Undec-10-enoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-07-21 till 1998-09-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enoic acid

EC Number:

203-965-8

EC Name:

Undec-10-enoic acid

Cas Number:

112-38-9

Molecular formula:

C11H20O2

IUPAC Name:

undec-10-enoic acid

Details on test material:

- Physical state: colorless amorphous solid
- Analytical purity: 100.2%
- Storage condition of test material: at RT in dark
- Lot 1410

Method

Species / strain

Species / strain / cell type:

lymphocytes: human

Details on mammalian cell type (if applicable):

- Type and identity of media: HEPES-buffered RPMI, 20% FCS, 50 ug/ml Gentamycin
- Properly maintained: yes
- Phytohaemaglutinine for stimulation (0.1 ml/10 ml culture)

Metabolic activation:

with and without

Metabolic activation system:

S 9 (Arochlor-induced rat liver)

Test concentrations with justification for top dose:

211.25, 325 and 500 µg/ml

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

Migrated to IUCLID6: and methylmethanesulphonate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium in suspension;


DURATION
- Preincubation period: 44 h
- Exposure duration: 3 h
- Fixation time (start of exposure up to fixation or harvest of cells): 3 h (methanol and glacial acetic acid)
SPINDLE INHIBITOR (cytogenetic assays): Colchicine 1 ug/ml added after 2 h to arrest cells in metaphase
STAIN (for cytogenetic assays): Gurr`s Giemase R66


NUMBER OF REPLICATIONS: one male and one female donor, control and all 4 doses with and without S9


NUMBER OF CELLS EVALUATED: 200 (min. 160)

Evaluation criteria:

no data

Statistics:

no data

Results and discussion

Test results

Species / strain:

lymphocytes: human

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions, the test substance undecylenic acid was unable to induce chromosome aberrations in human lymphocytes.

Executive summary:

Undecylenic acid was tested in an in vitro cytogenetic assay according to OECD guideline 473 and EU method B10. The test substance, undecylenic acid, was applied to primary human lymphocyte cultures in the presence or absence of a metabolic activating system (rat liver S9). Treatment of cells with the test subtance in the presence or absence of S9 resulted in similar numbers of aberrations compared to negative controls, while cell cultures treated with positive control substances resulted in significant elevation of aberrations. Under the experimental conditions, the test substance undecylenic acid was unable to induce chromosome aberrations in human lymphocytes.