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EC number: 426-290-2 | CAS number: 74149-72-7
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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:
- 06 February 1997 - 07 April 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline except for invalid positive control (MNNG) in the 1st experiment without S9; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- In the 2nd experiment without metabolic activation, EMS and BrdU were used as positive controls because MNNG was probably too old and did not incude mutants. This change from the experimental protocol did not affect the results or conclusions of the study
- Qualifier:
- according to guideline
- Guideline:
- other: 87/302/EWG, S.61
- Deviations:
- yes
- Remarks:
- idem above
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 426-290-2
- EC Name:
- -
- Cas Number:
- 74149-72-7
- Molecular formula:
- C20H20N2O7
- IUPAC Name:
- methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): UD-CG 115 nitrobenzamide (Gamma-NAP)
- Substance type: monosonstituent
- Analytical purity: 99.8%
- Lot/batch No.: 1/94
- Expiration date of the lot/batch: February 1999
- Storage conditions of test material: at room temperature (dark) and ambient humidity.
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Properly maintained: yes/no
- Periodically checked for Mycoplasma contamination: yes/no
- Periodically checked for karyotype stability: yes/no
- Periodically "cleansed" against high spontaneous background: yes/no - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induction (S9-mix)
- Test concentrations with justification for top dose:
- Between 5 and 50 µg/mL; higher doses elicit precipitation
- Vehicle / solvent:
- DMSO.
Rationale: DMF and acetone did not improve solubility.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: MNNG, DMBA, BrdU
- Evaluation criteria:
- A positive response is defined if there is a reproducible and concentration-dependent increase in mutant frequency for a minimum of two
successive concentrations, irrespective of individual statistically significant. Comparisons were made against the negative control values in the
respective test. In addition, historical control frequencies obtained in similar gene mutation experiments were also taken into consideration.
Accordingly, the mutant frequency must exceed 30-35/10E6 in order to compensate for random fluctuations that are typical for this assay.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- 50 µg/mL
- Vehicle controls validity:
- other: yes except MNNG (1st exp. -S9)
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Precipitates at 50 µg/mL.
-S9: Minor cytotoxicity (not dose-limiting) at 25-50 µg/mL: 81% and 76% survivals. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
There was no dose-dependant increase of the number of the mutants and the rate of mutants over the total dose-range of 5 to 50 µg/mL
(limit of precipitation) in V79 mammalian cells. - Executive summary:
Not cytotoxic in V79 CHL cells.
Precipitates at 50 µg/mL.
Negative for mammalian gene mutation, with and without activation.
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