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EC number: 231-714-2 | CAS number: 7697-37-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- NA to 1989-03-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study according to OECD Guideline 471 however only four strains of S.typhimurium (TA 1535, TA 100, TA 1537, and TA 98) were used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four strains of S.typhimurium (TA 1535, TA 100, TA 1537, and TA 98) were used.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Nitric acid
- EC Number:
- 231-714-2
- EC Name:
- Nitric acid
- Cas Number:
- 7697-37-2
- Molecular formula:
- HNO3
- IUPAC Name:
- nitric acid
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Nitric acid
- Analytical purity: 60% aqueous solution
- Other: test substance no.: 88/972
Constituent 1
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: see below in any other information on materials and methods
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- The standard plate test and the preincubation test (with and without metabolic activation for all test strains): 20, 100, 500, 2500, and 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s): aqua dest.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua dest. (vehicle of test substance)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9: for TA 100, TA 98, TA 1537 and TA 1535 at 10 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua dest. (vehicle of test substance)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9: for TA 1537 at 100 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua dest. (vehicle of test substance)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- without S9: for TA 98 at 10 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua dest. (vehicle of test substance)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N-nitro-N-nitroso-guanidine (MNNG)
- Remarks:
- without S9: for TA 100 and TA 1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: in agar (plate incorporation); experiment 2: preincubation
DURATION
- Preincubation period: 20 minutes (experiment 2)
- Exposure duration: 48 hours (experiment 1 and 2)
- Selection time (if incubation with a selection agent): 48 hours (experiment 1 and 2)
SELECTION AGENT (mutation assays):
- histidine (S. typhimurium strains)
NUMBER OF REPLICATIONS:
- 3 (experiment 1 and 2)
DETERMINATION OF CYTOTOXICITY
- Method: The toxic effects of the test substance were detected by a substantial reduction in mean revertant colony counts or by the sparce or absent background bacterial lawn.
-Other: The positive controls were dissolved in DMSO
- Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Statistics:
- A statistical analysis of the data was not required.
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- for TA 1537 at 5000 ug/plate for both experiment 1 and 2
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: A weakly bacteriotoxic effect (reduced his - background growth, decrease in the number of his revertant) observed only using TA 1537 at 5000 ug/plate without S9 in the standard plate test and with S9 in the preincubation test.
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Mutagenicity: An increase in the number of his + revertants was not observed both in the standard plate test and in the pre-incubation test either without S9 mix or after the addition of a metabolizing system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
other: negative with and without metabolic activation
Under conditions of the study, the test substance was not mutagenic in the Ames test under the experimental conditions chosen in this study.
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