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Diss Factsheets
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EC number: 203-965-8 | CAS number: 112-38-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-09-22 till 1987-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1893
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Remarks:
- (bone marrow)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- 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: solid
- Batch 1410
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chalres River, Cléon, France
- Age at study initiation: 7 weeks
- Weight at study initiation: 29g (males) 22g (females)
- Housing: wire mesh bottom stainless steel cages
- Diet / Water (e.g. ad libitum): ad lib.
- Acclimation period:2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 60+/-10
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 10% gum arabic, freshly prepared
- Details on exposure:
- no
- Duration of treatment / exposure:
- single
- Frequency of treatment:
- single treatment on day 1
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- Dose / conc.:
- 4 000 mg/kg bw/day
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide ip (15 males and 15 females)
Examinations
- Tissues and cell types examined:
- bone marrow smears
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
both femurs severed, bone marrow flushed out with calf`s serum, cells opbtained by mild centrifugation and spread over slides after mild homogenization; fixed with methanol and stained automatically
- Evaluation criteria:
- An increase in micronucleated polychromatic cells shows a possible genotoxic effect.
When the ratio PCE / NCE decreases, this represents marrow cytotoxicity. - Statistics:
- no
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- for all doses similar to that of control animals
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): similar for control and 24/48h-groups; 72 h not evaluated
- Appropriateness of dose levels and route: 3 cases of mortality (high dose, only males, 24/48h)
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions, undecylenic acid did not reveal any in vivo genotoxic activity in the micronucleus test in mice.
- Executive summary:
The in vivo genotoxic potential of undecylenic acid was assessed in the mouse by micronucleus test according to OECD guideline 474 and EU method B.12. Undecylenic acid was administered once by oral gavage at dose levels of 1,2 and 4 g/kg bw to CD-1 mice. Each group consisted of 15 male and 15 female animals. Cyclophosphamide served as positive control.
No clinical signs were reported throughout the study, but three maled of the highest dose group were found dead 24 or 72 h after treatment. The PCE/NCE ratio obtained in all treated animals (24 and 48h after treatment) was similar to that of the control animals, and evaluation of the samples obtained 72 h after treatment was not considered necessary.
Under the experimental conditions, undecylenic acid did not reveal any in vivo genotoxic activity in the micronucleaus test in mice.
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