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EC number: 203-931-2 | CAS number: 112-05-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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
- Details on test material:
- - Name of test material (as cited in study report): pelargonic acid
- Substance type: organic acid
- Physical state: clear, clorless liquid
- Analytical purity: 102% (by gas chhromatography)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Frederick, MD, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: males 21.5-37.6 g; females 21.4-31.0 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle/solvent used:corn oil
- Justification for choice of solvent/vehicle: low water solubility of the test substance
- Concentration of test material in vehicle: approx. 12.5, 25, and 50%
- Amount of vehicle: dose volume was 10 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Pelargonic acid was suspended in corn oil. - Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- single dose
- Post exposure period:
- sampling at 24, 48, and 72 hours post dosing
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1250, 2500, and 5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- - Positive control substance: cyclophosphamide
- Route of administration: oral gavage
- Doses / concentrations: 80 mg/kg bw
Examinations
- Tissues and cell types examined:
- Erythrocytes
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES: sampling at 24, 48, and 72 hours after single treatment
DETAILS OF SLIDE PREPARATION: At 24, 48, and 72 hours after administration of the test material or the vehicle, the appropriate groups of animals were sacrificed by CO2 asphyxiation. Sacrifice time for the vehicle and positive control groups was 24 hours. Bone marrow cells were flushed from both femurs of each animal with fetal calf serum and centrifuged. Supernatants were discarded; pellets were resuspended in residual supernatant, spread onto slides and air dried. The slides were fixed in methanol. stained with May-Grunwald and Giemsa solutions. cover slipped, coded and scored.
METHOD OF ANALYSIS: 1000 cells per animal were examined for the occurrence of micronuclei.
- Evaluation criteria:
- The test material was considered positive for micronuclei induction if a significant increase (p ≤ 0.05) in micronucleated polychromatic erythrocytes at any test dose compared to the vehicle control was seen.
- Statistics:
- The results were evaluated for statistical significance using an analysis of variance on the square root arcsine transformation, performed on the proportion of cells with micronuclei/animal. Tukey's Studentized range test with adjustment for multiple comparisons was used at each harvest time to determine which dose groups, if any, were significantly different (p ≤ 0.05) from the vehicle control. Analyses were performed separately for each harvest time and sex, and also at each harvest time for the sexes combined.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no
- Ratio of PCE/NCE (for Micronucleus assay): unchanged
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Pelargonic acid was negative in a mouse micronucleus test. - Executive summary:
Pelargonic acid (in corn oil) was examined in a mouse micronucleus test equivalent to OECD test guideline No. 475 for its genotoxicity in vivo. 15 male and female mice were used per dose level (0, 1250, 2500, 5000 mg/kg bw; single oral gavage). At 24, 48, and 72 hours after administration of the test material or the vehicle, bone marrow cells were harvested from both femurs, washed and stained. 1000 cells per animal were examined for chromosomal changes.
There was no statistically significant increase (p > 0.05) in micronucleated polychromatic erythrocytes at any test dose or any time after dosing compared to the vehicle control. The vehicle control and the positive control (cyclophosphamide, harvest at 24 hours) performed as expected.
The study is not yet available. The findings are available in a second source publication (reliability 4) and are used as a Weight of Evidence approach (EPA OPPT, 1995). In conclusion, pelargonic was negative in this adequately conducted in vivo micronucleus test.
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