-phenylazo-2-naphthol
- EC Number:
- 212-668-2
- EC Name:
- 1-phenylazo-2-naphthol
- Cas Number:
- 842-07-9
- Molecular formula:
- C16H12N2O
- IUPAC Name:
- 1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Solvent yellow 14
- Molecular formula (if other than submission substance): C16H12N2O
- Molecular weight (if other than submission substance): 248.28 g/mole
- InChl (if other than submission substance):1S/C16H12N2O/c19-15-11-10-12-6-4-5-9-14(12)16(15)18-17-13-7-2-1-3-8-13/h1-11,19H/b18-17+
- Substance type: Organic
- Physical state: Solid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Solvent yellow 14
- Molecular formula: C16H12N2O
- Molecular weight: 248.284 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Method
- Target gene:
- Thymidine kinase gene
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: L5178Y tk+/tk- 3.7.2 C mouse lymphoma cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The tkt/tk- -3.7.2C heterozygote of L5178Y mouse lymphoma cells were maintained in Fischer’s medium at 37°C on gyratory tables. Fischer’s medium (designated F0) was supplemented with 2 mM L-glutamine, sodium pyruvate, 110 µg/ml, 0.05% pluronic F68, antibiotics, and 10% heat-inactivated donor horse serum (v/v) (designated Flop)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes, Laboratory cultures were confirmed as free from mycoplasma by cultivation or Hoechst staining techniques
- Periodically checked for karyotype stability: No data available
- Periodically "cleansed" against high spontaneous background: No data available - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, Post-mitochondria1 supernatant fractions of liver homogenates (S9) were preparedfrom 200 g, male, Fischer 344 rats
- Test concentrations with justification for top dose:
- 0, 1, 2, 4, 8, 16 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ACET
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- ethylmethanesulphonate
- methylmethanesulfonate
- Details on test system and experimental conditions:
- DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth
METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 6 X 10 6 cells
DURATION
- Preincubation period: No data
- Exposure duration: 4 hrs
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 11-14 dats
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): TFT
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Duplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: Three aliquots (each containing 10 6 cells)
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Toxicity was expressed as either a reduction of cell population growth in suspension during the expression period or a reduction in cloning efficiency. A measure of the overall toxicity was the relative total growth (RTG)
- Any supplementary information relevant to cytotoxicity: Mutant fraction was also calculated
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: Mutant selection was done by seeding 1000000 cells by mixing with cloning medium at 37°C to give final concentrations of 0.35% Noble agar and 3 pg TFT/ml, then poured into 90
mm Petri plates. The agar was solidified at 4°C for 5-10 min, then the plates were incubated for 11-14 days in 5% C02:95% air at 37°C. Colonies were counted using an Artek 880 Automated
Colony Counter, with the colony size discriminator control in the “off” position. A check on the instrument indicated that colonies of about 8.1 mm in diameter were counted. - Rationale for test conditions:
- No data available
- Evaluation criteria:
- Mutant colonies were counted and mutant fraction was determined. Primary judgments were made at the level of individual experiments, but judgment on the mutagenic potential of a chemical was made on a basis of consensus of all valid experimental results.
Positive (+)
A test was considered positive when, out of three trials, a positive
Negative (-)
A test was considered negative when, out of three trials, a positive response or a positive dose was not reproducible.
Questionable (?)
A test was considered questionable when, out of three trials, neither a positive nor a negative response was reproduced. - Statistics:
- The statistical analysis was based upon the mathematical model proposed for this system [Lee and Caspary, 19831 and consisted of a dose trend test [Barlow et al., 1972, p. 2151 and a variance analysis of pair-wise comparisons of each dose against the vehicle control. Significant differences from concurrent vehicle control values at the 5% level after variance analysis are
indicated by underlines of the average mutant fractions at the appropriate concentrations. For further discussion of the data evaluation procedure readers should refer to McGregor et al. [1988b].
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data availableTEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: Yes, precipitation was noted at and above 12.5 µg/ml without S9 metabolic activation system
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: Ten-fold differences in test compound concentrations were used in the toxicity test, the highest being 5 mg/ml unless a much lower concentration was indicated by the poor solubility of a compound. This test was followed by at least two experiments in the absence of S9 mix. If no clear positive response was observed, then two experiments were performed in the presence of S9 mix. Test compound concentrations were primarily two-fold dilutions from the highest testable concentration, as estimated from the toxicity test.
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: No data]
Any other information on results incl. tables
Results with activation(S9):
Conc. µg/ml |
Trial 1 |
Trial 2 |
Trial 3 |
|||||||||
|
CE |
RTG |
MC |
Avg. MF |
CE |
RTG |
MC |
Avg. MF |
CE |
RTG |
MC |
Avg. MF |
ACET |
82 |
115 |
86 |
|
96 |
117 |
86 |
|
92 |
103 |
145 |
|
0 |
84 57 58 |
98 92 94 |
115 114 113 |
53 |
90 90 97 |
90 88 105 |
103 73 108 |
33 |
101 97 95 |
103 96 97 |
135 132 154 |
49 |
1 |
72 63 |
91 87 |
113 120 |
58 |
67 65 |
82 83 |
73 89 |
41 |
105 94 |
87 77 |
155 175 |
56 |
2 |
60 57 |
72 73 |
152 102 |
72 |
84 64 |
73 52 |
109 107 |
49 |
96 84 |
70 71 |
163 176 |
63 |
4 |
51 56 |
37 36 |
134 118 |
79 |
47 63 |
27 28 |
133 144 |
85 |
83 86 |
39 42 |
134 199 |
66 |
8 |
38 24 |
18 11 |
172 143 |
175 |
39 38 |
13 9 |
86 124 |
91 |
72 68 |
19 16 |
151 178 |
79 |
16 |
62 52 |
32 28 |
137 101 |
69 |
24 33 |
6 9 |
45 85 |
75 |
54 47 |
9 6 |
148 142 |
96 |
MCA 2.5 |
18 15 |
5 4 |
134 177 |
418 |
13 14 |
3 2 |
193 262 |
566 |
58 54 |
28 21 |
570 603 |
349 |
CE=cloning efficiency (%); RTG=relative total growth; MC= mutant colony count; MF= mutant fraction (mutant colonies per 1000000 clonable cells)
PRECIPITATION AT 16. UG/ML
Results without activation (S9):
Conc. µg/ml |
Trial 1 |
Conc. µg/ml |
Trial 2 |
||||||
|
CE |
RTG |
MC |
Avg. MF |
|
CE |
RTG |
MC |
Avg. MF |
Acet |
75 |
101 |
75 |
33 |
ACET |
90 |
106 |
120 |
45 |
0 |
95 96 113 |
98 101 100 |
111 165 126 |
39 58 37 |
0 |
78 76 68 |
102 107 85 |
98 114 115 |
48 |
3.125 |
138 r 121 r |
97 87 |
201 147 |
48 40 |
1 |
70 67 |
84 83 |
108 113 |
52 56 |
6.25 |
108 86 |
118 93 |
170 99 |
52 39 |
2 |
77 88 |
87 100 |
109 109 |
47 41 |
12.5 |
70 79 |
54 59 |
104 116 |
50 49 |
4 |
86 106 |
67 92 |
141 139 |
55 44 |
25 |
37 48 |
6 6 |
1157 1330 |
1042 927 |
8 |
73 88 |
89 80 |
82 141 |
38 54 |
50 |
Lethal Lethal |
|
|
|
16 |
74 71 |
34 26 |
133 114 |
60 53 |
EMS 250µg/mL |
82 66 |
124 80 |
223 156 |
90 79 |
|
73 74 |
69 73 |
399 427 |
182 193 |
MMS 15µg/mL |
37 45 |
25 25 |
146 182 |
131 136 |
50 |
52 41 |
32 31 |
261 218 |
167 176 |
Precipitation at 12.5 and 16 µg/ml
Applicant's summary and conclusion
- Conclusions:
- 1-phenylazo-2-naphthol shows failed to induce mutation in L5178Y tk+/tk– mouse lymphoma cell without S9 metabolic activation and did induce mutation with of S9 metabolic activation system.
- Executive summary:
1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) was tested for its mutagenic potential in the L5178Y tk+/tk–mouse lymphoma cell forward mutation assay at concentration of 0, 1, 2, 4, 8, 16 µg/ml. Two trials were conducted in the absence of S9 mix.
In the first trial, no mutagenicity was observed up to a concentration of 12.5 µg/ml, where precipitation occurred. In the second trial, no mutagenicity was observed when the concentration of solvent yellow 14 was restricted to 16 µg/ml, giving an RTG of about 30%.
In three trials performed in the presence of S9 mix, statistically significant dose-related mutagenic responses were obtained at doses below those at which precipitation occurred. The LOED was 8 µg/ml, and it was noted that significant responses occurred only when the RTG was below 30% and associated with decreases in cloning efficiency.
1-phenylazo-2-naphthol failed to induce mutation in L5178Y tk+/tk– mouse lymphoma cell without S9 metabolic activation and did induce mutation with of S9 metabolic activation system.
Since mutagenic response is observed for the chemical with metabolic activation system, hence, 1-phenylazo-2-naphthol is likely to classify as a gene mutant in vitro.
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