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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 resultsopen allclose all
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
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.