Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-972-6 | CAS number: 112-44-7
- 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 cytogenicity / micronucleus study
- 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:
- other: GLP guideline study.
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:
- other: OECD TG 487
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
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
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): n-undecanal
- Physical state: liquid, colourless
- Purity: 92.8 %
- Batch no: 50000018013
- Storage condition of test material: at room temperature < 21°C, under nitrogen gas
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: human
- Details on mammalian cell type (if applicable):
- - Cell type. lymphocytes
- Type and identity of media: RPMI 1640 medium, containing fetal calf serum, gentamycin and heparin
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix, contained 10% v/v S9 fraction from Aroclor induced male Sprague Dawley rat liver fraction, and cofactors
- Test concentrations with justification for top dose:
- 0, 1.25, 2.5, 5, 10, 20, 40, 80, 160, 300, and 600 µg/mL (precipitation at 600 µg/mL)
- Vehicle / solvent:
- - Vehicle used:DMSO
- Justification for choice of solvent/vehicle: low water solubility of the test substance
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin and cyclophosphamide
- 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:
- Exposure duration: 4 hrs (withand without out S-9 mix) and 24 hrs inteh absnece of S-9 mix
- Expression time (cells in growth medium): 24 hrs
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells): up to 48 hrs
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays): cytochalasin B
STAIN (for cytogenetic assays): acridine orange
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 2000 binucleated cells/dose level
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index, CBPI (cytokinesis block proliferation index)
OTHER EXAMINATIONS:
- Determination of polyploidy: no - Evaluation criteria:
- The vehicle/negative control results should lie within or close to the negative historical control range. The positive controls should produce a substantial increase in the incidence of MBC (at least twice) compared with the concurrent control; values should lay beyond the 99% upper limit of the historical negative/vehicle control range.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at 600 µg/mL
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: yes - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of Results
Treatment |
Conc. (mg/mL) |
Average CBPI |
Cytotoxicity (%)a |
Total No. of BC examined |
Total Number of MBC |
% MBC |
|||||||
4 hours treatment in the absence of S9 (0S9) |
|||||||||||||
Vehicle |
- |
1.9 |
0 |
2000 |
12 |
0.6 |
|||||||
n-Undecanal |
80.0 |
1.8 |
10 |
2000 |
14 |
0.7 |
|||||||
|
160 |
1.9 |
6 |
2000 |
10 |
0.5 |
|||||||
|
300 |
1.8 |
14 |
2000 |
8 |
0.4 |
|||||||
|
600 |
1.5 |
45 |
1698b |
8 |
0.5 |
|||||||
MMC |
0.3 |
1.6 |
30 |
2000 |
134 |
6.7* |
|||||||
4 hours treatment in the presence of S9 (+S9) |
|||||||||||||
Vehicle |
- |
1.9 |
0 |
2000 |
8 |
0.4 |
|||||||
n-Undecanal |
160 |
1.8 |
11 |
2000 |
16 |
0.8 |
|||||||
|
300 |
1.7 |
24 |
2000 |
9 |
0.5 |
|||||||
|
600 |
1.6 |
30 |
2000 |
12 |
0.6 |
|||||||
CP |
10 |
1.5 |
41 |
2000 |
91 |
4.6* |
|||||||
24 hours treatment in the absence of S9 (0S9) |
|||||||||||||
Vehicle |
- |
2.0 |
0 |
2000 |
3 |
0.2 |
|||||||
n-Undecanal |
40.0 |
1.9 |
10 |
2000 |
4 |
0.2 |
|||||||
|
80.0 |
1.7 |
25 |
2000 |
10 |
0.5 |
|||||||
|
160 |
1.5 |
44 |
2000 |
15 |
0.8 |
|||||||
|
300 |
1.2 |
84 |
NR |
|||||||||
MMC |
0.2 |
1.6 |
42 |
2000 |
334 |
16.7* |
CBPI Cytokinesis-Block Proliferation Index
BC, MBC Binucleated cells, micronucleated binucleated cells (%MBC calculated based on rounded values)
NR Not reported as considered excessively toxic (Cytotoxicity > 60% relative to vehicle control)
* Substantial positive response (at least twice the concurrent vehicle control in terms of %MBC)
a Cytotoxicity calculation based on unrounded values
b Not enough cells available
Applicant's summary and conclusion
- Conclusions:
- N-undecanal was not clastogenic in an in-vitro micronucleus test using human lymphoctyes, with and without metabolic activation.
- Executive summary:
N-undecanal (80, 160, 300, 600 µg/mL; dosed selection was based on preliminary studies. Precipitation at 600 µg/mL) was tested in an in-vitro micronucleus test using human lymphocytes, with and without metabolic activation, for its potential to induce micronuclei. The test was conducted under GLP conditions and according to the OECD guideline 487. Human blood cell cultures were treated for 48 hours with phytohemagglutinin to stimulate lymphocyte division. Cells were then treated with the test substance for 4 hours in the presence and absence of metabolic activation (and additionally for 24 hours in the absence of metabolic activation). At the end of a 24-hour expression period under cytochalasin B the cells were harvested, stained, and 2000 binucleated cells/dose level were then examined for the occurrence of micronuclei. The results were compared with those of the concurrent and historical vehicle (DMSO) and positive controls (mitomycin and cyclophosphamide).
N-undecanal was tested up into cytotoxic concentrations, but did not induce the formation of micronuclei, with or without metabolic activation. The negative and positive controls performed as expected. Thus, n-undecanal was not genotoxic (clastogenic) in this assay (Charles River, 2010).
This study is considered to be valid and useful for assessment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.