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EC number: 226-107-4 | CAS number: 5280-80-8
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (mostly due to limited documentation before GLP (only the arithmetic means were shown in tables; no data on test substance purity), only 4 S. typhimurium strains tested; the activation mixture was tested only with strain TA 1535).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]
- EC Number:
- 226-107-4
- EC Name:
- 3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]
- Cas Number:
- 5280-80-8
- Molecular formula:
- C44H38Cl4N8O6
- IUPAC Name:
- 3,3'-{(2,5-dimethyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(5-chloro-2-methylphenyl)benzamide]
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch: EN 44395
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of liver from rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 15, 45, 135, 405 and 1215 µg/0.1 mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see Details on test system and conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
In the experiments in which the substance was metabolically activated, activation mixture was added also. 1 mL activation mixture contains: 0.3 mL S9 fraction and 0.7 mL of a solution of co-factors.
The plates were incubated for about 48 hours at 37 °C in darkness.
NUMBER OF REPLICATIONS: triplicate
Positive controls:
1) for strain TA 98: daunorubicin-HCl (DAUNOBLASTIN), 5 and 10 µg/0.1 mL phosphate buffer;
2) for strain TA 100: 4-nitroquinoline-N-oxide, 0.125 and 0.25 µg/0.1 mL phosphate buffer;
3) for strain TA 1535: N-methyl-N'-nitro-N-nitrosoguanidine, 3 and 5 µg/0.1 mL phosphate buffer;
4) for strain TA 1537: 9(5) aminoacridine hydrochloride monohydrate, 50 and 100 µg/0.1 mL DMSO.
The activation mixture was tested with Strain TA 1535 and cyclophosphamide (ENDOXAN-ASTA), 250 µg/0.1 mL phosphate buffer. - Evaluation criteria:
- A test substance is generally considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration.
- Statistics:
- When the colonies had been counted, the arithmetic mean was calculated.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (tested up to precipitating concentrations)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 45 µg/0.1 mL and above, the substance precipitated in soft agar.
Any other information on results incl. tables
Standard plate test (15 - 1215 µg/0.1 mL) | ||||||
Strain | Metabolic activation system | mean his+-revertant colonies (negative control) | maximum revertant factor (conc. (µg/0.1 mL)) | dose dependency | Assessment | maximum revertant factor (positive control) |
TA 98 | no | 11 | 1.4 (45) | no | negative | 17.5 / 34.1* (D-HCl) |
yes | 29 | 1.1 (45 / 135) | no | negative | / | |
TA 100 | no | 127 | 1.2 (135) | no | negative | 4.2 / 6.6** (NQNO) |
yes | 140 | 1.1 (405) | no | negative | / | |
TA 1537 | no | 3 | 1.7 (135) | no | negative | 12.8 / 138****(AA) |
yes | 5 | 1.0 (135 / 405) | no | negative | / | |
TA 1535 | no | 5 | 2.2 (1215) | no | negative | 158.8 / 173.8*** (MNNG) |
yes | 6 | 1.8 (15) | no | negative | 37.1 (CPP) | |
* 5 / 10 µg/0.1 mL | ||||||
** 0.125 / 0.25 µg/0.1 mL | ||||||
*** 3 / 5 µg/0.1 mL | ||||||
**** 50 / 100 µg/0.1 mL | ||||||
D-HCl = Daunorubicin | ||||||
NQNO = 4-Nitroquinolin-N-oxide | ||||||
MNNG = N-Methyl-N'-nitro-N-nitroso-guanidine | ||||||
AA = 9 (5) Aminoacridine hydrochloride | ||||||
CPP = Cyclophosphamide |
A slight increase in the number of back-mutant colonies (from 5 to 8) was observed in the experiment without microsomal activation on strain TA 1535. This is attributed to a higher incidence of spontaneously occurring back-mutants.
Applicant's summary and conclusion
- Conclusions:
- negative
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