Nitric acid

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:

1989

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

Test material information

Constituent 1

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

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.

Controls

Controls 1

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

Controls 2

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

Controls 3

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

Controls 4

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.