(E)-4-decenal

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:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted according to OECD Guidelines, with no or minor deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(E)-4-decenal

EC Number:

265-741-6

EC Name:

(E)-4-decenal

Cas Number:

65405-70-1

Molecular formula:

C10H18O

IUPAC Name:

(E)-4-decenal

Test material form:

other: colorless to yelow liquid

Details on test material:

Batch No. 9000525487
Purity 99,1%
Expiration date February 08, 2004

Method

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 micrograms/plate
Experiment II: 1, 3, 10, 33, 100, 333 and 1000 micrograms/plate

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: sodium azide, NaN3

Remarks:

TA1535 and TA100 without metabolic activation

Controls 2

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamide

Remarks:

TA1537 and TA98 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

TA102 without metabolic activation

Controls 4

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA 1535, TA 1537, TA 98, TA 100 and TA 102 with metabolic activation

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Relevant toxic effects, evident asa reduction in the number of revertants, occurred in the test groups with and without metabolic activation at higher concentrations.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion it can be stated, that during the described mutagenicity test under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore the Decenal-4-trans is considered to be non-mutagenic in this Salmonella Typhimurium reverse mutation assay.