Potassium nitrite

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:

data from handbook or collection of data

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Effect of test chemical on bacterial gene mutation

Author:

H. P. TIL et.al.

Year:

1988

Bibliographic source:

Food and Chemical Toxicology, 1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Principles of method if other than guideline:

AMES test was performed according to OECD Guidelines to evaluate the mutagenic potential of the test chemical.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Potassium nitrite

EC Number:

231-832-4

EC Name:

Potassium nitrite

Cas Number:

7758-09-0

Molecular formula:

HNO2.K

IUPAC Name:

potassium nitrite

Test material form:

solid

Details on test material:

- Name of test material : Potassium nitrite
- Molecular formula : KNO2
- Molecular weight : 85.103 g/mol
- Smiles notation : N(=O)[O-].[K+]
- InChl : 1S/K.HNO2/c;2-1-3/h;(H,2,3)/q+1;/p-1
- Substance type: Inorganic
- Physical state: Solid
-Purity;97%

Method

Target gene:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system:
- source of S9: S-9 mix with 10% S-9 prepared from livers of Aroclor 1254-treated rats

Test concentrations with justification for top dose:

Concentrates of the urine was used(from urine of rats receiving 3000 mg/litre of test chemical)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [none; no data; acetone; arachis oil; beeswax; carbowaxe; castor oil; cetosteryl alcohol; cetyl alcohol; CMC (carboxymethyl cellulose); coconut oil; corn oil; cotton seed oil; DMSO; ethanol; glycerol ester; glycolester; hydrogenated vegetable oil; lecithin; macrogel ester; maize oil; olive oil; paraffin oil; peanut oil; petrolatum; physiol. saline; poloxamer; polyethylene glycol; propylene glycol; silicone oil; sorbitan derivative; soya oil; theobroma oil; vegetable oil; aqueous solvents (water or saline or culture medium)]: DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Β-glucuronidase

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: in medium; Standard plate method

Rationale for test conditions:

Not specified

Evaluation criteria:

Evaluation was done considering a dose dependent increase in the number of revertants /plate.

Statistics:

Not specified.

Results and discussion

Test results

Key result

Species / strain:

bacteria, other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

There was no evidence of increased mutagenic activity in the urine of rats receiving 3000 mg/litre, either in the presence or in the absence of S-9 mix .

Remarks on result:

other: No mutagenic effct were observed

Applicant's summary and conclusion

Conclusions:

Test chemical was evaluated for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA by AMES test. The test result was considered to be negative in all strain in the presence and absence of metabolic activation S9.

Executive summary:

AMES test was performed according to OECD Guidelines to evaluate the mutagenic potential of the test chemical. The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA in the presence and absence of metabolic activation S9. There was no evidence of increased mutagenic activity in the urine of rats receiving 3000 mg/litre, either in the presence or in the absence of S-9 mix.. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA by AMES test. Hence the substance cannot be classified as gene mutant in vitro.