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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Undecanal was neither mutagenic in bacterial (Salmonella typhimurium) nor mammalian cells (HGPRT assay) in vitro. Undecanal was not clastogenic in-vitro in human leucocytes. All assays were conducted with and without metabolic activation.
Link to relevant study records
- 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.
- 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
- 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 - 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.
- 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'.
- 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.
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- 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
- Target gene:
- HPRT (hypoxanthine-guanine phosphoribosyl transferase)
- 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; 0.6-15 µg/mL without //7.2-230 with S-9 mix
2nd experiment:
exposure 24 hours; 0.6-25 µg/mL without S-9 mix;
exposure 4 hours; 7.8-500 µg/mL with S-9 mix - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: low solubility of test article - 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), DMBA (7,12-dimethylbenz(a)anthracene)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
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.
- Key result
- 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:
- not examined
- 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'.
- Conclusions:
- 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.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 APR 2010 to 13 JUL 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 471)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to Chemikaliengesetz (Chemicals act) of the Federar Republio of Germany (ChemG) §19a and §19b and annexes 1 and 2 in the version of 02 July 2008 published in Bundesgesetzblatt No. 28/2008, pp. 1146 - 1184
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal fraction (S9) produced from the livers of male Sprague-Dawley rats treated i.p. with 500 mg Aroclor 1254/kg body weight
- Test concentrations with justification for top dose:
- 1st experiment: 4982, 1495, 498, 150, and 50 µg/plate (plate incorporation)
2nd experiment: 5036,2518, 1259, 630, and 315 µg/plate (pre-incubation method) - Vehicle / solvent:
- - Solvent: Ethanol
- Justification for choice of solvent/vehicle: high tolerance for the tester strains, complete dissolution of the test substance - Untreated negative controls:
- yes
- Remarks:
- (water)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (ethanol and DMSO)
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: see below "Details on test system"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
1st experiment: plate incorporation
2nd experiment: preincubation
DURATION
- Preincubation period: 20 min, 37 °C
- Exposure duration: 48 h, 37 °C
NUMBER OF REPLICATIONS: 4
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth ==> inhibition of growth of the background lawn
POSITIVE CONTROLS
sodium azide (1 µg/plate; TA 100 and TA 1535 without metabolic activation)
4-nitro-o-phenylenediamine (20 µg per plate; TA 97a, TA 98 and TA 102 without metabolic activation)
2-aminoanthracene (1 µg/plate; TA 97a, TA 100, TA 102 and TA 1535 with metabolic activation)
benzo(a)pyrene (20 µg/plate; TA 98 with metabolic activation) - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of in the number of revertant colonies per plate (increase factor (f(I)) >= 2) in at least one strain can be observed. A concentration-related increase can also be taken as a sign of mutagenic activity.
- Statistics:
- calculation of mean values with standard deviations
- Key result
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
In general, the determined values for the spontaneous reversion rates as well as the positive controls were within the normal range of the laboratory.
In isolated cases of outliers, the differences to the respective maximum or minimum of the history were marginal only. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
N-undecanal was not mutagenic under the conditions of this study. - Executive summary:
N-undecanal (purity: 92.8%) was examined in the Ames-test according to OECD TG 471 under GLP conditions using the Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535 both in the absence and presence of metabolic activation (S9 from male Aroclor 254 induced rat liver). The test substance concentrations in the first experiment were 4982, 1495, 498, 150, and 50 µg/plate (plate incorporation). To verify the results a second experiment was performed with the pre-incubation method using concentrations of 5036, 2518, 1259, 630, and 315 µg/plate.
Testing up to the limit dose required no cytotoxicity was observed with n-undecanal.
In both tests, the vehicle controls (DMSO, ethanol), the negative (water) and the positive controls performed as expected, while n-undecanal did not increase the number of revertants in any strain at any dose, with or without metabolic activation. Thus, n-undecanal was not mutagenic.
This study is classified as reliable without restrictions. It was performed in accordance with OECD test guideline 471 and GLP (LAUS, 2010).
Referenceopen allclose all
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
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 |
4 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)
Mean revertant values of first experiment (plate incorporation assay)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H20 |
Mean |
121 |
115 |
10 |
20 |
119 |
101 |
178 |
155 |
10 |
9 |
sd |
9.0 |
1,7 |
1.9 |
3.7 |
7.7 |
23.5 |
15.5 |
13.6 |
3.4 |
1.5 |
|
DMSO |
Mean |
125 |
128 |
7 |
12 |
118 |
118 |
154 |
164 |
11 |
10 |
sd |
10.5 |
12.7 |
1.7 |
5.9 |
11.4 |
22.9 |
35.7 |
14.3 |
4.3 |
4.8 |
|
Ethanol |
Mean |
142 |
130 |
8 |
14 |
107 |
115 |
204 |
130 |
9 |
10 |
sd |
223 |
9.0 |
2.4 |
3.9 |
15.0 |
10.1 |
60.3 |
9.7 |
3.0 |
1.5 |
|
Pos.Contr. |
Mean |
652 |
878 |
1000 |
849 |
717 |
567 |
687 |
599 |
533 |
573 |
sd |
• 138 |
122 |
231 |
79 |
53 |
112 |
95 |
125 |
64 |
22 |
|
f(l) |
5,22 |
6.86 |
142.9 |
7075 |
6,03 |
4.81 |
4.46 |
3.65 |
53.30 |
57.30 |
|
4982 µg/pl. |
Mean |
116 |
121 |
11 |
9 |
108 |
108 |
169 |
154 |
11 |
9 |
sd |
6 |
4 |
2 |
1 |
17 |
14 |
10 |
31 |
4 |
1 |
|
f(l) |
0.82 |
0.93 |
1.38 |
0.64 |
1.01 |
0.94 |
0.83 |
1.18 |
112 |
0.90 12 2 |
|
1495 µg/pl. |
Mean |
121 |
122 |
7 |
10 |
120 |
122 |
154 |
169 |
12 |
|
sd |
15 |
8 |
3 |
1 |
22 |
17 |
22 |
12 |
2 |
||
f(l) |
0.85 |
0.94 |
0.88 |
0.71 |
1.12 |
1.06 |
0.75 |
1.30 |
1.33 |
1.20 |
|
498 µg/pl. |
Mean |
112 |
109 |
'11 |
10 |
111 |
102 |
124 |
129 |
9 |
12 |
sd |
9 |
12 |
1 |
4 |
5 |
16 0.89 |
9 |
17 0.99 |
3 |
2 |
|
f(l) |
0.79 |
0.84 |
1.38 |
0.71 |
1.04 |
0.61 |
1.00 |
1.20 |
|||
150 µg/pl. |
Mean |
120 |
113 |
11 |
8 |
116 |
114 |
148 |
156 |
10 |
11 |
sd |
12 |
8 |
5 |
3 |
4 |
6 0.99 |
29 |
22 |
0 |
2 |
|
f(l) |
0.85 125 |
0.87 |
1,38 |
0.57 |
1.08 |
0.73 |
1.20 |
1.11 |
1.10 |
||
50 µg/pl. |
Mean |
113 |
9 |
13 |
116 |
117 |
152 |
147 |
12 |
13 |
|
sd |
15 |
6 |
3 |
2 |
11 |
4 |
25 |
39 |
5 |
4 |
|
f(l) |
0.88 |
0.87 |
1.13 |
0,93 |
1.08 |
1.02 |
0.75 |
1.13 |
1.33 |
1.30 |
f(I)= increase factor, see ecaluation criteria
Mean revertant values of second experiment (pre-incubation assay)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
109 |
121 |
9 |
7 |
135 |
93 |
204 |
212 |
10 |
16 |
sd |
6.3 |
11.0 |
1.4 |
0.5 |
3.9 |
19.1 |
27.0 |
42.6 |
1.9 |
1.3 |
|
DMS0 |
Mean |
110 |
120 |
10 |
10 |
126 |
88 |
137 |
145 |
12 |
14 |
sd |
4.5 |
1.7 |
0.6 |
0.0 |
6.8 |
14.8 |
12.1 |
21.9 |
2.9 |
1.8 |
|
Ethanol |
Mean |
118 |
108 |
9 |
7 |
84 |
127 |
128 |
225 |
15 |
14 |
sd |
7.3 |
6.3 |
1.4 |
1.5 |
13.6 |
4.9 |
9.7 |
31.4 |
5.6 |
1.3 |
|
Pos.Contr. |
Mean |
504 |
824 |
218 |
185 |
465 |
727 |
401 |
717 |
291 |
584 |
sd |
81 |
178 |
16 |
49 |
41 |
231 |
33 |
82 |
94 |
148 |
|
f(l) |
4.58 |
6.87 |
21.80 |
18.50 |
3.44 |
8.26 |
2.93 |
4.94 |
29.10 |
41.71 |
|
5036µg/pl. |
Mean |
116 |
97 |
10 |
10 |
114 |
112 |
215 |
212 |
12 |
11 |
sd |
5 |
4 0.90 |
1 |
0 |
2 |
3 |
14 |
15 |
2 |
1 |
|
0.98 |
1.11 |
1.43 |
1.36 |
0.88 |
1.68 |
0.94 |
0.80 |
0.79 |
|||
2518µg/pl.. |
Mean |
108 |
105 |
9 |
10 |
120 |
112 |
192 |
115 |
11 |
11 |
sd |
7 |
5 |
1 |
2 |
6 |
2 |
39 |
5 |
1 |
1 |
|
f(l) |
0.92 |
0.97 |
1.00 |
1.43 11 |
1.43 10 |
0.88 |
1.50 |
0.51 |
0.73 |
0.79 |
|
1259µg/pl. |
Mean |
114 |
113 |
11 |
11 |
138 |
137 |
13 |
16 |
||
sd |
11 |
13 |
2 |
3 |
1 |
3 |
14 |
17 |
2 |
1 |
|
f(l) |
0.97 |
1.05 |
1.22 |
1.57 |
0.12 |
0.09 |
1.08 |
0.61 |
0.87 |
1.14 |
|
630µg/pl. |
Mean |
110 |
108 |
8 |
8 |
117 |
127 |
135 |
151 |
10 |
13 |
sd |
11 |
7 |
2 |
2 |
10 |
5 |
19 |
17 |
1 |
3 |
|
f(l) |
0.93 |
1.00 |
0.89 |
1.14 |
1.39 |
1.00 |
1.05 |
0.67 |
0.67 |
0.93 |
|
315µg/pl. |
Mean |
117 |
109 |
10 |
10 |
130 |
104 |
130 |
145 |
13 |
12 |
sd |
15 |
4 |
1 |
0 |
16 |
3 |
27 |
14 |
2 |
1 |
|
f(l) |
0.99 |
1.01 |
1.11 |
1.43 |
1.55 |
0.82 |
1.02 |
0.64 |
0.87 |
0_86 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There are no studies available on in vivo genotoxicity of n-undecanal.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
In the absence of a species specific mode of action the results of the available assays are regarded as relevant for humans.
Additional information
Bacterial cell mutagenicity
N-undecanal (purity: 92.8%) was examined in the Ames-test according to OECD TG 471 under GLP conditions (RL1) using the Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535 both in the absence and presence of metabolic activation (S9 from male Aroclor 254 induced rat liver). The test substance concentrations in the first experiment were 4982, 1495, 498, 150, and 50 µg/plate (plate incorporation). To verify the results a second experiment was performed with the pre-incubation method using concentrations of 5036, 2518, 1259, 630, and 315 µg/plate.
Testing up to the limit dose required no cytotoxicity was observed with n-undecanal.
In both tests, the vehicle controls (DMSO, ethanol), the negative (water) and the positive controls performed as expected, while n-undecanal did not increase the number of revertants in any strain at any dose, with or without metabolic activation. Thus, n-undecanal was not mutagenic.
This study is classified as reliable without restrictions. It was performed in accordance with OECD test guideline 471 and GLP (LAUS, 2010).
In a study, which is lacking substantial data (not reliable, RL3), the test substance (Undecanal, purity at least 97%) was examined using the Ames-test (Spot test) with the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 (with and without metabolic activation) at a concentration of 3 µmol/plate (~ 500 µg/plate). No cytotoxic and mutagenic effects were observed at this concentration tested (Florin et al., 1980).
Mammalian cell mutagenicity
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).
Chromosome damage
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.
Justification for classification or non-classification
Based on the available information, no classification is required according to Regulation (EC) No 1272/2008.
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