Registration Dossier
Registration Dossier
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EC number: 273-086-2 | CAS number: 68937-75-7
Genetic toxicity: in vitro
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- 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
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: cultured peripheral human
- Details on mammalian cell type (if applicable):
- - Type and identity of media: F10 complete culture medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not required. Cell cultures were started within 4 hours after blood collection.
- Periodically checked for karyotype stability: not required. Cell cultures were started within 4 hours after blood collection.
- Periodically "cleansed" against high spontaneous background: not required. Cell cultures were started within 4 hours after blood collection. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 9000g supernatanet (S9) from Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- Experiment I:
With and without metabolic activation: 100, 333, 420, 480, 520*, 750* µg/mL
Experiment II:
without metabolic activation: 10, 33, 100, 240, 300 µg/mL
with metabolic activation: 333, 420, 480, 520* µg/mL
* = precipitation - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: low solubility of pelargonic acid
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C and cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 hours
- Exposure duration:
First experiment: with S9: 3 hours. Without S9: 3, 24, and 48 hours.
Second experiment: with S9: 3 hours. Without S9: 24 and 48 hours.
- Expression time (cells in growth medium): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 51- 96 hours
SPINDLE INHIBITOR (cytogenetic assays): colchicine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 200/dose level/experiment
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- A result was considered positive if a statistically significant (p<0.05) increase of the number of cells with chromosome aberrations was seen.
- Statistics:
- Chi-squrae test
Results and discussion
Test results
- Species / strain:
- lymphocytes: cultured peripheral human
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: at 480 µg/mL the pH was lowered to 7.34, compared to pH=7.48 of the solvent control
- Effects of osmolality: no
- Precipitation: yes; at 520 and 750 µg/mL in the first and second experiment
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: yes
Applicant's summary and conclusion
- Conclusions:
- Pelargonic acid did not induce chromosomal aberrations and was not clastogenic in human lymphocytes with and without metabolic activation
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