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EC number: 931-038-4 | CAS number: -
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 July - 10 September, 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP conform. Reliability has been set to 2 as study is used within a ReadAcross Approach. Read-across hypothesis: for details please see read-across report in IUCLID section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Undecanal
- EC Number:
- 203-972-6
- EC Name:
- Undecanal
- Cas Number:
- 112-44-7
- Molecular formula:
- C11H22O
- IUPAC Name:
- undecanal
Constituent 1
Method
- Target gene:
- HPRT (hypoxanthine-guanine phosphoribosyl transferase)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (minimal essential medium) containing Hank’s salts, neomycin (5 µg/mL) and amphotericin B (1 %).
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-naphthoflavone induced rat liver S9 from male Wistar rats
- Test concentrations with justification for top dose:
- 1st experiment: exposure 4 hours; 0.6-20 µg/mL without //7.2-230 µg/mL with S-9 mix
2nd experiment:
exposure 24 hours; 0.6-25 µg/mL without S-9 mix;
exposure 4 hours; 7.l8-500 µg/mL with S-9 mix - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: low solubility of test article
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: EMS (ethylmethane sulfonate; CAS no. 62-50-0), DMBA (7,12-dimethylbenz(a)anthracene; CAS no. 57-97-6)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hrs in the 1st experiment; 24 hrs without S-9 mix, 4 hrs with S-9 mix, in the 2nd experiment
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 7 or 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): 7 or 8 days
SELECTION AGENT (mutation assays): 6-thioguanine
SPINDLE INHIBITOR (cytogenetic assays): not required
STAIN (for cytogenetic assays): not required
NUMBER OF REPLICATIONS: 2
NUMBER OF EXPERIMENTS: 2
NUMBER OF CELLS EVALUATED: all surviving colonies counted
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response (i.e. at least 3 times the spontaneous mutation frequency) at one of the test points.
- Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 7.5-20 µg/mL/without S-9 mix); 250 mµ/mL with S-9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was seen at 115 µg/mL and above - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Read-across justification: for details please see read-across report in IUCLID section 13
Tab 1: The cell cultures were evaluated at the following concentrations:
exposure |
S9 |
concentrations in µg/mL |
||||||
|
|
Experiment I |
||||||
4 hours |
- |
0.6 |
1.3 |
2.5 |
5.0 |
7.5 |
10.0* |
15.0* |
4 hours |
+ |
|
|
28.8 |
57.5 |
115.0P |
172.5P |
230.0P |
|
|
Experiment II |
||||||
24 hours |
- |
|
|
2.5 |
5.0 |
10.0 |
15.0 |
20.0 |
24 hours |
+ |
|
|
31.3 |
62.5 |
125.0P |
187.5P |
500.0P |
P = precipitation
* mutagenicity evaluation was performed only in culture II
For further details see the Summary of results (attached document)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Undecanal was not mutagenic in a mammalian cell HPRT assay. - Executive summary:
Undecanal was tested for its genotoxic potential in mammalian cells in-vitro (Chinese hamster, V79 cells) at concentrations from 0.6 to 500 µg/mL in the presence and absence of metabolic activation. The assay was conducted according to the OECD TG 476 and under GLP conditions. Precipitation of undecanal was seen at 115 µg/mL and above. In the first experiment, cytotoxicity was seen at 7.5 and 20 µg/mL and higher in the absence of metabolic activation after a 4-hour exposure period. In the second experiment, cytotoxicity was seen at 25 µg/ml without S-9 mix (exposure period 24 hours), and at 500 µg/mL (with S-9 mix, exposure period 4 hours).
Undecanal did not increase the mutation frequency such that the evaluation criteria for rating the test substance as positive were met. Vehicle and positive controls performed as expected and were comparable with historical control data of this laboratory. Therefore, undecanal was considered to be non-mutagenic in this HPRT assay (Harlan, 2010).
This study is considered to be valid and suitable for assesement.
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