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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
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:
other: GLP compliant study according to OECD guideline (473)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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
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

According to GHS criteria, no classification of undecylenic acid is required.
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.