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EC number: 279-211-7 | CAS number: 79665-24-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study, performed according to OECD testing guideline 471. Non-standard test strain; no Prival Modification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- TA 1538 used instead of E.coli strain
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 279-211-7
- EC Name:
- N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 79665-24-0
- Molecular formula:
- C44H34Cl2N6O4
- IUPAC Name:
- 2-Naphthalenecarboxamide, N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[2-(5-chloro-2-methylphenyl)diazenyl]-3-hydroxy-
- Details on test material:
- - Substance type: red
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: AL 56/37+38
- Expiration date of the lot/batch: December 31, 1988
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Other: stable for at least 2 hours in H20, polyethylene glycol, CMC, and dimethylformamid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium, other: TA 1538
- Additional strain / cell type characteristics:
- other: his G 46; rfa-; uvrB-; :base-pair substitutions
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 10; 100; 333.3; 1000; and 5000 µg/plate
- Vehicle / solvent:
- DMF
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 1535, TA 100: sodium azide; TA 1537, TA 1538, TA 98: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
The assay was performed in two independent experiments, using identical procedures, both with and without· liver microsomal activation. Each concentration, including the controls, was tested in triplicate. - Evaluation criteria:
- A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains
TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential
of the test article regardless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Only weak toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in some of the test groups with and without metabolic activation at the highest investigated dose.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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