''amyl nitrite'', mixed isomers

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals

Author:

Mortelmans, K.; Haworth, S.; Lawlor, T.; Speck, W.; Tainer, B.; Zeiger, E.

Year:

1986

Bibliographic source:

Environmental Mutagenesis Vol. 8, Supplement 7, 1-119

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

''amyl nitrite'', mixed isomers

EC Number:

203-770-8

EC Name:

''amyl nitrite'', mixed isomers

Cas Number:

463-04-7

Molecular formula:

C5H11NO2

IUPAC Name:

pentyl nitrite

Test material form:

liquid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

10, 33, 100, 333, 1000, 3333, 6666 µg/plate

Vehicle / solvent:

Dimethyl Sulfoxide

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoanthracene, 4-Nitro-O-Phenylenediamine

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

positive

Remarks:

333 µg/well

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

The test item is positive in an bacteria reverse mutation assay with and without metabolic activation in the strain Salmonella typhimurium TA1535.

Executive summary:

The test item has been tested for mutagenic potential in bacteria in an bacteria reverse mutation assay (Ames test) according to international accepted protocolls. The following concentrations were tested: 10, 33, 100, 333, 1000, 3333, 6666 µg/plate with and without metabolic activation (S9 -mix) on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100.

The test item was positive in S. typhimurium TA 1535 at 333 µg/plate with and without metabolic activation.