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EC number: 308-114-5 | CAS number: 97862-65-2
Genetic toxicity: in vitro
Administrative data
- 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:
- 1985-11-12 to 1986-04-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- EC Number:
- 308-114-5
- EC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Cas Number:
- 97862-65-2
- Molecular formula:
- C40H28CrN8O10S2.C28H31N2O3.C20H32N
- IUPAC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Constituent 1
- Specific details on test material used for the study:
- - Purity: Commercial grade
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Hams's F10 tissue culture medium plus 3 % FCS
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (aroclor1254 induced)
- Test concentrations with justification for top dose:
- Preliminary cytotoxixity test:
31 ng/mL to 2000 mg/mL
Main mutagenicity test
without metabolic activation: 0.5, 1, 2, 4, 8, 12, 16 and 20 µg/mL
with metabolic activation: 12.5, 25, 50, 100, 200, 300, 400 and 500 µg/mL - Vehicle / solvent:
- The test item was dissolved in DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation: ethylmethanesulphonate; with metabolic activation: N-dimethylnitrosamine
- Positive control substance:
- N-dimethylnitrosamine
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5 h (with and without S9 mix)
- Expression time (cells in growth medium): 6 days
- Selection time (if incubation with a selection agent): 7 days
SELECTION AGENT: 6-thioguanine (6 TG) and 8-azaguanine (8 TG)
STAIN: Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF EXPERIMENTS: 1
DETERMINATION OF CYTOTOXICITY
- Method: survivng colonies determined with the aid of an electric colony counter - Evaluation criteria:
- A test substance is considered mutagenic in this test system, if the analysis of the data demonstrates either:
- a dose-dependent increase in the mutant frequency and
an increase in the highest mutant frequency with respect to the negative control by a factor of at least 2.5;
or
- an increase in any mutant frequency by a factor of 3.0 or more with respect to the negative control at any concentration tested and an absolute difference of at least 20 clones per 10 cells plated between the negative control and substance treated dishes. - Statistics:
- All mutant frequencies are normalized to a virtual cloning efficiency of 100% at the end of the expression period. If the cloning efficiency is lower than 15%, the corresponding mutant frequency is usually not calculated, owing to the high statistical insignificance of the result.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 90 % reduction in viability was observed between 125 - 250 µg/mL (with metabolic activation) and between 7.813 and 15.625(without metabolic activation).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: In the preliminary toxicity tests, a 90% reduction in the viability of the cells treated with the test item was obtained between the concentrations of 125 and 250 µg/mL in the experiment with microsomal activation and between the concentrations of 7.813 and 15.625 µg/mL in the experiment without microsomal activation.
COMPARISON WITH HISTORICAL CONTROL DATA: The mutant frequencies of the negative and positive controls were in the range of the historical control.
Any other information on results incl. tables
Table: Mutation frequencies without metabolic activation
Treatment conc. (µg/mL) |
Mutant frequency (x10-6) |
|
Selection Agent 8-AG |
Selection Agent 6-TG |
|
0.5 |
< 4.0 |
6.0 |
1.0 |
4.8 |
4.8 |
2.0 |
< 4.0 |
6.6 |
4.0 |
< 4.0 |
< 4.0 |
8.0 |
5.2 |
13.9 |
12.0 |
-- |
-- |
16.0 |
-- |
-- |
20.0 |
-- |
-- |
Solvent control |
< 4.0 |
< 4.0 |
300 nL/mL EMS |
3157.3 |
3712.0 |
Table: Mutation frequencies with metabolic activation
Treatment conc. (µg/mL) |
Mutant frequency (x10-6) |
|
Selection Agent 8-AG |
Selection Agent 6-TG |
|
13 |
< 4.0 |
5.1 |
25 |
< 4.0 |
< 4.0 |
50 |
< 4.0 |
4.7 |
100 |
15.7 |
15.7 |
200 |
< 4 |
<4 |
300 |
-- |
-- |
400 |
-- |
-- |
500 |
-- |
-- |
Solvent control |
< 4.0 |
< 7.1 |
1 µL/mL DMN |
800.0 |
683.0 |
Applicant's summary and conclusion
- Executive summary:
The test material did not induce gene mutations in a mammalian cell line.
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